Demystifying the IRB Process: An Interactive Conversation with QIP Scott Meyers, CIP

OHRA Office of Human Research Administration Harvard Longwood Medical Area (Harvard Chan School, HMS, HSDM) Managing Director - Leslie Howes Institutional Review Board Assistant Director, Kim Serpico Department-assigned IRB Review Specialists: Grace Bullock Alma Castro Elizabeth Ehrlich Keren-Nicole Insalaco Quality Improvement Program Assistant Director, Alyssa Speier QA/QI Specialists: Lisa Gabel Scott Meyers

Quality Improvement Program (QIP) Services Study Consultation: can meet with the research team to help anticipate and resolve regulatory issues that may hinder IRB review and approval Process Submission Assistance: can assist with navigation and submission through ESTR, or help respond to IRB questions QIP Education Series: monthly sessions during the academic year on various topics related to human research In-service: available, by request, to conduct personalized group/department trainings https://www.hsph.harvard.edu/ohra/quality-improvement-program-qip/

IRB’s Primary Function To Ensure: Participant Protection: Rights and Welfare Safety Privacy and Confidentiality Compliance with IRB-approved protocol, Institutional policies, and federal regulations Function under federal Regulations 45 CFR 46 (HHS “Common Rule”) and 21 CFR parts 50, 46, 312 and 812 (FDA)

Key Regulatory Definitions Research is defined as a… “systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” Human Subject is a… “living individual about whom an investigator (whether professional or student) conducting research obtains Information or biospecimens through intervention/interaction with the individual, or Uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens” Minimal Risk means… “that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”

Types of IRB Reviews & Determinations Non-Full Board Review – on a rolling basis Not Human Subjects Research determination Exemption determination Expedited approval Full Board (Convened IRB) Review - monthly

Common Confusions per your IRB Review Specialists I don’t speak “IRB”…(IRB Jargon) Why are you saying my research is not research? (QI vs Research) What are these new Common Rule Changes? Why are there so many rules for informed consent? When do I even need informed consent? Why do I need a Reliance Agreement? Are deidenitified and coded the same? Are there really risks to participants in survey research? Etc, etc, etc!