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Series: Practical guidance to qualitative research. Part 5: Co-creative qualitative approaches for emerging themes in primary care research: Experience-based co-design, user-centred design and community-based participatory research

Affiliations.

1 Research Centre Autonomy and Participation of Chronically Ill People, Zuyd University of Applied Sciences, Heerlen, The Netherlands.
2 Department of Family Medicine, Maastricht University, Maastricht, The Netherlands.
3 Research Centre for Midwifery Science, Zuyd University of Applied Sciences, Maastricht, The Netherlands.
PMID: 35037811
PMCID: PMC8765256
DOI: 10.1080/13814788.2021.2010700

This article, the fifth in a series aiming to provide practical guidance for qualitative research in primary care, introduces three qualitative approaches with co-creative characteristics for addressing emerging themes in primary care research: experience-based co-design, user-centred design and community-based participatory research. Co-creation aims to define the (research) problem, develop and implement interventions and evaluate and define (research and practice) outcomes in partnership with patients, family carers, researchers, care professionals and other relevant stakeholders. Experience-based co-design seeks to understand how people experience a health care process or service. User-centred design is an approach to assess, design and develop technological and organisational systems, for example, eHealth, involving end-users in the design and decision-making processes. Community-based participatory research is a collaborative approach addressing a locally relevant health issue. It is often directed at hard-to-reach and vulnerable people. We address the context, what, why, when and how of these co-creative approaches, and their main practical and methodological challenges. We provide examples of empirical studies using these approaches and sources for further reading.

Keywords: Primary care; co-creation; eHealth; patient and public involvement; qualitative research.

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The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.

Phases and teams in experience-based…

Phases and teams in experience-based co-design. Based on Bate and Roberts [16].

Phases of community-based participatory research.…

Phases of community-based participatory research. Based on Israel et al. [44].

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Overview of the Research Process

First Online: 01 January 2012

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Research is a rigorous problem-solving process whose ultimate goal is the discovery of new knowledge. Research may include the description of a new phenomenon, definition of a new relationship, development of a new model, or application of an existing principle or procedure to a new context. Research is systematic, logical, empirical, reductive, replicable and transmittable, and generalizable. Research can be classified according to a variety of dimensions: basic, applied, or translational; hypothesis generating or hypothesis testing; retrospective or prospective; longitudinal or cross-sectional; observational or experimental; and quantitative or qualitative. The ultimate success of a research project is heavily dependent on adequate planning.

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Supino, P.G. (2012). Overview of the Research Process. In: Supino, P., Borer, J. (eds) Principles of Research Methodology. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-3360-6_1

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The language of research (part 5): research terminology — validity

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What Is Qualitative Research? | Methods & Examples

What Is Qualitative Research? | Methods & Examples

Published on June 19, 2020 by Pritha Bhandari . Revised on June 22, 2023.

Qualitative research involves collecting and analyzing non-numerical data (e.g., text, video, or audio) to understand concepts, opinions, or experiences. It can be used to gather in-depth insights into a problem or generate new ideas for research.

Qualitative research is the opposite of quantitative research , which involves collecting and analyzing numerical data for statistical analysis.

Qualitative research is commonly used in the humanities and social sciences, in subjects such as anthropology, sociology, education, health sciences, history, etc.

How does social media shape body image in teenagers?
How do children and adults interpret healthy eating in the UK?
What factors influence employee retention in a large organization?
How is anxiety experienced around the world?
How can teachers integrate social issues into science curriculums?

Approaches to qualitative research, qualitative research methods, qualitative data analysis, advantages of qualitative research, disadvantages of qualitative research, other interesting articles, frequently asked questions about qualitative research.

Qualitative research is used to understand how people experience the world. While there are many approaches to qualitative research, they tend to be flexible and focus on retaining rich meaning when interpreting data.

Common approaches include grounded theory, ethnography , action research , phenomenological research, and narrative research. They share some similarities, but emphasize different aims and perspectives.

Qualitative research approaches
Approach	What does it involve?
Grounded theory	Researchers collect rich data on a topic of interest and develop theories .
	Researchers immerse themselves in groups or organizations to understand their cultures.
Action research	Researchers and participants collaboratively link theory to practice to drive social change.
Phenomenological research	Researchers investigate a phenomenon or event by describing and interpreting participants’ lived experiences.
Narrative research	Researchers examine how stories are told to understand how participants perceive and make sense of their experiences.

Note that qualitative research is at risk for certain research biases including the Hawthorne effect , observer bias , recall bias , and social desirability bias . While not always totally avoidable, awareness of potential biases as you collect and analyze your data can prevent them from impacting your work too much.

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Each of the research approaches involve using one or more data collection methods . These are some of the most common qualitative methods:

Observations: recording what you have seen, heard, or encountered in detailed field notes.
Interviews: personally asking people questions in one-on-one conversations.
Focus groups: asking questions and generating discussion among a group of people.
Surveys : distributing questionnaires with open-ended questions.
Secondary research: collecting existing data in the form of texts, images, audio or video recordings, etc.
You take field notes with observations and reflect on your own experiences of the company culture.
You distribute open-ended surveys to employees across all the company’s offices by email to find out if the culture varies across locations.
You conduct in-depth interviews with employees in your office to learn about their experiences and perspectives in greater detail.

Qualitative researchers often consider themselves “instruments” in research because all observations, interpretations and analyses are filtered through their own personal lens.

For this reason, when writing up your methodology for qualitative research, it’s important to reflect on your approach and to thoroughly explain the choices you made in collecting and analyzing the data.

Qualitative data can take the form of texts, photos, videos and audio. For example, you might be working with interview transcripts, survey responses, fieldnotes, or recordings from natural settings.

Most types of qualitative data analysis share the same five steps:

Prepare and organize your data. This may mean transcribing interviews or typing up fieldnotes.
Review and explore your data. Examine the data for patterns or repeated ideas that emerge.
Develop a data coding system. Based on your initial ideas, establish a set of codes that you can apply to categorize your data.
Assign codes to the data. For example, in qualitative survey analysis, this may mean going through each participant’s responses and tagging them with codes in a spreadsheet. As you go through your data, you can create new codes to add to your system if necessary.
Identify recurring themes. Link codes together into cohesive, overarching themes.

There are several specific approaches to analyzing qualitative data. Although these methods share similar processes, they emphasize different concepts.

Qualitative data analysis
Approach	When to use	Example
	To describe and categorize common words, phrases, and ideas in qualitative data.	A market researcher could perform content analysis to find out what kind of language is used in descriptions of therapeutic apps.
	To identify and interpret patterns and themes in qualitative data.	A psychologist could apply thematic analysis to travel blogs to explore how tourism shapes self-identity.
	To examine the content, structure, and design of texts.	A media researcher could use textual analysis to understand how news coverage of celebrities has changed in the past decade.
	To study communication and how language is used to achieve effects in specific contexts.	A political scientist could use discourse analysis to study how politicians generate trust in election campaigns.

Qualitative research often tries to preserve the voice and perspective of participants and can be adjusted as new research questions arise. Qualitative research is good for:

Flexibility

The data collection and analysis process can be adapted as new ideas or patterns emerge. They are not rigidly decided beforehand.

Natural settings

Data collection occurs in real-world contexts or in naturalistic ways.

Meaningful insights

Detailed descriptions of people’s experiences, feelings and perceptions can be used in designing, testing or improving systems or products.

Generation of new ideas

Open-ended responses mean that researchers can uncover novel problems or opportunities that they wouldn’t have thought of otherwise.

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Researchers must consider practical and theoretical limitations in analyzing and interpreting their data. Qualitative research suffers from:

Unreliability

The real-world setting often makes qualitative research unreliable because of uncontrolled factors that affect the data.

Subjectivity

Due to the researcher’s primary role in analyzing and interpreting data, qualitative research cannot be replicated . The researcher decides what is important and what is irrelevant in data analysis, so interpretations of the same data can vary greatly.

Limited generalizability

Small samples are often used to gather detailed data about specific contexts. Despite rigorous analysis procedures, it is difficult to draw generalizable conclusions because the data may be biased and unrepresentative of the wider population .

Labor-intensive

Although software can be used to manage and record large amounts of text, data analysis often has to be checked or performed manually.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

Chi square goodness of fit test
Degrees of freedom
Null hypothesis
Discourse analysis
Control groups
Mixed methods research
Non-probability sampling
Quantitative research
Inclusion and exclusion criteria

Research bias

Rosenthal effect
Implicit bias
Cognitive bias
Selection bias
Negativity bias
Status quo bias

Quantitative research deals with numbers and statistics, while qualitative research deals with words and meanings.

Quantitative methods allow you to systematically measure variables and test hypotheses . Qualitative methods allow you to explore concepts and experiences in more detail.

There are five common approaches to qualitative research :

Grounded theory involves collecting data in order to develop new theories.
Ethnography involves immersing yourself in a group or organization to understand its culture.
Narrative research involves interpreting stories to understand how people make sense of their experiences and perceptions.
Phenomenological research involves investigating phenomena through people’s lived experiences.
Action research links theory and practice in several cycles to drive innovative changes.

Data collection is the systematic process by which observations or measurements are gathered in research. It is used in many different contexts by academics, governments, businesses, and other organizations.

There are various approaches to qualitative data analysis , but they all share five steps in common:

Prepare and organize your data.
Review and explore your data.
Develop a data coding system.
Assign codes to the data.
Identify recurring themes.

The specifics of each step depend on the focus of the analysis. Some common approaches include textual analysis , thematic analysis , and discourse analysis .

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This new collection of articles on participatory research from new generation of researcher-activists is heartily welcome. With a wide variety of epistemological and contextual locations, the collection will inspire continued creativity and plurality in the elaboration of participatory research. Hopefully, the transformational potential of participatory research will begin to contribute to post-pandemic, resilient and fairer reconstruction of societies around the world.

Recognising the ever-pressing need for research approaches that can assist, support, or facilitate processes of social transformation across different contexts, problems, inequalities, exclusions, and injustices, the editors and authors of The SAGE Handbook of Participatory Research and Inquiry exhibit the historical trajectories, wealth, diversity, and practicalities of participatory research. In traversing the roots of participatory research through its progression and expansion with theoretical orientations, political and ethical commitments, contextual and disciplinary articulations, and specific methods, readers can find exceptional coverage of past and current iterations of the research practice recognised broadly under the umbrella of participatory research. This text is a valuable guiding resource for researchers, doctoral students, and all who undertake participatory research and its many and varied forms, aims, subtleties, challenges, and potentials.

Achieving the 2030 Agenda for Sustainable Development and meeting commitments to the Paris Agreement requires impactful solutions that reach the poorest and most marginalized to deliver on the promise of the SDGs to leave no one behind. With the COVID-19 pandemic and its impacts on rising poverty and hunger, the climate crisis and increasing environmental pressures, we must redouble our efforts to achieve our goals. This requires drawing on the richness of ideas and experiences across communities, including young people, women and girls and indigenous peoples, for a deeper understanding of their challenges and what works in practice to overcome them, so we can act on that knowledge to create a sustainable and inclusive future for all.

Participatory research is an essential tool to deliver on that objective. Participatory research sets out open and inclusive approaches that engage the poorest and most marginalized – so we can gain knowledge and understanding of the issues that affect their lives and turn those into action. Participatory research empowers young people to learn and apply research techniques to discover solutions for their own issues – grounded in the belief that youth are valuable experts and that power between youth and adults should be shared. It can support governments in establishing better ways of listening to people whom they are meant to serve and taking their views into account, especially groups that are frequently overlooked. This is essential to rebuild trust and foster a renewed social contract between governments and their people and within societies.

This Handbook provides a comprehensive overview of different participatory research methods that researchers with varied expertise in the field can use to support the type of social transformation that we need. I encourage all researchers to make full use of it to accelerate achievement of the SDGs and fulfil the Paris Agreement towards a better, more sustainable and peaceful future for our people and planet.

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ACM SIGSOFT Software Engineering Notes

This article is the fifth installment of our series of articles on survey research. In it, we discuss what we mean by a population and a sample and the implications of each for survey research. We provide examples of correct and incorrect sampling techniques used in software engineering surveys.

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A research problem is a definite or clear expression [statement] about an area of concern, a condition to be improved upon, a difficulty to be eliminated, or a troubling question that exists in scholarly literature, in theory, or within existing practice that points to a need for meaningful understanding and deliberate investigation. A research problem does not state how to do something, offer a vague or broad proposition, or present a value question. In the social and behavioral sciences, studies are most often framed around examining a problem that needs to be understood and resolved in order to improve society and the human condition.

Bryman, Alan. “The Research Question in Social Research: What is its Role?” International Journal of Social Research Methodology 10 (2007): 5-20; Guba, Egon G., and Yvonna S. Lincoln. “Competing Paradigms in Qualitative Research.” In Handbook of Qualitative Research . Norman K. Denzin and Yvonna S. Lincoln, editors. (Thousand Oaks, CA: Sage, 1994), pp. 105-117; Pardede, Parlindungan. “Identifying and Formulating the Research Problem." Research in ELT: Module 4 (October 2018): 1-13; Li, Yanmei, and Sumei Zhang. "Identifying the Research Problem." In Applied Research Methods in Urban and Regional Planning . (Cham, Switzerland: Springer International Publishing, 2022), pp. 13-21.

