1. IRB-Investigator/ Research Coordinator Mtg. “What You Can Do to Facilitate an Efficient IRB Review” January 13, 2004 George Gasparis

2. Objectives 1)Provide Information to Assist in the Submission of Research Proposals to the IRB and Tips to Facilitate an Efficient IRB Review 2)Provide a Basic Understanding of IRB Requirements for Approval

3. Human Research at Columbia University Health Sciences Governed by Ethical Principles and the Requirements of HHS and FDA Regulations and NY State Law

4. DEPARTMENT OF HEALTH & HUMAN SERVICES

5. Food and Drug Administration (FDA) Regulations 21 CFR 50 - Informed Consent 21 CFR 56 - IRB 21 CFR 312 – IND, Sponsor 21 CFR 600 – Biologics 21 CFR 812 - Devices

6. 45 CFR Part 46 HHS Regulations for the Protection of Human Subjects

7. 45 CFR Part 46 Subpart A -- Basic Protections Subpart B -- Pregnant Women, Fetuses, and Neonates Fetuses, and Neonates Subpart C -- Prisoners Subpart D -- Children

8. ABCs of 45 CFR 46 Each performance site needs: Each performance site needs: A. Assurance of Compliance Approved by OHRP (not required by FDA regulations) B. Board Approval (i.e., IRB, REB, ethics cmte.) C. Consent Obtained from Each Subject, Unless Waived by the IRB Waived by the IRB

9. Columbia University Health Sciences Federalwide Assurance (FWA): Federalwide Assurance (FWA): FWA00002636 FWA00002636 -Applies the Belmont Report and the Common Rule to all of its Human Subjects Research Regardless of Support

10. New York Presbyterian Hospital Federalwide Assurance (FWA): Federalwide Assurance (FWA): FWA00002635 FWA00002635 -Applies the Belmont Report and the Common Rule to all of its Human Subjects Research Regardless of Support

11. When Does Human Subjects Research Need IRB Review? Not Human Subjects No IRB Review Research Needed HHS Regulations Human Subjects Research that is not exempt Needs IRB Review Exempt Research Needs Determination of Status by Someone Other Than The Investigator

12. When does Human Subjects Research Need IRB Review? When does Human Subjects Research Need IRB Review? Not Human Subjects Research (No IRB Review) Oral History Evaluation Oral History Evaluation Polling QA Gray Area Human Research IRB Review Ethnography Pedagogical Res. Ethnography Pedagogical Res.

13. Types of IRB Review Types of IRB Review 1)Determination if human subjects research 2)Exempt 3)Expedited Review 4) Full Committee Review

14. IRB Review and Approval (46.111) This section of the regulations provides the criteria for IRB approval of research. It includes requirements, such as: -risks to subjects are minimized, -risks are in relation to anticipated benefits, -selection of subjects is equitable, -informed consent will be sought from each subject, and will be appropriately documented, and will be appropriately documented,

15. IRB Review and Approval (46.111) (cont’d) This section of the regulations provides the criteria for IRB approval of research. It includes requirements, such as: -the research plan makes adequate provision for monitoring of data, -adequate provisions for privacy/confidentiality of subjects, -when subjects are likely to be vulnerable – adequate safeguards have been included

16. IRB Review and Approval (46.111) Risks to subjects are minimized: First, must identify risks: Examples: -Emotional distress-Psychological trauma -Invasion of privacy-Embarrassment -Loss of social status-Loss of employment -Stigmatization

17. Which Regulations Apply? HHS FDA

18. Informed Consent: Differences Between FDA and HHS Regulations WAIVER OF CONSENT HHS - Provides for Waiver of Consent or Elements of Consent for Minimal Risk Research (45 CFR 46.1116d) (45 CFR 46.1116d) FDA - Does Not Have Such a Provision

19. Informed Consent: Differences Between FDA and HHS Regulations HHS - Provides for Waiver of Documentation of Consent FDA - Does Not Have Such a Provision

20. IRB-Investigator/ Research Coordinator Mtg. “What You Can Do to Facilitate an Efficient IRB Review” January 13, 2004

21. “What You Can Do to Facilitate an Efficient IRB Review” Definition of Human Subjects Research Tips to Facilitate Efficient IRB Review IRB Terminology Related to Data Collection Criteria for IRB Approval Categories of Exempt Research Categories of Expedited Review Criteria for Waiver of the Elements of Consent Criteria for Waiver of Written Documentation of Informed Consent