how to write conflict of interest in research

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How to Write a Conflict of Interest Statement

Last Updated: March 22, 2024

This article was co-authored by Sarah Evans . Sarah Evans is a Public Relations & Social Media Expert based in Las Vegas, Nevada. With over 14 years of industry experience, Sarah is the Founder & CEO of Sevans PR. Her team offers strategic communications services to help clients across industries including tech, finance, medical, real estate, law, and startups. The agency is renowned for its development of the "reputation+" methodology, a data-driven and AI-powered approach designed to elevate brand credibility, trust, awareness, and authority in a competitive marketplace. Sarah’s thought leadership has led to regular appearances on The Doctors TV show, CBS Las Vegas Now, and as an Adobe influencer. She is a respected contributor at Entrepreneur magazine, Hackernoon, Grit Daily, and KLAS Las Vegas. Sarah has been featured in PR Daily and PR Newswire and is a member of the Forbes Agency Council. She received her B.A. in Communications and Public Relations from Millikin University. This article has been viewed 128,733 times.

Businesses and non-profits create conflict of interest policies to ensure board members, employees, and managers do not seek personal gain while working for the organization. For example, a board member with a side business might offer their services for hire to the organization. This creates a conflict—is the board member hiring themselves because it is in the organization’s best interest, or in their own best interest? Most contracts and company policies include a conflict of interest statement to prohibit any activity that may lead to a conflict. A basic conflict of interest policy should explain what qualifies as a conflict and the steps your organization will take to analyze the conflict. You should also create a conflict disclosure form for employees to fill out.

Beginning Your Conflict of Interest Policy

• For example, you can write something like the following: “Our organization strives to maintain the highest standards of integrity, and it is vital that the public be confident of our commitment. Accordingly, any appearance of a conflict must be avoided. To maintain our integrity and credibility, we have adopted the following policy.”
• If you’re a non-profit, you can write something like this: “The purpose of this policy is to protect the Organization’s tax-exempt status when contemplating a transaction or arrangement that could benefit an officer, director, or employee. This policy is intended to supplement but not replace any applicable state and federal laws governing conflict of interest that apply to non-profit organizations.”

• You might call this person an “interested person” throughout the policy.
• Alternately, you could define “interested person” in your definition section.

• “Interested person”: You might define this as follows: “Any principal officer, director, or member of a committee with powers delegated by a governing board, who has a direct or indirect financial interest, as defined below.”
• “Financial interest”: You probably will define this broadly. For example, “A person has a Financial Interest if they have, directly or indirectly, any potential or actual ownership, compensation arrangement, or investment in any entity with which the Organization has a transaction or arrangement.”
• “Immediate family member”: Often means spouse or partner, and children. You may define it more broadly.

Explaining How Conflicts Are Managed

• Sample language might read: “An Interested Person shall disclose the existence of a Financial Interest and disclose all material facts to the directors. In an effort to aid the disclosure, each member shall complete a conflict-of-interest form as circumstances warrant, and no less frequently than annually.”
• Revise this language to suit your purposes. You might want someone to report a potential conflict to someone else.

• You could write: “Each individual covered by this policy must file an annual disclosure, which the Executive Vice President will review. As soon as any covered individual learns of a potential conflict, they must promptly disclose the circumstances to the EVP within 30 days and recuse him or herself until the matter is reviewed.”

• For example, if a board member has a conflict, they can make a presentation to the other board members. After the presentation, they leave and the board votes on whether there is a conflict of interest.
• If an employee reports a conflict, someone in management (such as the President or Vice President) can review to see if the conflict is significant. If it is, they can refer the matter to the Board of Directors, which will decide if a conflict or appearance of a conflict exists. They can then ask the employee to withdraw from the activity.

• The board should determine whether they can with reasonable effort obtain a more advantageous arrangement or transaction. If they can’t, then the disinterested directors shall decide whether the transaction or arrangement is in the organization’s best interest, for its own benefit, and is fair and reasonable.
• You can also have the Chairperson of the Board appoint a disinterest person to investigate alternatives.

• You might write: “If the committee has reason to believe an individual failed to disclose potential or actual conflicts, then it will inform the member. The member has a chance to explain the failure to disclose to the committee. If the committee still has reason to believe a conflict exists, it will take corrective action.”

• Members of the governing board who receive direct or indirect compensation cannot vote on matters related to their compensation.
• Members of committees whose committee handles compensation matters cannot vote on matters relating to their compensation.
• Nothing prohibits a voting member who receives direct or indirect compensation from providing information about compensation to any committee.

Completing the Policy

• A requirement that the minutes contain the name of the person with a disclosed interest, the nature of the interest, and what action was taken to determine whether an actual conflict existed. Also note the board’s decision as to whether a conflict existed.
• A requirement that the minutes reflect the names of anyone present to discuss or vote on a transaction or arrangement, the content of the discussion, and the proposed alternatives. Also record the votes taken.

• whether your compensation arrangements are the result of arm’s-length bargaining, reasonable, and based on credible survey information
• whether joint ventures, partnerships, and arrangements with management organizations comport with your written policies and are properly recorded
• whether these joint ventures reflect reasonable investment or payments for goods and services and do not result in impermissible private benefit or excess benefit transaction

• For example, you can include the following: “To avoid confusion, members who address the public should clarify if they are speaking as private individuals or speaking for the organization. Sometimes the organization is asked to speak publicly on issues, or to provide representatives to state boards. Requests will come to the Administrative Office and be reviewed by the Executive Vice President. If appropriate, the EVP will forward the information to the President.”

• If you don’t yet have a lawyer, you can obtain a referral by contacting your local or state bar association.
• Call and schedule a consultation. Ask how much the lawyer charges.

Creating a Disclosure Form

• Ask other businesses or non-profits if they have a form you can look at. Use it as a guide when drafting your own.

• You can title your form “Conflict of Interest Disclosure Form.”

• For example, you can write: “A potential or actual conflict of interest arises when your obligations are likely to be compromised by other material interests or relationships, especially when those interests are not disclosed. You should disclose any business, personal, or volunteer affiliations that could give rise to real or apparent conflicts.”

• Do you serve as an officer of an organization that has a relationship or does business with us?
• Have you ever served as a director of a business in which our organization invests?
• Do you have a family relationship with anyone who has a noted relationship with our business? These family relationships include: spouse, parent, child, grandparent, grandchild, great-grandchild, and siblings. The spouse of any child, grandchild, great-grandchild, or sibling is also considered a family relationship.
• Have you ever participated in a compensation relationship, employment agreement, investment opportunity, or other arrangement, directly or indirectly, with a third-party vendor doing business with us that could personally benefit you?
• Have you ever received any direct or indirect loans, gifts, payments, discounts, fees, or free services from any organization or person engaged in any transaction with us?
• Do you share ownership of a business that does business with us? Ownership means voting power in a corporation, beneficial interest in a trust, or profits interest in a partnership.

• Remember that this is confidential information which you shouldn’t share with other people. Safeguard the form as you would other confidential employee information.

Expert Q&A

Expert interview.

Thanks for reading our article! If you’d like to learn more about business writing, check out our in-depth interview with Sarah Evans .

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About This Article

A conflict of interest statement outlines a policy to ensure no employees or board members make decisions for the company that would benefit their own personal interests. Search for a sample policy online so you don’t need to draft it from scratch. Make sure you define special terms like "interested person" at the end of the document. This will make it more clear which terms apply to which people. State that interested persons have the duty to disclose any conflicts of interest. Then, describe how conflicts will be resolved. For example, the interested person may be allowed to make a presentation, then the board can vote to decide if there’s a conflict. You should also describe the penalties for not disclosing their conflict of interest. For more tips, including how to create a disclosure form, read on! Did this summary help you? Yes No

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Conflicts of interest

What is a ‘conflict of interest’.

Any financial interests or connections, direct or indirect, or other situations that might raise the question of bias in the work reported or the conclusions, implications or opinions stated – including pertinent commercial or other sources of funding for the individual author(s) or for the associated department(s) or organization(s), personal relationships, or direct academic competition.

How can I be sure if I should declare something?

Please consider the following Conflict of Interest test: is there any arrangement that would compromise the perception of your impartiality or that of your co-authors if it was to emerge after publication and you had not declared it?

Who should make the declaration?

The corresponding author is expected to obtain the relevant information from all co-authors.

How should the declaration be made?

Most journals require a declaration of any Conflict of Interest to be included in the manuscript upon submission. This information will be available to the Editors. If your manuscript is published, this information will be communicated in a statement in the published paper.

Depending on the journal, you may also be asked to submit signed Conflict of Interest form(s) if your article is accepted for publication.

In both cases the corresponding author has to be in a position to report for all co-authors.

What happens if I do not know about any potential Conflict of Interest for my co-authors?

On submission any potential Conflict of Interest should be clearly stated for each author – the Editors reserve the right to require further information before the paper is reviewed. As corresponding author it is your responsibility to confirm with your co-authors whether they have any conflicts to declare. If you are unable to do this you will need to co-ordinate the completion of written forms from all co-authors, and submit these to the editorial office before the manuscript can be processed.

Are referees and editors covered by a similar code?

All referees are either asked to decline to review a manuscript if they have a potential conflict or declare any potential conflict.

All Editors have submitted a Conflict of Interest statement to the publisher or society. Editors would not handle the review of a manuscript if there was a potential Conflict of Interest, and instead would pass it on to another editorial colleague.

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How to Best Handle Conflicts of Interest in Research | Orvium

In the research world, conflict of interest (COI) is always a risk, and this usually occurs when a researcher has competing interests that may interfere with their research. These interests could be financial, personal, or institutional and could lead to bias, mistrust, and a lack of transparency in research findings.

In this article, we will define conflict of interest in research, give examples of COI, explore how it affects research, and discuss potential solutions to minimize its impact.

What is Conflict of Interest in Research?

Conflict of research interest refers to a situation where a researcher has external interests that may influence their research findings’ objectivity, integrity, and credibility. COI can arise when a researcher has financial, personal, or institutional relationships that could affect their research, such as:

• Financial conflicts of interest : when a researcher has economic interests in the outcome of their study, such as ownership of a company or stock in a pharmaceutical company that develops drugs.
• Personal conflicts of interest : when a researcher has personal relationships that could affect their research, such as close friendships or family ties with participants or co-authors.
• Institutional conflicts of interest : when a researcher’s institution has financial or other interests in the research outcome, such as a university that receives funding from a pharmaceutical company.

Examples of Conflict of Interest in Research

Conflict of interest can take many forms and is not always easy to detect. Here are some examples of COI in research:

• a researcher that is employed by a company that produces a product they are researching;
• a researcher who serves on the advisory board of a pharmaceutical company that produces a drug that they are researching;
• a researcher who receives funding from a government agency has a vested interest in the outcome of their research;
• a researcher with a financial interest in publishing their research, such as receiving royalties from a book or article;
• a researcher with a personal relationship with a participant in their study could compromise the objectivity of their research, such as a romantic partner or close friend.

How Conflict of Interest Affects Research

Conflict of interest can affect research in several ways:

• Bias : COI can lead to bias in research findings, as the researcher may consciously or unconsciously skew the results in favor of their interests or those who fund or employ them.
• Credibility : conflict of interest can also damage the credibility of the research and the researcher. When a conflict of interest is discovered, it can cast doubt on the study’s validity and the researcher’s motives.
• Ethics : COI can raise ethical concerns about the treatment of research participants. For example, a researcher with a financial interest in a particular outcome may be tempted to manipulate data or withhold information from participants to achieve that outcome.
• Public perception : last but not least, conflict of interest can also have a negative impact on public perception of research and science as a whole. When the public becomes aware of conflicts of interest, it can erode trust in the scientific community and lead to skepticism about the legitimacy of research findings.

Researchers need to be aware of these potential impacts and take steps to minimize the risks associated with conflict of interest. This can include being transparent about potential conflicts , involving independent reviewers or advisors, and establishing clear guidelines for ethical conduct in research.

Solutions to Conflict of Interest in Research

To minimize the impact of conflict of research interest, there are several potential solutions:

• Disclosure : researchers should disclose any potential conflicts of interest at the outset of their research. This can help mitigate the conflict’s impact by making others aware of the potential bias and allowing for independent review and oversight.
• Separation of roles : in cases where a researcher has a potential conflict of interest, it may be necessary to separate their roles. For example, a researcher employed by a company that produces a product they are researching may need to hand off specific responsibilities to another researcher who does not have a conflict of interest.
• Independent oversight : establishing independent oversight or research review can help identify and mitigate potential conflicts of interest. This can include separate ethics review boards, external peer reviewers, or independent statisticians to analyze the data.
• Funding transparency : funding sources should be publicly disclosed and available. This can help to identify potential conflicts of interest and allow for independent review of the research findings.
• Collaboration : collaboration between researchers and stakeholders with diverse perspectives can help to identify and address potential conflicts of interest. This can include involving patient groups, community organizations, or independent experts in the research process.

These are just a few examples of potential solutions to address conflict of research interest. Ultimately, it is up to individual researchers, institutions, and funding agencies to implement policies and procedures that effectively manage and mitigate the risks associated with conflict of interest.

Conflict of research interest is a complex issue that can affect research findings’ objectivity, integrity, and credibility. Researchers, institutions, and peer reviewers should work together to minimize the impact of COI on research by disclosing external interests, subjecting research to rigorous peer review, separating roles, and establishing oversight mechanisms. By doing so, we can ensure that research remains trustworthy and credible.

Thanks to blockchain technology, our platform can offer several potential benefits in addressing conflict of research interest:

• Transparency : our platform allows for transparent tracking of the entire research process, from the data collection phase to publication. This can help to identify potential conflicts of interest and increase the credibility and transparency of research findings.
• Immutable records : by using blockchain technology, Orvium can ensure that records of the research process are tamper-proof and cannot be altered or manipulated. This can help increase trust in scientific publishing and reduce the risk of conflicts of interest.
• Decentralization : our decentralized platform allows for a more democratic and inclusive approach to scientific publishing, reducing the influence of specific stakeholders or funding sources that may have a conflict of interest. This can help to ensure that financial or other interests do not unduly influence research findings.
• Incentives : lastly, we offer a reward system for peer reviewers and authors, which can incentivize ethical behavior and reduce the risk of conflicts of interest. By offering rewards for high-quality research and peer review, we promote transparency and objectivity in the scientific publishing process.

While our platform cannot eliminate conflicts of research interest entirely, its blockchain-based platform offers several potential solutions to address them and improve the transparency and credibility of the scientific publishing process.

If you want to learn more about our platform, make sure to visit our website and platform . And also, make sure to follow us on Twitter , Facebook , Linkedin , or Instagram to keep up with the latest news and product features.

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Cochrane Training

Chapter 7: considering bias and conflicts of interest among the included studies.

Isabelle Boutron, Matthew J Page, Julian PT Higgins, Douglas G Altman, Andreas Lundh, Asbjørn Hróbjartsson; on behalf of the Cochrane Bias Methods Group

Key Points:

• Review authors should seek to minimize bias. We draw a distinction between two places in which bias should be considered. The first is in the results of the individual studies included in a systematic review. The second is in the result of the meta-analysis (or other synthesis) of findings from the included studies.
• Problems with the design and execution of individual studies of healthcare interventions raise questions about the internal validity of their findings; empirical evidence provides support for this concern.
• An assessment of the internal validity of studies included in a Cochrane Review should emphasize the risk of bias in their results, that is, the risk that they will over-estimate or under-estimate the true intervention effect.
• Results of meta-analyses (or other syntheses) across studies may additionally be affected by bias due to the absence of results from studies that should have been included in the synthesis.
• Review authors should consider source of funding and conflicts of interest of authors of the study, which may inform the exploration of directness and heterogeneity of study results, assessment of risk of bias within studies, and assessment of risk of bias in syntheses owing to missing results.

Cite this chapter as: Boutron I, Page MJ, Higgins JPT, Altman DG, Lundh A, Hróbjartsson A. Chapter 7: Considering bias and conflicts of interest among the included studies. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.4 (updated August 2023). Cochrane, 2023. Available from www.training.cochrane.org/handbook .

7.1 Introduction

Cochrane Reviews seek to minimize bias. We define bias as a systematic error , or deviation from the truth, in results. Biases can lead to under-estimation or over-estimation of the true intervention effect and can vary in magnitude: some are small (and trivial compared with the observed effect) and some are substantial (so that an apparent finding may be due entirely to bias). A source of bias may even vary in direction across studies. For example, bias due to a particular design flaw such as lack of allocation sequence concealment may lead to under-estimation of an effect in one study but over-estimation in another (Jüni et al 2001).

Bias can arise because of the actions of primary study investigators or because of the actions of review authors, or may be unavoidable due to constraints on how research can be undertaken in practice. Actions of authors can, in turn, be influenced by conflicts of interest. In this chapter we introduce issues of bias in the context of a Cochrane Review, covering both biases in the results of included studies and biases in the results of a synthesis. We introduce the general principles of assessing the risk that bias may be present, as well as the presentation of such assessments and their incorporation into analyses. Finally, we address how source of funding and conflicts of interest of study authors may impact on study design, conduct and reporting. Conflicts of interest held by review authors are also of concern; these should be addressed using editorial procedures and are not covered by this chapter (see Chapter 1, Section 1.3 ).

We draw a distinction between two places in which bias should be considered. The first is in the results of the individual studies included in a systematic review . Since the conclusions drawn in a review depend on the results of the included studies, if these results are biased, then a meta-analysis of the studies will produce a misleading conclusion. Therefore, review authors should systematically take into account risk of bias in results of included studies when interpreting the results of their review.

The second place in which bias should be considered is the result of the meta-analysis (or other synthesis) of findings from the included studies . This result will be affected by biases in the included studies, and may additionally be affected by bias due to the absence of results from studies that should have been included in the synthesis. Specifically, the conclusions of the review may be compromised when decisions about how, when and where to report results of eligible studies are influenced by the nature and direction of the results. This is the problem of ‘non-reporting bias’ (also described as ‘publication bias’ and ‘selective reporting bias’). There is convincing evidence that results that are statistically non-significant and unfavourable to the experimental intervention are less likely to be published than statistically significant results, and hence are less easily identified by systematic reviews (see Section 7.2.3 ). This leads to results being missing systematically from syntheses, which can lead to syntheses over-estimating or under-estimating the effects of an intervention. For this reason, the assessment of risk of bias due to missing results is another essential component of a Cochrane Review.

Both the risk of bias in included studies and risk of bias due to missing results may be influenced by conflicts of interest of study investigators or funders . For example, investigators with a financial interest in showing that a particular drug works may exclude participants who did not respond favourably to the drug from the analysis, or fail to report unfavourable results of the drug in a manuscript.