Importance of...

The purpose of a problem statement is to:

Introduce the reader to the importance of the topic being studied . The reader is oriented to the significance of the study.
Anchors the research questions, hypotheses, or assumptions to follow . It offers a concise statement about the purpose of your paper.
Place the topic into a particular context that defines the parameters of what is to be investigated.
Provide the framework for reporting the results and indicates what is probably necessary to conduct the study and explain how the findings will present this information.

In the social sciences, the research problem establishes the means by which you must answer the "So What?" question. This declarative question refers to a research problem surviving the relevancy test [the quality of a measurement procedure that provides repeatability and accuracy]. Note that answering the "So What?" question requires a commitment on your part to not only show that you have reviewed the literature, but that you have thoroughly considered the significance of the research problem and its implications applied to creating new knowledge and understanding or informing practice.

To survive the "So What" question, problem statements should possess the following attributes:

Clarity and precision [a well-written statement does not make sweeping generalizations and irresponsible pronouncements; it also does include unspecific determinates like "very" or "giant"],
Demonstrate a researchable topic or issue [i.e., feasibility of conducting the study is based upon access to information that can be effectively acquired, gathered, interpreted, synthesized, and understood],
Identification of what would be studied, while avoiding the use of value-laden words and terms,
Identification of an overarching question or small set of questions accompanied by key factors or variables,
Identification of key concepts and terms,
Articulation of the study's conceptual boundaries or parameters or limitations,
Some generalizability in regards to applicability and bringing results into general use,
Conveyance of the study's importance, benefits, and justification [i.e., regardless of the type of research, it is important to demonstrate that the research is not trivial],
Does not have unnecessary jargon or overly complex sentence constructions; and,
Conveyance of more than the mere gathering of descriptive data providing only a snapshot of the issue or phenomenon under investigation.

Bryman, Alan. “The Research Question in Social Research: What is its Role?” International Journal of Social Research Methodology 10 (2007): 5-20; Brown, Perry J., Allen Dyer, and Ross S. Whaley. "Recreation Research—So What?" Journal of Leisure Research 5 (1973): 16-24; Castellanos, Susie. Critical Writing and Thinking. The Writing Center. Dean of the College. Brown University; Ellis, Timothy J. and Yair Levy Nova. "Framework of Problem-Based Research: A Guide for Novice Researchers on the Development of a Research-Worthy Problem." Informing Science: the International Journal of an Emerging Transdiscipline 11 (2008); Thesis and Purpose Statements. The Writer’s Handbook. Writing Center. University of Wisconsin, Madison; Thesis Statements. The Writing Center. University of North Carolina; Tips and Examples for Writing Thesis Statements. The Writing Lab and The OWL. Purdue University; Selwyn, Neil. "‘So What?’…A Question that Every Journal Article Needs to Answer." Learning, Media, and Technology 39 (2014): 1-5; Shoket, Mohd. "Research Problem: Identification and Formulation." International Journal of Research 1 (May 2014): 512-518.

Structure and Writing Style

I. Types and Content

There are four general conceptualizations of a research problem in the social sciences:

Casuist Research Problem -- this type of problem relates to the determination of right and wrong in questions of conduct or conscience by analyzing moral dilemmas through the application of general rules and the careful distinction of special cases.
Difference Research Problem -- typically asks the question, “Is there a difference between two or more groups or treatments?” This type of problem statement is used when the researcher compares or contrasts two or more phenomena. This a common approach to defining a problem in the clinical social sciences or behavioral sciences.
Descriptive Research Problem -- typically asks the question, "what is...?" with the underlying purpose to describe the significance of a situation, state, or existence of a specific phenomenon. This problem is often associated with revealing hidden or understudied issues.
Relational Research Problem -- suggests a relationship of some sort between two or more variables to be investigated. The underlying purpose is to investigate specific qualities or characteristics that may be connected in some way.

A problem statement in the social sciences should contain :

A lead-in that helps ensure the reader will maintain interest over the study,
A declaration of originality [e.g., mentioning a knowledge void or a lack of clarity about a topic that will be revealed in the literature review of prior research],
An indication of the central focus of the study [establishing the boundaries of analysis], and
An explanation of the study's significance or the benefits to be derived from investigating the research problem.

NOTE: A statement describing the research problem of your paper should not be viewed as a thesis statement that you may be familiar with from high school. Given the content listed above, a description of the research problem is usually a short paragraph in length.

II. Sources of Problems for Investigation

The identification of a problem to study can be challenging, not because there's a lack of issues that could be investigated, but due to the challenge of formulating an academically relevant and researchable problem which is unique and does not simply duplicate the work of others. To facilitate how you might select a problem from which to build a research study, consider these sources of inspiration:

Deductions from Theory This relates to deductions made from social philosophy or generalizations embodied in life and in society that the researcher is familiar with. These deductions from human behavior are then placed within an empirical frame of reference through research. From a theory, the researcher can formulate a research problem or hypothesis stating the expected findings in certain empirical situations. The research asks the question: “What relationship between variables will be observed if theory aptly summarizes the state of affairs?” One can then design and carry out a systematic investigation to assess whether empirical data confirm or reject the hypothesis, and hence, the theory.

Interdisciplinary Perspectives Identifying a problem that forms the basis for a research study can come from academic movements and scholarship originating in disciplines outside of your primary area of study. This can be an intellectually stimulating exercise. A review of pertinent literature should include examining research from related disciplines that can reveal new avenues of exploration and analysis. An interdisciplinary approach to selecting a research problem offers an opportunity to construct a more comprehensive understanding of a very complex issue that any single discipline may be able to provide.

Interviewing Practitioners The identification of research problems about particular topics can arise from formal interviews or informal discussions with practitioners who provide insight into new directions for future research and how to make research findings more relevant to practice. Discussions with experts in the field, such as, teachers, social workers, health care providers, lawyers, business leaders, etc., offers the chance to identify practical, “real world” problems that may be understudied or ignored within academic circles. This approach also provides some practical knowledge which may help in the process of designing and conducting your study.

Personal Experience Don't undervalue your everyday experiences or encounters as worthwhile problems for investigation. Think critically about your own experiences and/or frustrations with an issue facing society or related to your community, your neighborhood, your family, or your personal life. This can be derived, for example, from deliberate observations of certain relationships for which there is no clear explanation or witnessing an event that appears harmful to a person or group or that is out of the ordinary.

Relevant Literature The selection of a research problem can be derived from a thorough review of pertinent research associated with your overall area of interest. This may reveal where gaps exist in understanding a topic or where an issue has been understudied. Research may be conducted to: 1) fill such gaps in knowledge; 2) evaluate if the methodologies employed in prior studies can be adapted to solve other problems; or, 3) determine if a similar study could be conducted in a different subject area or applied in a different context or to different study sample [i.e., different setting or different group of people]. Also, authors frequently conclude their studies by noting implications for further research; read the conclusion of pertinent studies because statements about further research can be a valuable source for identifying new problems to investigate. The fact that a researcher has identified a topic worthy of further exploration validates the fact it is worth pursuing.

III. What Makes a Good Research Statement?

A good problem statement begins by introducing the broad area in which your research is centered, gradually leading the reader to the more specific issues you are investigating. The statement need not be lengthy, but a good research problem should incorporate the following features:

1. Compelling Topic The problem chosen should be one that motivates you to address it but simple curiosity is not a good enough reason to pursue a research study because this does not indicate significance. The problem that you choose to explore must be important to you, but it must also be viewed as important by your readers and to a the larger academic and/or social community that could be impacted by the results of your study. 2. Supports Multiple Perspectives The problem must be phrased in a way that avoids dichotomies and instead supports the generation and exploration of multiple perspectives. A general rule of thumb in the social sciences is that a good research problem is one that would generate a variety of viewpoints from a composite audience made up of reasonable people. 3. Researchability This isn't a real word but it represents an important aspect of creating a good research statement. It seems a bit obvious, but you don't want to find yourself in the midst of investigating a complex research project and realize that you don't have enough prior research to draw from for your analysis. There's nothing inherently wrong with original research, but you must choose research problems that can be supported, in some way, by the resources available to you. If you are not sure if something is researchable, don't assume that it isn't if you don't find information right away--seek help from a librarian !

NOTE: Do not confuse a research problem with a research topic. A topic is something to read and obtain information about, whereas a problem is something to be solved or framed as a question raised for inquiry, consideration, or solution, or explained as a source of perplexity, distress, or vexation. In short, a research topic is something to be understood; a research problem is something that needs to be investigated.

IV. Asking Analytical Questions about the Research Problem

Research problems in the social and behavioral sciences are often analyzed around critical questions that must be investigated. These questions can be explicitly listed in the introduction [i.e., "This study addresses three research questions about women's psychological recovery from domestic abuse in multi-generational home settings..."], or, the questions are implied in the text as specific areas of study related to the research problem. Explicitly listing your research questions at the end of your introduction can help in designing a clear roadmap of what you plan to address in your study, whereas, implicitly integrating them into the text of the introduction allows you to create a more compelling narrative around the key issues under investigation. Either approach is appropriate.

The number of questions you attempt to address should be based on the complexity of the problem you are investigating and what areas of inquiry you find most critical to study. Practical considerations, such as, the length of the paper you are writing or the availability of resources to analyze the issue can also factor in how many questions to ask. In general, however, there should be no more than four research questions underpinning a single research problem.

Given this, well-developed analytical questions can focus on any of the following:

Highlights a genuine dilemma, area of ambiguity, or point of confusion about a topic open to interpretation by your readers;
Yields an answer that is unexpected and not obvious rather than inevitable and self-evident;
Provokes meaningful thought or discussion;
Raises the visibility of the key ideas or concepts that may be understudied or hidden;
Suggests the need for complex analysis or argument rather than a basic description or summary; and,
Offers a specific path of inquiry that avoids eliciting generalizations about the problem.

NOTE: Questions of how and why concerning a research problem often require more analysis than questions about who, what, where, and when. You should still ask yourself these latter questions, however. Thinking introspectively about the who, what, where, and when of a research problem can help ensure that you have thoroughly considered all aspects of the problem under investigation and helps define the scope of the study in relation to the problem.

V. Mistakes to Avoid

Beware of circular reasoning! Do not state the research problem as simply the absence of the thing you are suggesting. For example, if you propose the following, "The problem in this community is that there is no hospital," this only leads to a research problem where:

The need is for a hospital
The objective is to create a hospital
The method is to plan for building a hospital, and
The evaluation is to measure if there is a hospital or not.

This is an example of a research problem that fails the "So What?" test . In this example, the problem does not reveal the relevance of why you are investigating the fact there is no hospital in the community [e.g., perhaps there's a hospital in the community ten miles away]; it does not elucidate the significance of why one should study the fact there is no hospital in the community [e.g., that hospital in the community ten miles away has no emergency room]; the research problem does not offer an intellectual pathway towards adding new knowledge or clarifying prior knowledge [e.g., the county in which there is no hospital already conducted a study about the need for a hospital, but it was conducted ten years ago]; and, the problem does not offer meaningful outcomes that lead to recommendations that can be generalized for other situations or that could suggest areas for further research [e.g., the challenges of building a new hospital serves as a case study for other communities].

Alvesson, Mats and Jörgen Sandberg. “Generating Research Questions Through Problematization.” Academy of Management Review 36 (April 2011): 247-271 ; Choosing and Refining Topics. Writing@CSU. Colorado State University; D'Souza, Victor S. "Use of Induction and Deduction in Research in Social Sciences: An Illustration." Journal of the Indian Law Institute 24 (1982): 655-661; Ellis, Timothy J. and Yair Levy Nova. "Framework of Problem-Based Research: A Guide for Novice Researchers on the Development of a Research-Worthy Problem." Informing Science: the International Journal of an Emerging Transdiscipline 11 (2008); How to Write a Research Question. The Writing Center. George Mason University; Invention: Developing a Thesis Statement. The Reading/Writing Center. Hunter College; Problem Statements PowerPoint Presentation. The Writing Lab and The OWL. Purdue University; Procter, Margaret. Using Thesis Statements. University College Writing Centre. University of Toronto; Shoket, Mohd. "Research Problem: Identification and Formulation." International Journal of Research 1 (May 2014): 512-518; Trochim, William M.K. Problem Formulation. Research Methods Knowledge Base. 2006; Thesis and Purpose Statements. The Writer’s Handbook. Writing Center. University of Wisconsin, Madison; Thesis Statements. The Writing Center. University of North Carolina; Tips and Examples for Writing Thesis Statements. The Writing Lab and The OWL. Purdue University; Pardede, Parlindungan. “Identifying and Formulating the Research Problem." Research in ELT: Module 4 (October 2018): 1-13; Walk, Kerry. Asking an Analytical Question. [Class handout or worksheet]. Princeton University; White, Patrick. Developing Research Questions: A Guide for Social Scientists . New York: Palgrave McMillan, 2009; Li, Yanmei, and Sumei Zhang. "Identifying the Research Problem." In Applied Research Methods in Urban and Regional Planning . (Cham, Switzerland: Springer International Publishing, 2022), pp. 13-21.

