1. Welcome New IRB Member! This brief presentation covers: 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. The IRB Committees are required to have a minimum of five members each (on average 12-20 members), with varying backgrounds and expertise to provide complete and thorough review of research activities commonly conducted by the Institution. Each IRB Committee must include at least one member whose primary interests are in a scientific area, one member whose primary interests are in a non-scientific area and one member who is not affiliated with UCI (i.e. not a family member or spouse of an employee, not an active alumnus). At least one non-affiliated member and one non-scientist are present at convened meetings. 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 has the authority to approve a protocol (aka “A”), require specific changes (aka “M” for minor changes – also known as approved with conditions), table a protocol (aka “T”) when significant issues are noted or even disapprove a protocol. Your Role in the IRB

5. 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

7. 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

8. Ancillary Committees: IRB Administrator emails Committees for confirmation of clearance See Chart for Committees and impact on IRB reviewChart IRB Meeting Deadline IRB Full Committee Meeting ~ 4 days IRB Analyst sends out request for IRB Member attendance to secure quorum (1/2 of total Members + 1) IRB Analyst imports applications Electronic Submission of IRB applications (Apps, CPAs & MODs) IRB Administrator determines what has cleared the agenda, sets agenda. All designated IRB staff review applications, prepare checklists, send pre-review comments to the Lead Researcher (LR). The LR responds with revised documents. All checklists and final versions of all study documents uploaded into agenda for IRB review. Upon receipt of all LR responses, the IRB Analyst finalizes electronic agenda, sends e-link to IRB Members. “M” Minor Changes “T” Tabled “A” Approved as is IRB Staff send memos on behalf of the IRB LR responds to the IRB memo IRB Chair or Designee Reviews Response Approved IRB Staff finalize approval documents, send approval to LR & designated study team The Full Committee IRB Review Process “M” Minor Changes Agenda Clearance & Pre-Review Approx. 3 weeks before an IRB meeting the preparation begins 1 week before IRB meeting At the IRB meeting: Determinations

9. 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, Senior IRB Analyst or IRB Analyst).

10. The IRB Review Process: Tools At the Meeting: Agenda IRB Chair IRB Members Laminated Sheets Help with Voting / Determinations HRP Staff! (at the meeting – or anytime…that’s what we are here for!) Other Resources: Green (or Purple) Books- Tab Pertinent Sections & Bring Book to Meeting ORA Website- page for IRB Memberspage

11. 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