Further discussion of assessing risk of bias in the results of an individual randomized trial is available in Chapter 8 , and of a non-randomized study in Chapter 25 . Further discussion of assessing risk of bias due to missing results is available in Chapter 13 .

7.1.1 Why consider risk of bias?

There is good empirical evidence that particular features of the design, conduct and analysis of randomized trials lead to bias on average, and that some results of randomized trials are suppressed from dissemination because of their nature. However, it is usually impossible to know to what extent biases have affected the results of a particular study or analysis (Savović et al 2012). For these reasons, it is more appropriate to consider whether a result is at risk of bias rather than claiming with certainty that it is biased. Most recent tools for assessing the internal validity of findings from quantitative studies in health now focus on risk of bias, whereas previous tools targeted the broader notion of ‘methodological quality’ (see also Section 7.1.2 ).

Bias should not be confused with imprecision . Bias refers to systematic error , meaning that multiple replications of the same study would reach the wrong answer on average. Imprecision refers to random error , meaning that multiple replications of the same study will produce different effect estimates because of sampling variation, but would give the right answer on average. Precision depends on the number of participants and (for dichotomous outcomes) the number of events in a study, and is reflected in the confidence interval around the intervention effect estimate from each study. The results of smaller studies are subject to greater sampling variation and hence are less precise. A small trial may be at low risk of bias yet its result may be estimated very imprecisely, with a wide confidence interval. Conversely, the results of a large trial may be precise (narrow confidence interval) but also at a high risk of bias.

Bias should also not be confused with the external validity of a study, that is, the extent to which the results of a study can be generalized to other populations and settings. For example, a study may enrol participants who are not representative of the population who most commonly experience a particular clinical condition. The results of this study may have limited generalizability to the wider population, but will not necessarily give a biased estimate of the effect in the highly specific population on which it is based. Factors influencing the applicability of an included study to the review question are covered in Chapter 14 and Chapter 15 .

7.1.2 From quality scales to domain-based tools

Critical assessment of included studies has long been an important component of a systematic review or meta-analysis, and methods have evolved greatly over time. Early appraisal tools were structured as quality ‘scales’, which combined information on several features into a single score. However, this approach was questioned after it was revealed that the type of quality scale used could significantly influence the interpretation of the meta-analysis results (Jüni et al 1999). That is, risk ratios of trials deemed ‘high quality’ by some scales suggested that the experimental intervention was superior, whereas when trials were deemed ‘high quality’ by other scales, the opposite was the case. The lack of a theoretical framework underlying the concept of ‘quality’ assessed by these scales resulted in tools mixing different concepts such as risk of bias, imprecision, relevance, applicability, ethics, and completeness of reporting. Furthermore, the summary score combining these components is difficult to interpret (Jüni et al 2001).

In 2008, Cochrane released the Cochrane risk-of-bias (RoB) tool, which was slightly revised in 2011 (Higgins et al 2011). The tool was built on the following key principles:

• The tool focused on a single concept: risk of bias. It did not consider other concepts such as the quality of reporting, precision (the extent to which results are free of random errors), or external validity (directness, applicability or generalizability).
• The tool was based on a domain-based (or component) approach, in which different types of bias are considered in turn. Users were asked to assess seven domains: random sequence generation, allocation sequence concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective outcome reporting, and other sources of bias. There was no scoring system in the tool.
• The domains were selected to characterize mechanisms through which bias may be introduced into a trial, based on a combination of theoretical considerations and empirical evidence.
• The assessment of risk of bias required judgement and should thus be completely transparent. Review authors provided a judgement for each domain, rated as ‘low’, ‘high’ or ‘unclear’ risk of bias, and provided reasons to support their judgement.

This tool has been implemented widely both in Cochrane Reviews and non-Cochrane reviews (Jørgensen et al 2016). However, user testing has raised some concerns related to the modest inter-rater reliability of some domains (Hartling et al 2013), the need to rethink the theoretical background of the ‘selective outcome reporting’ domain (Page and Higgins 2016), the misuse of the ‘other sources of bias’ domain (Jørgensen et al 2016), and the lack of appropriate consideration of the risk-of-bias assessment in the analyses and interpretation of results (Hopewell et al 2013).

To address these concerns, a new version of the Cochrane risk-of-bias tool, RoB 2, has been developed, and this should be used for all randomized trials in Cochrane Reviews ( MECIR Box 7.1.a ). The tool, described in Chapter 8 , includes important innovations in the assessment of risk of bias in randomized trials. The structure of the tool is similar to that of the ROBINS-I tool for non-randomized studies of interventions (described in Chapter 25 ). Both tools include a fixed set of bias domains, which are intended to cover all issues that might lead to a risk of bias. To help reach risk-of-bias judgements, a series of ‘signalling questions’ are included within each domain. Also, the assessment is typically specific to a particular result. This is because the risk of bias may differ depending on how an outcome is measured and how the data for the outcome are analysed. For example, if two analyses for a single outcome are presented, one adjusted for baseline prognostic factors and the other not, then the risk of bias in the two results may be different. 

MECIR Box 7.1.a Relevant expectations for conduct of intervention reviews

7.2 Empirical evidence of bias

Where possible, assessments of risk of bias in a systematic review should be informed by evidence. The following sections summarize some of the key evidence about bias that informs our guidance on risk-of-bias assessments in Cochrane Reviews.

7.2.1 Empirical evidence of bias in randomized trials: meta-epidemiologic studies

Many empirical studies have shown that methodological features of the design, conduct and reporting of studies are associated with biased intervention effect estimates. This evidence is mainly based on meta-epidemiologic studies using a large collection of meta-analyses to investigate the association between a reported methodological characteristic and intervention effect estimates in randomized trials. The first meta-epidemiologic study was published in 1995. It showed exaggerated intervention effect estimates when intervention allocation methods were inadequate or unclear and when trials were not described as double-blinded (Schulz et al 1995). These results were subsequently confirmed in several meta-epidemiologic studies, showing that lack of reporting of adequate random sequence generation, allocation sequence concealment, double blinding and more specifically blinding of outcome assessors tend to yield higher intervention effect estimates on average (Dechartres et al 2016a, Page et al 2016).

Evidence from meta-epidemiologic studies suggests that the influence of methodological characteristics such as lack of blinding and inadequate allocation sequence concealment varies by the type of outcome. For example, the extent of over-estimation is larger when the outcome is subjectively measured (e.g. pain) and therefore likely to be influenced by knowledge of the intervention received, and lower when the outcome is objectively measured (e.g. death) and therefore unlikely to be influenced by knowledge of the intervention received (Wood et al 2008, Savović et al 2012).

7.2.2 Trial characteristics explored in meta-epidemiologic studies that are not considered sources of bias

Researchers have also explored the influence of other trial characteristics that are not typically considered a threat to a direct causal inference for intervention effect estimates. Recent meta-epidemiologic studies have shown that effect estimates were lower in prospectively registered trials compared with trials not registered or registered retrospectively (Dechartres et al 2016b, Odutayo et al 2017). Others have shown an association between sample size and effect estimates, with larger effects observed in smaller trials (Dechartres et al 2013). Studies have also shown a consistent association between intervention effect and single or multiple centre status, with single-centre trials showing larger effect estimates, even after controlling for sample size (Dechartres et al 2011).

In some of these cases, plausible bias mechanisms can be hypothesized. For example, both the number of centres and sample size may be associated with intervention effect estimates because of non-reporting bias (e.g. single-centre studies and small studies may be more likely to be published when they have larger, statistically significant effects than when they have smaller, non-significant effects); or single-centre and small studies may be subject to less stringent controls and checks. However, alternative explanations are possible, such as differences in factors relating to external validity (e.g. participants in small, single-centre trials may be more homogenous than participants in other trials). Because of this, these factors are not directly captured by the risk-of-bias tools recommended by Cochrane. Review authors should record these characteristics systematically for each study included in the systematic review (e.g. in the ‘Characteristics of included studies’ table) where appropriate. For example, trial registration status should be recorded for all randomized trials identified.

7.2.3 Empirical evidence of non-reporting biases

A list of the key types of non-reporting biases is provided in Table 7.2.a . In the sections that follow, we provide some of the evidence that underlies this list.

Table 7.2.a Definitions of some types of non-reporting biases

7.2.3.1 Selective publication of study reports

There is convincing evidence that the publication of a study report is influenced by the nature and direction of its results (Chan et al 2014). Direct empirical evidence of such selective publication (or ‘publication bias’) is obtained from analysing a cohort of studies in which there is a full accounting of what is published and unpublished (Franco et al 2014). Schmucker and colleagues analysed the proportion of published studies in 39 cohorts (including 5112 studies identified from research ethics committees and 12,660 studies identified from trials registers) (Schmucker et al 2014). Only half of the studies were published, and studies with statistically significant results were more likely to be published than those with non-significant results (odds ratio (OR) 2.8; 95% confidence interval (CI) 2.2 to 3.5) (Schmucker et al 2014). Similar findings were observed by Scherer and colleagues, who conducted a systematic review of 425 studies that explored subsequent full publication of research initially presented at biomedical conferences (Scherer et al 2018). Only 37% of the 307,028 abstracts presented at conferences were published later in full (60% for randomized trials), and abstracts with statistically significant results in favour of the experimental intervention (versus results in favour of the comparator intervention) were more likely to be published in full (OR 1.17; 95% CI 1.07 to 1.28) (Scherer et al 2018). By examining a cohort of 164 trials submitted to the FDA for regulatory approval, Rising and colleagues found that trials with favourable results were more likely than those with unfavourable results to be published (OR 4.7; 95% CI 1.33 to 17.1) (Rising et al 2008).

In addition to being more likely than unpublished randomized trials to have statistically significant results, published trials also tend to report larger effect estimates in favour of the experimental intervention than trials disseminated elsewhere (e.g. in conference abstracts, theses, books or government reports) (ratio of odds ratios 0.90; 95% CI 0.82 to 0.98) (Dechartres et al 2018). This bias has been observed in studies in many scientific disciplines, including the medical, biological, physical and social sciences (Polanin et al 2016, Fanelli et al 2017).

7.2.3.2 Other types of selective dissemination of study reports

The length of time between completion of a study and publication of its results can be influenced by the nature and direction of the study results (‘time-lag bias’). Several studies suggest that randomized trials with results that favour the experimental intervention are published in journals about one year earlier on average than trials with unfavourable results (Hopewell et al 2007, Urrutia et al 2016).

Investigators working in a non-English speaking country may publish some of their work in local, non-English language journals, which may not be indexed in the major biomedical databases (‘language bias’). It has long been assumed that investigators are more likely to publish positive studies in English-language journals than in local, non-English language journals (Morrison et al 2012). Contrary to this belief, Dechartres and colleagues identified larger intervention effects in randomized trials published in a language other than English than in English (ratio of odds ratios 0.86; 95% CI 0.78 to 0.95), which the authors hypothesized may be related to the higher risk of bias observed in the non-English language trials (Dechartres et al 2018). Several studies have found that in most cases there were no major differences between summary estimates of meta-analyses restricted to English-language studies compared with meta-analyses including studies in languages other than English (Morrison et al 2012, Dechartres et al 2018).

The number of times a study report is cited appears to be influenced by the nature and direction of its results (‘citation bias’). In a meta-analysis of 21 methodological studies, Duyx and colleagues observed that articles with statistically significant results were cited 1.57 times the rate of articles with non-significant results (rate ratio 1.57; 95% CI 1.34 to 1.83) (Duyx et al 2017). They also found that articles with results in a positive direction (regardless of their statistical significance) were cited at 2.14 times the rate of articles with results in a negative direction (rate ratio 2.14; 95% CI 1.29 to 3.56) (Duyx et al 2017). In an analysis of 33,355 studies across all areas of science, Fanelli and colleagues found that the number of citations received by a study was positively correlated with the magnitude of effects reported (Fanelli et al 2017). If positive studies are more likely to be cited, they may be more likely to be located, and thus more likely to be included in a systematic review.

Investigators may report the results of their study across multiple publications; for example, Blümle and colleagues found that of 807 studies approved by a research ethics committee in Germany from 2000 to 2002, 135 (17%) had more than one corresponding publication (Blümle et al 2014). Evidence suggests that studies with statistically significant results or larger treatment effects are more likely to lead to multiple publications (‘multiple (duplicate) publication bias’) (Easterbrook et al 1991, Tramèr et al 1997), which makes it more likely that they will be located and included in a meta-analysis.

Research suggests that the accessibility or level of indexing of journals is associated with effect estimates in trials (‘location bias’). For example, a study of 61 meta-analyses found that trials published in journals indexed in Embase but not MEDLINE yielded smaller effect estimates than trials indexed in MEDLINE (ratio of odds ratios 0.71; 95% CI 0.56 to 0.90); however, the risk of bias due to not searching Embase may be minor, given the lower prevalence of Embase-unique trials (Sampson et al 2003). Also, Moher and colleagues estimate that 18,000 biomedical research studies are tucked away in ‘predatory’ journals, which actively solicit manuscripts and charge publications fees without providing robust editorial services (such as peer review and archiving or indexing of articles) (Moher et al 2017). The direction of bias associated with non-inclusion of studies published in predatory journals depends on whether they are publishing valid studies with null results or studies whose results are biased towards finding an effect.

7.2.3.3 Selective dissemination of study results

The need to compress a substantial amount of information into a few journal pages, along with a desire for the most noteworthy findings to be published, can lead to omission from publication of results for some outcomes because of the nature and direction of the findings. Particular results may not be reported at all ( ‘selective non-reporting of results’ ) or be reported incompletely ( ‘selective under-reporting of results’ , e.g. stating only that “P>0.05” rather than providing summary statistics or an effect estimate and measure of precision) (Kirkham et al 2010). In such instances, the data necessary to include the results in a meta-analysis are unavailable. Excluding such studies from the synthesis ignores the information that no significant difference was found, and biases the synthesis towards finding a difference (Schmid 2016).

Evidence of selective non-reporting and under-reporting of results in randomized trials has been obtained by comparing what was pre-specified in a trial protocol with what is available in the final trial report. In two landmark studies, Chan and colleagues found that results were not reported for at least one benefit outcome in 71% of randomized trials in one cohort (Chan et al 2004a) and 88% in another (Chan et al 2004b). Results were under-reported (e.g. stating only that “P>0.05”) for at least one benefit outcome in 92% of randomized trials in one cohort and 96% in another. Statistically significant results for benefit outcomes were twice as likely as non-significant results to be completely reported (range of odds ratios 2.4 to 2.7) (Chan et al 2004a, Chan et al 2004b). Reviews of studies investigating selective non-reporting and under-reporting of results suggest that it is more common for outcomes defined by trialists as secondary rather than primary (Jones et al 2015, Li et al 2018).

Selective non-reporting and under-reporting of results occurs for both benefit and harm outcomes. Examining the studies included in a sample of 283 Cochrane Reviews, Kirkham and colleagues suspected that 50% of 712 studies with results missing for the primary benefit outcome of the review were missing because of the nature of the results (Kirkham et al 2010). This estimate was slightly higher (63%) in 393 studies with results missing for the primary harm outcome of 322 systematic reviews (Saini et al 2014).

7.3 General procedures for risk-of-bias assessment

7.3.1 collecting information for assessment of risk of bias.

Information for assessing the risk of bias can be found in several sources, including published articles, trials registers, protocols, clinical study reports (i.e. documents prepared by pharmaceutical companies, which provide extensive detail on trial methods and results), and regulatory reviews (see also Chapter 5, Section 5.2 ).

Published articles are the most frequently used source of information for assessing risk of bias. This source is theoretically very valuable because it has been reviewed by editors and peer reviewers, who ideally will have prompted authors to report their methods transparently. However, the completeness of reporting of published articles is, in general, quite poor, and essential information for assessing risk of bias is frequently missing. For example, across 20,920 randomized trials included in 2001 Cochrane Reviews, the percentage of trials at unclear risk of bias was 49% for random sequence generation, 57% for allocation sequence concealment; 31% for blinding and 25% for incomplete outcome data (Dechartres et al 2017). Nevertheless, more recent trials were less likely to be judged at unclear risk of bias, suggesting that reporting is improving over time (Dechartres et al 2017).

Trials registers can be a useful source of information to obtain results of studies that have not yet been published (Riveros et al 2013). However, registers typically report only limited information about methods used in the trial to inform an assessment of risk of bias (Wieseler et al 2012). Protocols, which outline the objectives, design, methodology, statistical consideration and procedural aspects of a clinical study, may provide more detailed information on the methods used than that provided in the results report of a study. They are increasingly being published or made available by journals who publish the final report of a study. Protocols are also available in some trials registers, particularly ClinicalTrials.gov (Zarin et al 2016), on websites dedicated to data sharing such as ClinicalStudyDataRequest.com , or from drug regulatory authorities such as the European Medicines Agency. Clinical study reports are another highly useful source of information (Wieseler et al 2012, Jefferson et al 2014).

It may be necessary to contact study investigators to request access to the trial protocol, to clarify incompletely reported information or understand discrepant information available in different sources. To reduce the risk that study authors provide overly positive answers to questions about study design and conduct, we suggest review authors use open-ended questions. For example, to obtain information about the randomization process, review authors might consider asking: ‘What process did you use to assign each participant to an intervention?’ To obtain information about blinding of participants, it might be useful to request something like, ‘Please describe any measures used to ensure that trial participants were unaware of the intervention to which they were assigned’. More focused questions can then be asked to clarify remaining uncertainties.

7.3.2 Performing assessments of risk of bias   

Risk-of-bias assessments in Cochrane Reviews should be performed independently by at least two people ( MECIR Box 7.3.a ). Doing so can minimize errors in assessments and ensure that the judgement is not influenced by a single person’s preconceptions. Review authors should also define in advance the process for resolving disagreements. For example, both assessors may attempt to resolve disagreements via discussion, and if that fails, call on another author to adjudicate the final judgement. Review authors assessing risk of bias should have either content or methodological expertise (or both), and an adequate understanding of the relevant methodological issues addressed by the risk-of-bias tool. There is some evidence that intensive, standardized training may significantly improve the reliability of risk-of-bias assessments (da Costa et al 2017). To improve reliability of assessments, a review team could consider piloting the risk-of-bias tool on a sample of articles. This may help ensure that criteria are applied consistently and that consensus can be reached. Three to six papers should provide a suitable sample for this. We do not recommend the use of statistical measures of agreement (such as kappa statistics ) to describe the extent to which assessments by multiple authors were the same. It is more important that reasons for any disagreement are explored and resolved.