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Principles of survey research: part 5: populations and samples

2002, ACM SIGSOFT Software Engineering Notes

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Since 2016, Brynne Rhodes has been encouraging kids to set up pink lemonade stands in their communities to support breast cancer research through BCRF. At just seven years old, Brynne raised $1,000 for BCRF in honor of her mom, Kim, who had been diagnosed with stage two breast cancer the year prior—and she wanted other kids to make a positive impact, too.

The mother-daughter duo’s nationwide campaign, the Pink Lemonade Stand Challenge (PLSC), has since raised more than $180,000 for lifesaving research—all thanks to kids and families taking the challenge in their communities, college students fundraising on campus, companies hosting stands in their stores and offices, and more. PLSC and its fundraisers have been featured on the TODAY show and other major national and local news outlets.

“Breast cancer impacts most families, and it is the number one cancer diagnosis in women worldwide,” Brynne said. “My goal is to inspire people everywhere to #MakeAStand and make an impact. I love that our supporters can raise awareness and funds for breast cancer research in a hopeful way that brings communities together.”

Summer is the perfect time to take the challenge. Here are five reasons why:

1. You’ll support lifesaving breast cancer research

BCRF is the sole beneficiary of PLSC fundraising. When you support BCRF, you support the largest private funder of breast cancer research—and metastatic breast cancer research—in the world and the highest-rated breast cancer research organization in the U.S. Today, BCRF supports a global legion of 255 breast cancer researchers studying every aspect of the disease from prevention to metastasis.

2. You’ll help spread the word about BCRF and research

When you take the PLSC, you not only fund research through BCRF, but you become an important voice for research in your community. At BCRF, we believe that research will end breast cancer for good. In taking the PLSC, you’ll introduce people to BCRF’s lifesaving mission and why research is so critical.

3. You’ll be part of something bigger

From Hawaii to New York supporters in 37 states across the country—and counting—have taken the challenge and set up lemonade stands in their towns and cities. You can help the PLSC reach all 50 states and feel good knowing you are part of a movement to end breast cancer.

4. You can help people in your community

One in eight women in the U.S. will be diagnosed with breast cancer in her lifetime, and there are currently more than four million people with a history of the disease. Breast cancer research is a cause that, unfortunately, touches too many lives and likely many women, men, and families where you live.

5. You and your kids will have a lot of fun

Last but not least: Taking the challenge is both meaningful and fun! Play music, color the sidewalk in chalk, get crafty with your signs and lemonade stand, and spend an afternoon knowing that you’ve made an incredible impact for people diagnosed with breast cancer now and in the future.

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Organize a pink lemonade stand and pledge to donate the money you raise to BCRF.
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Part 1. Overview Information

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All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

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November 22, 2023 - Notice of Change to IC-specific Information for the NINDS for PAR-22-105 and PAR-22-109 Dissemination and Implementation Research in Health NOFOs. See Notice NOT-NS-24-032
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September 16, 2023 - Notice of Technical Assistance Webinar and FAQs for NOT-HL-23-113 (NOSI). See Notice NOT-HL-23-111 .
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March 28, 2023 - Notice of Early Expiration of NOT-HD-22-043 "Notice of Special Interest ( NOSI ): Implementation Science to Advance Maternal Health and Maternal Health Equity for the IMPROVE initiative". See Notice NOT-HD-23-008
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July 18, 2022 - Notice of NHLBI Participation in PAR-22-105. See Notice NOT-HL-22-026 .
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See Section III. 3. Additional Information on Eligibility .

The purpose of this Funding Opportunity Announcement (FOA) is to support studies that will identify, develop, and/or test strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, practices, programs, tools, treatments, guidelines, and policies. Studies that promote equitable dissemination and implementation of evidence-based interventions among underrepresented communities are encouraged. Conversely, there is a benefit in understanding circumstances that create a need to stop or reduce ( de-implement ) the use of practices that are ineffective, unproven, low-value, or harmful. In addition, studies to advance dissemination and implementation research methods and measures are encouraged. Applications that focus on re-implementation of evidence-based health services (e.g. cancer screening) that may have dropped off amidst the ongoing COVID pandemic are encouraged.

All applications must be within the scope of the mission of one of the Institutes/Centers listed above.

30 days prior to the application due date

Application Due Dates			Review and Award Cycles
New	Renewal / Resubmission / Revision (as allowed)	AIDS	Scientific Merit Review	Advisory Council Review	Earliest Start Date
June 15, 2022	July 05, 2022 *	September 07, 2022 *	November 2022	January 2023	April 2023
October 05, 2022 *	November 05, 2022 *	January 07, 2023 *	March 2023	May 2023	July 2023
February 05, 2023 *	March 05, 2023 *	May 07, 2023 *	July 2023	October 2023	December 2023
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All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Not Applicable

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online.
Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 2. Full Text of Announcement

Section i. funding opportunity description.

The purpose of this Funding Opportunity Announcement (FOA) is to support studies that will identify, develop, and/or test strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, practices, programs, tools, treatments, guidelines, and policies (herein referred to collectively as evidence-based interventions). Studies that promote equitable dissemination and implementation of evidence-based interventions among underrepresented communities are encouraged. Conversely, there is a benefit in understanding circumstances that create a need to stop or reduce ( de-implement ) the use of practices that are ineffective, unproven, low-value, or harmful. In addition, studies to advance dissemination and implementation research methods and measures are encouraged. Applications that focus on re-implementation of evidence-based health services (e.g. cancer screening) that may have dropped off amidst the ongoing COVID pandemic are encouraged.

Each year, billions of U.S. tax dollars are spent on research and hundreds of billions are spent on delivery of health interventions, healthcare services, and public health programs in clinical and community settings. However, relatively little is spent on research to understand how best to ensure that the lessons learned from research are relevant to inform and improve the quality of health, delivery of services, and the utilization and sustainability of evidence-based interventions. For years, we have known of the limitations of research publications in leading to widespread uptake of evidence-based interventions, but too often the scientific pathway ends prematurely, before we can determine the best ways to improve equitable adoption, implementation, and sustainability. Given the interest and investment in intervention trials that seek to determine the optimal interventions to be used in clinical and community settings, it is essential that practitioners (e.g., healthcare providers, public health practitioners), consumers, families, caregivers, communities (e.g., workplace, school, place of worship), healthcare practice settings, and policymakers are equipped with empirically-supported strategies to integrate scientific knowledge and effective health interventions into everyday use. The National Institutes of Health has recognized that closing the gap between biomedical or basic behavioral discovery, population health, and healthcare delivery and public health is both a complex challenge and an absolute necessity if we are to ensure that all populations benefit from the Nation’s investments in scientific discoveries.

For many years, health researchers may have assumed that evidence-based interventions would be readily adopted and implemented; however, compelling evidence suggests that this has not been the case. Even when interventions have been tested within effectiveness studies, the development of knowledge to support their broader dissemination and implementation (e.g., cost and financing of the intervention, practitioner training, availability of resources, integration into community or healthcare systems, delivery to underserved or under-resourced populations, monitoring the quality or equity of intervention delivery) has often remained outside the scope of these large-scale clinical trials. This has also been the case for the dissemination and implementation of policies and guidelines.

Dissemination and implementation research intends to bridge the gap between research, practice, and policy by building a knowledge base about how health information, effective interventions, and new clinical practices, guidelines, and policies are communicated and integrated for public health and health care service use in specific settings.

For the purpose of this FOA, we make a distinction between "dissemination research" and "implementation research", as follows:

Dissemination research is defined as the scientific study of the targeted distribution of information and intervention materials to a specific public health, clinical practice, or policy audience. The intent is to understand how best to communicate and integrate knowledge and the associated evidence-based interventions.

We are currently missing critical information about how, when, by whom, and under what circumstances evidence spreads throughout communities, organizations, front line workers and consumers of public health and clinical services. As a prerequisite for unpacking how information can lead to intervention or service changes, we need to understand how and why information on physical and behavioral health, preventive services, disease management, decision making, and other effective interventions may or may not reach stakeholders. We need to understand what underlies the creation, transmission, and reception of information on evidence-based pharmacological, behavioral, psychosocial, genomic, policy, and systems interventions. Successful dissemination of evidence for effective health interventions may occur quite differently depending on whether the audience consists of consumers, caregivers, practitioners, policymakers, employers, administrators, or other stakeholder groups. Moving the field forward will require studies identifying mechanisms and approaches to package and convey the evidence necessary to improve public health, community, and healthcare services in ways relevant to local settings.

Implementation research is defined as the scientific study of the use of strategies to adopt and integrate evidence-based health interventions into clinical and community settings to improve individual outcomes and benefit population health.

Implementation research seeks to understand the behavior of practitioners and support staff, organizations, consumers and family members, and policymakers in context as key influences on the adoption, implementation, and sustainability of evidence-based health interventions. Implementation studies should not assume that effective interventions can be integrated into any service setting and for consumer groups and populations without attention to local context, nor that a unidirectional flow of information (e.g., publishing a recommendation, trial, or guideline) is sufficient to achieve practice change. Relevant studies should develop a knowledge base about "how" evidence-based interventions are integrated within diverse practice settings and patient populations, which likely will require more than the distribution of information about the interventions. This research announcement encourages studies to test models, theories, and conceptual frameworks of the implementation process that move away from an exclusively "top-down" or reductionist approach to a greater emphasis on the resources of local care settings and the needs of multiple stakeholders, including approaches such as systems science, team science, community engaged research, participatory action research, citizen science, and related approaches that engage stakeholders and end-users throughout the research process.

Dissemination and Implementation (D&I) Research: Broadly, studies in this field typically involve both interdisciplinary cooperation and transdisciplinary collaboration, utilizing theories, empirical findings, and methods from a variety of scientific disciplines. Relevant fields include but are not limited to: information science, organizational and management theory, health economics, behavioral science, public health, business and public administration, statistics, anthropology, epidemiology, decision science, engagement science, systems science, health equity research, engineering, and marketing. D&I research will often include significant and ongoing collaboration with stakeholders from multiple public health and/or clinical practice settings as well as consumers of services and their families/social networks. This FOA will support a variety of rigorous study designs including (but not limited to) observational, experimental, quasi-experimental, and simulation modeling that produce evidence on relevant outcomes (e.g., acceptability, feasibility, adoption, fidelity, penetration, sustainability), costs, and/or unanticipated consequences of dissemination and implementation efforts. The goal is to conduct dissemination and implementation studies utilizing research designs that are rigorous and measures that are relevant to stakeholders. Wherever possible, studies of dissemination or implementation strategies should build knowledge both on the overall effectiveness of the strategies, as well as "how and why" they work. Data on mechanisms of action, moderators and mediators, and costs of dissemination and implementation strategies will greatly aid decision-making on which strategies work for which interventions, in which settings, and for what populations.

For additional resources on dissemination and implementation research, including information on D&I training opportunities, funded studies, key references, past workshops and conferences, visit: http://cancercontrol.cancer.gov/is/ ; and https://prevention.nih.gov/research-priorities/dissemination-implementation .

Specific Objectives and Scope of this FOA

This FOA invites research grant applications that will identify, develop, and/or test strategies to disseminate and implement evidence-based interventions into public health, clinical practice, and community (e.g., workplace, school, place of worship) settings. Studies that promote equitable dissemination and implementation of evidence-based interventions are encouraged. In addition, studies to advance dissemination and implementation research methods and measures are encouraged. All applications should be within the scope of the mission of at least one of the participating Institutes/Centers.

