A Community Health Center’s Perspective on the Feasibility, Reality and Benefits of Research Myechia Minter-Jordan MD, MBA President and CEO The Dimock Center

Goals for our discussion today  Develop an understanding of the potential strategies for research engagement  Understand how to develop and maintain community education on research principles  Develop a strategy for engaging your health center in community based participatory research  Develop a strategy for engaging academia in community based initiatives  Understand the pros and cons- and be prepared for them

3 Topics to be Covered  Different models of approaching research IRB, Ethics Committee, Education and Engagement IRB, Ethics Committee, Education and Engagement  Dimock’s decision making process- what did we decide and why?  Engaging in research What makes sense for your organization What makes sense for your organization  Dimock’s experience  Challenges and benefits of engaging in research

Our Mission At Dimock, we believe every life is precious. We commit to enhance the quality of life of each individual we serve, of the people we employ, and the communities in which we live by providing accessible, comprehensive, innovative, culturally competent health and human services. Our Vision Our Vision is a healthy community where we make a difference in every life.

Behavioral HealthChild and FamilyHealth Services DetoxEarly Head StartPedi Outpatient addiction services Head StartAdult Adult/Pediatric MHPreschoolEye Recovery Homes Early InterventionDental Shelter GEDHIV Residential Svcs OB GYN Over 17,000 patients and 70,000 visits/yr

What is an IRB?  Local independent committee that reviews and approves human subject research before it can begin  Main responsibility: to protect the rights and welfare of human research subjects Including vulnerable populations Including vulnerable populations  Ensures No “Conflicts of Interest 6

Why is an IRB Significant for a community health center?  All institutions that accept research funding from the federal government must have IRB review of research involving human subjects  Even if a given research project does not involve federal funds, ethical principles and good clinical practice call for review and approval (by an IRB) to provide public assurance that the rights, safety, and well being of participants are protected!  Patients, families and clients served at community health centers often represent our most vulnerable patients 7

Approaches/Models to engagement in research  Ethics Committee  Local IRB Review Organization/Institution has its own IRB Organization/Institution has its own IRB  Utilize Other IRB (cede review, affiliations) Organization/Institution relies on another IRB for single studies or all studies Organization/Institution relies on another IRB for single studies or all studies  IRB Reciprocity Multiple sites form a consortium Multiple sites form a consortium Utilize one of the IRBs (from consortium) for review of a collaborative protocol (e.g. Harvard Catalyst) Utilize one of the IRBs (from consortium) for review of a collaborative protocol (e.g. Harvard Catalyst)  Central IRB Independent/Commercial IRB (pay for service) Independent/Commercial IRB (pay for service) 8

Why did we think about this issue?  Multiple requests for research  Lack of internal knowledge about how to conduct research  Increased reliance on academic partners  Need for community input  Ongoing data collection- what could we learn from it?  Ethics Committee vs. IRB

Creating a Research Community  Role of the Community Health Center : Close gap between community and researchers (build trust) Close gap between community and researchers (build trust) Share information with the community at start of the study, during the study and at the end(results) Share information with the community at start of the study, during the study and at the end(results) Share community concerns – be their voice! Share community concerns – be their voice! Offer diversity (race, gender cultural background) Offer diversity (race, gender cultural background) Help define the research community Help define the research community 10

Challenges  Cultural challenges- think “Champion”  Infrastructure-consider partnerships  Research vs. productivity- grants?  Research vs. Mission  Building a business case  Organizational buy-in

The Dimock Experience  Connection with HSPH  Compilation of policies/procedures/forms  Initial Training  Choosing members  Filing of necessary documentation  Creation of a research champion  Ongoing training

Training Those individuals involved in the conduct of research must have a basic understanding of: Historical background and landmark documentsHistorical background and landmark documents federal regulations and research ethics and how they relate to their individual role in the projectfederal regulations and research ethics and how they relate to their individual role in the project important research-related definitions such as : Human Subject, Research, and Informed Consentimportant research-related definitions such as : Human Subject, Research, and Informed Consent an IRB; what it is, what rules it must follow and whyan IRB; what it is, what rules it must follow and why Training should be initial and ongoing! 13

How to Fulfill Training Requirements  CITI Training  Alternative Training 14

Benefits  Involvement of the health center board- consumers!  Leverage patient relationships to engage in efforts to improve care  Autonomy- choosing what is best for your patients  Enhancing and creating partnerships  Recruitment and retention of providers

More Benefits…  Make use of your HIT  Direct impact on care delivery  Funding opportunities  Staffing  Increasing the visibility of your organization

The Dimock IRB- status update  Study review examples 1. Focus groups to assess acceptability of pre-exposure prophylaxis of HIV among Black Women 2. Sex differences in Infants activity preferences 3. Survey to Assess Acceptability of HIV Pre-Exposure Prophylaxis among Black women 4. A Comparison of Individual Versus Practice Level Operationalizations of the Medical Home 5. Using Recovery Support Navigators and Incentives to Improve Substance Abuse 6. Medicaid Client Outcomes and Costs 6. Medicaid Client Outcomes and Costs

The Dimock IRB- status update  Cultural change-excitement and engagement  Impact on patient care- e.g. internet usage study  Enhanced recruitment and retention  Ongoing training  Ceding  General perspectives on research at Dimock  Ongoing academic collaborations

Top Ten Reasons Engage in Research  1. Your patients  2. Your community  3. Your providers  4. Your care delivery  5. Your organization  6. Partnerships  7. Use of Data  8. Funding  9. Influence  10. Visibility and Prestige

Contact Information  Myechia Minter-Jordan MD, MBA  President and CEO  The Dimock Center 