MECIR Box 7.3.a Relevant expectations for conduct of intervention reviews

The process for reaching risk-of-bias judgements should be transparent. In other words, readers should be able to discern why a particular result was rated at low risk of bias and why another was rated at high risk of bias. This can be achieved by review authors providing information in risk-of-bias tables to justify the judgement made. Such information may include direct quotes from study reports that articulate which methods were used, and an explanation for why such a method is flawed. Cochrane Review authors are expected to record the source of information (including the precise location within a document) that informed each risk-of-bias judgement ( MECIR Box 7.3.b ).

MECIR Box 7.3.b Relevant expectations for conduct of intervention reviews

Many results are often available in trial reports, so review authors should think carefully about which results to assess for risk of bias. Review authors should assess risk of bias in results for outcomes that are included in the ‘Summary of findings’ table ( MECIR Box 7.1.a ). Such tables typically include seven or fewer patient-important outcomes (for more details on constructing a ‘Summary of findings’ table, see Chapter 14 ).

Novel methods for assessing risk of bias are emerging, including machine learning systems designed to semi-automate risk-of-bias assessment (Marshall et al 2016, Millard et al 2016). These methods involve using a sample of previous risk-of-bias assessments to train machine learning models to predict risk of bias from PDFs of study reports, and extract supporting text for the judgements. Some of these approaches showed good performance for identifying relevant sentences to identify information pertinent to risk of bias from the full-text content of research articles describing clinical trials. A study showed that about one-third of articles could be assessed by just one reviewer if such a tool is used instead of the two required reviewers (Millard et al 2016). However, reliability in reaching judgements about risk of bias compared with human reviewers was slight to moderate depending on the domain assessed (Gates et al 2018).

7.4 Presentation of assessment of risk of bias

Risk-of-bias assessments may be presented in a Cochrane Review in various ways. A full risk-of-bias table includes responses to each signalling question within each domain (see Chapter 8, Section 8.2 ) and risk-of-bias judgements, along with text to support each judgement. Such full tables are lengthy and are unlikely to be of great interest to readers, so should generally not be included in the main body of the review. It is nevertheless good practice to make these full tables available for reference.

We recommend the use of forest plots that present risk-of-bias judgements alongside the results of each study included in a meta-analysis (see Figure 7.4.a ). This will give a visual impression of the relative contributions of the studies at different levels of risk of bias, especially when considered in combination with the weight given to each study. This may assist authors in reaching overall conclusions about the risk of bias of the synthesized result, as discussed in Section 7.6 . Optionally, forest plots or other tables or graphs can be ordered (stratified) by judgements on each risk-of-bias domain or by the overall risk-of-bias judgement for each result.

Review authors may wish to generate bar graphs illustrating the relative contributions of studies with each of risk-of-bias judgement (low risk of bias, some concerns, and high risk of bias). When dividing up a bar into three regions for this purpose, it is preferable to determine the regions according to statistical information (e.g. precision, or weight in a meta-analysis) arising from studies in each category, rather than according to the number of studies in each category.

Figure 7.4.a Forest plot displaying RoB 2 risk-of-bias judgements for each randomized trial included in a meta-analysis of mental health first aid (MHFA) knowledge scores. Adapted from Morgan et al (2018).

7.5 Summary assessments of risk of bias

Review authors should make explicit summary judgements about the risk of bias for important results both within studies and across studies (see MECIR Box 7.5.a ). The tools currently recommended by Cochrane for assessing risk of bias within included studies (RoB 2 and ROBINS-I) produce an overall judgement of risk of bias for the result being assessed. These overall judgements are derived from assessments of individual bias domains as described, for example, in Chapter 8, Section 8.2 .

To summarize risk of bias across study results in a synthesis, review authors should follow guidance for assessing certainty in the body of evidence (e.g. using GRADE), as described in Chapter 14, Section 14.2.2 . When a meta-analysis is dominated by study results at high risk of bias, the certainty of the body of evidence may be rated as being lower than if such studies were excluded from the meta-analysis. Section 7.6 discusses some possible courses of action that may be preferable to retaining such studies in the synthesis.

MECIR Box 7.5.a Relevant expectations for conduct of intervention reviews

7.6 Incorporating assessment of risk of bias into analyses

7.6.1 introduction.

When performing and presenting meta-analyses, review authors should address risk of bias in the results of included studies ( MECIR Box 7.6.a ). It is not appropriate to present analyses and interpretations while ignoring flaws identified during the assessment of risk of bias. In this section we present suitable strategies for addressing risk of bias in results from studies included in a meta-analysis, either in order to understand the impact of bias or to determine a suitable estimate of intervention effect (Section 7.6.2 ). For the latter, decisions often involve a trade-off between bias and precision. A meta-analysis that includes all eligible studies may produce a result with high precision (narrow confidence interval) but be seriously biased because of flaws in the conduct of some of the studies. However, including only the studies at low risk of bias in all domains assessed may produce a result that is unbiased but imprecise (if there are only a few studies at low risk of bias).

MECIR Box 7.6.a Relevant expectations for conduct of intervention reviews

7.6.2 Including risk-of-bias assessments in analyses

Broadly speaking, studies at high risk of bias should be given reduced weight in meta-analyses compared with studies at low risk of bias. However, methodological approaches for weighting studies according to their risk of bias are not sufficiently well developed that they can currently be recommended for use in Cochrane Reviews.

When risks of bias vary across studies in a meta-analysis, four broad strategies are available to incorporate assessments into the analysis. The choice of strategy will influence which result to present as the main finding for a particular outcome (e.g. in the Abstract). The intended strategy should be described in the protocol for the review.

(1) Primary analysis restricted to studies at low risk of bias

The first approach involves restricting the primary analysis to studies judged to be at low risk of bias overall. Review authors who restrict their primary analysis in this way are encouraged to perform sensitivity analyses to show how conclusions might be affected if studies at a high risk of bias were included.

(2) Present multiple (stratified) analyses

Stratifying according to the overall risk of bias will produce multiple estimates of the intervention effect: for example, one based on all studies, one based on studies at low risk of bias, and one based on studies at high risk of bias. Two or more such estimates might be considered with equal prominence (e.g. the first and second of these). However, presenting the results in this way may be confusing for readers. In particular, people who need to make a decision usually require a single estimate of effect. Furthermore, ‘Summary of findings’ tables typically present only a single result for each outcome. On the other hand, a stratified forest plot presents all the information transparently. Though we would generally recommend stratification is done on the basis of overall risk of bias, review authors may choose to conduct subgroup analyses based on specific bias domains (e.g. risk of bias arising from the randomization process).

Formal comparisons of intervention effects according to risk of bias can be done with a test for differences across subgroups (e.g. comparing studies at high risk of bias with studies at low risk of bias), or by using meta-regression (for more details see Chapter 10, Section 10.11.4 ). However, review authors should be cautious in planning and carrying out such analyses, because an individual review may not have enough studies in each category of risk of bias to identify meaningful differences. Lack of a statistically significant difference between studies at high and low risk of bias should not be interpreted as absence of bias, because these analyses typically have low power.

The choice between strategies (1) and (2) should be based to large extent on the balance between the potential for bias and the loss of precision when studies at high or unclear risk of bias are excluded.

(3) Present all studies and provide a narrative discussion of risk of bias

The simplest approach to incorporating risk-of-bias assessments in results is to present an estimated intervention effect based on all available studies, together with a description of the risk of bias in individual domains, or a description of the summary risk of bias, across studies. This is the only feasible option when all studies are at the same risk of bias. However, when studies have different risks of bias, we discourage such an approach for two reasons. First, detailed descriptions of risk of bias in the Results section, together with a cautious interpretation in the Discussion section, will often be lost in the Authors’ conclusions, Abstract and ‘Summary of findings’ table, so that the final interpretation ignores the risk of bias and decisions continue to be based, at least in part, on compromised evidence. Second, such an analysis fails to down-weight studies at high risk of bias and so will lead to an overall intervention effect that is too precise, as well as being potentially biased.

When the primary analysis is based on all studies, summary assessments of risk of bias should be incorporated into explicit measures of the certainty of evidence for each important outcome, for example, by using the GRADE system (Guyatt et al 2008). This incorporation can help to ensure that judgements about the risk of bias, as well as other factors affecting the quality of evidence, such as imprecision, heterogeneity and publication bias, are considered appropriately when interpreting the results of the review (see Chapter 14 and Chapter 15 ).

(4) Adjust effect estimates for bias

A final, more sophisticated, option is to adjust the result from each study in an attempt to remove the bias. Adjustments are usually undertaken within a Bayesian framework, with assumptions about the size of the bias and its uncertainty being expressed through prior distributions (see Chapter 10, Section 10.13 ). Prior distributions may be based on expert opinion or on meta-epidemiological findings (Turner et al 2009, Welton et al 2009). The approach is increasingly used in decision making, where adjustments can additionally be made for applicability of the evidence to the decision at hand. However, we do not encourage use of bias adjustments in the context of a Cochrane Review because the assumptions required are strong, limited methodological expertise is available, and it is not possible to account for issues of applicability due to the diverse intended audiences for Cochrane Reviews. The approach might be entertained as a sensitivity analysis in some situations.

7.7 Considering risk of bias due to missing results

The 2011 Cochrane risk-of-bias tool for randomized trials encouraged a study-level judgement about whether there has been selective reporting, in general, of the trial results. As noted in Section 7.2.3.3 , selective reporting can arise in several ways: (1) selective non-reporting of results, where results for some of the analysed outcomes are selectively omitted from a published report; (2) selective under-reporting of data, where results for some outcomes are selectively reported with inadequate detail for the data to be included in a meta-analysis; and (3) bias in selection of the reported result, where a result has been selected for reporting by the study authors, on the basis of the results, from multiple measurements or analyses that have been generated for the outcome domain (Page and Higgins 2016).

The RoB 2 and ROBINS-I tools focus solely on risk of bias as it pertains to a specific trial result. With respect to selective reporting, RoB 2 and ROBINS-I examine whether a specific result from the trial is likely to have been selected from multiple possible results on the basis of the findings (scenario 3 above). Guidance on assessing the risk of bias in selection of the reported result is available in Chapter 8 (for randomized trials) and Chapter 25 (for non-randomized studies of interventions).

If there is no result (i.e. it has been omitted selectively from the report or under-reported), then a risk-of-bias assessment at the level of the study result is not applicable. Selective non-reporting of results and selective under-reporting of data are therefore not covered by the RoB 2 and ROBINS-I tools. Instead, selective non-reporting of results and under-reporting of data should be assessed at the level of the synthesis across studies. Both practices lead to a situation similar to that when an entire study report is unavailable because of the nature of the results (also known as publication bias). Regardless of whether an entire study report or only a particular result of a study is unavailable, the same consequence can arise: bias in a synthesis because available results differ systematically from missing results (Page et al 2018). Chapter 13 provides detailed guidance on assessing risk of bias due to missing results in a systematic review.

7.8 Considering source of funding and conflict of interest of authors of included studies

Readers of a trial report often need to reflect on whether conflicts of interest have influenced the design, conduct, analysis and reporting of a trial. It is therefore now common for scientific journals to require authors of trial reports to provide a declaration of conflicts of interest (sometimes called ‘competing’ or ‘declarations of’ interest), to report funding sources and to describe any funder’s role in the trial.

In this section, we characterize conflicts of interest in randomized trials and discuss how conflicts of interest may impact on trial design and effect estimates. We also suggest how review authors can collect, process and use information on conflicts of interest in the assessment of:

• directness of studies to the review’s research question;
• heterogeneity in results due to differences in the designs of eligible studies;
• risk of bias in results of included studies;
• risk of bias in a synthesis due to missing results.

At the time of writing, a formal Tool for Addressing Conflicts of Interest in Trials (TACIT) is being developed under the auspices of the Cochrane Bias Methods Group. The TACIT development process has informed the content of this section, and we encourage readers to check http://tacit.one for more detailed guidance that will become available.

7.8.1 Characteristics of conflicts of interest

The Institute of Medicine defined conflicts of interest as “ a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest” (Lo et al 2009). In a clinical trial, the primary interest is to provide patients, clinicians and health policy makers with an unbiased and clinically relevant estimate of an intervention effect. Secondary interest may be both financial and non-financial.

Financial conflicts of interest involve both financial interests related to a specific trial (for example, a company funding a trial of a drug produced by the same company) and financial interests related to the authors of a trial report (for example, authors’ ownership of stocks or employment by a drug company).

For drug and device companies and other manufacturers, the financial difference between a negative and positive pivotal trial can be considerable. For example, the mean stock price of the companies funding 23 positive pivotal oncology trials increased by 14% after disclosure of the results (Rothenstein et al 2011). Industry funding is common, especially in drug trials. In a study of 200 trial publications from 2015, 68 (38%) of 178 trials with funding declarations were industry funded (Hakoum et al 2017). Also, in a cohort of oncology drug trials, industry funded 44% of trials and authors declared conflicts of interest in 69% of trials (Riechelmann et al 2007).

The degree of funding, and the type of the involvement of industry funders, may differ across trials. In some situations, involvement includes only the provision of free study medication for a trial that has otherwise been planned and conducted independently, and funded largely, by public means. In other situations, a company fully funds and controls a trial. In rarer cases, head-to-head trials comparing two drugs may be funded by the two different companies producing the drugs.

A Cochrane Methodology Review analysed 75 studies of the association between industry funding and trial results (Lundh et al 2017). The authors concluded that trials funded by a drug or device company were more likely to have positive conclusions and statistically significant results, and that this association could not be explained by differences in risk of bias between industry and non-industry funded trials. However, industry and non-industry trials may differ in ways that may confound the association; for example due to choice of patient population, comparator interventions or outcomes. Only one of the included studies used a meta-epidemiological design and found no clear association between industry funding and the magnitude of intervention effects (Als-Nielsen et al 2003). Similar to the association with industry funding, other studies have reported that results of trials conducted by authors with a financial conflict of interest were more likely to be positive (Ahn et al 2017).

Conflicts of interest may also be non-financial (Viswanathan et al 2014). Characterizations of non-financial conflicts of interest differ somewhat, but typically distinguish between conflicts related mainly to an individual (e.g. adherence to a theory or ideology), relationships to other individuals (e.g. loyalty to friends, family members or close colleagues), or relationship to groups (e.g. work place or professional groups). In medicine, non-financial conflicts of interest have received less attention than financial conflicts of interest. In addition, financial and non-financial conflicts are often intertwined; for example, non-financial conflicts related to institutional association can be considered as indirect financial conflicts linked to employment. Definitions of what should be characterized as a ‘non-financial’ conflict of interest, and, in particular, whether personal beliefs, experiences or intellectual commitments should be considered conflicts of interest, have been debated (Bero and Grundy 2016).

It is useful to differentiate between non-financial conflicts of interest of a trial researcher and the basic interests and hopes involved in doing good trial research. Most researchers conducting a trial will have an interest in the scientific problem addressed, a well-articulated theoretical position, anticipation for a specific trial result, and hopes for publication in a respectable journal. This is not a conflict of interest but a basic condition for doing health research. However, individual researchers may lose sight of the primacy of the methodological neutrality at the heart of a scientific enquiry, and become unduly occupied with the secondary interest of how trial results may affect academic appearance or chances of future funding. Extreme examples are the publication of fabricated trial data or trials, some of which have had an impact on systematic reviews (Marret et al 2009).

Few empirical studies of non-financial conflicts of interest in randomized trials have been published, and to our knowledge there are none that assess the impact of non-financial conflicts of interest on trial results and conclusions. However, non-financial conflicts of interests have been investigated in other types of clinical research; for example, guideline authors’ specialty appears to have influenced their voting behaviour while developing guidelines for mammography screening (Norris et al 2012).

7.8.2 Conflict of interest and trial design

Core decisions on designing a trial involve defining the type of participants to be included, the type of experimental intervention, the type of comparator, the outcomes (and timing of outcome assessments) and the choice of analysis. Such decisions will often reflect a compromise between what is clinically and scientifically ideal and what is practically possible. However, when investigators have important conflicts of interest, a trial may be designed in a way that increases its chances of detecting a positive trial result, at the expense of clinical applicability. For example, narrow eligibility criteria may exclude older and frail patients, thus reducing the possibility of detecting clinically relevant harms. Alternatively, trial designers may choose placebo as a comparator despite an effective intervention being in regular use, or they may focus on short-term surrogate outcomes rather than clinically relevant long-term outcomes (Estellat and Ravaud 2012, Wieland et al 2017).

Trial design choices may be more subtle. For example, a trial may be designed to favour an experimental drug by using an inferior comparator drug when better alternatives exist (Safer 2002) or by using a low dose of the comparator drug when the focus is efficacy and a high dose of the comparator drug when the focus is harms (Mann and Djulbegovic 2013). In a typical Cochrane Review with fairly broad eligibility criteria aiming to identify and summarize all relevant trials, it is pertinent to consider the degree to which a given trial result directly relates to the question posed by the review. If all or most identified trials have narrow eligibility criteria and short-term outcomes, a review question focusing on broad patient categories and long-term effects can only be answered indirectly by the included studies. This has implications for the assessment of the certainty of the evidence provided by the review, which is addressed through the concept of indirectness in the GRADE framework (see Chapter 14, Section 14.2 ).

If results in a meta-analysis display heterogeneity, then differences in design choices that are driven by conflicts of interest may be one reason for this. Thus, conflicts of interest may also affect reflections on the certainty of the evidence through the GRADE concept of inconsistency.

7.8.3 Conflicts of interest and risk of bias in a trial’s effect estimate

Authors of Cochrane Reviews have sometimes included conflicts of interest as an ‘other source of bias’ while using the previous versions of the risk-of-bias tool (Jørgensen et al 2016). Consistent with previous versions of the Handbook , we discourage the inclusion of conflicts of interest directly in the risk-of-bias assessment. Adding conflicts of interest to the bias tool is inconsistent with the conceptual structure of the tool, which is built on mechanistically defined bias domains. Also, restricting consideration of the potential impact of conflicts of interest to a question of risk of bias in an individual trial result overlooks other important aspects, such as the design of the trial (see Section 7.8.2 ) and potential bias in a meta-analysis due to missing results (see Section 7.8.4 ).

Conflicts of interest may lead to bias in effect estimates from a trial through several mechanisms. For example, if those recruiting participants into a trial have important conflicts of interest and the allocation sequence is not concealed, then they may be more likely to subvert the allocation process to produce intervention groups that are systematically unbalanced in favour of their preferred intervention. Similarly, investigators with important conflicts of interests may decide to exclude from the analysis some patients who did not respond as anticipated to the experimental intervention, resulting in bias due to missing outcome data. Furthermore, selective reporting of a favourable result may be strongly associated with conflicts of interest (McGauran et al 2010), due to either selective reporting of particular outcome measurements or selective reporting of particular analyses (Eyding et al 2010, Vedula et al 2013). One study found that use of modified-intention-to-treat analysis and post-randomization exclusions occurred more often in trials with industry funding or author conflicts of interest (Montedori et al 2011). Accessing the trial protocol and statistical analysis plan to determine which outcomes and analyses were pre-specified is therefore especially important for a trial with relevant conflicts of interest.