Examples of relevant research topics include but are not limited to:

Studies on culturally-tailored implementation strategies to enhance the adoption and integration of health promotion, prevention, screening, early detection, and diagnostic interventions, as well as effective treatments, clinical procedures or guidelines into existing care systems.
Studies on the implementation of multiple evidence-based interventions within community or clinical settings (including community clinics, FQHCs, and primary care clinics) to meet the needs of complex patients and diverse systems of care.
Longitudinal and follow-up studies on the factors that contribute to the sustainability of evidence-based interventions in public health and clinical practice.
Studies testing dissemination or implementation strategies to eliminate health disparities and improve quality of care in underserved populations (based on their racial or ethnic group, religion, socioeconomic status, gender, age, mental health, cognitive, sensory or physical disability, sexual orientation or gender identity, geographic location (place/context) or other characteristics historically linked to discrimination or exclusion).
Studies conducting comparative economic evaluations of implementation strategies in a variety of settings and across phases of implementation.
Studies on measuring and tracking adaptations to evidence-based interventions and implementation strategies over time.
Studies on scaling-up evidence-based implementation strategies.
Studies on reducing or stopping ("de-implementing") the use of clinical and community practices that are ineffective, unproven, low-value, or harmful.
Studies on the relationship of context, including but not limited to the role of social determinants of health or social needs, and local capacity of clinical and community settings to adoption, implementation, and sustainability of evidence-based practices.
Prospective or retrospective studies of the adoption, implementation, and sustainability of health policies and their interaction with programs and contextual factors.
Studies of influences on the creation, packaging, transmission, and reception of evidence for effective health interventions.
Studies of strategies to impact organizational structure, climate, culture, and processes to enable dissemination and implementation of clinical/public health information and effective clinical/public health interventions.
Studies on the development of study designs, research methods, and analytic approaches for studying dissemination and implementation.
Studies that focus on the testing of theories, models, and frameworks for D&I processes.
Studies on developing and validating reliable D&I relevant outcome and process measures.
Studies on developing and validating pragmatic and actionable measures to guide selection, continuation, and discontinuation of implementation strategies over time.
Studies on developing and strengthening tools and techniques for conducting rapid and rigorous qualitative data collection and analysis, including approaches for comparisons of qualitative data across implementation contexts appropriate for accelerated implementation timelines.
Studies on policies and other contextual factors that influence the success of dissemination or implementation efforts.
Studies on collecting and sharing multi-level qualitative and quantitative D&I-related data.
Studies that examine policy implementation, specifically the implementation and dissemination of health care and public health policies across federal, state, local and organizational policies.

Key characteristics of dissemination and implementation (D&I) research that applicants could consider including in their applications (where applicable) include but are not limited to:

Description and justification of the evidence-based intervention and hypothesized strategies to improve implementation outcomes (e.g., acceptability, feasibility, adoption, fidelity, penetration, sustainability) as well as health service outcomes (e.g., quality, equity).
Understanding of contextual factors that can influence dissemination or implementation of the evidence-based intervention in various settings under investigation
Incorporation and justification of the use of theories, models, and/or frameworks that are relevant to understanding dissemination and implementation, to inform study hypotheses, measures, and outcomes.
Consideration of the extant literature on barriers to and facilitators of the dissemination and implementation of practices to improve health.
Identification of possible mediators, moderators, and mechanisms of action that explain the impact of dissemination or implementation strategies on relevant outcomes.
Consideration and characterization of the multi-level context and environment in which the proposed research will be conducted, including a description of the intended implementers.
Consideration of the use of qualitative and/or mixed methods approaches.
Development and/or use of appropriate D&I related outcomes, measures, and analyses. Applicants are encouraged to review available resources and use standard measures and validated instruments where possible, rather than developing their own measures for each study.
Attention to issues of resources expended, program costs, cost-effectiveness, or other economic outcomes related to dissemination and/or implementation.
Incorporatation of stakeholder-relevant outcomes (i.e., outcomes relevant to patients, consumers, families, practitioners, administrators, and/or policymakers).
Formation of transdisciplinary teams of researchers and stakeholders, given the range of expertise that may be needed for conducting dissemination and implementation research.
Adequate consideration and specification of the equity-related approach and outcomes.

Information relevant to Specific Institutes/Centers

In addition to the above description of the scientific objectives, resources communicating scientific interests of selected Institutes and Centers (I/Cs) are summarized below. Applicants are encouraged to contact the Scientific/Research contact of the intended I/C to ensure that the aims of the proposed project are consistent with I/C mission.

National Eye Institute (NEI)

The National Eye Institute (NEI) will support Dissemination and Implementation (D&I) Research efforts relevant to NEI’s mission to eliminate vision loss and improve quality of life through vision research. NEI encourages applications that investigate strategies to promote adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions and practices in the prevention and management of eye- and/or vision-related conditions. Such strategies may include (but are not limited to) the use of digital health technologies such as telehealth (e.g., teleophthalmology, teleoptometry), and imaging-based artificial intelligence (AI) decision support systems.Addressing accessibility needs of individuals with blindness and low vision are encouraged. Additionally, NEI invites applications that seek to advance vision health equity through D&I Research. Examples include (but are not limited to) investigations of implementation strategies that incorporate social determinants of health; research that engage public health practitioners in community settings; and multilevel or intersectoral collaborations (e.g., transportation, education, housing) outside of the traditional vision-health sector.

All investigators are encouraged to contact the NEI Scientific/Research program director in advance of submission. NEI will not support clinical trials that are greater than minimal risk on this funding opportunity. Minimal risk is defined as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

National Cancer Institute (NCI)

NCI seeks implementation science projects across the cancer control continuum. Areas of interest include prevention, detection, and in areas less represented in the NCI-funded portfolio, including in cancer diagnosis, treatment, and survivorship. Examples include (but are not limited to) studies that seek to understand and evaluate sustainable approaches to coordinate cancer treatment across fragmented systems; optimizing survivorship care among oncology and non-oncology providers; and survivorship care delivery in diverse settings (e.g.,community practices, rural settings). Additionally, NCI is interested in supporting applications that focus on understanding strategies to promote sustainability and scale up of effective cancer control interventions, studies that seek to understand de-implementation, and studies that seek to advance measures and methods. Policy implementation research studies are encouraged.

NCI is interested in applications that seek to advance health equity through implementation science. Areas of interest include projects that promote equitable reach, delivery, and implementation of evidence-based interventions in/with communities and populations experiencing health disparities. To advance the equitable implementation, the NCI is interested in implementation strategies that incorporate social determinants of health or social needs in developing and testing strategies to advance adoption, adaptation, fidelity, acceptability, cost, and sustainability of evidence-based interventions in cancer prevention and control. Implementation research aims should be guided by equity-oriented theoretical models and frameworks and the equity related outcomes or approaches clearly described. Multilevel approaches and transdisciplinary and intersectoral collaborations (e.g., transportation, housing, food systems) are encouraged. To the extent possible, studies may include an evaluation to assess that implementation projects are not inadvertently exacerbating health disparities or inequalities. Research that engages public health practitioners in community settings (e.g., health departments, coalitions, community organizations) as well as practice-based research are encouraged.

In efforts to advance the field, NCI launched the Consortium for Cancer Implementation Science (CCIS) which broadly focuses on cancer control priorities, cross-collaborations across disciplines and institutions, and innovative solutions to advance measures and methods in implementation science. Applications that advance scientific priorities of the CCIS action groups are encouraged. See annual meeting summaries at: https://cancercontrol.cancer.gov/is/initiatives/ccis .

We encourage applicants to contact program staff for assistance early in the application process.

National Human Genome Research Institute (NHGRI)

NHGRI will support the evaluation of approaches that will incorporate genomics to improve the effectiveness of healthcare. In general, NHGRI supports studies that provide generalizable methods and knowledge. Applications for studies relevant only to a particular disease or organ system should be directed to the appropriate Institute or Center. NHGRI strongly encourages potential applicants to contact program staff in the early stages of developing your application.

National Institute on Aging (NIA)

NIA is interested in research to identify and understand barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based health interventions, tools, and policies related to aging or older adults.

For clinical trial proposals, D&I strategies studied should be limited to strategies to disseminate and/or implement interventions that have evidence of efficacy/potency, as well as evidence that the intervention can be delivered in the community with fidelity. NIA is especially interested in receiving applications that fall within Stage V of the NIH Stage Model for Behavioral Intervention Development that focus on the mechanisms that promote the successful implementation and dissemination of interventions, consistent with the NIH Science of Behavior Change emphasis on mechanisms of change.

Information about the NIH Stage Model for Behavioral Intervention Development can be found at: https://www.nia.nih.gov/research/dbsr/stage-model-behavioral-intervention-development .

Information regarding NIH’s Science of Behavior Change (SOBC) program can be found at: https://commonfund.nih.gov/behaviorchange .

National Institute of Allergy and Infectious Diseases (NIAID)

Applicants applying to NIAID should identify partnerships with relevant policy and/or program leaders with a stated commitment to evaluate and incorporate changes which are proven to be both successful and cost-effective. Ideally, research teams will include local experts from an implementing organization and meaningfully incorporate input from community members.

NIAID will not accept clinical trials using new drugs or diagnostic tools, or using existing drugs/diagnostics for new purposes in response to this FOA. However, trial methodology to assess the impact of new strategies for disseminating and/or implementing accepted/validated interventions for prevention or treatment will be allowed.

Applicants seeking funding for clinical trials should refer to the following NIAID website: https://www.niaid.nih.gov/grants-contracts/investigator-initiated-clinical-trial-resources

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. In the context of this FOA, the NIAMS is interested in research related to the dissemination and implementation of research finding from clinical and translational studies. Clinical research areas include rheumatology, orthopedics, dermatology, metabolic bone diseases, heritable disorders of bone and cartilage, inherited and inflammatory muscle diseases, and sports and rehabilitation medicine. Applicants are encouraged to discuss potential applications with the appropriate NIAMS program director.

National Institute of Mental Health (NIMH)

The National Institute of Mental Health (NIMH) is interested in applications relevant to dissemination and implementation (D&I) research that support the NIMH Strategic Plan for Research . All applications that propose clinical trials to test D&I strategies are required to include a study design using an experimental therapeutics approach, in which clinical trials test implementation effects on mental health outcomes as well as elucidate the implementation strategy’s mechanism(s) of action (see NIMH Clinical Trials FOAs ). Applications must specify the target/mechanism and assess whether the implementation-induced changes in the target account for the hypothesized outcome (i.e., fidelity, acceptability, feasibility, appropriateness). It is recommended that investigators contact NIMH Scientific/Research staff well in advance of submitting applications to discuss the match to NIMH priorities.

National Institute on Minority Health and Health Disparities (NIMHD)

The mission of NIMHD is to lead scientific research to improve minority health and reduce health disparities in populations that experience health disparities (i.e., African Americans/Blacks, Hispanic/Latinos, American Indians/Alaska Natives, Asians, Native Hawaiians, and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minority populations). In the context of this FOA, NIMHD is especially interested in domestic D&I research that utilizes the NIMHD Research Framework .

National Institute of Dental and Craniofacial Research (NIDCR)

The NIDCR is interested in D&I research applications relevant to dental, oral, or craniofacial health that align with the NIDCR Strategic Plan. Investigators proposing research that meets the NIH definition of a clinical trial should refer to NIDCR Clinical Trials FOAs. All investigators are encouraged to contact NIDCR Scientific/Research staff well before submission to discuss scientific priorities.

National Center for Complementary and Integrative Health (NCCIH)

For specific information about NCCIH priorities for dissemination and implementation research refer to the NCCIH strategic plan ( https://www.nccih.nih.gov/about/nccih-strategic-plan-2021-2025 ), our priorities for implementation science ( https://www.nccih.nih.gov/about/nccih-strategic-plan-2021-2025/top-scientific-priorities/implementation-science-for-complementary-and-integrative-health ), and our website.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

The institute encourages D&I applications relevant to the NICHD mission, including (but not limited to) normal and abnormal human development, contraception, fertilization, pregnancy, childbirth, prenatal and postnatal development, childhood development through adolescence, intellectual and developmental disabilities, and rehabilitation medicine.

NICHD is interested in D&I applications relevant to the institute’s mission, especially studies that aim to promote broad implementation and adaptation of interventions with proven efficacy, as well as studies that aim to de-implement interventions that have been shown not to be efficacious.

Visit https://www.nichd.nih.gov/about/org/der/branches and https://www.nichd.nih.gov/about/org/ncmrr to get more information about NICHD research priorities.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIDDK will support evaluation of approaches that improve the effectiveness of healthcare, improve uptake of evidence-based interventions in diverse populations and settings, reduce/eliminate disparities, and improve health equity for research areas within its mission , including diabetes, other endocrine and metabolic diseases, digestive diseases, nutritional disorders, obesity, kidney diseases, and urologic conditions. NIDDK strongly encourages potential applicants to contact program staff for assistance in the early stages of developing applications.

National Institute of Nursing Research (NINR)

The National Institute of Nursing Research (NINR) supports research that uses nursing’s holistic, contextualized perspective to improve individual and population health outcomes and advance health equity across clinical and community settings. NINR encourages research that integrates factors at multiple levels including social determinants to identify their role in health, health improvement, and health disparities. Applicants seeking funding for D&I research are referred to NINR’s policy on clinical trials and strongly encouraged to contact program staff in advance of a submission.

Office of Research on Women’s Health (ORWH)

The Office of Research on Women’s Health (ORWH) is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that women's health research is part of the scientific framework at the NIH, and throughout the scientific community. In general, ORWH is interested in research that considers the influence of sex and gender on health and disease, and the total health of women across the full spectrum of research. ORWH encourages interdisciplinary approaches and would be interested in partnering to support research that examines ways to integrate evidence-based practices, interventions, and policies into practice settings to improve the health of women, especially research on the consequences of pregnancy for the health of a woman across her life course. The Trans-NIH Strategic Plan for the Health of Women covering FY 2019 - 2023 is available on the ORWH website ( https://www.nih.gov/women/strategicplan ) for additional guidance.

