Engaging Community Health Workers in Research: Ethical Challenges and Practical Solutions

1. Engaging Community Health Workers in Research: Ethical Challenges and Practical Solutions Camille Nebeker Graduate & Research Affairs San Diego State University Research Conference on Research Integrity Niagara Falls, NY May 15-17, 2009

2. Co-authors • Karen Coleman, Ph.D, Program Evaluation • Jennifer Terpstra, MPH, Graduate Research Assistant, doctoral student • Gayle Simon, MPH, Resource Specialist

3. Presentation Goals • Describe role of community health workers (CHW) in health promotion research • Address challenges and ethical concerns associated with this research approach • Discuss need for changing research practices and policy when working with CHWs

4. Community Health Workers • Integral part of public health promotion in underserved communities. Involved in: • Participant identification • Subject recruitment • Informed Consent • Data collection

5. Community Health Workers Advantages to research effectiveness • increased recruitment • participation • retention

6. Protection of Human Subjects “…I have become increasingly aware of the challenges we face on our community-based studies that involve the Latino community and utilize promotoras… it would be a great resource for us to have culturally tailored, Spanish language training materials that emphasize the application of human subjects protections to field situations common to the promotoras.”

7. Focus Groups – Project Managers/Principal Investigators • A series of six focus groups were convened with PM/PIs who have involved CHWs/promotores to deliver research.   • Participants described training needs specific to human subjects’ protections and challenges faced with training.

8. Focus Groups with Promotores • Two focus groups were held with CHWs/promotores experienced in community based research and community service projects. • CHWs/promotores were asked to describe their responsibilities as research staff, their knowledge of research procedures and the challenges they faced as members of a research team.

9. Research Challenges • Research Integrity • Participant Protections • Informed Consent • Voluntary Participation • Confidentiality • CHW Protection

10. Research Integrity • Role in research vs role in the community • Pros and cons of “bridging the gap” • Implementing research protocol • Random assignment • Belief that research benefits participant • Need for training in basic research methods

11. Participant Protections • Informed Consent • Lack of understanding of importance of process • Conflict with role in service project vs. research project • Voluntary Participation • Possible perceived obligation to participate due to CHWs role in the community • Pressure surrounding recruitment goals – may not convey risks • Confidentiality • Knowledge of community members • Social interactions

12. CHW Protections • Participant Expectations • Complexity of research protocol • Conflict of commitment • Research Protocol • Provide assistance if believed needed

13. Discussion • Traditional experimental design • Inappropriate for community-based research • Fundamental gap between research, practice and policy • Alternatives to traditional models • Adaptation for CHWs • Must fit with relationship to community • Community-centric approaches for interventions

14. Recommendations - Training • Training for CHW • Project TRES • Ethical practices with human subjects • Intended to complement project specific training • Basic Research Concepts

15. Basic Research Concepts

16. TRES Topics • Roles/responsibilities of the research team • Research vs. service projects • Risks and benefits of research • Informed consent process (identification, recruitment and enrollment) • Confidentiality and privacy

17. Web Training

18. Roles & Responsibilities • Consider design that puts fewer demands on the CHW • Randomize neighborhoods rather than individuals • Evaluate CHWs role in recruitment and screening • Conflicts with no-treatment controls

19. Cultural Sensitivity • Consent process must reflect community and culture • Family involvement • Interactions slower to develop • More time to consider involvement • Consent document • Flexibility • Language and terms

20. Limitations • Focus groups were conducted to inform curricular development – not to gather information on challenges associated with the CHW model. • Important issues may be overlooked since specific questions were not included for this purpose. • Small sample size and limited qualitative analyses

21. Acknowledgements • Project TRES (Training in Research Ethics and Standards) was funded by the National Institutes of Health (NHLBI). • Project TRES is the result of the significant contributions of the following individuals (in alphabetical order): • Karen Coleman, Program Evaluator • John Elder, Co-investigator • Michael Kalichman, Consulting Co-investigator, UCSD • Lori J. McNicholas, Curriculum Development • Camille Nebeker, Principal Investigator • Gayle Simon, Human Research Ethics Specialist • Greg Talavera, Co-investigator • Ana Talavera, Project Manager • Students Assistants: Carmen Violich, Gabriel Crosswaithe, Paulina Martinez, Izzybeth Rodriguez

22. Thank you.