Review authors should explain how consideration of conflicts of interest informed their risk-of-bias judgements. For example, when information on the analysis plans is lacking, review authors may judge the risk of bias in selection of the reported result to be high if the study investigators had important financial conflicts of interest. Conversely, if trial investigators have clearly used methods that are likely to minimize bias, review authors should not judge the risk of bias for each domain higher just because the investigators happen to have conflicts of interest. In addition, as an optional component in the revised risk-of-bias tool, review authors may reflect on the direction of bias (e.g. bias in favour of the experimental intervention). Information on conflicts of interest may inform the assessment of direction of bias.

7.8.4 Conflicts of interest and risk of bias in a synthesis of trial results

Conflicts of interest may also affect the decision not to report trial results. Conflicts of interest are probably one of several important reasons for decisions not to publish trials with negative findings, and not to publish unfavourable results (Sterne 2013). When relevant trial results are systematically missing from a meta-analysis because of the nature of the findings, the synthesis is at risk of bias due to missing results. Chapter 13 provides detailed guidance on assessing risk of bias due to missing results in a systematic review.

7.8.5 Practical approach to identifying and extracting information on conflicts of interest

When assessing conflicts of interest in a trial, review authors will, to a large degree, rely on declared conflicts. Source of funding may be reported in a trial publication, and conflicts of interest may be reported in an accompanying declaration, for example the International Committee of Medical Journal Editors ( ICMJE ) declaration. In a random sample of 1002 articles published in 2016, authors of 229 (23%) declared having a conflict of interest (Grundy et al 2018). Unfortunately, undeclared conflicts of interest and sources of funding are fairly common (Rasmussen et al 2015, Patel et al 2018).

It is always prudent to examine closely the conflicts of interest of lead and corresponding authors, based on information reported in the trial publication and the author declaration (for example, the ICMJE declaration form). Review authors should also consider examining conflicts of interest of trial co-authors and any commercial collaborators with conflicts of interest; for example, a commercial contract research organization hired by the funder to collect and analyse trial data or the involvement of a medical writing agency. Due to the high prevalence of undisclosed conflicts of interest, review authors should consider expanding their search for conflicts of interest data from other sources (e.g. disclosure in other publications by the authors, the trial protocol, the clinical study report, and public conflicts of interest registries (e.g. Open Payments database)).

We suggest that review authors balance the workload involved with the expected gain, and search additional sources of information on conflicts of interest when there is reason to suspect important conflicts of interest . As a rule of thumb, in trials with unclear funding source and no declaration of conflicts of interest from lead or corresponding authors, we suggest review authors search the Open Payments database, ClinicalTrials.gov , and conflicts of interest declarations in a few previous publications by the study authors. In trials with no commercial funding (including no company employee co-authors) and no declared conflicts of interest for lead or corresponding authors, we suggest review authors not bother to consult additional sources. Also, for trials where lead or corresponding authors have clear conflicts of interest, little additional information may be gained from checking conflicts of interest of co-authors.

Gaining access to relevant information on financial conflicts of interest is possible for a considerable number of trials, despite inherent problems of undeclared conflicts. We expect that the proportion of trials with relevant declarations will increase further.

Access to relevant information on non-financial conflicts of interest is more difficult to gain. Declaration of non-financial conflicts of interest is requested by approximately 50% of journals (Shawwa et al 2016). The term was deleted from ICMJE’s declaration in 2010 in exchange for a broad category of “Other relationships or activities” (Drazen et al 2010). Therefore, non-financial conflicts of interests are seldom self-declared, although if available, such information should be considered.

Non-financial conflicts of interest are difficult to address due to lack of relevant empirical studies on their impact on study results, lack of relevant thresholds for importance, and lack of declaration in many previous trials. However, as a rule of thumb, we suggest that review authors assume trial authors have no non-financial conflicts of interest unless there are clear suggestions of the opposite. Examples of such clues could be a considerable spin in trial publications (Boutron et al 2010), an institutional relationship pertinent to the intervention tested, or external evidence of a fixated ideological or theoretical position.

7.8.6 Judgement of notable concern about conflict of interest

Review authors should describe funding information and conflicts of interest of authors for all studies in the ‘Characteristics of included studies’ table ( MECIR Box 7.8.a ). Also, review authors may want to explore (e.g. in a subgroup analysis) whether trials with conflicts of interest have different intervention effect estimates, or more variable effect estimates, than trials without conflicts of interest. In both cases, review authors need to aim for a relevant threshold for when any conflict of interest is deemed important. If put too low, there is a risk that trivial conflicts of interest will cloud important ones; if set too high, there is the risk that important conflicts of interest are downplayed or ignored.

This judgement should take into account both the degree of conflicts of interest of study authors and also the extent of their involvement in the study. We pragmatically suggest review authors aim for a judgement about whether or not there is reason for ‘notable concern’ about conflicts of interest. This information could be displayed in a table with three columns:

• trial identifier;
• judgement (e.g. ‘notable concern about conflict of interest’ versus ‘no notable concern about conflict of interest’); and
• rationale for judgement, potentially subdivided according to who had conflicts of interest (e.g. lead or corresponding authors, other authors) and stage(s) of the trial to which they contributed (design, conduct, analysis, reporting).

A judgement of ‘notable concern about conflict of interest’ should be based on reflected assessment of identified conflicts of interest. A hypothetical possibility for undeclared conflicts of interest is, as a rule of thumb, not considered sufficient reason for ‘notable concern’. By ‘notable concern’ we imply important conflicts of interest expected to have a potential impact on study design, risk of bias in study results or risk of bias in a synthesis due to missing results. For example, financial conflicts of interest are important in a trial initiated, designed, analysed and reported by drug or device company employees. Conversely, financial conflicts of interest are less important in a trial initiated, designed, analysed and reported by academics adhering to the arm’s length principle when acquiring free trial medication from a drug company, and where lead authors have no conflicts of interest. Similarly, non-financial conflicts of interest may be important in a trial of a highly controversial and ideologically loaded question such as the adverse effect of male circumcision. Non-financial conflicts of interest are less concerning in a trial comparing two treatments in general use with no connotation to highly controversial scientific theories, ideology or professional groups. Mixing trivial conflicts of interest with important ones may mask the latter and will expand review author workload considerably.

MECIR Box 7.8.a Relevant expectations for conduct of intervention reviews

7.9 Chapter information

Authors: Isabelle Boutron, Matthew J Page, Julian PT Higgins, Douglas G Altman, Andreas Lundh, Asbjørn Hróbjartsson

Acknowledgements: We thank Gerd Antes, Peter Gøtzsche, Peter Jüni, Steff Lewis, David Moher, Andrew Oxman, Ken Schulz, Jonathan Sterne and Simon Thompson for their contributions to previous versions of this chapter.

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Conflicts of Interest

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• Data Management
• Human Subjects
• Peer Review
• Publication
• Research Misconduct
• Social Responsibility
• Stem Cell Research
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• Regulations and Guidelines

What is a conflict of interest?

What should you do, financial vs. non-financial conflicts, conflicts of conscience.

Another potential conflict can come in the form of conscience. An individual might suffer a conflict of conscience if, for example, the mission or expectations of the institution are incompatible with his or her personal values.

Risks of Conflicts of Interest

Stelfox et al. (1998) reviewed the literature in 1995 and 1996 for reports on the safety of calcium channel antagonists. They classified reports as being supportive, neutral, or critical of these drugs. For reports supportive of calcium channel antagonists, virtually all authors had financial relationships with drug companies. However, only 43% of the authors of reports critical of the drugs had such connections with drug companies. Many different hypotheses might explain this trend, but it seems clear that it would be valuable to know if a published study was supported by industry.

Intentional Bias: Is it Research Misconduct?

Conflicts of interest do not necessarily amount to research misconduct. However, if the potential for personal gain is great, then principles that guide responsible conduct in research may be compromised. In an extreme case, it is conceivable that someone could knowingly compromise principles of good scientific practice in pursuit of a particular research finding our outcome.

Unintentional bias

Disclosure of conflicts.

In a survey of 789 scientific papers published by Massachusetts scientists in the leading journals of cell and molecular biology, 34% of the articles had at least one author with a significant financial interest. Despite this high rate of financial interests, only about 0.5% of over 61,000 comparable papers included disclosure statements.

Perceptions may outweigh even the best of practices

When large sums of money are involved, it may be difficult for the public, legislators, the judicial system, and even colleagues to be convinced that results were not biased for personal gain. Perceived impropriety can result in consequences as damaging as if intentional misconduct had been committed. With increased media, governmental, and public scrutiny , a researcher's reputation, research funding, and employment can depend as much on perceptions of integrity as on integrity itself.

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Conflicts of Interest (COI) in Research

• What is a conflict of interest?
• Types of COIs in research
• How does COI affect research studies?
• Questions to ask about COI before participating in a research study

Conflict of Interest in Research: What Is It and How It Can Impact

Learn how a conflict of interest might be employed in research, how they can impact, what the types are and how to dodge them.

When submitting a research paper to a journal, magazine, or other platform, you may be required to disclose any potential conflicts of interest. Conflicts of interest are widespread in academic and scientific publications. Conflicts of interest have the potential to skew several aspects of research, including how a study is designed, how data is collected, processed, and published, and who is involved in the work.

Their sheer presence is not unethical; but, failing to recognize or declare them is, and this can tarnish a researcher’s reputation. It is the obligation of everyone engaged in research and publishing, particularly researchers, to identify and declare any conflicts for the publication to go smoothly.

Understanding the conflict of interest in research

A conflict of interest in research occurs when financial or other personal factors affect or appear to impair a researcher’s professional judgment in doing or reporting research. The circumstances, not the actions or character of an individual investigator, define a conflict of interest.

The key ethical dilemma is what to do with such circumstances, if not handled appropriately, it may cast doubt on the impartiality of your research or your unbiased participation in a specific decision-making process. 

A conflict of interest emerges when a researcher does evaluative research for a firm in which the researcher has a financial interest, or when the researcher accepts funding from a company with an interest in your research. The most serious kind of conflict of interest occurs when researchers start negotiating with a company in which they or their relatives have a monetary interest.

How can conflict of interest affect research?

Conflicts of interest can taint people’s perceptions of researchers and the scientific industry. When large amounts of money are at stake, it can be difficult to convince the public, lawmakers, the legal system, and even colleagues that the conclusions were not influenced for personal gain.

Unintentional wrongdoing can have the same harmful consequences as intended wrongdoing. With increased media, governmental, and public scrutiny, a researcher’s reputation, research funding, and career might be as dependent on perceptions of honesty as they are on genuine integrity. 

Types of conflict of interest in research

The following are the primary forms of conflicts of interest to be aware of:

Financial connections are the most prevalent source of conflict of interest in research, as they may influence an individual’s thinking and hence alter the research output. It is normal to require the researcher to report not just any conflicting financial relationships they may have individually, but also those of their closest family members, as these may potentially represent indirect conflicts of interest.

Personal ties or affiliations are the most prevalent non-financial conflicts of interest in research. A personal conflict of interest exists, for example, if a researcher is related to the editor of the journal to which they submit a paper. Another personal conflict of interest occurs when views and ideologies influence research. For example, suppose a researcher is writing a religious paper and has a strong religious belief that influences how the study is conducted and presented. 

Professional

Professional conflicts of interest are those that can provide a professional advantage. As a journal reviewer and researcher, for instance, you may find yourself reviewing a paper on the same topic as your own, which can be a conflict of interest since you may reject the paper because it diminishes the value of your own.

How to prevent conflict of interest? 

• List any financial support you and your co-authors receive that might be construed as a conflict with your research aims. 
• List any social or personal activities that may impact how you do your research. 
• Examine any current or recent institutional relationships you may have that may be considered to impair your objectivity in your research.
• Examine and adhere to all of the criteria provided by your preferred journal on what constitutes a conflict of interest and how authors should declare them.

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Conflict of Interest Principles and Examples

Information for departments and individuals.

Staff, students and others working in the University are encouraged to discuss issues related to conflicts of interest with Heads of Department, colleagues, mentors, supervisors, tutors, or others as appropriate.

Additional information

See the quick links for further guidance and training.

Use the contact details on this page if you have questions about how to apply the policy and procedures in a particular situation.

Conflict of Interest Principles

Roles and activities outside the university, student supervision and teaching, other university activities (committee work, procurement, recruitment, admissions, contract negotiation), illustrative examples of conflicts of interest, examples for academics, examples for researchers, examples for members of staff and committee attendees.

COI Committee Secretary:  [email protected]

For further information contact the Risk, Compliance and Assurance Team:

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Conflicts of Interest in Research

• First Online: 29 June 2023

Cite this chapter

• Camilo Noguera Pardo 4  

Part of the book series: Collaborative Bioethics ((CB,volume 3))

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Conflict of interest’s guidelines and regulations have been focused on ensuring good science, mainly understood as a science free from external coercion. However, recent major adverse events involving researchers with significant financial interests in the results of their studies have increased concerns about the risks that financial conflicts of interest pose to well-being of subjects who agree to participate in research. In this chapter, I describe what a conflict of interest in research is, sinoptically explore the main ethical concerns related to it, and propose what compelling requirements for policy and governance are.

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In 2021, Facebook stopped funding the research by saying that this “is over, for now”.

Researchers may have interests in competing products that are not under study and have a conflict of interest despite not being directly financially associated with a particular study.

Moore was near death in 1976 when diagnosed with hairy cell leukemia, a rare and potentially fatal form of cancer. Concerned that Moore’s dangerously swollen spleen might burst, surgeons at UCLA Medical Center removed it. Within days, Moore’s doctors were amazed to discover that his blood profile had returned to normal. His disease remained in remission until 1996.When Dr. David Golde, a UCLA researcher, examined Moore’s spleen, he found that it contained unique blood cells that produced a type of protein that stimulates the growth of white blood cells that can help fight infections. Using new biotechnology, Golde and other researchers developed the cells into a replicating cell that makes the protein in large quantities. In 1984, the regents of the University of California patented the cell line, dubbed “Mo,” and named Golde and research assistant Shirley Quan as the inventors. Once he learned of the patent, Moore filed a lawsuit seeking a fair share of the potential profits from products or research derived from the “Mo” cell line (taken from: McLellan, 2001 ).

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About this chapter

Noguera Pardo, C. (2023). Conflicts of Interest in Research. In: Valdés, E., Lecaros, J.A. (eds) Handbook of Bioethical Decisions. Volume II. Collaborative Bioethics, vol 3. Springer, Cham. https://doi.org/10.1007/978-3-031-29455-6_6

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What are Conflict of Interest Statements, Funding Source Declarations, Author Agreements/Declarations and Permission Notes?

Many Journals request that the Author(s) supply them with one or more of these items at initial submission stage.

Please note:  Most journals require a formal format for these items. A generic form can be found further down this page.

To create one of these items, you're required to:

• Have located a journal to submit to.
• Have checked the Guide for Authors for that journal (sometimes a sample form is provided for you to download and complete).

If these are part of journal requirements, it'll be listed at the 'Attach File/Upload Files' step during the submission process.

Journals may request one or more of the following be uploaded as part of your submission:

An  Author Agreement  is a statement to certify that all authors have seen and approved the final version of the manuscript being submitted. They warrant that the article is the authors' original work, hasn't received prior publication and isn't under consideration for publication elsewhere.

A  Conflict of Interest or Competing Interest  is defined as a set of conditions in which professional judgment concerning a primary interest, such as the validity of research, may be influenced by a secondary interest, such as financial gain. See the  Competing Interests Factsheet  for more information.

A  Declaration of Interest  (sometimes called a Disclosure Statement) is a notification from the author that there's no financial/personal interest or belief that could affect their objectivity, or if there is, stating the source and nature of that potential conflict. To prevent ambiguity, authors must state explicitly whether potential competing interests do or don't exist, so you may be asked to provide one, even if no competing interests exist.

• Many Elsevier journals use our Declaration Tool helps authors step-by-step through the process of preparing well-considered and ICMJE-compliant Please watch this short video on  how to use the Declaration Tool in Editorial Manager .
• Many medical journals follow  ICMJE Recommendations . For these titles, you can download the  ICMJE COI form , complete it and save it on your computer, then submit the completed form to the journal along with your manuscript.

Please refer to each journal’s guide for authors for information on how to provide a Declaration of Interest statement for that journal.

A  Funding Source Declaration  contains a declaration of any funding or research grants (and their source) received in the course of study, research or assembly of the manuscript.

A  Permission Note  is a statement that permission has been received to use any material in the manuscript such as figures etc. which isn't original content. See Elsevier's  Permission Guidelines  for more information.

When in doubt, always consult with your professor, advisor, or someone in a position of authority who can guide you to the right course of action.

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Conflict of Interest

Reflect on your own research practices.

Have you ever witnessed or experienced a conflict of interest in your personal or professional roles? How did the conflict(s) impact your and others’ behaviours?

What strategies might you use to limit the influences of secondary interests or biases in the conduct of your research?

When something from your personal or private life influences — or appears to influence — your duties as a researcher, you may have entered a conflict of interest.

Having a conflict of interest does not imply that anyone has necessarily done anything wrong; however, researchers should identify, disclose and manage conflicts in a timely, open, forthright, constructive and accountable manner to preserve the integrity of the people and processes involved in their research.

Some conflicts of interest are permissible, while others that cannot be appropriately managed are prohibited. Failure to disclose and manage any real, potential or perceived conflicts of interest is a form of research misconduct; it erodes the public’s confidence in the ability of researchers to make professional judgments without bias.

Each researcher plays a role in protecting the reputation and maintaining the integrity of their research by mitigating the potential for, or existence of, conflicts of interest. 

BEST PRACTICES

Avoid and minimize conflict

Whenever possible, avoid conflicts of interest by removing yourself from any decision-making process that could create a conflict. If removal is not appropriate, you can also recruit a disinterested third party to oversee the decision-making process.

Be transparent about your potential or perceived conflicts

Fully disclosing all potential or existing conflicts of interest helps foster integrity in your research, which in turn, could protect you from allegations of misconduct. The university or your department may be able to offer support to help manage and mitigate against conflicts of interest when you declare them, thereby supporting the continuity of your research as well as your reputation.