National Institute of Neurological Disorders and Stroke (NINDS)

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in mission relevant applications. The NINDS supports dissemination and implementation research focused on identifying, monitoring, scaling-up, and/or testing strategies for overcoming environmental, social, community, structural, and healthcare system factors that lead to or are associated with disparities (or inequities) in neurological diseases and care across the lifespan. Some priority disease areas include stroke and other cerebrovascular diseases, Alzheimer’s disease-related dementias (including frontotemporal neurodegeneration, Lewy body dementias, vascular contributions to cognitive impairment and dementia and mixed etiology dementia), epilepsy, migraine, nervous system infections, spinal cord injury, headache, Parkinson's disease, and other neurodegenerative disorders, brain trauma, neurodevelopmental disorders, and the neurological consequences of HIV/AIDS. Applicants are encouraged to incorporate community engagement strategies into their study designs. Applicants are also encouraged to incorporate a plan to enhance diverse perspectives ( https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp ) and community engagement strategies into their study designs when appropriate.

Applicants considering submitting a clinical trial should review the NINDS Clinical Trial policy ( https://www.ninds.nih.gov/current-research/research-funded-ninds/clinical-research ).

Clinical trials are research studies in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. For this funding announcement, only the following types of clinical trials will be supported:

Mechanistic trials , defined as studies designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention (i.e., HOW an intervention works, but not IF it works or is safe).
Basic Experimental Studies with Humans (BESH) , defined as basic research studies involving humans that seek to understand the fundamental aspects of phenomena.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)

Local Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

Eligible Agencies of the Federal Government
U.S. Territory or Possession
Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement , are allowed.

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
Dun and Bradstreet Universal Numbering System (DUNS) Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application . This means that the NIH will not accept:

A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications ).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed activity
Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
Names of other key personnel
Participating institution(s)
Number and title of this funding opportunity

The letter of intent should be sent to:

Gila Neta, PhD National Cancer Institute (NCI) Telephone: 240-276-6785 Email: [email protected]

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

SF424(R&R) Other Project Information

SF424(R&R) Senior/Key Person Profile

R&R or Modular Budget

R&R Subaward Budget

PHS 398 Cover Page Supplement

PHS 398 Research Plan

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: The Research Strategy should clearly describe the following within the appropriate section (i.e., Significance, Investigator(s), Innovation, Approach, Environment):

Significance

The estimated public health benefit of the research, and whether the existing data, public health and patient needs justify dissemination and implementation.
If the aims of the proposed project are achieved, how the study results will advance dissemination and implementation knowledge. The ability of potential adopters and organizations to determine the applicability of the results to their setting.
The reach (to the population that will benefit from the knowledge/intervention) that will be achieved and the equitability of the reach and likely outcomes through the knowledge/service delivery contexts selected.
The resource requirements and costs of the intervention.

Investigator(s)

Whether the investigators are part of stakeholder teams or have strong links and engagement of stakeholders necessary to accomplish the project aims.
Clear evidence of dissemination and implementation research expertise as part of the team.
How the proposed dissemination or implementation research contributes new and innovative concepts, outcomes, measures, and/or design approaches to the field.
How the study proposed promises to speed the translation of research into practice and/or produce novel and robust findings.
Demonstrate an understanding of dissemination and implementation research principles. How the dissemination or implementation approach is appropriate to the problem and population using research methods that are relevant, rigorous and practical.
Justify the study design on the basis of the current state-of-the-art and or contextual factors relevant to dissemination and/or implementation.
How the procedures to assess and analyze the dissemination or implementation strategies are appropriate.
How the measurements and analysis plan are linked to the study aims, and whether the analysis incorporates the best available data to track dissemination or implementation process and impact, including cost-effectiveness.
Where applicable, how the proposed plan for analysis takes into account hierarchical relationships among multiple levels of outcomes (e.g. patient/consumer, provider, system).
The appropriateness of the plans to sustain effective dissemination and implementation approaches once the research-funding period has ended.

Environment

How the applicants are positioned to influence large or influential networks capable of taking the results of the proposed study to scale to achieve public health impact.
How the proposed approaches take advantage of unique features of the intervention delivery environment or employ useful, collaborative arrangements
Evidence of institutional support to sustain dissemination or implementation strategies once the research funding ends.

Letters of Support: the letters of collaboration and institutional support should include the level of commitment to the project.

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement , and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement .

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII .

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form . Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

In order to expedite review, applicants are requested to notify the {IC} Referral Office by email at {[email protected]} when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy . Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Specific to this FOA: What is the estimated public health benefit of the research?Do the existing data, public health and patient needs justify dissemination and implementation? If the aims of the proposed project are achieved, how will dissemination and implementation knowledge be advanced? How broad a reach (to the population that will benefit from the knowledge/intervention) will be achieved and how equitable will reach and outcomes likely be through the knowledge/service delivery contexts selected? Has consideration been given to the resource requirements and costs of the intervention? Will potential adopters and organizations be able to determine the applicability of the results to their setting?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Specific to this FOA: Are the investigators part of stakeholder teams or have strong links and engagement of stakeholders necessary to accomplish the project aims?Is there clear evidence of dissemination and implementation research expertise as part of the team?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Specific to this FOA: Does the proposed dissemination or implementation research contribute new and innovative concepts, outcomes, measures, and/or design approaches to the field?Does the study proposed promise to speed the translation of research into practice and/or produce novel and robust findings?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Specific to this FOA: Does the applicant demonstrate an understanding of dissemination and implementation research principles? Has the applicant justified the study design on the basis of the current state-of-the-art and or contextual factors relevant to dissemination and/or implementation? Is the dissemination or implementation approach appropriate to the problem and population using research methods that are relevant, rigorous and practical? Are the procedures to assess and analyze the dissemination or implementation strategies appropriate? Are the measurements and analysis plan linked to the study aims, and does the analysis incorporate the best available data to track dissemination or implementation process and impact, including cost-effectiveness? Where applicable, does the proposed plan for analysis take into account hierarchical relationships among multiple levels of outcomes (e.g. patient, provider, system)? How appropriate are the plans to sustain effective dissemination and implementation approaches once the research-funding period has ended?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Specific to this FOA: Are the applicants positioned to influence large or influential networks capable of taking the results of the proposed study to scale to achieve public health impact? Do the proposed approaches take advantage of unique features of the intervention delivery environment or employ useful, collaborative arrangements? Is there evidence of institutional support to sustain dissemination or implementation strategies once the research funding ends?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects .

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research .

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section .

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

For Renewals, the committee will consider the progress made in the last funding period.

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan ; (2) Sharing Model Organisms ; and (3) Genomic Data Sharing Plan (GDS) .

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), in accordance with NIH peer review policy and procedures , using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Scientific and technical merit of the proposed project as determined by scientific peer review.
Availability of funds.
Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons . Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement .

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement .

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website ( https://register.clinicaltrials.gov ). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities , including of note, but not limited to:

Federalwide Research Terms and Conditions
Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov .
For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html .
HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html . For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm .
For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html .

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement . Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement . NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact) Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources) Email: [email protected] (preferred method of contact) Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace) Contact Center Telephone: 800-518-4726 Email: [email protected]

Gila Neta, PhD National Cancer Institute (NCI) Telephone: 240-276-6785 Email: [email protected]

Jimmy Le, Sc.D National Eye Institute (NEI) Telephone: 301-435-8160 Email: [email protected]

Robb Rowley, MD National Human Genome Research Institute (NHGRI) Telephone: 301-827-9126 E-Mail: [email protected]

Miya Whitaker, Psy.D., M.A. National Institute on Alcohol Abuse and Alcoholism Telephone: 301-443-0635 Email: [email protected]

Lindsey Ann Martin, PhD National Institute of Environmental Health Sciences (NIEHS) Telephone: 984-287-4036 E-mail: [email protected]

Lori Ducharme National Institute On Drug Abuse (NIDA) Telephone: 301-827-6331 E-mail: [email protected]

Denise Pintello, Ph.D. National Institute of Mental Health (NIMH) Telephone: 301-451-1481 Email: [email protected] /"> [email protected]

Faye H. Chen, Ph.D. National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS) Telephone: 301-594-5055 E-mail: [email protected]

William Elwood, PhD Chief, Behavioral and Social Sciences Research Branch National Institute Of Dental & Craniofacial Research (NIDCR) Telephone: 301-402-0116 E-mail: [email protected]

Elizabeth L Neilson, PhD, MPH, MSN Office of Disease Prevention (ODP) Telephone: 301-827-5578 Email: [email protected]

Lynn S. Adams, PhD National Institute of Nursing Research (NINR) Telephone: 301-594-8911 Email: [email protected]

Jennifer N. Baumgartner, Ph.D. National Center for Complementary and Integrative Health (NCCIH) Telephone: 301-402-4084 Email: [email protected]

Rebecca Mandt, Ph.D. National Institute of Allergy and Infectious Diseases (NIAID) Telephone: 301-435-7695 Email: [email protected]

Lisa Onken, Ph.D. National Institute On Aging (NIA) Telephone: 30l- 496-3131 E-mail: [email protected]

Lana O Shekim, Ph.D. National Institute On Deafness And Other Communication Disorders (NIDCD) Telephone: 301- 496-5061 E-mail: [email protected]

Shavon Artis Dickerson, Dr.P.H., M.P.H. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Telephone: 301-435-3055 Email: [email protected]

Damiya Eve Whitaker Office Of Research On Women's Health (ORWH) Telephone: 240-276-6170 E-mail: [email protected]

Richard T. Benson, MD, PhD National Institute of Neurological Disorders and Stroke (NINDS) E-mail: [email protected]

Marion Koso-Thomas, MD, MPH Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) Telephone: 301-435-6873 Email: [email protected]

Crystal Barksdale, PhD, MPH National Institute On Minority Health And Health Disparities ( NIMHD ) Telephone: 301-402-1366 E-mail: [email protected]

Cara C. Lewis, Ph.D. National Heart, Lung, and Blood Institute ( NHLBI ) Telephone: 301-594-9230 Email: [email protected]

Wenjuan Wang, Ph.D. Center for Scientific Review (CSR) Telephone: 301-480-8667 Email: [email protected]

Karen Robinson-Smith National Eye Institute(NEI) Telephone: 301-435-8178 Email: [email protected]

Crystal Wolfrey National Cancer Institute ( NCI ) Telephone: 301-496-8634 Email: [email protected]

Deanna L Ingersoll National Human Genome Research Institute (NHGRI) Telephone: 301-435-7858 E-mail: [email protected]

Judy Fox National Institute on Alcohol Abuse and Alcoholism (NIAAA) Telephone: 301-443-4707 Email: [email protected]

Jenny L Greer National Institute of Environmental Health Sciences (NIEHS) Telephone: 984-287-3332 E-mail: [email protected]

Pamela G Fleming National Institute On Drug Abuse (NIDA) Telephone: 301-480-1159 E-mail: [email protected]

Tamara Kees National Institute of Mental Health (NIMH) Telephone: 301-443-8811 Email: [email protected]

Erik Edgerton National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS) Telephone: 301-594-7760 E-mail: [email protected]

Gabriel Hidalgo National Institute of Dental and Craniofacial Research (NIDCR) Telephone: 301-827-4630 Email: [email protected]

Todd Le National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Telephone: 301-594-7794 Email: [email protected]

Kelli Oster National Institute of Nursing Research (NINR) Telephone: 301-594-2177 Email: [email protected]

Shelley Headley National Center for Complementary and Integrative Health (NCCIH) Telephone: 301-594-3788 Email: [email protected]

Ann Devine National Institute of Allergy and Infectious Diseases (NIAID) Telephone: 240-669-2988 Email: [email protected]

Ryan Blakeney National Institute On Aging (NIA) Phone: 301-451-9802 E-mail: [email protected]

Christopher Myers National Institute On Deafness And Other Communication Disorders (NIDCD) Telephone:301-435-0713 E-mail: [email protected]

Chief Grants Management Officer National Institute of Neurological Disorders and Stroke (NINDS) Email: [email protected]

Margaret Young Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Telephone: 301-642-4552 Email: [email protected]

Priscilla Grant, JD National Institute On Minority Health And Health Disparities ( NIMHD ) Telephone: 301-594-8412 E-mail: [email protected]

Anthony Agresti National Heart, Lung, and Blood Institute (NHLBI) Telephone: 301-827-8014 Email: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts . All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.

Dr. Patrick King named Fulbright Scholar, will research musical theater in Spain

During a summer in Barcelona, Spain, the idea began to grow.

Lake Michigan College Theatre Instructor Dr. Patrick King was visiting his partner, voiceover artist, and director Jenny Beacraft when he became fascinated by the musical theater of the region.

"My research area is musical theater in a historical context," King said. "Catalonia is one of those regions with its own identity within, and they would say separate, from Spanish culture. There is a home-grown Catalan-language musical theater scene that is incredibly popular but, like popular musical theater in the United States, is often critically and academically ignored. As a historical researcher, it seems that the plays people want to see that may seem trivial in the moment can really tell you a lot about that culture."

