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

2. 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. Your Role in the IRB

3. 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 Your Role in the IRB

4. 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) Your Role in the IRB: What to Know

6. 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 Your Role in the IRB: What to Know

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