Regularly review for any potential conflicts

Be mindful of your relationships and affiliations as you take on new or expanded roles and responsibilities in your personal and professional capacities and consider if any of them may impact your role as a researcher or introduce conflicts. By reviewing these affiliations regularly, you can identify conflicts promptly and maintain an updated Conflict of Interest Declaration, which in turn helps you to protect against unintentional violations of scholarly integrity.

Confusion about regulations and policies

In addition to UBC policies, other federal, institutional or organizational policies may also apply to your research. At the outset of your research, ask about any new or previously unknown requirements and adhere to them — doing so could protect your professional reputation and the integrity of your research. Mentors, peers or UBC’s Office of Research Services can all provide information or resources to help you understand and navigate the policies and regulations that might apply to you.

Outdated Conflict of Interest Declarations

At UBC, faculty and staff members are reminded to complete a Conflict of Interest Declaration annually. However, circumstances may change throughout the year as you consult and engage in activities outside the university to advance and share your knowledge. Periodically review your relationships to identify and disclose any real or potential conflicts to the university. The responsibility of keeping your declarations up to date — and the consequences for not doing so — primarily rests with you.

Recognizing conflicts

Private and personal interests can cloud your objective and professional judgment and make it difficult to recognize that your situation involves a conflict of interest. Having conversations with trusted colleagues about your affiliations and using a systematic approach to assess a situation will help you to better identify, disclose and manage conflicts of interest.

  Downloads

• Researcher's Checklist: Identifying Conflicts of Interest

Helpful Links

• Conflict of Interest and Conflict of Commitment Resource Hub, UBC University Counsel
• Staff Conflict of Interest Initiative, UBC
• US Financial Conflict of Interest, Office of Research Ethics

Relevant Policies

• UBC's Conflict of Interest and Conflict of Commitment Policy
• Tri-Agency's Conflict of Interest and Confidentiality

Continue to Funding & Financial Management

The developed content is adapted from the following:

• (2004). Tool 8.1: Checklist for identifying a conflict of interest in Managing Conflicts Of Interest In The Public Sector. Sydney, N.S.W.: ICAC/Crime and Misconduct Commission (Queensland). Retrieved from: https://www.integrity.qld.gov.au/assets/document/catalogue/icac_info_sh…
• MacDonald, M (n.d.) Ethics and Conflict of Interest. Retrieved from: https://ethics.ubc.ca/peoplemcdonaldconfclit-htm/
• University of British Columbia (2012) Conflict of Interest and Conflict of Commitment (Policy No. SC3). Vancouver, BC. Office of University Counsel.

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COI: Conflicts of Interest Overview

Categories:

Conflict of Interest

• Regulatory Compliance

Introduction

The overview contains a brief review of the policies and procedures associated with the disclosure and management of conflicts of commitment and interest at Stanford University. This page also includes information to help identify and mitigate potential conflicts. In addition, this overview contains summaries of policies specific to the School of Medicine.

Defining Conflicts

Conflict of commitment.

Stanford faculty members owe their primary professional allegiance to the University, and their primary commitment of time and intellectual energies should be to the education, research, and scholarship programs of the institution. The specific responsibilities and professional activities that constitute an appropriate and primary commitment will differ across schools and departments, but they should be based on a general understanding between the faculty member and his or her department chair and school dean. Even with such understandings in place, however, attempts of faculty to balance University responsibilities with external activities--such as consulting, public service, or pro bono work--can result in conflicts regarding allocation of time and energies. Conflicts of commitment usually involve issues of time allocation. Whenever an individual's outside professional activities (as defined in the RPH:  Stanford’s Policy on Consulting and Other Outside Professional Activities ) exceed the permitted limits (normally thirteen days per quarter), or whenever a full-time faculty member's primary professional loyalty is not to Stanford, a conflict of commitment exists. Due to conflict of commitment concerns Stanford prohibits direction of a program of research or scholarship at another institution that could be conducted appropriately at Stanford (i.e. outside PI-ship).

If a situation that raises questions about a possible conflict of commitment arises, faculty should discuss the situation with their department chair or school dean, or with the Dean of Research.

Stanford University is an institution of public trust; faculty must respect that status and conduct their affairs in ways that will not compromise the integrity of the University or that trust. A conflict of interest occurs when there is a divergence between an individual’s private interests and his or her professional obligations to the University such that an independent observer might reasonably question whether the individual’s professional actions or decisions are determined by considerations of personal financial gain. Such situations do NOT necessarily imply wrong-doing or inappropriate activities. However, in a research university setting, they can compromise, or be perceived as compromising, important academic values, research integrity, or the university mission. At Stanford, it is essential for all faculty, staff, and students to understand how these divergent interests can become a problem and how they should be disclosed and managed. Conflicts of interest often arise at the intersection of two fundamental missions: to push the boundaries of knowledge and to transfer that knowledge to the private sector for the benefit of the public. There may be, for example, significant personal financial incentives related to outside consulting, patenting and licensing an invention, or being involved with a ‘start up’ company. Considerations of personal financial gain, however, must not influence the decisions or actions of individuals in carrying out their University responsibilities. The perception that such incentives might harm research objectivity, the protection of human subjects, or adversely affect other institutional responsibilities in the areas of education, clinical care, or administrative activities is enough to mandate that such conflicts be identified and then eliminated, mitigated, or managed.

Consulting Policies

Stanford policies concerning the outside professional activities of Stanford personnel include:  Consulting and Other Outside Professional Activities By Members of the Academic Council and Medical Center Line Faculty , which applies to faculty; the  Conflict of Commitment and Interest for Academic Staff  policy; and the Staff Policy on Conflict of Commitment and Interest for all other staff. The staff policies only permit consulting with the written permission of the department/program chairman, by the principal investigator, or by the director of the appropriate library, relative to the specific appointment of the staff person.

In addition to the limit set on the time that a full-time faculty member may spend on outside consulting, Stanford's policy also prohibits:

• Management roles (activities or titles that constitute or imply managerial or supervisory responsibility); titles such as CEO, Director, Scientific Officer, or Vice President, etc. are designations generally assigned to people with line management responsibilities
• Ghost writing or publishing articles or other forms of scholarly communication under a faculty member’s own name in the course of an outside professional activity that are written in whole or material part by employees of the outside entity

Conflicts of Interest in Research

Conflicts of interest are common and practically unavoidable in a modern research university. Conflicts of interest can call into question the professional objectivity and ethics of the individual, and reflect negatively on the University. Opportunities to profit from research may influence or appear to influence the choice of the direction of the research, the design and conduct of the research, objectivity of the data, or interpretation of research results. Moreover, in human research, these opportunities to profit may influence or appear to influence a researcher's judgments about which human subjects to enroll, the clinical care provided to subjects, and the proper use of subjects' confidential health information, and such influences may create biases in study design, data collection and analysis, adverse event reporting, or the presentation and publication of research findings. On the other hand, there may be special circumstances that create compelling reasons for an individual to engage in research involving human subjects despite having a financial conflict of interest. Stanford seeks to help faculty, staff, and students in translating their discoveries and developments as part of its mission to benefit the public. The university also seeks to minimize the adverse affects of conflicts of interest and to advise faculty and staff on how to avoid, mitigate, or, if warranted, manage those conflicts. The purpose of Stanford’s Faculty Policy on Conflicts of Commitment and Interest and policies on consulting and other professional activities is to describe the risks, explain the requirements for how faculty, staff, and trainees must address these risks through disclosure, and provide information about the standards and processes that Stanford uses to review and assess personal financial interests related to University responsibilities.

While most disclosures of financial interests will probably be deemed de minimus or not significant conflicts of interest, financial interests above certain thresholds will automatically be deemed significant conflicts of interest and will require closer scrutiny and possible elimination, mitigation, and/or management. The thresholds are as follows:

• Payments for services over $10,000/a year or the ownership or promise of stock or stock options in a publicly traded company valued at over $10,000 or 0.5% of the total value of the company 
• The ownership or promise of stock or stock options of any amount in a privately held or start-up company

In addition, research funded by the Public Health Service (PHS) and National Science Foundation have specific requirements that are covered in  PHS and NSF Requirements Regarding Financial Disclosures and Agency Notifications .

Special Policy for Conflicts of Interest in Human Subjects Research

Financial interests or compensated relationships above these thresholds if the research involves human subjects will require that all conflicted investigators provide compelling reasons justifying their involvement in the research despite their conflict, if their financial interests are above the thresholds described in this document. A simple statement of an investigator's importance or expertise will not suffice. An investigator with a significant financial stake in the outcome of the research would need to provide a sufficient reason detailing his/her unique contribution to the study, explain how the investigator’s conflict of interest serves the subjects’ interests, present a reasonable plan that will protect the human subjects, the data, and the university, and describe their plan for transferring expertise to other non-conflicted investigators. Without compelling reasons and a plan that isolates the investigator from direct interaction with the human subjects or identified specimens, the Conflict of Interest Committee may require that the investigator either divest his/her financial interest or not perform the work at Stanford.  

Disclosure of Personal Financial Interests

All faculty investigators, and any other non-faculty participants in the research, who have responsibility for the design, conduct, or reporting of the research must disclose any personal financial interests that reasonably appear to be related to the project. Personal financial interests in a company may reasonably appear to be related to the research/scholarship if that company/organization:

• Sponsors research at Stanford in which the investigator is directly involved
• Has financial interests that could reasonably be considered to have a potential influence on the design, conduct, or reporting of the investigator’s research/scholarship
• Has a reasonable possibility of being financially affected by the investigator’s research/scholarship
• Makes gifts to Stanford that benefit the investigator’s research/scholarship (including equipment gifts or loans)
• Makes a product that is under study in research in which the investigator is involved
• licenses Stanford intellectual property in which the investigator has a financial interest
• Has a Materials Transfer Agreement or Human Tissue Agreement (MTA/HTA) to provide materials used in the investigator’s research or for materials provided by the investigator to the company/organization
• Sponsors or makes a product that is under study in human subjects in which the investigator is directly or indirectly involved
• Has interests that are related to the investigator’s general scientific or scholarly expertise

The financial interest thresholds defined as significant financial interests (SFI) by the Public Health Service (PHS) (see  here  for further information) are as follows:

• Payments for services over $5,000/year or the ownership or promise of stock or stock options valued at $5,000 in a publicly traded company
• The ownership or promise of stock or stock options of any amount in a privately-held or start-up company
• Royalties over $5,000/year not paid through Stanford University

While most disclosures of financial interests will be deemed de minimus or not significant in terms of potential effects on the individual’s ability to perform his or her duties without risk of bias, financial interests above thresholds will automatically be deemed significant conflicts of interest and will require closer scrutiny and possible elimination, mitigation, and/or management.

Prior Approval 

Effective September 1 st , 2023, Stanford faculty and research personnel will be able to request prior approval for outside activities through our Outside Professional Activities Certification System (OPACS). This module aims to enhance, streamline and document the process of obtaining prior approval for certain Outside Professional Activities in accordance with Stanford's updated Research Policy Handbook, Section 4.1 on Conflict of Interest and Conflict of Commitment (COIC).

Please see this document for more details and information.  It is important to note that all activities that have been disclosed and received approval before September 1, 2023, do not necessitate resubmission for prior approval.

The implementation of this online module will further strengthen our commitment to managing COIC effectively and transparently.

Assessing Conflicts of Interest in Research

Financial interests above thresholds that are disclosed and deemed to be related to a faculty member’s research responsibilities will be further reviewed to determine if the financial interest or relationship could have a direct and significant effect on the faculty member’s performance of his or her research. In addition, we need to ensure that:

• An open academic environment is maintained
• There are not restrictions on publication or dissemination of research results
• Intellectual property is licensed fairly
• The use of University resources, including personnel, students, and facilities, is appropriate
• The academic activities of students and postdoctoral scholars are free from the personal financial interests of the faculty member
• The work of students, staff, postdoctoral scholars, and collaborators is not exploited in the course of a faculty member’s outside obligations

Eliminating, Mitigating, or Managing Conflicts of Interest in Research

If it is determined that a significant financial interest could have a direct and significant effect on the research, and/or the research on the financial interest, the conflict will need to be eliminated or managed according to a plan provided to the faculty member by the Cognizant dean for COI. Other administrative actions, such as disclosure in publications and public talks, may be required when the financial interest is not considered likely to directly and significantly affect performance of research. Some common strategies for eliminating, mitigating, or managing conflicts include:

• Public disclosure of significant financial interests
• Training on conflicts of interest and commitment for all involved students and personnel
• Independent monitoring and oversight of the activity
• Modification of the Stanford research activity to remove the conflicted faculty member from participation in all or a portion of the research
• Divestiture of significant financial interests
• Other mitigating strategies

Other Requirements for PHS-Funded Research

Additional requirements under regulations for PHS-funded research include the following.

• Agency notification of any identified financial conflicts of interest (FCOIs) both when a Stanford investigator is directly involved with PHS funded research as well as when an investigator at an institution receiving a sub-contract through Stanford has an  FCOI  prior to the expenditure of funds.
• Response to any requests that the University receives for information on Financial Conflicts of Interests (FCOIs) on PHS-funded research within five days of such requests.
• The inclusion of any sponsored or reimbursed travel paid by any entity except a federal, state, or local government agency; an institution of higher education or an academic teaching hospital; a medical center or a research institute affiliated with an institution of higher education; or as a personal financial interest requiring disclosure.  Disclose your travel that may be related to PHS-funded research at  opacs.stanford.edu  and click on Travel in the left-hand column.  Follow the instructions on the travel disclosure form. Note that your initial disclosure must include reimbursed or sponsored travel received in the preceding twelve months.
• Faculty investigators must complete training on conflicts of interest prior to engaging in PHS-sponsored research and again every four years.

Types of Conflicts of Interest

Conflicts of interest in teaching and educational activities.

Education and guidance given to students by faculty, including the nature and direction of research or other studies, should be governed by what is in the academic interest of the student. In addition, personal financial interests should not influence the content of any educational activity or presentation at Stanford or elsewhere when given to students or the public, and any personal financial interests related to the educational activity should be disclosed. A financial interest in a company/organization could create a conflict of interest related to institutional responsibilities for education if that company/organization:

• Provides financial support for the faculty member’s trainees (students, graduate students, postdocs)
• Has products (excluding textbooks) or devices that are used in faculty member’s teaching
• Produces or markets distance learning services or materials in which the faculty member has an interest
• Supports faculty member’s participation as a lecturer/speaker in educational activities or on-line education programs

Such conflicts need to be disclosed and reviewed by the Dean, Cognizant dean, or COI Program administrator to ensure that such interests do not negatively affect students and trainees. In addition, the School of Medicine has several specific policies addressing educational conflicts of interest. The policy on Commercial Support of Continuing Medical Education has prohibited the direct support of topic specific Continuing Medical Education (CME) by the commercial sector. See a link to the policy below in Related Items. Support from industry for CME will be considered only in the following general categories:

• medical, pediatric, and surgical specialties
• diagnostic and imaging technologies and disciplines
• health policy and disease prevention
• other broadly defined topic areas

The School of Medicine’s Stanford Industry Interactions Policy ( SIIP ) requires that non-CME educational activities supported by industry be designated for broadly defined areas only, not involve promotion or marketing, and that industry not influence the curriculum, among other things. Conflicts of interest must be disclosed to the learners. Industry support for educational activities involving medical and graduate students and postdoctoral fellows and trainees must be approved by the Senior Associate Dean for Education. SIIP also prohibits industry-sponsored "speakers bureaus” (i.e., contractual relationships to give talks in which the topic(s) and/or content are provided by the company) and dedicated marketing and training programs designed solely or predominantly for sales or marketing purposes.

Conflicts of Interest in Administrative Responsibilities

Stanford policy on conflicts of interest applies to administrative duties carried out on behalf of the institution. A financial interest in a company/organization could create a conflict of interest if:

• The faculty member is directly involved or in a position to influence decisions or requests to purchase goods or services from this entity or provide goods or services to the entity
• Another faculty member who reports to this faculty member is engaged in human subjects research related to the interests of this entity (e.g., testing a drug, device, or diagnostic)

These conflicts of interest need to be reported and reviewed by the Dean, Cognizant dean for COI, COI program administrator, or if human subjects research is involved, by the Institutional Conflict of Interest Committee (ICOIC).

Conflicts of Interest in Clinical Care

Stanford School of Medicine has a policy on Conflicts of Interest in Clinical Care which recognizes that physicians have a unique opportunity to improve patient care through collaboration with industry. However, these interactions must take place in an atmosphere of high integrity and transparency so that collaborations with industry can optimally benefit patients and improve human health and well-being. Accordingly, Stanford physicians are expected to fully disclose financial relationships with companies that produce, manufacture, or provide medical devices, implants, pharmaceuticals, biologics, diagnostics, or other medical care related products that may be used in the care of their patients. A financial interest in a company could create a conflict of interest if:

• The physician prescribes pharmaceuticals made or supplied by this entity for FDA-approved or non-FDA-approved indications
• The physician uses a medical device or implant made or supplied by this entity
• The physician refers patients to a health care facility with which he/she has a financial relationship
• The physician is involved in evaluating products made or supplied by this entity

Clinical care conflicts need to be reviewed by the Senior Associate Deans for Clinical Affairs.

Created: 03.12.2021

Updated: 04.26.2024

Conflict of Interest in Research

Applies to:  Faculty (including part-time and visiting faculty), postdoctoral scholars, academic staff, staff, and students (including graduate/undergraduate student workers and graduate assistants) employed by University of Southern California and its subsidiaries including Keck Medicine of USC (“USC Employees”). This policy continues to apply to individuals who are on sabbatical or other leaves, or who are visiting other institutions.

Issued: March 1, 2013 Last Revised: October 14, 2022 Last Reviewed: October 14, 2022                                                    

2. Policy Purpose

The purpose of this policy is to promote the highest ethical standards in situations where conflicts of interest may occur in the conduct of research.

The University of Southern California (“USC”) encourages its faculty, staff, and students to participate in meaningful professional relationships with industrial and other private partners. These partnerships are established for mutually beneficial reasons and many times produce knowledge and technology that will help to meet societal needs.

In certain circumstances, relationships with outside interests can create, or appear to create conflicts of interest or situations where competing interests can conflict. While having a conflict of interest does not imply wrongdoing or inappropriate activity, conflicts do require review and management to ensure that the conflict does not improperly influence, or appear to improperly influence, how USC research is proposed, conducted, or reported. Transparency is the cornerstone of effective conflict oversight and management. Many times, disclosure itself minimizes a perception of bias in the conduct of research. It is therefore critical that all conflicts be disclosed promptly, fully, and thoroughly, in advance, in the manner provided in this policy. This policy explains the process for identifying and disclosing conflicts and the methods by which they are managed by the university.