In August, King will spend the 2024-2025 academic year in Barcelona at the Universitat Autònoma de Barcelona (or Autonomous University of Barcelona), researching Catalan musical theater as a Fulbright U.S. Scholar.

The competitive and prestigious Fulbright Scholar Program awards more than 1,700 fellowships each year, enabling 800 U.S. Scholars to go abroad and 900 Visiting Scholars to come to the United States. Fulbright Scholars raise the profile of their home institutions to establish research and exchange relationships and gain valuable international insights. Fulbright Scholars then return to their home institutions to share their experiences with students and colleagues.

"The whole mission of Fulbright is this cross-border understanding and the ability to learn from other cultures and bring those ideas back here," King said. "I think it reflects well on Fulbright that they want community college scholars to be in the mix. They know our work is teaching, and we don't often have time for research and writing. It is a credit to them that they recognize the importance of community colleges in the ecosystem of academia; that we do matter."

The Autonomous University of Barcelona, which has a theater studies program within its Catalan department, will serve as the host institution for King during the research project. King will work with professors, historians, and other theater professionals to learn more about the current and historical Catalan musical theater scene. He expects to work with Dagoll Dagom, a Catalan theater company founded in 1974, who will be staging the Catalan musical "Mar i Cel."

"I describe it as their 'Les Misérables,'" King said. "It is a big spectacle that has been on and off for decades. Dagoll Dagom, the theater that produces it, says that this is the last time they will stage the production, so being able to look at that production as it is being staged at a time when Catalonia is really in flux feels like an important cultural moment."

King holds a doctorate in theater history and performance studies from Tufts University and an undergraduate degree in theater from Northwestern. Before teaching at LMC, he was a graduate instructor at Tufts University and guest lectured at Rutgers University. His previous research has been published in the peer-reviewed journals Text & Presentation and Puppetry International and presented at the Mid-America Theatre Conference, the Center for Humanities at Tufts, and the American Society for Theatre Research.

"I hope that this opportunity also shines a light on the possibilities that our students have to make leaps like this themselves," King said. "Being a student at a community college, it can be hard to imagine with broad horizons. I want them to see this and have that perspective that we are in conversation with the world."

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Eur J Gen Pract
v.28(1); 2022

Series: Practical guidance to qualitative research. Part 5: Co-creative qualitative approaches for emerging themes in primary care research: Experience-based co-design, user-centred design and community-based participatory research

Albine moser.

a Research Centre Autonomy and Participation of Chronically Ill People, Zuyd University of Applied Sciences, Heerlen, The Netherlands

b Department of Family Medicine, Maastricht University, Maastricht, The Netherlands

Irene Korstjens

c Research Centre for Midwifery Science, Zuyd University of Applied Sciences, Maastricht, The Netherlands

KEY POINTS ON CO-CREATIVE QUALITATIVE APPROACHES

Experience-based co-design seeks to understand how people experience a health care process or service.
User-centred design is an approach to assess, design and develop technological and organisational systems, for example, eHealth, involving end-users in the design and decision-making processes.
Community-based participatory research is a collaborative approach addressing a locally relevant health issue. It is often directed at hard-to-reach and vulnerable people.

Introduction

Over the years, in our supervisory work, we have noticed that qualitative research tends to evoke many questions and challenges. This article, the fifth in a series aiming to provide practical guidance for qualitative research [ 1–4 ], introduces three co-creative (and mostly) qualitative approaches for addressing emerging themes in primary care research: experience-based co-design to improve the quality of care, user-centred design to develop and evaluate eHealth resources and community-based participatory research to improve local health collaboratively.

A changing primary care

Primary care faces a changing context, including the increasing provision of chronic care and elderly care, shared decision-making and proactive care planning, e- and mHealth, preventive and community care, and interprofessional collaboration with nurses, paramedics and relevant services [ 5–8 ]. These changes have consequences for primary care research. By nature, general practitioners are co-creators in working with their patients and other professionals on seeking solutions for complex health issues in daily practice. However, the ‘explicit’ idea of co-creation may not be very familiar to general practitioners, depending on their national policy context [ 9 ].

Co-creative approaches

In research, co-creation means an iterative and non-linear process throughout the research continuum and the collaborative generation of knowledge by academics working alongside stakeholders [ 10 ]. We use the term co-creative qualitative approaches as an umbrella concept. The three co-creative approaches have different origins, core principles, goals and stakeholders ( Box 1 ) but they share common ground. They start from solving a problem in practice, supporting stakeholder involvement and equal partnerships among the stakeholders, empowering vulnerable people/communities and bridging the gap between practice and research. They complement the scientific knowledge and expertise of general practitioners and other primary care professionals. They provide insights into needs, experiences, aspirations, stakes and changes from a multi-perspective. Co-creative approaches are relatively novel to primary care but they are rather familiar in other settings such as hospitals, psychiatric care or social care and to disciplines such as nursing, sociology or developmental research.

Summary of the origin, core principles, goals and key stakeholders of three co-creative qualitative research approaches.

Summary of the origin, core principles, goals and key stakeholders of three co-creative qualitative research approaches

	Experience-based co-design	User-centred design	Community-based participatory research
Origin	Participatory designs, ethnography, phenomenology, design science, management science	Computer science and sociology	Psychology, sociology and pedagogy
Core principles	Understanding of patient experience for improving and redesigning health services Stakeholders collaborate on the redesign of process	In-depth knowledge of what matters to the intended users and their abilities. Support services must be designed to support eHealth	Perceived power imbalances, mostly the very vulnerable or minorities are affected Sustainable change depends on mutual trust, power-sharing and continuous engagement
Goals	Improved patient experience of health services	eHealth that is acceptable, usable and fits the intended users. eHealth that is feasible and supports work processes to deliver efficient care	Local and scientific learning Integrated knowledge transfer Change that reduces inequalities
Key stakeholder	Patients, family carers, professionals, managers, quality officers, change facilitators, researchers	Patients, family carers, professionals ICT designers, support staff, representatives of the health care system, researchers	(Vulnerable) members of the community, health and social care providers, advocate groups, policymakers, researchers

A growing body of literature suggests that co-creation can ultimately result in improved efficiencies and outcomes, increased patient satisfaction and trust and greater capacity for research [ 11 ]. It is a bottom-up approach to improve health services and the population’s health that general practitioners and primary care professionals serve [ 12 ]. We are aware that in scientific literature many different terms are used that fit our notion of co-creation such as co-design, co-production, partnership approaches, stakeholder engagement, patient and public involvement, and participatory research [ 13 ].

Stakeholders

Co-creation aims to define the (research) problem, develop and implement interventions and evaluate and define (research and practice) outcomes in a partnership with those who have a stake. For this article, we define stakeholders as those who have an explicit interest in a particular practice, process, decision and/or health outcome and the supporting evidence. Common stakeholders in primary care research are patients, family carers, researchers, care professionals (including managers), advocacy organisations and other relevant stakeholders (e.g. local policymakers, insurance companies). However, every research project using co-creation requires a stakeholder analysis at the stage of defining the research problem. The initial project members start with a brainstorm of all possible stakeholders and then prioritise them according to their power over, influence on, and their interest in the problem and the project. They explore their motivations, interests, positions, expectations and expected benefits [ 14 ].

Target audience and content of this article

This paper is relevant for researchers who want to use these co-creative designs and general practitioners who will increasingly read articles using this methodology. They might consider our introduction a ‘first date’. We address possible questions about the context and the what, why, when, and how of these approaches and their main practical and methodological challenges. We provide examples of published empirical studies in primary care and other health care domains and sources for further reading.

Experience-based co-design to improve the quality of care

Providing high-quality care services is the goal of every primary care professional. Classic ways for improving quality of care are based on evaluating biomedical and psychosocial outcomes, functioning and cost-effectiveness [ 15 ]. In recent years, there has been a shift towards quality of care improvement based on patient experiences by actively involving patients, family carers and the public in the design process of health services. An innovative approach to improving the quality of care services is experience-based co-design [ 16 ]. Published empirical studies using this approach include:

Empowering people to help speak up about safety in primary care: using co-design to involve patients and professionals in developing new interventions for patients with multimorbidity [ 17 ].
Improving the experience of older people with colorectal and breast cancer in patient-centred cancer care pathways using experience-based co-design [ 18 ].
A road less travelled: using experience-based co-design to map children’s and families’ emotional journey following burn injury and identify service improvements [ 19 ].

The goal of experience-based co-design is to facilitate collaborative work between patients, family carers and professionals towards a common goal – to improve the quality of care. This approach is a form of action research that seeks to capture and understand how people experience a process or service [ 16 ]. An experience-based co-design approach deliberately draws out the subjective, personal feelings of patients, family carers, the public and professionals to identify touchpoints – key moments that shape a person’s overall experience. Experience-based co-design enables patients, family carers, the public and professionals – as partners – to co-design services or care pathways to improve the quality of care based on experiences.

Why and when?

Health care professionals often think they have the unique expert knowledge to improve care processes and create value for patients [ 16 ]. Berwick [ 20 ] proposed shifting away from professional dominance to a greater focus on co-creation. There is a growing interest in patient and public involvement, often triggered by health policy initiatives and support for co-creating value across health care.

Patient and public involvement entail the active participation of patients, family carers and the public in planning, delivering and evaluating health care services. It involves the ongoing process of patient and service user initiation, building reciprocal relationships, co-learning and re-assessment and feedback [ 21 ]. Involving patients can happen at the individual level – in decisions about individual care and treatment – and at the collective level – in decisions about the delivery of care services [ 22 ].

Based on an adapted version of Arnstein’s [ 23 ] participation ladder, we distinguish five levels of involvement: information, consultation, advising, partnership and citizen control ( Box 2 ). In the primary care context, by the active involvement of patients, family carers, the public and professionals, co-design connects the knowledge of stakeholders to address quality of care priority concerns.

Five levels of patient involvement. Based on Arnstein’s participation ladder [ 23 ].

Five levels of patient involvement. Based on Arnstein's participation ladder [ 23 ].

Information	Researchers provide information to patients and the public.
Consultation	Researchers seek views of the patients and the public.
Advising	Researchers selectively include patients and the public in decisions and selectively adopt the advice given.
Partnership	Research teams share responsibilities in decisions and research activities as equal partners throughout the research process.
Citizen control	Patients and the public have complete control over the design, execution and dissemination of research, and researchers are involved on request.

Experience-based co-design projects to improve the quality of care typically last 12 months [ 24 ], and the process contains discovery and co-design phases [ 25 ] ( Figure 1 ). The start involves setting up a core group that runs the project and recruiting a researcher.

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Phases and teams in experience-based co-design. Based on Bate and Roberts [ 16 ].

The discovery phase begins with observations by the researcher that provide valuable insights into how the service to be improved works. These insights are helpful to sensitise researchers for the subsequent interviews. The discovery phase proceeds with discovery interviews, which aim to explore and learn from the impact of illness on patients’ and family carers’ everyday lives. Discovery interviews – conducted with patients, family carers and professionals about their experiences with a health service – produce knowledge about needs that may significantly impact care, recovery and wellbeing. The touchpoints are identified based on the experiences of participants. Interviews are filmed to develop a video to trigger a dialogue between patients, family carers and professionals.

In editing the video, researchers identify areas for quality improvement, often following a certain chronology, for example, diagnosis, treatment and follow-up. The video is an important catalyst in the co-design process as the visualisation of patient experiences helps (re)connect people with similar experiences and stories and offers an emotionally and cognitively powerful starting point for the co-design process [ 26 ].

Next, the various areas for improvements are prioritised in the co-design team: separately within each group (mostly patients, family carers and professionals) and then with all the groups together. Each meeting starts with presenting the various areas for improvement, illustrated by videotaped quotes from the previous phase. Then, the participants jointly choose three or four areas as the key priority for quality improvement.

In the co-design phase, co-design quality improvement groups – small working groups of patients, family carers and professionals – design and implement quality improvement activities to target the key priority issues highlighted at the co-design meetings.

Finally, the improvements are evaluated in a closing event, and the gains are communicated and celebrated by the co-design team. Experience-based co-design is a change approach and process that improves health care and scientific insights into change processes.

User-centred design to develop and evaluate eHealth resources

eHealth is the use of (digital) information and communication technology (ICT), in particular internet technology, to support or improve health and health care [ 27 ]. It offers a comprehensive promise for a better quality of primary care and high-quality data for quality assurance, education and research [ 27 ]. Innovative but valid research methodology is a prerequisite for the ongoing success and sustainability of eHealth [ 28 ]. End-users need to be involved in the development and implementation of eHealth via co-creation processes, and design should be mindful of vulnerable groups and eHealth illiteracy. An appropriate approach is user-centred design.

Published empirical studies using this approach include:

User-centred design of a tablet waiting room tool for complex patients to prioritise discussion topics for primary care visits [ 29 ].
Development of a mobile clinical prediction tool to estimate future depression severity and guide treatment in primary care: user-centred design [ 30 ].
Creating guardians of physiologic birth: the development of an educational initiative for student midwives in the Netherlands [ 31 ].

