Building Networks: Responsible Research in Diverse Community Settings Thursday, April 14, 2016

2. Keith C. Norris, MD, PhD, FASN Professor of Medicine, Geffen School of Medicine, UCLA Co-Director, UCLA-CTSI Community Engagement and Research Program PI, NIH Diversity Program Consortium Coordination and Evaluation Center at UCLA Building Networks: Responsible Research in Diverse Community SettingsThursday, April 14, 2016

3. NIH1 Potential Conflicts of Interest*# * Activities within the last year Grants: 1 Honoraria: 2 Consulting: 3 Advisory Boards: 4 Speaker Bureau: 5 Financial Ownership: 6 # None related to this talk AbbVie4

4. Learning Objectives • Understand the nuances of Research Networks involving Diverse Communities • Recognize the stakeholders and their roles • Why and How should research embrace a greater integration of community approaches • Be able to describe key ethical considerations for patients, study participants, the community and the IRBfor “Community Engaged Research” across Research Networks

5. Lillian Mobley Mary Henry Loretta Jones Ed Corbett Ernie Smith, Ph.D. Sylvia Drew-Ivie, JD HAAF CDC NIH – RCMI/NIMHD NIH - NIA NIH – CTSI/NCATS Drew/UCLA/RAND Venice Family Clinic T.H.E. Clinic Acknowledgements And all the many active members & organizations of the greater LA community

6. NIH-RCMI Translational Research Network Consortium of biomedical, behavioral and clinical researchers at RCMI funded and partner institutions working with healthcare providers and the community to address health disparities through collaboration

7. NIH Biomedical Workforce Diversity Consortium National Research Mentoring Network NRMN BUilding Infrastructure Leading to Diversity (BUILD) Test the ability of leveraging the power of diversity to provide the nation with best practices to optimize student/trainee success in biomedical sciences, and to create sustained transformative impact at an institutional level.

8. The NIH policy on Diversity • NIH encourages institutions to diversify their faculty populations to enhance the participation of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women at senior facultylevels. See NIH Notice: NOT-OD-15-053 • For HS and undergraduates: also includes low income or educationally disadvantaged backgrounds • May expand in the near future

9. Why This Talk for the Office of Research Integrity • Why and How should research embrace a greater integration of community approaches. • Understand the nuances of Research Networks involving Diverse Communities • Do approaches to research in diverse communities require a different degree of sensitivity, awareness and understanding at the level of institutional research? • Research community has an intense focus on Personalized Medicine and biomarkers and this has led to increased concerns for many diverse communities

10. Increasing Importance for Academia, Community and Others to Partner • Enormous amounts of new knowledge are barreling down the information highway, but they are not arriving at the doorsteps of our patients. • This is particularly true for a disproportionately high percentage of women, racial/ethnic minorities, and other high-risk groups in the US. Why partner? New approaches to achieve new results! Lenfant C. Clinical Research to Clinical Practice - Lost in Translation? N Engl J Med 2003;349:868-74.

11. Ethical Perspectives in Network Based Research Different perspectives to consider on identification and evaluation of risks and benefits • Participant • Researcher • Institution • Community • Regulatory

12. How do we ensure the institutional research office is a facilitatorand not a barrierto Community Engagement & other partnerships in Research? Barriers to Clinical Research in Underserved Communities • Understanding Clinical Research • Concerns of not being a benefactor • Communication (Language, culture) • Research ethics/Participant protection • Lack of Academic-Community “Partnership” • Institutional • e.g. lack of institutional research appreciation of community voice; finding the balance between protective vs. patronizing • Corbie-Smith G, et al. Distrust, race, and research. Arch Intern Med. 2002 Nov 25;162(21):2458-63. • Boulware LE, et al. Race and trust in the health care system. Public Health Rep. 2003 Jul-Aug;118(4):358-65. • Calderón JL, et al. Ethno-medical Perspectives on Research Participation. Medscape General Medicine. 2006 Apr 25;8(2):23. • Braunstein JB, et al. Race, medical researcher distrust, perceived harm, and willingness to participate in CV prevention trials. Medicine (Baltimore). 2008 Jan;87(1):1-9.

