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 Full Board Expedited Exempt Not Human Subjects Research 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 1)Risks to subjects are minimized 2)Risks to subjects are reasonable in relation to anticipated benefits 3)Selection of subjects is equitable 4)Informed consent will be sought from each prospective subject or the subject's legally authorized representative 5)Informed consent will be appropriately documented 6)Data collection is monitored to ensure subject safety 7)Privacy and confidentiality is protected 8)Additional safeguards are included for the protection of vulnerable subjects

8. IRB SUBMISSIONS 2014 ( Initial applications only ) Not Human Subjects Research –34 Exempt –102 Expedited Review –55 Full Board –10

17. Principal Investigator Application submitted via eProtocol IRB staff screens application for completeness  Administrative screening  Application Analysis 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 Application returned to PI for additional information/revisions PI makes changes requested by IRB or “Other Committees” PI notified Other Committee Review Full Board IRB Meeting  Approved  Approved with conditions  Tabled Or Expedited Review  Approved  Recommended for Full Board IRB Review Process (Cycles)

18. IRB REVIEW CYCLES Snapshot of 43 current submissions Cycle 1 Cycle 2 Cycle 3 Cycle 4 Cycle 5 Cycle 6 Cycle 7 Cycle 8 NHSR411 Exempt5511 Expedited Review 971111 Full Board1

19. COMMON ISSUES TO DELAY IRB REVIEW Informed Consent –Waiver of consent vs waiver of documentationWaiver 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) 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