The Institutional Review Board

1. The Institutional Review Board

2. What is an IRB? • An IRB is committee set up by an institution to review, approve, and regulate research conducted under its jurisdiction.

3. Purpose of the IRB • To protect the rights of human subjects in research • To ensure human subjects are informed of their rights as participants and understand the consequences of the research • The IRB is not charged with evaluating or modifying the science of a research project beyond protecting the rights of human subjects

4. Who are the members? • UMKC faculty and staff (scientists and non-scientists) from various academic disciplines (10 schools or departments represented) and Truman Medical Center (legal and medical) employees. • Two individuals not affiliated with UMKC who represents the concerns of the community and vulnerable populations.

5. Legal structure • IRBs are governed by - OHRP (Code of Federal Regulations Title 45, Part 46) and FDA (21 CFR 50 & 56) • This covers all institutions receiving funding from or operating on behalf of the Federal government • In practice, all research involving human subjects is reviewed by the IRB, whether it is federally funded or not

6. Types of IRB Review • More than minimal risk • No more than minimal risk • Fits one of the 9 categories • Less than minimal risk • Fits one of 6 categories • Does not meet the federal definition of “Research” and/or “human subject”

7. Criteria for IRB Approval • Risks to subjects are minimized • Risks to subjects are reasonable in relation to anticipated benefits • Selection of subjects is equitable • Informed consent will be sought from each prospective subject or the subject's legally authorized representative • Informed consent will be appropriately documented • Data collection is monitored to ensure subject safety • Privacy and confidentiality is protected • Additional safeguards are included for the protection of vulnerable subjects

8. IRB Submissions2014 (Initial applications only) • Not Human Subjects Research • 34 • Exempt • 102 • Expedited Review • 55 • Full Board • 10

17. IRB Review Process (Cycles) Other Committee Review Principal Investigator Application submitted via eProtocol Application returned to PI for additional information/revisions PI makes changes requested by IRB or “Other Committees” PI notified Once “complete” the application is: • Determination made by IRB staff (NHSR & Exempt applications) • Scheduled for full board meeting • Sent to IRB members for review IRB Staff IRB staff screens application for completeness • Administrative screening • Application Analysis Full Board IRB Meeting • Approved • Approved with conditions • Tabled Or Expedited Review • Approved • Recommended for Full Board IRB

18. IRB Review Cycles • Snapshot of 43 current submissions

19. Common issues to delay IRB review • Informed Consent • Waiver of consent vs waiver of documentation • Multiple types of consent • Privacy vs Confidentiality • Incomplete responses to IRB comments and questions

20. Updates to the IRB website • http://ors.umkc.edu/research-compliance-(iacuc-ibc-irb-rsc)/institutional-review-board-(irb) • IRB Metrics • Informed Consent • Exempt Determinations • Collaborations with other institutions • Vulnerable populations • Privacy and Confidentiality