1. CUMC IRB Investigator Meeting Human Subjects Research Non-Compliance September 15, 2005

2. July 21, 2005Page 2 Objectives Today’s session will provide information on: Definition of Non-Compliance Types of Non-Compliance Process for Handling Allegations of Non-Compliance Overview of the newly designed IRB website

3. July 21, 2005Page 3 Federal Regulations for the Protection of Subjects from Research Risks 45 CFR Part 46 Subpart A -- Basic Protections Subpart B -- Pregnant Women, Neonates and Fetuses Subpart C -- Prisoners Subpart D -- Children

4. July 21, 2005Page 4 FDA Regulations Code of Federal Regulations: -Title 21, Parts 50.23 -Title 21 CFR 50.24 -Title 21 CFR 312 -Title 21 CFR 812

5. July 21, 2005Page 5 45 CFR Part 46.103(b)(5) & 21 CFR 56.108(b) Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Department or Agency head (and FDA when applicable) of: (i) any unanticipated problems involving risks to subjects or others; (ii) or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and; (ii) any suspension or termination of IRB approval.

6. July 21, 2005Page 6 Serious noncompliance may include, but is not limited to: 1) failure to obtain or maintain IRB approval before conducting any research involving human subjects, 2) enrollment of subjects without obtaining legally-effective informed consent, or 3) failure to report serious and unanticipated problems involving risks to subjects or others in accordance with institutional policy.

7. July 21, 2005Page 7 Columbia University Policy All potential noncompliance with regulations, or University policy, for the protection of human subjects in research must be promptly reported to the IRB.

8. July 21, 2005Page 8 Compliance Oversight Team (COT) - will be responsible for investigating allegations of research noncompliance.

9. July 21, 2005Page 9 Concerns about possible Research Noncompliance may be discussed with an IRB Chair, the Executive Director of the IRB or the Associate Director of the IRB. Any individual may make an allegation of Noncompliance. Any such allegation shall be documented in writing and given to the Executive Director or Associate Director of the IRB.

10. July 21, 2005Page 10 PHASES OF A RESPONSE TO AN ALLEGATION 1. Inquiry: the gathering of preliminary information and fact-finding to assess whether the allegation has merit; 2. Investigation: following an inquiry, the process of auditing applicable records and data to gather facts relevant to the allegation; 3. Outcome: final report with determinations and recommendations for corrective actions

11. July 21, 2005Page 11 Corrective actions may include: a. suspension or termination of the Principal Investigator’s research protocol(s); b. required training with respect to Human Subjects Research and the regulatory requirements for the conduct of such Research;

12. July 21, 2005Page 12 Corrective actions may include: c. changes in the research protocol(s) to further protect Human Subjects; d. Restrictions on the research or the Principal Investigator; e. destruction of data collected;

13. July 21, 2005Page 13 Corrective actions may include: f. disallowance of the publication of data collected during the period of Noncompliance; g. oversight monitoring by the COT; and h. any other appropriate action.

14. July 21, 2005Page 14 APPEAL The Principal Investigator has the right to appeal after his/her receipt of the report The appeal should be made to the appropriate institutional official.

15. July 21, 2005Page 15 NOTIFICATION TO REGULATORY AGENCIES OR FUNDING SOURCES The IRB will report noncompliance to: -designated IRB; -institutional officials, deans, department chairs; -legal counsel; -the appropriate regulatory agencies (e.g., OHRP, FDA, etc.) and sponsors.