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Institutional Review Boards
UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
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Basic Folder Information

4.4 Human Subject Conflict of Interest Committee


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

October 27, 2006



4.4 Human Subject Conflict of Interest Committee

A Human Subject Conflict of Interest (HSCOI) Committee has been constituted to review and make recommendations on conflicts of interest.  This Committee shall be composed of the chairs and vice-chairs of the UM IRB panels with the exception of the chairs and vice-chairs of panels employed by an extramural, commercial IRB.  Membership on this committee shall also include a community representative and the Assistant Provost for IRB Affairs who shall chair this Committee.  This membership structure shall enhance consistency among the UM IRB panels with regard to managing conflicts of interest. 

Information about conflicts of interest shall be provided by Principal Investigators to the HSRO for forwarding to the members of the Human Subject Conflict of Interest Committee.  HSCOI Committee members may make individual recommendations directly to the Committee chair or, if one or more members so request, the Committee shall be convened in a meeting to deliberate and make recommendations on the matter.  The Committee chair is responsible for summarizing Committee recommendations and for forwarding this summary and individual written statements if submitted by committee members, to the IRB for its deliberations.

The HSCOI Committee may not suspend an on-going study or disapprove a study undergoing initial review.  Rather, the HSCOI may make such recommendations as it believes appropriate to the IRB. 

If the putative conflict of interest is disclosed after IRB approval of a study and that study has not yet commenced and no subjects have been enrolled, the Principal Investigator may voluntarily suspend enrollment and the putative conflict of interest shall be reviewed in the same manner as for new studies (i.e. the Human Subject Conflict of Interest Committee shall make recommendations to the IRB and the IRB shall deliberate on the management of the conflict (see below). 

If the putative conflict of interest is disclosed after IRB approval of a study and subjects have been enrolled, the information shall be forwarded by the HSRO to the HSCOI in a timely manner both to provide the IRB with recommendations on conflict management and also for a recommendation as to whether the conflict poses additional risk to subjects.  If the Committee believes that risk to subject is increased by the conflict in a manner that requires immediate suspension of the study until the conflict is managed, this recommendation shall be forwarded to the Associate Vice Provost for Human Subject Research who may suspend the study pending IRB review.



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