BUILDING PRIMARY CARE RESEARCH INFRASTRUCTURE AT YOUR COMMUNITY HEALTH CENTER

Transcription

1 BUILDING PRIMARY CARE RESEARCH INFRASTRUCTURE AT YOUR COMMUNITY HEALTH CENTER Harvard Catalyst Community Health Innovation and Research Program Grant # 1 UL1 RR First Edition 1

2 Editors Shalini A. Tendulkar, ScD, ScM LeRoi Hicks, MD, MPH Karen Hacker, MD, MPH Harvard Catalyst Staff Karen Emmons, PhD Jonathan Finkelstein, MD, MPH Kerry Foley Evan Kutsko Contributors Safety-net Infrastructure Initiative Staff Nazmim Bhuiya, MPH Jocelyn Chu, ScD, MPH Alice Knowles, MS Anne Shila Waritu, MPH Kelly Washburn, MPH 2

3 Toolkit Overview This toolkit is designed to provide Community Health Centers with the elements needed to build a primary care research infrastructure. The toolkit is organized in eight easilynavigated, interactive, stand-alone modules. 3

4 Contents Module 1: Quality Improvement and Research Module 2: Building Primary Care Research Infrastructure Module 3: Data Module 4: Study Design and Methods Overview Module 5: Dissemination and Action Module 6: Funding your Research Module 7: Partnerships for Research Module 8: Ethics and the Institutional Review Board 4

5 Module 8 Ethics and Institutional Review Boards 5

6 Module 8 Learning Objectives After completing this module, participants will be able to: 1. List ethical challenges and considerations in community-based research 2. Discuss the purpose and function of an Institutional Review Board 3. Identify the different types of IRB review 6

7 Assessing the Ethics in Research Individual versus community Weighing the risks and benefits for community participation in research Role of the clinician researcher 7

8 Limitations of Biomedical Framework Focused on protection of individual as research subject Lacks ethical precepts for: Community collaboration and consideration of culture The ethical conduct of research with community partners Community level concerns and risks 8 McDonald, M.A. (2009). Ethics and community-engaged research. Retrieved from Duke Center for Community Research, Duke University Medical Center. Retrieved August 11, 2011 from

9 Ethical Considerations in Community-Based Research How are individuals different from communities or community organizations? Individuals: make decisions for themselves are able to provide informed consent are protected if incapable of giving consent Communities often don t have one decision-maker may include a wide range of diverse opinions 9

10 Community Values and Ethics Some standard protocols may not be acceptable to community organizations Use of control groups Different treatments or interventions Random assignment of participants 10

11 Institutional Review Board A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research. 11 Office for Human Research Protections. (1993). IRB Guidebook. Retrieved August 11, 2011 from

12 Institutional Review Board Internal IRBs Committees at academic institutions and medical facilities to monitor research studies involving human participants External IRBs Independent or commercial IRBs with identical responsibilities to academic or medical institution IRBs. 12

13 Who Sits on the IRB? Board chair Staff Experts in the field Community residents/representatives Balance by gender, ethnicity 13

14 The Belmont Principles Respect -voluntary consent -privacy Benefits -maximize benefits -minimize risk Justice -equal participation 14

15 What Does the IRB Review? Research that involves: Review of medical and administrative record data Research that uses leftover tissues Health services research Survey research Behavioral research Biomedical and other clinical research 15

16 Types of Review Full Full IRB committee review Expedited Reviewed by a selection of staff/experts in the field Exempt Not reviewed by IRB, IRB chair makes decision Clinical trials Vulnerable populations (children, prisoners) No more than minimal risk Interviews, focus groups Surveys Specimens, non-invasive Non invasive Educational settings, educational tests Document review 16

17 Criteria for IRB Approval Risks Minimized, reasonable in relation to anticipated benefits Selection of participants is equitable Informed consent Sought from each participant Informed consent is appropriately documented 17

18 Criteria for IRB Approval Data collection monitored for participant safety Privacy and confidentiality of participant is protected Additional safeguards are included for vulnerable populations 18

19 IRB Review Process 19 University of Washington Human Subjects Division. University of Washington. Web. < Started>.

20 Resources NIH online training in research with human subjects HHS Office of Human Research Protections IRB Guidebook irb_guidebook.htm 20 Please see Appendix H for an example of an IRB consent form and Appendix I for a sample IRB Expedited Application.

21 Discussion Questions What does minimal, reasonable risk mean to you when thinking about your patient population? How do you define patient benefit? 21

22 Please do not reprint or distribute any of the materials in this module without permission. For permission, please contact: Karen Hacker, MD, MPH Executive Director of Institute for Community Health Director of Harvard Catalyst Safety-net Infrastructure Project, CHIRP This module contains images from the Microsoft Office Online ClipArt Gallery. 22