3. Scope and Application

This policy applies to all university faculty members (including part-time and visiting faculty), staff and other employees, and students (including postdoctoral fellows) who propose, conduct, or report research on behalf of the university, regardless of funding source. This policy applies to all sponsored projects, including government and non-government funded projects (such as industry or foundation sponsors), university funded projects, gift funded projects, clinical trials, and also to unfunded research projects.

Investigators are not permitted to begin any research activity when there is an actual or apparent conflict of interest before they receive a written determination from the Vice President of Research as to how to manage the conflict.

Special care must also be taken when students or trainees are involved with research where an actual or apparent conflict of interest exists so that academic progress is not impeded or affected by a faculty member or supervisor’s conflict of interest.

4. Definitions

5. policy details, 5.1 general principles.

Investigators and research personnel are responsible for identifying and disclosing Conflicts of Interest covered by this policy. Investigators and/or research personnel should evaluate potential conflicts of interest on an ongoing basis and disclose, promptly and in advance, financial interests and outside activities giving rise to a Conflict of Interest. This responsibility arises when a new proposal is submitted; a new relationship is established with an outside entity; or when a prior relationship with an outside entity changes. 

If a Conflict of Interest is above certain financial thresholds or involves human subjects research it is considered a Significant Conflict of Interest. In the case of a Significant Conflict of Interest, the investigator or research personnel must present compelling circumstances as to why the research should proceed.  This determination will depend in each case upon the nature of the science, the nature of the interest, how closely the interest is related to the research, and the degree to which the interest may be affected by the research.

If a Conflict of Interest is found to be manageable, the university will require the implementation of a management plan designed to mitigate or eliminate the conflict, as described below.  If the university determines that the conflict cannot be effectively mitigated or eliminated through the implementation of a management plan, the research will not be allowed to proceed unless the investigator eliminates the outside interest or activity giving rise to the conflict.

Investigators and research personnel are not permitted to begin any research activity when a Conflict of Interest exists, until they report the conflict and receive a written determination from the Vice President of Research, or their designee, on how to manage it. Investigators and research personnel also are not permitted to begin an external activity that would create a Conflict of Interest until they report the conflict and receive a written determination from the Vice President of Research, or their designee, on how to manage it.

Investigators must submit an annual disclosure of financial interests related to their institutional responsibilities (regardless of whether the interest creates a Conflict of Interest) when mandated by a research sponsor (e.g., the Department of Health and Human Services [HHS], Department of Energy), in accordance with the schedule established by the university. The university may also require disclosures at other times. Investigators who have or are seeking support from any sponsors who require an annual disclosure must:

• Have a current annual disclosure at the time of proposal submission.
• Update their annual disclosures within 30 days of the time they obtain a financial interest with an entity that was not disclosed at the time of the most recent annual disclosure.
• Update their disclosure on an annual basis.

Investigators are responsible for confirming that research personnel under their supervision who are involved in proposing, conducting, or reporting research on the investigator’s project identify and disclose any Conflict of Interest.

5.2 Financial interests and outside activities that must be disclosed

Equity interests

If the company is privately held, all equity interests must be disclosed regardless of value. If the company is publicly traded, equity interests of $5000 or more must be disclosed, unless the equity interest is maintained in an investment vehicle (e.g., mutual fund, retirement account) where the investigator, research personnel, or close relation does not directly control investment decisions.

Management roles

A management role is one where the investigator, research personnel, or close relation maintains significant decision-making authority in an outside entity that is either a research sponsor or may benefit economically from the outcome of the research. It also includes acting as a chief scientific officer, board member, founder, or any similar role.

Payments for Services

Payments for services from a research sponsor or an entity that may benefit economically from the outcome of the research that total $5,000 or more when aggregated over a twelve-month period must be disclosed.  This includes but is not limited to payments for:

•  Service on a board, advisory committee, or review panel
•  Scientific or technical appointments
• Payments for lectures and similar public appearances
•  Honoraria
•  Paid authorship
•  Consulting

Sponsored travel

Sponsored travel or reimbursement of expenses associated with travel and provision of services that totals $5,000 or more when aggregated over a 12-month period is also considered a conflict of interest to the extent the sponsorship/reimbursement is not reasonable. Unreasonable sponsored/reimbursed travel includes, but is not limited to, travel paid for or reimbursed for the investigator’s family.

Intellectual property

Personal receipt of intellectual property rights (e.g., share in patents, copyrights or royalties) directly from a research sponsor or a company who may benefit economically from the outcome of the research (e.g., licensee).

Compensated Outside Research

Participation as a principal investigator, co-principal investigator, co-investigator, paid consultant, or paid staff member on sponsored projects at another entity (as distinct from research collaborations with other entities via a subcontract or subaward to USC) must be disclosed to the appropriate dean and the Vice President for Research and are prohibited unless specially approved by the dean and the Vice President for Research or their designee. 

Please note that, regardless of the nature of financial interest or covered outside activity, disclosure obligations apply to domestic as well as foreign activities.

5.3 Significant conflicts

A Significant Conflict of Interest requires that the investigator or research personnel present compelling circumstances as to why the research should proceed.  If the CIRC concludes that the investigator has presented compelling circumstances, it will implement conflict mitigation requirements, including but not limited to those discussed above.  If the CIRC concludes that the investigator has not presented compelling circumstances, the research cannot proceed as proposed.

5.4  Financial interests and outside activities that are not permitted

Certain types of financial interests and outside activities are not permitted because there is no feasible way to manage the Conflict of Interest. These include:

• Participating in a paid “speaker’s bureau” (i.e., talks/presentations in which the topic(s) and/or content are provided by the company) for a research sponsor or a company that may benefit economically from the outcome of research.
• Incentive payments, bonus payments, finder fees, or any type of payment or incentive based on outcome, where the payment or incentive is made to the researcher or to research personnel relating to the proposal, conduct, supervision, or reporting of research (e.g., additional personal payments to investigators or research personnel who enroll a certain number of participants in a project within a certain period of time), or payment or incentive with respect to the evaluation of a product or service intended for a commercial market.
• Accepting personal gifts, gratuities, or special favors from an actual or prospective sponsor of an investigator’s research, other than occasional gifts or nominal or modest value (less than $50 in value or isolated invitations to meals).

Maintaining a financial interest or engaging in an outside activity for a research sponsor who seeks to restrict publication of research results, other than reasonable delays of publication in order to protect proprietary rights (i.e., patent rights).  This does not include restrictions on publication for reasons of national security and/or export control, if the requirements of USC’s International Collaborations and Export Controls policy are followed.

5.5 Standards of review applicable to disclosed conflicts of interest

After a financial interest or outside activity related to research is disclosed, the university reviews the disclosure on a case-by-case basis to determine whether the disclosure constitutes a Conflict of Interest, and if so, how to appropriately mitigate the Conflict of Interest in a way that preserves the integrity and objectivity of the research.  Faculty must keep in mind that certain financial interests and outside activities may create a Conflict of Interest that cannot be effectively mitigated or managed.

Required elements of conflict management

All management plans implemented to mitigate Conflicts of Interest will contain, at minimum, the following elements:

•  All relevant publications, proposals, and presentations must contain a statement disclosing support received from, or financial interests in, any source outside of USC.
•  All informed consent documents in the context of human subjects research must disclose support received from, or financial interests in, any source outside USC.  Conflicted investigators are not permitted to consent human subjects.
•  The investigator and/or research personnel and their close relations will not represent the university in any intellectual property or other contractual negotiations between USC and the outside entity.
•  Investigators must notify students of the presence of a Conflict of Interest if students are to perform as research assistant or research staff on the research, along with a notification to the students and their advisors of the student’s rights.  In order to protect student rights, the university may appoint a third-party monitor (e.g., faculty member, the Graduate School) to ensure the student is making timely progress towards degree objectives and that the student’s rights are otherwise protected.

Management plans implemented to mitigate a Conflict of Interest may contain additional measures, including but not limited to:

•  Recusal of the conflicted individual from data collection and/or data analysis for the relevant research project
•  Referral to a supervisor or independent individual approved by the CIRC for monitoring or oversight.
•  Reduction of involvement or role for the conflicted individual for the relevant research project
•  Termination of student involvement in the research project or appointment of an independent monitor
•  Removal of the conflicted individual from the research project.
•  Divestiture of relevant financial interests
•  Severance of outside activities that pose a conflict of interest.

Additional review

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Researcher Perspectives on Conflicts of Interest: A Qualitative Analysis of Views from Academia

The increasing interconnectedness of academic research and external industry has left research vulnerable to conflicts of interest. These conflicts have the potential to undermine the integrity of scientific research as well as to threaten public trust in scientific findings. The present effort sought to identify themes in the perspectives of faculty researchers regarding conflicts of interest. Think-aloud interview responses were qualitatively analyzed in an effort to provide insights with regard to appropriate ways to address the threat of conflicts of interest in research. Themes in participant responses included disclosure of conflicts of interest, self-removal from situations where conflict exists, accommodation of conflict, denial of the existence of conflict, and recognition of complexity of situations involving conflicts of interest. Moral disengagement operations are suggested to explain the appearance of each identified theme. In addition, suggestions for best practices regarding addressing conflicts of interest given these themes in faculty perspectives are provided.

Introduction

In 1998, Dr. Andrew Wakefield and his colleagues published an article linking the measles, mumps, and rubella (MMR) vaccine to autism ( Godlee et al. 2011 ). All cases reported in the article were subject to misrepresentation or undisclosed alteration, leading to the eventual retraction of the article in 2010 ( Godlee et al. 2011 ). Despite this retraction, the article’s publication catalyzed a chain reaction leading to a worldwide vaccine scare ( Deer 2011 ) that continues to rage today. In fact, as recently as 2013, Britain experienced serious outbreaks of measles thought to be a consequence of failure to vaccinate infants in the aftermath of the article’s publication ( The New York Times 2013 ).

Further investigation with regard to the reasons for the consistent falsification of results evident in the Wakefield piece revealed that the principal investigator was involved in a lawsuit centering on the MMR vaccine, involvement for which he had received payment—a clear and undisclosed conflict of interest ( Deer 2011 ). In addition to a sharp decline in vaccinations of infants and resulting international health concerns, Wakefield’s misconduct has led to widespread mistrust of medicine and of medical research. While this case serves as an extreme example of the negative ramifications of conflicts of interest in research, even lesser infractions may be extremely damaging to the scientific community with regard to public trust.

The increasing interconnectedness of research and industry has led to a rise in the potential for conflicts of interest in research like the one evident in the Wakefield scandal. According to a 2000 report by Boyd and Bero, about $1.5 billion flows from industry to academic institutions annually; it is likely that this figure is even larger today. Additionally, at least one fourth of investigators in biomedical research have industry affiliations, and a significant relationship exists between industry sponsorship in this area and pro-industry conclusions ( Bekelman et al. 2003 ). Similarly, according to Lexchin, Bero, Djulbegovic, and Clark (2003), studies sponsored by pharmaceutical companies were much more likely to have outcomes favoring the sponsor than were studies with a different sponsor. Given the prevalence of the potential for conflicts of interest in research across industries due to external sponsorship, as well as the evidence that these conflicts do, in fact, shift research findings in favor of industry sponsors, it is increasingly evident that conflicts of interest pose a severe threat to the credibility of research.

Cohen (2001) defines a conflict of interest as existing “whenever an individual or an institution has a primary allegiance that requires certain actions, and simultaneously, has a secondary interest that (1) could abrogate that primary allegiance and (2) is sufficiently tempting to raise a reasonable possibility that it might actually do so.” Such conflicts are of concern due to the possibility that inappropriate factors may influence research at any stage—from research design to data analysis to the presentation of results ( Bird and Spier 2008 ). Although they are frequently related to the involvement of industry in research, conflicts of interest may spring from any situation in which the expectations of others may influence research, be those others collaborators, competitors, investors, or the public at large ( Bird and Spier 2008 ).

Given the likely influence of conflicts of interest on the work of academic researchers as indicated by the extensive financial investment of industry sponsors, alongside the expectations of the individuals and groups mentioned above, it is of particular importance that we understand the views of individuals conducting research in an academic context with regard to the appropriate ways in which to deal with these conflicts. According to previous research, the most commonly used strategy among academic researchers for addressing conflicts of interest is simply to disclose the conflict ( Boyd and Bero 2007 ). This is also the most preferred strategy among institutions responsible for the management of conflicts of interest, with other common tactics including close oversight or management of research by institutions or banning of ties with industry entirely ( Glaser and Bero 2005 ). In a meta-analysis of studies examining the beliefs of researchers regarding the appropriateness and impact of industry financial ties, as well as the disclosure of those ties, Glaser and Bero (2005) found that the majority of researchers believed that these relationships could influence findings in the interest of corporate sponsors but that disclosing conflicts of interest would effectively eliminate bias. The authors interpret this finding as illustrating a degree of naiveté among investigators about the mechanisms by which financial incentives operate to induce bias in research.

Krimsky (2005) explains the emphasis on disclosure in terms of what he calls the funding effect, where the presence of funding affects scientific outcomes. As public concern regarding this phenomenon has increased, the public has increasingly turned to disclosure as a way to assess the integrity of scientific research ( Krimsky 2005 ). Krimsky (2005) concludes from a judicial standpoint that disclosure of conflicts fails to provide an adequate solution to conflicts of interest in science as this topic pertains to the provision of expert testimony. Given this conclusion, it is doubtful that disclosure alone may prove an adequate solution to the problem of the funding effect.

In fact, arguments made by former New England Journal of Medicine editor Marcia Angell (2000) suggest that recusal may be a far more appropriate approach to addressing conflicts of interest than mere disclosure. Angell (2000) suggests that the close ties between, in particular, academic medicine and industry are so close that the goals of medicine cannot help but be influenced by those of industry. Although financial relationships of this nature are not so blatantly influential as to be considered bribes, they cannot help but influence the types of research conducted by medical scientists and the way in which results are reported. Angell (2008) goes so far as to suggest that clinical trials of prescription drugs be administered by an impartial group within the National Institutes of Health, rather than by investor-owned companies, implying that conflicts of interest in this area are too great to be overcome, even with disclosure.

It seems likely given these statements and findings that researchers in academia have misconceptions regarding the threats that conflicts of interest pose to their research, as well as the appropriate ways to address these threats. The present effort seeks to research a greater understanding of the perspectives on conflicts of interest possessed by researchers in an academic context, with the hope of providing recommendations for best practices for managing conflicts of interest. This leads to our first research question:

Research Question 1: What themes appear in the ways in which research professionals view conflicts of interest?

In addition, given the potentially negative ramifications of conflicts of interest, it may be of use to identify the mechanisms most likely used by researchers in order to justify the perpetuation of these conflicts. Bandura’s (1999) description of moral disengagement serves as a potential explanation for such behavior given the fact that the disengagement practices described serve to prevent the activation of self-regulatory mechanisms governing moral conduct. In this instance, the activation of these mechanisms would lead researchers to engage in behaviors intended to prevent the influence of conflicts of interest; moral disengagement mechanisms would allow researchers to justify not engaging in such behaviors.

Specifically, Bandura (1999) identifies seven moral disengagement mechanisms. The first of these, moral justification, involves the portrayal of unethical conduct as serving socially worthy or moral purposes. Second, euphemistic labeling involves the use of language to verbally sanction behavior. When engaging in advantageous comparison, a third mechanism, individuals contrast behavior with worse offenses executed by others. Displacement of responsibility occurs when individuals view their actions as flowing from the orders of an authority figure. Similarly, diffusion of responsibility involves sharing blame with a group and therefore diminishing it. Disregard for or distortion of consequences, a sixth mechanism, involves minimizing or ignoring the harm of immoral actions. Finally, dehumanization involves stripping victims of detrimental acts of their human qualities. While these mechanisms may help to explain the justification of conflicts of interest among researchers, it is unclear which, if any, serve as primary explanatory factors for this behavior. This leads to our second research question:

Research Question 2: Do any of the themes identified in researcher perspectives on conflicts of interest reflect moral disengagement operations?

In order to investigate these questions, we conducted a number of interviews with researchers in an academic setting regarding their responses to a measure intended to assess ethical decision making. Interviews were then transcribed and then qualitatively analyzed in order to identify themes surrounding conflicts of interest.

The faculty sample included 64 researchers at a large southwestern university, 37 of whom were male and 27 of whom were female. The sample included assistant professors (15), associate professors (28), full professors (20), and one adjunct professor. Participants were drawn from six broad areas of study, including six from biological sciences, such as botany and chemistry; seven from physical sciences, such as engineering and meteorology; 14 from social sciences, such as political science and sociology; 22 from health sciences, such as medicine and dentistry; ten from performance, such as dance and music; and five from humanities, such as history and philosophy. Graduate liaisons from all departments across campus recruited faculty members to serve as participants in a study of ethical decision making.

Ethical Decision-Making Instrument

The measures of ethical decision making used to provide fodder for interviews in the study at hand was developed by Mumford et al. (2006) . In order to develop this battery of measures, Mumford et al. (2006) reviewed codes of conduct across fields of study in order to establish general dimensions of ethical behavior in research: data management, study content, professional practices, and business practices. In order to tap these dimensions, six equivalent measures were developed with content varying by subject area—biological science, physical science, social science, health science, performance, and humanities—but covering similar ethical dilemmas.

Each of the measures described above includes between four and six scenarios. Each scenario then forms the basis for approximately five corresponding questions, each asking individuals to indicate the best two of the approximately eight responses provided. Each response bears a low, medium, or high label with regard to ethical decision making, with low responses representing poor ethical decisions, medium, moderate or acceptable decisions, and high, excellent decisions or choices. Mumford and colleagues provide construct validity evidence for this battery, including correlation of the measures with expected outcomes and causes of ethical decisions, in their 2006 validation piece. An example scenario, along with a follow-up question and relevant responses, is provided in Table 1 .

Example ethical decision-making measure scenario and questions

Item responses are labeled to indicate whether they represent low-quality (L), medium-quality (M), or high-quality (H) responses to the ethical decision-making scenario

The area-appropriate versions of these measures were made available to participants via Qualtrics, an online survey tool, allowing for scoring of measure responses to take place prior to participant interviews. Following completion, responses were scored on the basis of the system described above, with high responses receiving a larger number of points than low responses. Each participant received a score for each scenario, as well as a score for the measure overall formed by averaging individual scenario scores. Then, participant scores on each scenario were compared with their overall scores in order to identify scenarios where participants had displayed unusually good or poor ethical decision making. A cutoff of half a standard deviation was used for this procedure, such that scenarios with scores more than half a standard deviation higher than the participants’ average scores were identified as examples of particularly good ethical decision making and those with scores more than half a standard deviation lower than average were pulled as examples of relatively poor ethical decision making. It is important to note that these scenarios were identified on the basis of their standing compared to each participant’s average; no comparisons were made between participants.