The goal of user-centred design, stemming from social and technological design sciences, is to develop eHealth technologies with very high usability. It is a method to assess, design and develop technological and organisational systems, which involves end-users in design and decision-making processes [ 32 ]. Its key features are rapid cycles of problem identification and solution creation, in-depth understanding of end-user characteristics, the influence of end-users on how a design takes shape, iterative evaluation during the entire development process, and accounting for the implementation conditions from the beginning [ 33 ]. Ideally, the user-centred design considers all potential stakeholders, for example, patients, family carers, professionals and staff, ICT designers, representatives of the health care system and researchers responsible for the content of the technology. However, the end-users are mostly patients, family carers, professionals and staff.

Developing eHealth often uses new technologies and services for users experiencing complex health problems. User-centred design supports developing eHealth by understanding and solving the problem simultaneously and iteratively [ 33 ]. If end users are engaged to create and implement interventions themselves, the interventions will incorporate nuanced factors and consider social, structural and environmental determinants of health that affect the end-users. Without this input, these elements would not have been evident to researchers or professionals [ 33 ]. Apps developed with user-centred design have reported improved user acceptance, face validity, user-friendliness and uptake [ 30 ]. Critical for eHealth’s uptake and continuous use is that it is user-friendly, meets end users’ motives, values, needs and abilities and fits into the organisation of care.

User-centred design uses mostly qualitative or mixed methods [ 33 ]. The problem development cycle involves gathering and analysing data from users and other sources to define problems and needs. The solution development cycle involves the generation of ideas to build and test prototypes with end-users. Within and between these cycles, there are iterative feedback loops. Researchers and developers finalise and deploy an eHealth solution when it meets the end users’ key requirements.

A specific type of user-centred design is rapid prototyping, which is often used for developing educational (e-learning) programmes [ 34 ]. It involves overlapping stages of needs assessment, input and feedback from key stakeholders in designing subsequent prototypes to reach a final prototype for implementation and evaluation.

Various descriptions exist of the stages within each of the problem and solution development cycles in the user-centred design process, for example, a five-stage process consists of concept, design, testing and trials, production and deployment stages with end-users participating in all stages, except production [ 33 , 35 ] ( Box 3 ). The methods most used for involving end-users are usability tests, interviews and questionnaire surveys. Since capturing end users’ perspectives at various stages depends on the method applied, selecting an appropriate method is important [ 36 ]. This also requires in-depth consideration of all users and their activities, their actual daily environment and their functional limitations, innumeracy and skills [ 35 ]. For example, considering midwives’ high workloads, researchers chose individual interviews and written feedback rather than focus groups [ 31 ].

User-centred design stages: methods for capturing end users’ perspectives. Based on Shah et al. [ 35 ].

User-centred design stages: methods for capturing end users' perspectives. Based on Shah and Robinson [ 35 ].

	Concept stage	Design stage	Test and trials stage	Deployment stage
Interviews	X	X	X	X
Usability tests	X	X	X	X
Questionnaires	X	X	X	X
User and producer seminars	X	X	X	X
Task analysis	X	X	X
Observations	X	X	X
Simulations	X	X	X
Discussion	X	X
Video recording			X	X
Human factors approach		X	X
Use experiment				X
Focus groups (Delphi)				X
Users’ feedback	X
Design sessions		X

For less available end-users, including elderly people and people with disabilities and/or special needs, substitutes called ‘user surrogates’ might be involved [ 35 ]. A user surrogate is a user who has the knowledge or authority to perform tasks on behalf of another user. User surrogates report on what they know about the user or by role-playing how the user would behave.

Community-based participatory research to improve local health collaboratively

Primary care professionals often provide care to vulnerable groups, such as cultural minorities and deprived communities. They care for patients who struggle with health problems affected by their lifestyle choices, biography, life events, educational level, socioeconomic situation and social and physical environment. A research approach to address health disparities is community-based participatory research. It has often been used for hard-to-reach or very vulnerable communities. We define community as a group of people with common interests – such as shared values, culture, customs or identity or as all people living in a particular geographical area – such as a neighbourhood, district or local area, or as groups of people with a common interest living in a geographical area.

Participatory development and pilot testing of the Makasi intervention: a community-based outreach intervention to improve sub-Saharan and Caribbean immigrants’ empowerment in sexual health in France [ 37 ].
Implementing community-based participatory research in the study of substance use and service utilisation in Eastern European and Turkish communities in Belgium [ 38 ].
A community-based participatory research on improving the integration of health and social in the Netherlands [ 39 ].

The goal of community-based participatory research is to educate, improve practice or bring about social change. It is a collaborative approach to research, which seeks to address a locally relevant health issue [ 40 ]. What is unique to community-based participatory research is its emphasis on the diverse community partners involved and on striving for equal participation and ownership, reciprocity, co-learning and change [ 41 ]. This approach engages researchers and community members in all aspects of the research process, including needs assessment and agenda-setting, decision-making, capacity building, knowledge generation and the implementation and dissemination of findings [ 42 , 43 ]. Because of its focus on community engagement, community-based participatory research allows community partners working with academic partners to identify and address health problems affecting their communities ( Box 4 ). It fosters social connections that can lead to change and produces knowledge that can lead to action [ 44 ].

Sources for further reading on stakeholder analysis and management, patient and public involvement and three co-creative qualitative approaches.

Web sources on stakeholder analysis and management

NHS England and NHS Improvement www.england.nhs.uk/wp-content/uploads/2021/03/qsir-stakeholder-analysis.pdf .
State of Victoria, Department of Health and Human Services, State of Victoria, Australia www.dhhs.vic.gov.au/publications/stakeholder-engagement-and-public-participation-framework-and-toolkit .

Web sources on patient and public involvement

INVOLVE www.involve.org.uk .
James Lind Alliance www.jla.nihr.ac.uk .
Strategy for Patient-Oriented Research (SPOR) www.cihr-irsc.gc.ca/e/41204.html .
Gordon and Betty Moore Foundation and the American Institutes for Research www.air.org/project/roadmap-guides-patient-and-family-engagement-healthcare .
Patient‐Centered Outcomes Research Institute https://www.pcori.org/ .
Health Issues Centre https://healthissuescentre.org.au/health-services/consumer-engagement-guide .
National Framework of Consumer Involvement in Cancer Control https://canceraustralia.gov.au/sites/default/files/publications/national_consumer_framework_web_504af020f2184.pdf .

Web sources on budgeting involvement

The SPOR Networks in Chronic Disease and their Patient Partners https://diabetesaction.ca/wp-content/uploads/2018/07/TASK-FORCE-IN-PATIENT-ENGAGEMENT-COMPENSATION-REPORT_FINAL-1.pdf .
INVOLVE https://www.invo.org.uk/wp-content/uploads/2013/07/INVOLVEMHRNBudgeting09Jul2013.pdf .
National Institute for Health Research https://www.nihr.ac.uk/documents/payment-guidance-for-researchers-and-professionals/27392 .

Experience-based co-design

Bate B, Roberts G. Bringing user experience to health care improvement. Oxford: Radcliffe Publishing; 2007.
King’s Fund www.kingsfund.org.uk/projects/ebcd .
Boyd H, McKernon S, Old A. Health Service Co-design Working with patients to improve healthcare services guide and toolkit https://www.wdhb.org.nz/assets/Uploads/Documents/45f463d911/rttc_health-service-co-design-by-h-boyd.pdf .
Melchior I, Moser A, Stoffers S, et al. EBCD Methodiek: Versterken van de participatie van oudere patiënten en naasten ter verbetering van de kwaliteit van zorg http://www.innovatiesindezorg.eu/files/4914/8853/9220/EBCD_toolkit_methodiek_DEF.pdf .

User-centred design

Neuhauser L. Integrating participatory design and health literacy to improve research and interventions. Inf Serv Use. 2017;37(2):153–76.
Shah SGS, Robinson I. User involvement in healthcare technology development and assessment: structured literature review. Int J Health Care Qual Assur. 2006;19(6):498–513.
Tripp SD, Bichelmeyer B. Rapid prototyping: an alternative instructional design strategy. Educ Technol Res Dev. 1990;38(1):31–44.

Community-based participatory research

Cargo M, Mercer SL. The value and challenges of participatory research: strengthening its practice. Annu Rev Public Health. 2008;29(1):325–50.
Israel BA, Eng E, Schulz AJ, et al. Methods for community-based participatory research for health. 2nd ed. San Francisco (CA): Jossey-Bass; 2012.
Viswanathan M, Ammerman A, Eng E, et al. Community-based participatory research. Evidence Based Practice Centre Contract No. 290 – 02 – 0016, Agency for Healthcare Research and Quality; 2004. Available from: http://www.ahrq.gov/clinic/epcsums/cbprsum.htm .
Wallerstein N, Duran B, Oetzel J-G, et al. Community-based participatory action research for health. San Francisco (CA): John Wiley; 2018.

Community participation in primary care has its origins in the Alma-Ata Declaration of 1978 [ 45 ], which stated that people have the right and duty to participate individually and collectively in the planning and implementation of their health care. The benefits include the following: ensuring that the research topic reflects a major issue identified by the community; improving the quality, validity and sensitivity of the research by drawing upon community wisdom, thus promoting trust between communities and researchers; improving the translation of research findings into policy and practice; and enhancing uptake of the research findings by community members [ 42 ]. Researchers together with the local community might help address the well-described issue of ‘ivory tower’ research and have a social impact in the ‘real world’ [ 46 ].

Community-based participatory research can employ diverse methodologies, study designs and data collection methods, for example, qualitative case studies, environmental assessments, mixed methods research and randomised controlled trials. In general, there are seven phases [ 44 ] ( Figure 2 ). Researchers and the local community work together as partners.

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Phases of community-based participatory research. Based on Israel et al. [ 44 ].

The first phase is forming a community-based action research partnership involving activities to identify potential non-academic partners. Partners might include the following: patients; interpersonal support networks, including family members, mentors and friends; members of the general public who are not patients but who support or believe in the issue; those who interface directly with patients and/or patients’ interpersonal networks, including practitioners, health professionals and administrators; and others, such as service providers and policymakers. The activities aim to build trust and relationships, establish operating norms and community-based action research principles to ensure equity and power-sharing and create an infrastructure for the research [ 43 ].

The second phase entails assessing community strengths and dynamics. This involves activities such as discovering and assessing the strengths and resources in the community, key cultural and historical dimensions, influential organisations, power relationships in the community and partners to be involved to ensure that the community voice is heard [ 45 ].

The third phase is identifying priority local health concerns and research questions. Key activities are to identify the major health problems that community partners experience as affecting the community and that need to be addressed and prioritise health concerns and their contributing factors. Finally, the researchers and community partners formulate the key research questions for the study.

The fourth phase involves collaboratively designing and conducting interventions and/or policy research. This involves prioritising the research questions and goal, selecting the research design and data collection methods and deciding the most appropriate intervention. In addition, it involves determining how to carry out the research design and the intervention selected and, finally, agreeing on the evaluation.

The fifth phase is feeding back and interpreting the findings within the community. This involves data analysis: sharing (preliminary) findings from surveys, in-depth interviews, focus group discussions, etc. and engaging the community partners to make sense of the findings.

The sixth phase is disseminating and translating the research findings. This involves identifying the most important findings for sharing with the community, the community’s role in communicating and translating the findings, disseminating the findings into broader interventions and policy changes and publishing the research results. This might lead to the formation of a community-based action research partnership.

All phases share an underlying continuous process of maintaining, sustaining and evaluating the community partnerships. The researchers and community partners are reflective about their working relationships and shared long-term goals and capacities. All these approaches might integrate some mixed-methods research such as pilot testing or proof-of-concept [ 47 ].

Challenges in applying co-creative approaches

Drawing on our experience with co-creative research projects and based on the methodological and empirical papers we referenced, we provide a brief overview of practical and methodological challenges that such research projects may face.

Practical challenges

Unclear purpose and expectation.

Stakeholders and researchers need to understand what the project goal is and why the process of co-creation is essential [ 40 , 46 ]. It helps to work step-by-step and establish a shared starting point in each phase of the co-creative approach. At the time, researchers, especially the principal investigator, need to keep track of the scope and expected outcomes of the project [ 44 ].

Skills, capacities and financial resources

Some stakeholders might lack the skills to adopt a view beyond their personal stakes [ 18 ]. Researchers need to make optimal use of the various stakeholders’ capacities in different project phases or research activities. Some stakeholders, especially patients and vulnerable community members, might lack the resources to participate in meetings [ 43 , 48 ], for example, affording public transport or self-confidence to speak up. Researchers, especially principal investigators, need to balance preferred ways of engagement in co-creation, meaningful activities to stakeholders and the available time, enabling measures, time demands and financial resources [ 44 ]. It is important for principal investigators to budget for stakeholder involvement in their research projects adequately. When applying for research grants, stakeholder involvement, especially patient and public involvement should be explicitly budgeted ( Box 5 ). Funders often check to ensure budgets have been thoughtfully allocated to promote meaningful participation.

