Unique Challenges in Conducting Community-Based Research

1. Unique Challenges in Conducting Community-Based Research Julie M. Kaberry, MHP, CIP Administrative Chair, HSPH IRB jkaberry@hsph.harvard.edu 617-432-2149

2. Community Based Research:What? • Collaborative approach • equitably involves researchers and community members in the research process • development of the research question • Implementation of the research • analysis of the results • dissemination of results to the community • Bridge the gap between knowledge produced through research and what is needed and practiced in the community

3. Community Based Research (CBR): Why? • Engage local knowledge • Strengths and resources exist among community members to address and promote health and well-being • Focus on issues important to the community • community members have more ownership over longterm community based problems • Foster collaborative research partnerships and enhance public trust in research • Communities can feel exploited when research does produce beneficial change for the community (that warranted the research) but researchers gain benefits

4. What is a Community? • A unit of identity - a geographic neighborhood, dispersed geographic ethnic group; overlapping communities in a defined area • Groups with similar interests or ideals(e.g. religion) • Community Partners represent community interests, needs, and/or concerns • knowledgeable about the community • empowered to represent that community • e.g. elected officials, school boards, health departments, faith-based organizations

5. CBR Partnership and Collaboration Benefits • Promotes a co-learning and empowering process that attends to social inequalities; a reciprocal transfer of knowledge, skills, capacity and power • Facilitates collaborative partnership in all phases of the research: • Define the research problem (ensure relevancy) • data collection • interpretation of results • application of results to address community concerns

6. Community Partners: Engaged? • What is the scope of research activities and engagement of community partners in those activities? • Examples of activities that may engage a community partner/members: • Receipt of federal funds $$ • Obtaining data about research participants • through intervention or interaction • Obtaining identifiable private information or identifiable specimens • even if not directly interacting with participants • Obtaining informed consent

7. IRB: Engaged? Engagement = IRB Review • Local IRB - what is the application process? • Is there a Community Advisory Board (CAB)? • CAB - consensus decision making, resource sharing in research; local context and knowledge • Who are its representative members? • What human subjects education training (e.g. CITI) is required? • Is an IRB Authorization Agreement or Individual Investigator agreement needed?

8. IRB Considerations The Research Protocol: • Is the community clearly defined? • Describe potential benefits of the research to the local community and/or society • Are your recruitment strategies and materials culturally appropriate and adapted to the participants? Who approaches people about the study and how? • Is there a plan to disseminate aggregate results to the community where the research is conducted? • Describe the Principal Investigator’s experience conducting research at study site(s) and familiarity with local culture • Describe plan for ongoing monitoring regulatory compliance

9. Ethical Considerations: The Belmont Report Basic ethical principles underlying acceptable conduct of human subjects research: • Respect for Persons: • Individual autonomy – participant must choose • Beneficence: • Protect from harm • Minimize risks - maximize benefits • Justice: • Fair and equal • how participants are chosen • how participants experience the risks of the research

10. Ethical Considerations: The Belmont Report UNIVERSALprinciples • Do not change regardless of culture, economic status, educational status, etc. • Community-engaged research must meet the same standards and comply with same regulations that govern all research • May present different dimension of ethical questions • E.g. individual protections vs. consideration for communities

11. Belmont Principle: Respect for Persons • People make decisions to participate in research for themselves • Autonomous individuals weigh the risks and benefits and make a decision based on their personal understanding of the research, their own values and interests and their own circumstances • Voluntarily provide informed consent Community Considerations: • Community groups may hold different views and priorities, decision making is more complex • One person (e.g. tribal leader) or multiple leaders may be weighing the risks and benefits for a larger group - decide if the community should participate

12. Respect for Persons: Informed Consent Research Protocol Sec. 9.1- Describe the setting, role of individuals involved, timeframe(s), and steps to minimize coercion/undue influence during the consent process • Does the consent form and consent process use appropriate (linguistically and culturally) language? • Whose permission is needed to speak with community groups? (e.g. Native American elders, Faith based leader) • Getting written informed consent can make doing the community research difficult (request a waiver?) A Community Advisory Board or community leader can serve as liaisons or partners with researchers to build community solidarity for consenting.

13. Belmont Principle: Beneficence • Maximize benefits and minimize risks • Risks and benefits are considered in relation to the individual Community Considerations: • Community level risks and benefits may be different from the risks and benefits for individuals • Multiple parties may perceive risks and benefits differently • Researchers, community organizations, community members • Can the benefits be identified, communicated and discussed among all partners? • What is the risk (and negative implication) of harmful results to the community ? • Are there mechanisms in place to manage harmful results?

14. Beneficence: Study Design Research Protocol Section 10 and 11 - Are there any reasonably foreseeable risks, discomforts, and inconveniences to participants and/or groups/communities?; Describe the potential benefits of the research to the local community or society • Community engaged research is commonly face-to-face methodology resulting in less anonymity. Has proper consideration been made to address privacy and confidentiality risks? • Risks are less likely to be physical, so have all legal, psychological, economic and social risks to the community been considered? • Requires risk assessment that includes assessing impacts to humans, the natural world, cultural, social, subsistence, economic and spiritual practices.

15. Beneficence: Study Design Cont. • Culturally based and community specific definitions of health and risk must be determined in collaboration with community members. • One sided designs and their results can stigmatize cultural groups and whole communities. • Choice of study design is best made with community consultation - how realistic is the choice? For example: • a longitudinal study might be feasible in a controlled clinical setting with a stable patient population, but this might not be feasible for a highly transient clinic setting. • an intervention might be feasible in the context of a research project with large participant incentives and dedicated research staff, but not be feasible in a natural setting—the one which will ultimately be the location of the intervention once the research is completed.

16. Belmont Principle: Justice • Fair distribution of the burdens and benefits of the research • Choosing participants fairly and equally • Research questions match the needs of the participant Community Considerations: • Research should benefit the community and not exploit it • Is the compensation coercive (in relation to the community’s needs)? • Research questions match the needs of the community, both individual and as a group • e.g. low income communities receiving free diabetic medication • Is participation in the research linked to the provision of services? Will services still be received if a community decides not to participate? • How will results be disseminated to the community? • What evidence is hypothesized that the community has benefited from the research study?

17. Justice: Sharing Results Research Protocol Section 21 - Is there a plan to share results with individual participants? Is there a plan to share results disseminate aggregate results to the community where the research is conducted? • Who is the target audience? • Will community partners oversee the data collection and provided local (vs. academic) translation of the findings? • What is the impact on the community? • Will dissemination be through multiple venues (e.g., community forums, presentations, journal articles, web sites, online)?

18. Justice: Sharing Results Cont. • Are these venues effective and accessible to both community members and researchers? Scheduling meetings, setting up locations are much more varied, require flexibility • Some communities rely on trusted sources for sharing information, such as faith-based organizations, local radio programs, the internet, and public spaces. Have these been adequately considered? • Avoid misunderstandings and conflicts – same data can be presented in multiple ways, eliciting different response. 1. Sixty percent of the young men in the Park neighborhood have been incarcerated by the age of 25 years. The average young man in the Park neighborhood aged 15-25 years old has had two sexually transmitted infections, and 25 percent of them have HIV infection. 2. Among the young men in our study, we found higher-than-expected rates of incarceration and sexually transmitted infections, especially HIV. These findings are very concerning to all of us. We must work together to better understand the factors contributing to incarcerations and sexually transmitted infections and to ultimately reduce these rates.

19. Questions?