Think-Aloud Interviews

The scenarios identified as extreme examples of good or poor ethical decision making for each participant were used as the basis for think-aloud interviews conducted with each participant approximately 1 week after completion of the measure. Interviews were conducted by industrial-organizational psychology graduate students familiar with the ethical decision-making literature. These interviewers asked participants to walk them through their thinking with regard to each answer for questions pertaining to the previously identified scenarios. Interviewers were not privy to whether each scenario had been identified due to receiving a higher or a lower score than the participant’s average, and interviewees were not informed as to their scores on the measure or on any given scenario.

A series of interview questions developed on the basis of the think-aloud protocol literature ( Fonteyn et al. 1993 ) were asked in order to encourage participants to think aloud about their decision-making processes. These questions, which were divided into an initial group, a follow-up group, and clarification questions, are provided in Table 2 . In addition to these prepared questions, additional questions were asked when necessary on the basis of participant responses.

Standardized interview questions

Interviewers participated in a two-month training program in order to standardize the interview procedure. The training process included two stages, one in which interviewers practiced on one another, with interviews recorded and reviewed for consistency, and one in which the interview protocol was piloted with two faculty volunteers. The latter interviews were also recorded and reviewed.

Interviews with participants were recorded. These recordings were then transcribed by a university service in order to allow for further analyses.

Content Analysis

Transcribed interviews were content analyzed with the help of a computer-assisted qualitative analysis program, NVivo. A list of keywords associated with conflicts of interest was developed and then reviewed by subject-matter experts in the area of ethical decision making. These keywords are presented in Table 3 . Within NVivo, these keywords were then used to identify excerpts of transcripts where participants discussed topics relevant to the subject matter at hand. The identified text was then exported from NVivo and assessed in order to eliminate any false hits.

Conflict of interest keywords

Content that was deemed relevant to conflicts of interest was then sorted into themes, each representing a different approach to handling these conflicts. Subject-matter experts then reviewed these themes in order to assess the degree to which they represented an accurate picture of faculty responses to issues involving conflicts of interest.

Because some participants discussed personal experiences in their interview responses or spoke in ways that would otherwise render them identifiable, no exact quotes have been presented in this report. Rather, the quotes below represent close approximations of participant statements rather than word-for-word examples from transcripts of participant interviews.

Within the 105 participant response excerpts deemed relevant to the topic at hand, five themes emerged, some with additional subthemes. The overall themes were (1) disclosure, (2) self-removal, (3) accommodation, (4) denial, and (5) recognition of complexity. Each theme will be discussed below, as well as subthemes illustrating nuances in differing interpretations of the best ways to handle conflict situations.

Disclose Your Conflict of Interest

Of the original group of 105 response excerpts, 61 implied that the best way to handle conflicts of interest is simply to disclose them. This majority of responses was then split into four subthemes to differentiate between different reasons cited for disclosure: (1) transfer, (2) advice, (3) awareness, and (4) procedure. Responses in each subtheme are described below.

Transfer: Place the Decision in the Hands of an Authority

Of the excerpts discussing disclosure, 22 of these stated that the reason for disclosing conflicts of interest is to transfer responsibility for decision making regarding how to handle those conflicts to an authority figure or another involved party. Examples similar to excerpts for this subtheme include, “It would be appropriate to call the director and notify him of the conflict of interest. He may well say that you should not review it,” or, “The board might say that you’re right and remove you from the reviewer position, which would be good because then the decision would no longer be in your control.”

Advice: Ask an Authority What to Do

Three of the responses grouped in the disclosure theme involved telling an authority figure about the conflict interest for the purpose of garnering advice to help make a decision rather than with the goal of relinquishing control over the decision. Some examples of this subtheme include, “I would advise the chair and ask for his advice regarding whether I should review this or not,” or “I have been in situations in the past in which I have had to ask someone above me or have given advice.”

Awareness: Someone Should Know About this

Fifteen of the 61 disclosure excerpts discussed disclosing a conflict of interest simply because someone else should be aware. While this approach may imply that advice will be given or that decision responsibility will be removed, participants speaking in this theme did not explicitly state that these were the channels of reasoning they used. Examples excerpts are along the lines of, “It is important to discuss these issues with involved parties right away,” and, “He needs to tell someone that he’s volunteering for another organization.”

Procedure: Follow Guidelines for Disclosing Conflicts of Interest

Individuals in this category invoked the power of guidelines in informing their decision-making processes. Twenty-one excerpts fell into this category. Examples include, “As long as the IRB is willing to approve the study, you may just have to jump through hoops,” and, “Disclose the conflict of interest; there’s a place on the form for that.”

Removal: Take Yourself Out of the Situation Immediately

Some individuals indicated that it is appropriate to immediately remove oneself from situations in which a conflict of interest may influence decision making. Twenty-five participant excerpts fell into this category. Some examples include, “Remove yourself from the board and make sure that no further activities pose conflicts of interest,” and, “I’m not going to do this; I’m not even going to explore it. I have this other thing going on.” These excerpts, rather than illustrating that disclosure is acceptable and sufficient, take the opposite stance: That there are no appropriate ways to manage conflicts of interest other than removal.

Accommodation: Everyone Has Conflicts of Interest: Just Work Around Them

Contrastingly, seven response excerpts presented the view that conflicts of interest are a part of everyday scientific research and are not matters of concern. Examples representing this theme are as follows: “You could do much more by combining your resources with a company than you could on your own, so I would like to do as much as I can and avoid the conflict,” or, “A person without much research experience might think that someone with a conflict of interest should remove himself, but that perspective doesn’t consider the collaborative relationships between investigators.”

Denial: I Do Not Believe this is a Conflict of Interest

Five response excerpts indicated denial that a conflict of interest was present, even in scenarios that had been crafted with the purpose of including such conflicts. These participants expressed sentiments such as, “I am not sure why this represents a conflict of interest,” or, “For him to work with both groups does not seem inappropriate to me.” These individuals rejected the notion that a conflict of interest was present at all.

Recognition of Complexity: Conflicts of Interest are Difficult to Handle

The final theme identified in participant responses consisted of excerpts that essentially just recognized that conflicts of interest are challenging. Five excerpts were grouped into this category. Examples of this perspective included: “There’s a balancing act between what you may do as a private citizen and what you may be allowed to do within the bounds of your job,” and, “This is a very difficult situation at this point.” These participants often did not offer a concrete or specific solution; instead, they reacted by pointing out complexities inherent in situations involving conflicts of interest.

Before turning to the implications flowing from the present study, a number of limitations should be noted. First, because participants were aware that the effort at hand focused on ethical decision making in research, they may have felt pressure to describe conflicts of interest in a manner in keeping with their understanding of relevant ethical guidelines. However, due to the fact that some responses displayed questionable levels of concern regarding the potential consequences of conflicts of interest, it would appear that such pressure did not prevent participants from displaying views conflicting with relevant guidelines.

In addition, participants responded to questions involving pre-existing cases rather than freely discussing their own experiences regarding conflicts of interest. Nevertheless, participants addressed concerns surrounding conflicts of interest in ways that reflected what they believed to be general best practices for dealing with situations along these lines. Therefore, it is reasonable to conclude that participant responses are consistent with real-world reactions despite the use of fictional cases to prompt discussion along these lines.

Despite these limitations, the present effort offers a number of valuable insights with regard to perspectives on conflicts of interest within academia. Our first research question asked what themes would appear in the ways in which researchers viewed conflicts of interest. The most frequently appearing theme in participant responses reflects the findings previously identified by Bero et al. ( Boyd and Bero 2007 ; Glaser and Bero 2005 ). Most researchers appear to believe that it is sufficient merely to disclose conflicts of interest. This echo of previous findings serves to emphasize the conclusion that this view is widespread among research scientists. However, simply reporting a conflict of interest without any attempt to manage that potential conflict is unlikely to fully undermine the likelihood of bias creeping into scientific practice and results.

The second most prevalent theme identified in the present study included the suggestion that researchers with conflicts of interest should remove themselves immediately from the situations in question. While this extreme approach might decrease the researcher’s own potential to produce biased work, it might also result in a severe loss of relevant expertise. Thus, a more nuanced approach may be more appropriate.

A minority of participants made statements to the effect that conflicts of interest are unimportant and should be worked around. Statements in this theme represent a potentially inappropriate degree of nonchalance. However, the idea of working around conflicts of interest—or, ideally, of working to ensure that these conflicts do not bias practice or results—may have virtue.

A small number of participants rejected the idea that conflicts of interest came into play in the scenarios they read. Finally, some participants simply stated that conflicts of interest are difficult to handle without making substantial recommendations regarding appropriate next steps. While simplistic, these excerpts may represent an adaptive response to conflicts of interest. After recognizing the difficulty inherent in working with conflicts of interest, researchers may respond by creating structures of checks and balances to avoid bias due to conflicts of interest.

Our second research question asked what moral disengagement operations come into play in order to allow researchers to feel comfortable allowing conflicts of interest the potential to influence their work. Some of the themes and subthemes described above bear features displaying similarity to Bandura’s (1999) moral disengagement operations. Specifically, with regard to the theme regarding disclosure of conflict of interest, variety exists regarding the disengagement operations exhibited. Some participants discussed disclosing the conflict in order to place the decision regarding their continued participation in relevant research in the hands of an authority figure. This approach strongly resembles displacement of responsibility, where individuals place the onus of their behaviors on an authority.

Other researchers stated that conflicts of interest are acceptable as long as others are made aware. This justification displays diffusion of responsibility. If other individuals are aware of the conflict, then they too share responsibility for any bias flowing from that conflict, diminishing the extent to which the conflicted researcher is held to blame. Other participants suggested that as long as procedural guidelines for disclosing conflicts of interest are followed, there should be no problem. By suggesting that the issue at hand is the need to follow guidelines, rather than the need to avoid bias of results, participants displayed distortion of consequences, described by Bandura (1999) as minimizing or ignoring the harms of unethical actions.

Some researchers indicated that everyone has conflicts of interest, making them unimportant. Such an approach represents a sort of advantageous comparison. By comparing themselves to others who possess conflicts of interest, researchers whose responses fall in this theme justify their behavior through contrast. Finally, some individuals expressed disbelief that conflicts of interest existed in the scenarios presented. Again, this approach represents disregard for consequences, ignoring the potential negative influence of situational factors.

Given the above explanation, it would appear that certain moral disengagement mechanisms, specifically advantageous comparison, displacement of responsibility, diffusion of responsibility, and disregard or distortion of consequences, are used by researchers in order to justify the continued presence of conflicts of interest in the research domains.

The findings described above bear a number of practical implications for the control of conflicts of interest within the scientific research community. First, educating researchers with regard to ways to address conflicts of interest other than disclosure appears to be a necessary next step. For example, in addition to disclosure, researchers might be advised to build checks and balances into their research in order to address potential biases due to conflicts of interest. In addition, educating researchers regarding the moral disengagement mechanisms typically acting to reinforce the influence of conflicts of interest may help to prevent the use of these operations by researchers. Finally, given the dependence of researchers on the authority to whom conflicts of interest are disclosed to control potential bias, it may be that greater oversight of research endeavors wherein such conflicts have been reported would be of great benefit.

While the study at hand does provide useful implications with regard to the views of researchers regarding conflicts of interest, areas related to these points are much in need of future research. First, it is unclear what the best ways to manage conflicts of interest within research settings may be, once these conflicts of interest have been disclosed. Also, it remains to be seen which approaches to the management of conflicts of interest as delineated by the themes described above are the most detrimental to research efforts in terms of the amount of bias accommodated.

In conclusion, the study at hand sought to identify themes in the perspectives of faculty researchers with regard to ways to respond to conflicts of interest. Five overall themes were identified: (1) disclosure, (2) self-removal, (3) accommodation, (4) denial, and (5) recognition of complexity. The disclosure theme was further broken into four subthemes: (1) transfer, (2) advice, (3) awareness, and (4) procedure. In addition, moral disengagement operations ( Bandura 1999 ) were offered as explanations for these themes in faculty perceptions. It is our hope that the present study will provide insight with regard to the best ways to combat the increasing prevalence of conflicts of interest in research.

Acknowledgments

We thank T. H. Lee Williams for his contributions to this effort. Parts of this work were sponsored by Grant No. R21 ES021075-01 from the National Institutes of Health.

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EDITORIAL article

Editorial: pathophysiology and management of amenorrhea and estradiol deficiency in girls and young women.

• 1 Digital Women's Health Initiative, Mary Elizabeth Conover Foundation, Tysons, VA, United States
• 2 Department of Obstetrics and Gynecology, University of Colorado-Anschutz Medical Campus, Denver, CO, United States

Editorial on the Research Topic Pathophysiology and management of amenorrhea and estradiol deficiency in girls and young women

Developmental endocrinology and women’s health

Developmental endocrinology is a fascinating and mature field that investigates the role of hormones in the growth and development of living organisms. Hormones influence various life processes, from the earliest stages of life to old age. As a study of bodily communication at the cellular and humoral level, it integrates all aspects of health. As such, women’s healthcare and research find a comfortable home here. As a multidisciplinary field, developmental endocrinology draws on knowledge and uses tools from several other areas, including developmental biology, genetics, physiology, and neuroscience. All these approaches unlock new insights into interactions involving growth and development, reproduction, metabolism, and behavior, all as influenced by hormonal action. Developmental endocrinology will continue to shed light on how hormones impact health and disease across the lifespan, and its enormous translational value makes it a crucial area of research that supports the health of women. Despite advances in the field, it is important to acknowledge that there has been a shortfall in investment in women’s health overall, including underinvestment in research in the specific context of women’s reproduction.

A crisis in women’s health care and research

The historical underinvestment in women’s healthcare and research is attracting increasing attention and can be recognized as a core disparity in need of redress. The World Economic Forum has declared that women are second-class citizens when it comes to health. According to their analysis, closing the gap in care could be worth $1 trillion annually by 2040 ( 1 , 2 ), in part because women’s health and women’s economic development are inextricably linked ( 3 ). In one specific example of a critical health disparity, young women experiencing myocardial infarction have an 84.3% higher mortality rate than young men ( 4 ). Such an enormously elevated risk of death points toward the critical need to better understand the sex differences in the biology of disease and improve care delivery for women. Consider that the NIH allocates only 11% of its budget to women’s health-specific research in the US ( 5 ). Such poor funding for women’s health research has resulted in health gaps like that seen for myocardial infarction that can only be addressed by additional funding and new business models to support gender-appropriate care. Although data about the financing of women’s health research could be more comprehensive and precise, public funding is the primary support mechanism. Creative ways to bolster funding are being considered across public and commercial research channels ( 6 – 10 ).

One report within this Research Topic, A Call for a US National Institute of Women’s Health and Human Development ( Nelson ), calls for a social enterprise approach to women’s health to synergize with government funding. Private equity and venture capital investments in women’s health are proliferating as opportunities in women’s health become more evident and more technology startups by women set out to disrupt the healthcare market. Within the feminine tech (“FemTech”) space, there is a concentration of activity concerning hormone replacement, consumer menstrual products, gynecological devices, fertility solutions, and maternal health patient support ( 7 ).

Another report herein, My 28 Days - a global digital women’s health initiative for evaluation and management of secondary amenorrhea: case report and literature review ( Nelson et al. ), suggests that digital health is another potential avenue for innovation, with the potential to make health more equitable ( 6 ) ( Figure 1 ). Feminine tech companies received only 3% of the total digital health funding, indicating the need for more investment in this space ( 7 ). Given the significant unmet need and resulting opportunity, those who continue to forgo investing in women’s health may find themselves left behind by the players that tap into this high-potential market. Having summarized the information in the above reports about the need for more and more thoughtful investment in women’s health research, we turn to the Research Topic’s entries that mainly focus on the endocrinology of ovarian insufficiency.

Figure 1 A global digital community provides more efficient information integration ( 6 ).

In Chronic and Cumulative Adverse Life Events in Women with Primary Ovarian Insufficiency: An Exploratory Qualitative Study ( Sun et al. ), the authors’ findings are consistent with the hypothesis that adverse life events play a role in the development of POI ( 5 ). Linking adverse life events with the pathophysiological outcome of accelerated ovarian demise is a direct example of how “women’s health and women’s economic [status] are inextricably linked,” considering that socioeconomic status can strongly correspond to the incidence of adverse life events ( 11 ). The authors indicate a need for more research in this area.

17-beta-estradiol deficiency

A unifying theme of several entries in this Research Topic is the hormone 17-Beta-Estradiol, the most potent naturally circulating and clinically significant estrogen. As noted in The Truth about 17-Beta Estradiol: Menopause beyond “Old Wives’ Tales ( Nelson ), 17-Beta-Estradiol production depends on complex interactions involving the hypothalamic-pituitary-ovarian axis supporting the growth and development of ovarian follicles. ( Figure 2 ) Recent studies have found that 17-Beta-Estradiol can rapidly activate cell signaling via membrane receptors and is involved in brain processes.

Figure 2 Menarche and the maintenance of normal regular menses require normal function of the hypothalamic-pituitary-ovarian axis. GnRH neurons located in the hypothalamus produce regular pulses of GnRH at set intervals determined by estradiol and progesterone levels. These GnRH pulses are required for the synthesis, storage, and release of FSH and LH by the anterior pituitary. Estradiol provides negative feedback to the central axis during follicular growth. This then switches to positive feedback under the influence of the preovulatory estradiol surge. This positive feedback induces the LH surge, which in turn induces ovulation. My 28 Days - a global digital women’s health initiative for evaluation and management of secondary amenorrhea: case report and literature review ( Nelson et al. ).

Preclinical studies in rodents have shown that estradiol can improve working and reference memory and decrease anxiety-like behaviors. Women receiving estradiol exhibit changes in frontal activation during working memory tasks. Adolescent girls and young women deficient in circulating estradiol need estradiol replacement therapy to develop and maintain secondary sex characteristics and bone mass. Women deficient in estradiol are at risk of significant morbidity and mortality related to osteoporosis, cardiovascular disease, and dementia, and even a shortened life expectancy. The best evidence supports using a physiologic approach to replacing 17-Beta-Estradiol by transdermal or transvaginal administration to avoid the “first pass hepatic effects” of oral estrogen administration.

In Abnormal Trabecular Bone Score, Lower Bone Mineral Density and Lean Mass in Young Women With Premature Ovarian Insufficiency (POI) Are Prevented by Oestrogen Replacement, Samad et al. found deficits in BMD, trabecular microarchitecture, and lean mass in women with POI. However, hormone replacement protects against declines in these variables. Their evidence supports assessing skeletal and muscle health in POI and the importance of hormonal replacement.

