Welcome New IRB Members! Today we will discuss: Your Role in the IRB: What to Know

1. Human Research Protections Welcome New IRB Members! Today we will discuss: Your Role in the IRB: What to Know The IRB Review Process Resources

2. Your Role in the IRB • Welcome to the UCI Institutional Review Board (IRB)! • The IRB is a committee of physicians, scientists, advocates and members of the community who come together to review research protocols. • The IRB has the oversight responsibility for protecting the rights and welfare of research participants.

3. Your Role in the IRB • The IRB is responsible for ensuring that any research study conducted at the institution is appropriate and will not place participants at any undue risk of harm. • The IRB also reviews the procedures to be followed during the conduct of research to make sure that research participants are treated with dignity and respect. • Your expertise on the IRB is invaluable & will positively contribute to the review process

4. Your Role in the IRB: What to Know The IRB considers 2 sets of regulations: • 1. Department of Health and Services (DHHS), Office of Human Research Protections (OHRP), Code of Federal Regulations (CFR) Title 45, Parts 46 • 2. Food and Drug Administration (FDA), CFR Title 21, parts 50, 54 and 56, 312 (drugs) & 812 (devices)

5. Your Role in the IRB: What to Know

6. Your Role in the IRB: What to Know Required Elements of Consent* • A statement that the study involves research • An explanation of the procedures of the research • A description of the procedures to be followed & duration • A description of any reasonably foreseeable risks or discomforts to the subject. • A description of any benefits to the subject or to others which may reasonably be expected from the research. • A disclosure of appropriate alternative procedures or courses of treatment, if any • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained • An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights • A statement that participation is voluntary *Additional elements may apply

7. The IRB Review Process • If you are assigned as a Primary or Secondary Reviewer, you will need to complete the Reviewer’s Checklist. This document is uploaded in the e-agenda, along with all pertinent review materials, such as the Protocol Narrative, Consent Form, Master Protocol and Investigator’s Brochure. • The Checklist addresses elements of IRB approval and elements of consent • Specific questions and concerns from Human Research Protection (HRP) Staff will be included for your response / comments • Some special determinations will need to be made – may involve Supplemental Checklists. This will be noted on the Checklist and the agenda. • Make sure all sections are complete, sign the checklist & hand to HRP Staff after the meeting • Any questions prior to the meeting, please contact HRP Staff (the IRB Administrator or Analyst)

8. The IRB Review Process: Tools At the Meeting: • Agenda • IRB Chair • Laminated Sheets Help with Voting / Determinations • HRP Staff Other Resources: • Green Books- Tab Pertinent Sections & Bring Book to Meeting • ORA Website

9. The IRB Review Process: Tools The Little Green Book-“Regulations and Guidance on the Protection of Human Subjects: Clinical Investigator, IRB and Sponsor Responsibilities” Common Pages to Note during IRB Review • Guide to Informed Consent: Page 35 • Expedited Review Categories: Pages 123-125 • Off Label Use of Drugs and Devices: Begins on Page 62 • No IND Needed: Page 62 • Emergency Use of Drugs / Biologics: Page 69 • Frequent Issues with Devices: Pages 82-104 • What is an IDE: Page 82 • 510K, HDE: Pages 86-87 • Exempt Devices: Page 90 • SR & NSR Devices: Pages 94-104