13. Network Partnership Framework to Promote Responsible Conduct of Research

14. Adapted from King KM, et al., J Community Med Public Health Care 2015, 2: 007

15. Network Partnership Framework to Promote Responsible Conduct of Research May require Data Sharing or Data User Agreements or other. When possible embed such agreements in acceptance of funding (e.g. NIH Notice of Grant Award) Adapted from King KM, et al., J Community Med Public Health Care 2015, 2: 007

16. Network Partnership Framework to Promote Responsible Conduct of Research Always refer back to MOU or other shared documents. Use Advisory Board to help reinforce values and to arbitrate the re-assessment of ethical issues Adapted from King KM, et al., J Community Med Public Health Care 2015, 2: 007

17. Nuances of Research Networks involving Diverse Communities • Gain consensus to create a Memorandum of Understanding (MOU) among all parties. • Establish guiding principals and capture the goals and concerns • Framework for inter-institutional IRB relianceif needed • Preferable to have one or more institutional officials from one or more sites involved throughout the process • Meet with stakeholders to discuss execution and implementation of the MOU and begin to understand the cultural context and research emphasis of each institution/entity. Adapted from King KM, et al., J Community Med Public Health Care 2015, 2: 007

18. Nuances of Research Networks involving Diverse Communities • Do not enter into partnership with assumptions. (Example: Articulated organizational/personal goals and time frames for each partner) • Value each partner for their strengths and unique contributions (e.g. teaching intensive academic partners, patient organizations, community “resident experts”). • Example: promote or require equity among members to lead/co-lead committees, manuscripts and grant proposals Adapted from King KM, et al., J Community Med Public Health Care 2015, 2: 007

19. Nuances of Research Networks involving Diverse Communities • Establish advisory boards, but recognize while they are important they support but do not replace the need for full partnership in truly partnered work Adapted from King KM, et al., J Community Med Public Health Care 2015, 2: 007

20. Community Members on Institutional Committees • A community member: usually non-scientific background and not affiliated with the institution. • Often are drawn from the local community; may be a patient, prior research participant, other. • Patient advocates: • e.g. former research subjects, teachers, nurses, members of vulnerable populations, retirees or experts in multicultural affairs. • Use patient/community Advocatesnot Activists. • Activists - persons highly driven by a specific agenda or cause

21. Case Study: MOU in RTRN • Key stakeholders at each institution assembled individuals with decision-making authority to implement the MOU and monitor IRB reliance, including IRB directors/ administrators, legal counsel, and Federalwide Assurance institutional officials. • Upon approval by the appropriate individuals, the MOU, and IRB Reliance Agreementwas signed by the institutional official. • Lessons learned for new NIH Consortium: The MOU was integrated into receipt of funding documents. • Hammat Z, et al. Partnering to Harmonize IRBs for Community-Engaged Research to Reduce Health Disparities. J Health Care Poor Underserved. 2011;22(4 Suppl):8-15.

22. Key Proposed Changes in the Common Rule Relevant to Network Ethics

23. Summary

24. Trust & Building a Community-Academic Partnered Research Network PUBLIC TRUST / UTILITY PublicParticipation Responsible Conduct of Research Responsible Conduct of Research InformationTechnology Practical TrialDesign CommunityContext REACHEFFICIENCYFIDELITY FEASIBILITYVALIDITY RELEVANCEFLEXIBILITY Research Findings Adapted from Wells KB, Staunton A, Norris KC, et al. Building an academic-community partnered network for clinical services research: the Community Health Improvement Collaborative (CHIC). Ethn Dis. 2006;16(1 Suppl 1):S3-17.

25. “Break from what you know, and you will know much more.” ― Ip Man