Huang et al. studied Lipid Profile in Patients With Primary Ovarian Insufficiency: A Systematic Review and Meta-Analysis and demonstrated that total cholesterol, triglycerides, and LDL levels were significantly higher in women with POI than controls. The authors recommend early medical intervention to minimize the risk of CVD morbidity and mortality associated with dyslipidemia in women with POI. Qiu et al. in Comparison of the reproductive outcome between 2 and 4 mg daily doses of estradiol after hysteroscopic adhesiolysis: a propensity score matching analysis-retrospective cohort study found no significant difference in outcome between the two groups. They suggest using the lower dose (2 mg) to minimize side effects.

What about progesterone?

In Adaptive, reversible, hypothalamic reproductive suppression: More than functional hypothalamic amenorrhea , Prior suggests that current concepts of menstrual and ovulation suppressions in women need to be redefined as a continuum that may in some cases be protective, adaptive, and potentially reversible. The work indicates that treatments for these conditions must be updated to fit these new concepts. The article suggests further research on using cyclic progesterone as a therapy and recommends prospective, randomized, controlled trials to investigate this avenue. Overall, this new understanding of women’s reproductive disturbances may provide a positive and more science-based approach to women’s hormonal health ( 12 ).

A final note

Findings in women’s health research, whether supported by public, private, or hybrid funding mechanisms, continue to be translated to the clinical arena. This Research Topic includes several examples where endocrinological interventions are supported as strategies to improve women’s health and well-being. Specifically with regards to POI and the loss of endogenous ovarian hormone production, we note that more and more clinically actionable information continues to be produced about how HRT can be used to alleviate symptoms and improve health. We must press for increased public funds for women’s health research to correct obvious and impactful health disparities between women and men, and creative partnerships between public and private entities are an additional way we can continue to narrow the gap.

Author contributions

LN: Writing – review & editing, Writing – original draft, Visualization, Resources, Project administration, Investigation, Formal Analysis, Conceptualization. JJ: Writing – review & editing.

Conflict of interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Publisher’s note

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.

1. Available online at: https://www.weforum.org/agenda/2024/01/women-healthcare-gap/ .

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2. Available online at: https://www.mckinsey.com/mhi/our-insights/closing-the-womens-health-gap-a-1-trillion-dollar-opportunity-to-improve-lives-and-economies .

3. Available online at: https://www.gatesfoundation.org/ideas/articles/womens-health-economic-power .

4. Song PS, Kim MJ, Seong SW, Choi SW, Gwon HC, Hur SH, et al. Gender differences in all- cause mortality after acute myocardial infarction: evidence for a gender-age interaction. J Clin Med . (2022) 11:541. doi: 10.3390/jcm11030541

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6. Nelson L. Primary Ovarian Insufficiency: A new paradigm for care and research. Res Features . (2024) 151. doi: 10.26904/RF-151-6106349171

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7. Available online at: https://www.mckinsey.com/industries/healthcare/our-insights/the-dawn-of-the-femtech-revolution .

8. Available online at: https://www.forbes.com/sites/dariashunina/2024/02/09/femtech-startups-uphill-battle-for—funding/?sh=344cafa15d27 .

9. Available online at: https://premier-research.com/learnings-insights/therapeutic-and-special-population-expertise/womens-health-clinical-trial-expertise .

10. Available online at: https://arpa-h.gov/news-and-events/arpa-h-announces-sprint-womens-health .

11. Verbeek T, Bockting CLH, Beijers C, Meijer JL, van Pampus MG, Burger H. Low socioeconomic status increases effects of negative life events on antenatal anxiety and depression. Women Birth . 2019 Feb;32(1):e138-e143. doi: 10.1016/j.wombi.2018.05.005

12. Cable JK, Grider MH. Physiology, Progesterone. In: StatPearls . (2023) StatPearls Publishing, Treasure Island (FL.

Keywords: women’s hormonal health, 17-beta-estradiol, 17-beta-estradiol deficiency, amenorrhea, women’s health advocacy, women’s health policy, primary ovarian insufficiency, physiologic hormone replacement therapy (P-HRT)

Citation: Nelson LM and Johnson J (2024) Editorial: Pathophysiology and management of amenorrhea and estradiol deficiency in girls and young women. Front. Endocrinol. 15:1397210. doi: 10.3389/fendo.2024.1397210

Received: 07 March 2024; Accepted: 10 April 2024; Published: 22 April 2024.

Edited and Reviewed by:

Copyright © 2024 Nelson and Johnson. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence: Lawrence M. Nelson, [email protected]

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

Money latest: The 'German classic' that's a healthier and cheaper alternative to crisps

Crisps are on the menu as we see where you can make healthier choices for the best value. Elsewhere, the boss of Sainsbury's has insisted customers like self-checkouts - do you agree? Leave your thoughts in the box below.

Friday 26 April 2024 19:45, UK

• New research reveals cost of having children
• Sainsbury's boss insists customers like self-checkouts
• FTSE 100 hits another record high
• Halifax hikes mortgage rates - as entire market moves upwards

Essential reads

• Do smart meters actually save you money?
• How to buy the least unhealthy crisps
• The world of dark tourism - what is it, is it ethical and where can you go?
• Money Problem : I have a mortgage offer - will it change now rates are rising?
• Savings Guide : Why locking into fixed-rate bond could be wise move
• Cheap Eats : Michelin chef's secret lasagne tip - and expensive ingredient you shouldn't use

Ask a question or make a comment

The family home where Captain Sir Tom Moore walked 100 laps to raise nearly £40m for the NHS during the first COVID lockdown is up for sale for £2.25m.

The Grade II-listed Old Rectory is described as a "magnificent seven-bedroom property" by estate agents Fine & Country.

In a video tour of the house, a sculpture of Captain Tom with his walking frame can be seen in the hallway, while a photo of the fundraising hero being knighted by the Queen is on a wall in the separate coach house building.

Introducing the property, an estate agent says in the tour video: "I'm sure you'll recognise this iconic and very famous driveway behind me as it was home to the late Captain Sir Tom Moore who walked 100 laps of his garden, raising over £37m for NHS charities."

It comes less than three months after the demolition of an unauthorised spa pool block in the grounds of the property in Marston Moretaine, Bedfordshire.

Speaking at an appeal hearing over that spa, Scott Stemp, representing Captain Tom's daughter Hannah Ingram-Moore and her husband, said the foundation named after the fundraising hero "is to be closed down" following a Charity Commission probe launched amid concerns about its management.

For the full story, click here ...

"Status symbol" pets are being given up by owners who get scared as they grow up, an animal charity has said, with the cost of living possibly paying a part in a rise in separations.

The Exotic Pet Refuge, which homes parrots, monkeys, snakes and alligators among others, says it receives referrals across the country, including from zoos and the RSPCA.

"They're a status symbol. People will say, 'OK, I'll have an alligator or a 10ft boa constrictor'," co-owner Pam Mansfield told the BBC.

"But when the animal gets big, they will get too frightened to handle them, and then the pet has to go."

She added people who want to get rid of the pets sometimes call zoos for help, which then call on her charity.

In some cases, owners don't have licences to own dangerous animals, she says, blaming a "lack of understanding" for what she says is a rise in the number of exotic animals needing to be rehomed.

She says people "just don't have the space" for some snakes, for example, with some growing to as much as 12ft and needing their own room.

The cost of living crisis has also forced owners to give their pets away, she says.

Her charity has also been affected by those increased costs, with the electricity bill rising to £10,000 a month at their highest, to fund things like heated pools for alligators.

Private car parks are accused of "confusing drivers" after introducing a new code of conduct - despite "doing all they can" to prevent an official government version.

The code of practice launched by two industry bodies - British Parking Association and the International Parking Community - includes a ten-minute grace period for motorists to leave a car park after the parking period they paid for ends.

It also features requirements for consistent signage, a single set of rules for operators on private land and an "appeals charter".

Private parking businesses have been accused of using misleading and confusing signs, aggressive debt collection and unreasonable fees.

That comes after a government-backed code of conduct was withdrawn in June 2022, after a legal challenges by parking companies.

RAC head of policy Simon Williams said: "We're flabbergasted that the BPA and the IPC have suddenly announced plans to introduce their own private parking code after doing all they can over the last five years to prevent the official government code created by an act of Parliament coming into force.

"While there are clearly some positive elements to what the private parking industry is proposing, it conveniently avoids some of the biggest issues around caps on penalty charges and debt recovery fees which badly need to be addressed to prevent drivers being taken advantage of."

BPA chief executive Andrew Pester said: "This is a crucial milestone as we work closely with government, consumer bodies and others to deliver fairer and more consistent parking standards for motorists."

IPC chief executive Will Hurley said: "The single code will benefit all compliant motorists and will present clear consequences for those who decide to break the rules."

Sky News has learnt the owner of Superdry's flagship store is weighing up a legal challenge to a rescue plan launched by the struggling fashion retailer.

M&G, the London-listed asset manager, has engaged lawyers from Hogan Lovells to scrutinise the restructuring plan.

The move by M&G, which owns the fashion retailer's 32,000 square foot Oxford Street store, will not necessarily result in a formal legal challenge - but sources say it's possible.

Read City editor Mark Kleinman 's story here...

NatWest says its mortgage lending nearly halved at the start of the year as it retreated from parts of the market when competition among lenders stepped up.

New mortgage lending totalled £5.2bn in the first three months of 2024, the banking group has revealed, down from £9.9bn the previous year.

The group, which includes Royal Bank of Scotland and Coutts, also reported an operating pre-tax profit of £1.3bn for the first quarter, down 27% from £1.8bn the previous year.

An unexplained flow of British luxury cars into states neighbouring Russia continued into February, new data shows.

About £26m worth of British cars were exported to Azerbaijan, making the former Soviet country the 17th biggest destination for UK cars - bigger than long-established export markets such as Ireland, Portugal and Qatar.

Azerbaijan's ascent has coincided almost to the month with the imposition of sanctions on the export of cars to Russia.

Read the rest of economics and data editor Ed Conway 's analysis here...

Rishi Sunak has hailed the arrival of pay day with a reminder his government's additional National Insurance tax cut kicks in this month for the first time.

At last month's budget, the chancellor announced NI will be cut by a further 2p - so some workers will pay 8% of their earnings instead of the 12% if was before autumn.

The prime minister has repeated his claim this will be worth £900 for someone on the average UK salary.

While this additional cut - on top of the previous 2p cut in January - does equate to £900 for those on average full-time earnings of £35,000, there are two key issues with Mr Sunak's claim:

• Once the effect of all income tax changes since 2021 are taken into account, the Institute for Fiscal Studies reports an average earner will benefit from a tax cut of £340 - far less than £900;
• Moreover, anyone earning less than £26,000 or between £55,000-£131,000 will ultimately be worse off.

In short, this is because NI cuts are more than offset by other tax rises.

We explain below how this is the case...

Tax thresholds

This is partly down to tax thresholds - the amount you are allowed to earn before you start paying tax (and national insurance) and before you start paying the higher rate of tax - will remain frozen. 

This means people end up paying more tax than they otherwise would, when their pay rises with inflation but the thresholds don't keep up. 

This phenomenon is known as "fiscal drag" and it's often called a stealth tax because it's not as noticeable immediately in your pay packet.

That low threshold of £12,570 has been in place since April 2021. 

The Office for Budget Responsibility says if it had increased with inflation it would be set at £15,220 for 2024/25.

If that were the case, workers could earn an extra £2,650 tax-free each year.

Less give, more take

Sky News analysis shows someone on £16,000 a year will pay £607 more in total - equivalent to more than three months of average household spending on food. 

Their income level means national insurance savings are limited but they are paying 20% in income tax on an additional £2,650 of earnings.

In its analysis , the IFS states: "In aggregate the NICs cuts just serve to give back a portion of the money that is being taken away through other income tax and NICs changes - in particular, multi-year freezes to tax thresholds at a time of high inflation."

Overall, according to the institute, for every £1 given back to workers by the National Insurance cuts, £1.30 will have been taken away due to threshold changes between 2021 and 2024.

This rises to £1.90 in 2027.

The UK could face a shortage of cava due to a drought in the sparkling wine's Spanish heartlands.

The Penedes area of Catalonia is dealing with its worst drought on record, with vineyards across the region so parched the roots of 30-year-old vines have died.

It's left shrivelled red and green grapes languishing under intense sun, fuelled by fossil-fuel driven climate change.

Cava is an increasingly popular drink in the UK, with 17.8 million bottles sold in 2023 - an increase of 5% from the previous year, when Britons stocked up on 16.8 million bottles, according to the Cava Regulatory Board.

That makes the UK the fourth-biggest buyer, behind only the US, Belgium and Germany.

Workforce slashed

The problems have been compounded after Catalonia-based cava producer Freixenet announced it will temporarily lay off 615 workers, almost 80% of its workforce.

Under Spanish law, companies facing exceptional circumstances can lay off staff or reduce working hours.

This measure is expected to take effect from May and it is not known how long it will last.

Price rises

One industry source told retail publication The Grocer  that cava shortages would push up prices "certainly for next year" if there isn't enough supply.

This could last for years if the drought persists, they added.

Consumer expert Helen Dewdney told MailOnline the staff cuts at Freixenet can only mean one thing - price rises.

However, she added, supermarkets say they are not experiencing any issues right now.

Parents are being hammered by rising childcare costs, according to a new study that suggests they may spend more than £160,000 raising their child to the age of 18.

Research by Hargreaves Lansdown has found that parents with children pay £6,969 a year more than couples without.

Over 18 years and assuming an annual inflation rate of 3%, that amounts to a whopping £163,175, the investment platform said.

Its study also found that parents were less likely to have money left at the end of the month.

Single parents carry the biggest burden, with the research suggesting they have just £85 left on average compared to £365 for couples with children.

Hargreaves Lansdown also found just 23% of single parents reported having enough emergency savings to cover at least three months' worth of essential expenses, compared to 63% of couples with children.

Parents are also at a slight disadvantage when it comes to pensions, the research found, with only 43% of couples with children on track for a moderate retirement income, compared to 47% without. Only 17% of single parents have a decent projected pension fund.

Sarah Coles, head of personal finance at the firm, said "having children is one of the most expensive decisions a person can make".

She adds that as a result of having a child, "financial resilience suffers across the board", and added: "For single parents, life is even tougher, and they face far lower resilience on almost every measure.

"It means we need all the help we can get."

By Daniel Binns, business reporter

One of the top stories shaking up the markets this morning is that UK-based mining company Anglo American has rejected a major $38.8bn (£31bn) takeover bid.

Details of the attempted buyout by Australian rival BHP emerged yesterday  - sending Anglo American shares soaring.

The deal would have created the world's biggest copper mining company - with the news coming as the price of the metal hit record highs this week.

However, Anglo American has now dismissed the proposal as "opportunistic" and said BHP had undervalued the company.

Anglo's shares are slightly down by 0.8% this morning - suggesting investors may not have given up hopes that a deal could eventually be agreed.

However, overall the FTSE 100 is up around 0.4% this morning, buoyed by strong reported earnings from US tech giants Microsoft and Google owner Alphabet.

It's helped the index, of the London Stock Exchange's 100 most valuable companies, hit yet another intraday (during the day) record of 8,136 points this morning.

The winning streak comes after a week of all-time highs on the index - including a record close of 8,078 points yesterday. The score is based on a calculation of the total value of the shares on the index.

Among the companies doing well this morning is NatWest - despite the bank reporting a fall in pre-tax profits of nearly 28% for the first quarter of the year.

Shares in the lender are up more than 3% after its results were better than expected by analysts.

On the currency markets, £1 buys $1.25 US or €1.16, almost on a par with yesterday.

Meanwhile, the price of a barrel of Brent crude oil has crept up slightly to $89 (£71).

Self-checkouts - they're like marmite, people seem to either love them or hate them.

But the boss of Sainsbury's has claimed that his customers do  enjoy using self-checkouts, despite criticism that that machines don't always provide the convenience promised.

Simon Roberts told The Telegraph that there are more of them in Sainsbury's stores "than a number of years ago" as shoppers like the "speedy checkout".

But despite this, he said there won't be a time when they'll replace cashiers completely.

"Over the last year, where we've put more self-checkouts in, we're always making sure that the traditional kind of belted checkout is there," he said.

His comments come after northern supermarket Booths ditched self-checkouts at all but two of its sites after customer feedback. 

Walmart and Costco in the US have also scaled back on the systems.

Let us know in the comments - do you love or hate self-checkouts?

We've all heard consumer advice that's repeated so often it almost becomes cliché. So, every Friday the Money team will get to the bottom of a different "fact" and decide whether it's a myth or must.

This week it is...

'Smart meters save you money'

For this one, we've enlisted the help of Dr Steve Buckley, also known as the Energy Doctor and head of data science at Loop...

So do smart meters help you save? 

"The short answer is both yes and no," Steve says.

"Installing a smart meter by itself won't magically reduce your energy consumption. But, by giving you easy access to your energy usage data, smart meters pave the way for savings that you couldn't achieve otherwise."

Before smart meters, most households only found out how much energy they had used when the bill arrived. 

By that stage it's too late to address wasteful usage, leading to what's known as "bill shock". 

"With a smart meter, you can see your usage and costs in real-time through an in-home display or an app provided by your supplier," Steve says. 

"This immediate feedback encourages you to use less energy. If you measure it, you can control it."

In 2022, the Department for Energy Security and Net Zero found that homes with smart meters used about 3.4% less electricity and 3% less gas. 

"This might not seem like a lot, but it adds up to a saving of over £50 per household annually," Steve says.  

If all homes in the UK made similar cuts, that would amount to savings of around £1.5bn and a potential reduction in CO2 emissions by about 2.7m tonnes each year. 

"Good for individual households but also great for the planet," Steve says. 

Smart meters are often installed at no extra cost to the consumer - it's effectively free data for households. 

Limitations

Smart meters are more or less what you make of them - a simple, free tool that allows you to see headline figures. 

However, "without detailed analysis, it's tough to identify and eliminate" where you could be wasting money, Steve says. 

Apps like Utrack, Loop and Hugo Energy can help you work out where you might be losing money by offering a more detailed breakdown if connected to your smart meter. 

Those tools are often free, but you may need to register your card details as proof of address. 

The tools give a number of useful insights, including looking at consumption in other households of similar size or monitoring where chunks of your money are going, such as to a faulty boiler or the "phantom load" (energy wasted by devices left on unnecessarily).

Myth or must?

Although smart meters alone don't reduce energy bills, they are a vital tool to help energy efficiency and cost savings. 

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