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

2. 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

3. 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

4. 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)

5. 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.”

6. 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

7. 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!