Multiple perspectives and conflicts

Various data types are collected during in-depth interviews, focus-group discussions, workshops etc., from different sources, for example, patients, professionals, and managers. The integration and prioritisation of these perceptions and concerns are challenges for stakeholders and researchers [ 49 ]. Conflicts may occur due to different decision-making styles, values, priorities, use of language, engagement history, perceived power imbalance, competition or lack of feedback on stakeholders’ input [ 40 ]. Researchers need to foster a democratic process of dialogue, shared responsibility and positive relationships [ 38 , 39 , 41 , 46 ].

Methodological challenges

Methodological quality.

Most stakeholders are primarily interested in how the project will address their perceived health issues, whereas researchers also strive for generating valid scientific knowledge. Researchers need to be flexible in all research steps in balancing practical relevance, methodological quality, and timing [ 40 , 44 , 49 ].

Research team

Co-creation requires various competencies in the research team. Usually, individual researchers in multidisciplinary teams bring in their specific expertise in certain research phases or steps. Researchers need to compose a research team that integrates competencies from different health disciplines, methodological competencies and social competencies in guiding all stakeholders through the co-creation process [ 41 , 49 ]. The flexible, time-consuming and sometimes unexpected nature of co-creation might cause time pressure [ 43 ]. Researchers need to balance getting things done and reflecting on the research process, methodological quality, stakeholder relationships and their own role [ 18 ].

Digital research

Other qualitative approaches, such as netnography [ 50 ], use of various formal and informal online data sources, digital data collection methods and interactive digital tools are fully in development. Digital research might support efficient data collection and management but might also bring inequality risk, for example, exclusion of people lacking digital skills [ 51 ]. Researchers need to consider ethical and methodological issues in digitalisation in qualitative research because it might be a promising way forward in co-creative approaches.

Acknowledgements

The authors thank the junior researchers who have participated for the last 10 years in the ‘Think tank on qualitative research’ project, a collaborative project between Zuyd University of Applied Sciences and Maastricht University, for their pertinent questions. The authors are grateful to Darcy Ummels for proofreading our manuscript and providing valuable feedback from the novice perspective.

Disclosure statement

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.

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Regents approve operating budget, tuition rates for 2024-25.

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Regents approve operating budget, tuition rates for 2024-25

A new University of Nebraska partnership will allow Nebraskans to earn Google Career Certificates in a variety of fields crucial to the state’s workforce growth and competitiveness, including cybersecurity, IT, data analytics and business intelligence.

The University of Nebraska Board of Regents on June 20 approved a 2024-25 operating budget that will eliminate the NU system’s current deficit, keep tuition affordable and make investments in strategic priorities to move Nebraska forward.

The $1.1 billion operating budget, approved by a 5-2 vote and with the support of all three student regents present at the meeting, supports the NU system’s vision for excellence at a time of significant change and challenge for all of higher education, according to Chris Kabourek, interim president. In closing NU’s shortfall for the current biennium, the budget also provides a “clean slate” for incoming President Jeffrey P. Gold, who assumes his new role July 1.

“I think this is a responsible budget that puts us in a strong position for the year ahead,” said Kabourek, adding thanks to the chancellors, chief business officers and leadership teams for the many months of work behind the final product.

Key elements of the budget are:

An inflationary tuition increase of 3.5%. The increase amounts to $135 more per semester for an undergraduate attending UNL, $120 more at UNO, and $105 more at UNK. There will be no impact for students who receive the Nebraska Promise, as the university is increasing its investment in need-based financial aid at the same rate as tuition.

Kabourek, a first-generation college student from David City, noted the university takes any cost increases for students seriously. Students’ contributions support outstanding faculty and the high-quality educational experience they receive at Nebraska, he said.

“We have big goals for excellence,” he said. “I think it’s fair for all of us — the university, the state and our students — to chip in to help get us where we want to go.”

A 3% pool for merit-based salary increases for non-unionized faculty and staff.

$11.8 million in permanent spending reductions, allocated across the four campuses and Office of the President, to be made in the upcoming year.

No allocations for inflation, which will require departments and units to reprioritize their spending to manage inflationary increases.

$1.5 million to expand the Presidential Scholars Program, the new scholarship program that provides a full cost of attendance scholarship, plus a $5,000 annual stipend, to Nebraska students who score a perfect 36 on the ACT. Funds will be used to allow students who score a 32 or above to compete for a limited number of additional scholarships.

$15 million in state funds for staffing and operations at the Kristensen Rural Health Education Complex on the UNK campus.

$1.5 million for priorities of President-Elect Gold’s choosing.

Kabourek noted that the economic headwinds facing the University of Nebraska and all of higher education have not gone away, and said the university community will need to continue to have conversations about priorities and resource allocation in order to “stay on offense.”

The board also approved the 2024-25 operating budget for the Nebraska College of Technical Agriculture. The tuition increase at NCTA amounts to $5 more per credit hour.

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MSU researcher part of $19 million NASA mission focused on ‘true brightness’ of stars, secrets of ‘dark energy’

Contact: Sarah Nicholas

STARKVILLE, Miss.—A Mississippi State University astrophysicist is going lightyears beyond star-gazing as she helps lead the science portion of a recently approved collaborative $19.5 million Landolt NASA Space Mission that will put an artificial star in orbit around the Earth.

This artificial star will allow scientists to calibrate telescopes and more accurately measure the brightness of stars ranging from those nearby to the distant explosions of supernova in far-off galaxies.

By establishing absolute flux calibration, the mission will begin to address several open challenges in astrophysics including the speed and acceleration of the universe expansion.

Angelle Tanner, an MSU associate professor in the Department of Physics and Astronomy, serves as the science-PI on the Landolt Mission, part of the NASA Astrophysics Pioneers program. She is managing a sub-grant of $300,000 for the project. For more on the Pioneers Program, visit https://science.nasa.gov/astrophysics/programs/astrophysics-pioneers/ .

Tanner’s work on the mission relies on cubesats—small satellites orbiting Earth.

“The program includes a cubesat and a set of ‘ground stations,’ which are telescopes,” Tanner said. The cubesat contains four lasers which are specially calibrated by The National Institute of Standards and Technology, an agency of the U.S. Department of Commerce.

“As the cubesat flies over a location, the ground stations will observe the cubesat in the same frame as their science target. The point is to use the image of the laser to determine the amount of starlight being absorbed by the Earth’s atmosphere. This will reduce the uncertainties in the value of the brightness of the star from 10 percent to one percent. That makes a difference when propagated into the properties of exoplanets and, believe it or not, some of the parameters used to determine the structure of the universe.”

Working with the team at George Mason University in Virginia—including Landolt Mission lead PI, George Mason Associate Professor of Physics and Astronomy Peter Plavchan—the mission is named in honor of LSU Professor Arlo Landolt, who Tanner calls the “the father of photometry.” To follow the mission’s progress, visit www.landolt.gmu.edu . For additional information on the mission, contact Tracy Mason, assistant dean of strategic communications and marketing at George Mason University, at [email protected] or call 703-229-2030.

Tanner is part of a group of scientists launching a new telescope to the moon’s surface, known as L-CAM1 last year but now updated to LUSTRESSO, and in 2020 was part of a collaborative group that discovered a new planet orbiting a nearby star 31.9 light-years away. Named AU Mic b, the planet is orbiting AU Microscopii, a nearby cool red dwarf star surrounded by a debris disk.

For more about the College of Arts and Sciences or the Department of Physics and Astronomy, visit www.cas.msstate.edu or www.physics.msstate.edu .

Mississippi State University is taking care of what matters. Learn more at www.msstate.edu .

Wednesday, June 12, 2024 - 8:59 am

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CU Boulder, industry partner on space docking and satellite AI research

Hanspeter Schaub standing in front of a vacuum chamber.

Docking with a satellite orbiting Earth is delicate business, with one wrong move spelling disaster. A team of industry and University of Colorado Boulder researchers is trying to make it easier.

The work is part of two major business-university grant partnerships that include the lab of Hanspeter Schaub, a professor and chair of the Ann and H.J. Smead Department of Aerospace Engineering Sciences.

“The goal with these grants is very much tech transfer,” Schaub said. “We’re combining university research with business goals and initiatives to develop a product or service.”

The first project is a U.S. Space Force Small Business Technology Transfer grant with In Orbit Aerospace Inc. The goal is to use electro adhesive forces to ease docking between satellites, future space cargo vehicles, or orbital debris. Electro adhesion uses short-range strong electric fields to hold together adjacent bodies, even if they are not made of magnetic materials.

“Docking in space is surprisingly difficult. If servicer bumps target vehicle in an unexpected manner, it’s going to bounce off and fly away. Electro adhesion has been used a lot already with manufacturing on Earth. With electric fields, you can create attractive forces to grab stuff. They’re not huge forces, but they’re nice,” Schaub said.

The team completed early work on the project last year and has now advanced to a second stage, which began in May.

Schaub’s portion of the grant is worth about $500,000 over 18 months, and includes numerical modeling and atmospheric experiments as well as the creation of samples to test in the lab’s vacuum chamber that approximates orbital conditions.

It is not the only business development grant in Schaub’s lab. He and Associate Professor Nisar Ahmed are also in the process of setting up a contract with Trusted Space, Inc. on a U.S. Air Force STTR grant to advance autonomous satellite fault identification. CU Boulder’s portion of this project is worth roughly $300,000 over 18 months.

Like all electronics and machines, satellites sometimes fail. The goal of the effort with Trusted Space is to develop an AI that can automatically identify likely sources of errors.

“If a satellite isn’t tracking in orbit, maybe something bumped into it, maybe the rate gyroscope is off, maybe everything is fine but a sensor is giving bad information. There might be 10 different reasons why and we’re trying to down select in an automated way so a human doesn’t have to scour through datasets manually,” Schaub said.

The team has completed proof of concept work on a Phase 1 grant and is now advancing to Phase 2, modeling dozens of potential errors.

Both grants make extensive use of Basilisk, a piece of software developed by Schaub’s lab to conduct spacecraft mission simulations.

Although many of Schaub’s grants are directly with government agencies or multi-university initiatives, he said conducting work with a business partner offers unique opportunities for advancing science and additional potential for students.

“Students get exposure to industry and are excited because suddenly people outside the research community are interested in what they’re doing,” Schaub said. “They attend meetings and see how projects are run, what challenges industry is trying to solve. It helps influence their dissertations and gives more focus. I see a lot of benefits and companies also often want to hire the students.”

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It’s time to take intel seriously as a foundry: part ii.

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Semiconductor manufacturing and advanced packaging at Intel Foundry

As my colleague indicated in a previous article (see below), Intel appears to be achieving its goal of becoming a leading semiconductor foundry. The company recently announced that it has begun volume production for both internal Intel customers and with external customers on the Intel 3 process and provided some technical details on this process at the IEEE Symposium on VLSI Technology & Circuits in Hawaii. Intel 3 represents the third process node in the Intel IDM 2.0 strategy which is aiming to develop five process nodes in four years and will be the first advanced node targeted at foundry manufacturing. Intel also indicated that Intel 3 will have a long life to support foundry customers for at least the next ten years opening it up to applications which require longer life cycles such as automotive and IoT. The production ramp of Intel 3 is more than just a manufacturing achievement, it represents a significant milestone and proof point for Intel Foundry.

Intel process roadmap to achieve five nodes in four years

According to Intel, Intel 3 has some significant enhancements over the previous Intel 4 process node, including a new FinFET transistor design, high-density cell structure, and multiple metal layer combinations. The result is the availability of multiple versions of the process to support standard logic and compute applications (Intel 3), 3D ICs (Intel 3T), analog chipsets (Intel 3E), and high-performance AI and compute applications (Intel 3PT) delivering up to an 18% improvement in performance per watt, lower leakage, and enhanced reliability.

Intel is in production on the Intel 3 and 3T processes with the Xeon 6 processors and will be rolling out the Intel 3E and Intel 3PT processes in conjunction with customer needs. Note that this is in addition to production on the mature Intel 16 process node for foundry customers. Intel will also be entering production of the final two process nodes in the IDM 2.0 strategy, Intel 20A and Intel 18A by the end of 2024. Intel 20A will be the first process to use Intel’s RibbonFET transistor design (otherwise known as gate-all-around transistors) and backside power delivery (or PowerVia) technology.

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As Tirias Research has stressed in our review of Intel’s turnaround strategy, the proof is in execution. Thus far, Intel has shown that it can deliver both process technology and new products faster than the company has ever done before. The Intel Foundry strategy will not only make the foundry more competitive, but it will also make Intel’s own products more competitive. It is definitely time to take Intel seriously as a foundry and as an industry leader once again.

The author and members of the Tirias Research staff do not hold equity positions in any of the companies mentioned. Tirias Research tracks and consults for companies throughout the electronics ecosystem from semiconductors to systems and sensors to the cloud. Tirias Research has consulted for Nvidia, AMD, Intel and companies throughout the semiconductor ecosystem.

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COMMENTS

Series: Practical guidance to qualitative research. Part 5: Co-creative
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