Community Engagement in Clinical Research

1. Community Engagement in Clinical Research An Introduction David O. Warner, M.D.

2. Why are we talking about “community engagement?” • Traditional research approaches • ~98% of Americans receive their health care outside of academic medical centers • The challenge of “translational research” • How to reach Billy in Sleepy Eye, MN?

3. The Translational Research Continuum What works under controlled conditions? (Up to phase III trials) “Bench” “Bedside” Basic Biomedical Discovery Clinical Efficacy T1 What works in real world settings? (e.g., Comparative Effectiveness Research) What is the effect on population health? (Outcomes research) T2 T4 Clinical Effectiveness T3 Clinical Practice How can we change practice? (Dissemination and Implementation Research) Community Practices Community Practices

4. The Translational Research Continuum What works under controlled conditions? (Up to phase III trials) “Bench” “Bedside” Basic Biomedical Discovery Clinical Efficacy T1 What works in real world settings? (e.g., Comparative Effectiveness Research) What is the effect on population health? (Outcomes research) “T2” Clinical Effectiveness Clinical Practice How can we change practice? (Dissemination and Implementation Research) Community Practices Community Practices

5. “Community engagement” as a key component of translational research • How to reach Billy? • Include him in the research process • The NIH response • Roadmap, CTSA, etc. • Issues arise… • The ethics of conducting research in communities - e.g., who benefits?

6. What is a “Community?” • A group of people linked by social ties who share common perspectives or interests, and may also share a geographic location (MacQueen et al) • Examples of communities • Olmsted County residents • Somali immigrants • Primary care physicians in Southeastern Minnesota • And many others…. • Communities are not homogeneous and seldom speak with a single voice

7. What is “Community Engagement”? …community engagement is a process of inclusive participation that supports mutual respect of values, strategies, and actions for authentic partnership of people affiliated with or self-identified by geographic proximity, special interest, or similar situations to address issues affecting the well-being of the community of focus. NIH Council of Public Representatives, October 2008

8. Unpacking Community Engagement… • A broad framework that includes the full spectrum of approaches that involve the community in the research process • Includes research ranging from that which incorporates only a few elements of community engagement with minimal collaboration to research in which community organizations and researchers are equal partners throughout the process • Builds on community strengths • Emphasis on partnerships and collaboration

9. Researcher or funding source identifies problem Researcher writes protocol, selects community to be studied, obtains funding Researcher recruits subjects from the community Researcher collects and analyzes data Traditional Research Approach Researcher writes article, obtains academic rewards, thanks community (sometimes)

10. COMMUNITY Community-engaged Research Approaches Problem identified of interest and relevance to the community Protocol tailored to specific community of interest, funding obtained and shared as appropriate Community members are participants in research, not just subjects Data analyzed and collected with community input as appropriate Results disseminated to both the academic world and the community Studies that recruit subjects in community settings are not necessarily community-engaged

11. Examples of community-engaged research approaches • Identifying research topic • Community members or researcher may make the initial approach • Example – chronic pain in Native Americans • Researcher and community may work together to refine • Plan developed and funding secured • Researcher contributes scientific expertise • Community also contributes; • Ideas on logistics and recruitment • Advice on tailoring for community context • Community receives research funds as appropriate

12. Examples of community-engaged research approaches • Study conduct • Community members involved as appropriate • e.g., hire study staff • Promote study within the community • Advice on study problems • Data analysis and reporting • Involvement of community as appropriate • Dissemination of results to the community and to the academic world • Community determines appropriate/relevant methods for their members

13. Community-based Participatory Research (CBPR) • One end of the community-engaged research spectrum • Equitable partnership between researcher and community in all research phases • Community identifies the problem to be addressed • Aims at achieving meaningful changes that will directly improve community health • Requires major investments of time and energy in building the relationships necessary for successful partnerships

14. Traditional Research Approach Researcher defines problem, community may contribute Community-engaged Research Research with the community Community-based Participatory Research Researcher brings his/her interests to the community to determine if the community is interested Community identifies problem or works with researcher to identify problem Researcher defines problem Research WITH community as partner Research WITH community as full partner Research IN or ON the community People as subjects People as participants People as participants & collaborators Community organizations may be asked to assist Community organizations may help recruit participants & serve on Advisory Board Community organizations are partners with researchers Researchers gain skills & knowledge Researchers gain skills & knowledge, some awareness of helping community develop skills Researchers & community work together to help build community capacity Researchers control process, resources & data interpretation Researchers control research, community representatives may help make minor decisions Researcher & community share control equally Researchers own data, control use & dissemination Researchers own the data; may involve community in decisions about how it will be used & disseminated Data is shared, researchers and community decide its use and dissemination From MA MacDonald, Duke University

15. Challenges of community-engaged research approaches • Requires considerable investment of time and energy to build relationships • And any relationship has high and low points…. • Community priorities may not reflect your research priorities • Community may have little capacity/experience with research, and follow a different timeline • Funding mechanisms/study sections may be unfamiliar with these approaches

16. Benefits of community-engaged research approaches • Can improve reliability and validity of study tools and procedures • Helps recruitment and study flow • Results more likely to be relevant • May improve external validity • Expanded opportunities for funding • NIH expanding RFAs • Foundation funding • Relationships have their own rewards

17. Successful Community-engaged Researchers… • View community partners as knowledgeable and important contributors to research • Acknowledge that they and community members bring their own beliefs to research • Think that the beliefs and values of community members should be recognized • Value relationships with the community as one of the benefits of research