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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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eProst User Guide
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Basic Folder Information

4.2 IRB Members, Alternate Members, Ad Hoc Members and Guests


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

October 27, 2006



4.2 IRB Members, Alternate Members, Ad Hoc Members and Guests

IRB members, alternate members and all staff and leaders of the HSRO shall sign an agreement defining that they understand and acknowledge that, as part of their duties or their activities at meetings or in the HSRO office environment,  they are bound by the University's conflict of interest policies.  This agreement shall also be signed by guests at IRB meetings and by consultants and others who provide input into an IRB review prior to their participation in that review. 

Included in these policies is that unless requested by the IRB chair or designee in charge of the meeting, IRB members, alternate members, ad hoc members, guests, HSRO staff, consultants or others may not participate in IRB deliberations of studies with which they, their spouses, or dependent children have a financial or personal interest in the sponsoring agency(s) or other interested parties or for which they may reasonably anticipate future financial benefit or support.  Individuals with any of the conflicts defined above may not vote or serve as a reviewer of the study being discussed and may not be counted in the meeting quorum (if applicable).  At the request of the IRB Chair or Chair-designee, however, such members or guests may be present at an IRB meeting to answer questions but may not be present during deliberations or voting on the study [45 CFR 46.107(e), 21 CFR 56.107(e)]. 

"Financial interest" includes but is not necessarily limited to:

1.  Salary, consulting fees, honoraria, royalty payments, dividends, loans or other compensation from sponsoring agency(s), other interested parties or individuals with any of the conflicts for services, payments or consideration with value that  exceed $10,000 in any preceding 12 month period or in an anticipated 12 month period

2.  Serving in a management position such as director, officer, partner or trustee with the sponsoring agency(s), any entity allied with the sponsoring agency(s) or other interested entity

3.  Having an ownership interest, equity in the form of stock, stock options or any other investment equal to or exceeding $10,000 (current market value) or a 5% or greater ownership interest in sponsoring agency(s) or any entity allied with the sponsoring agency(s) or other interested entity

4.  Having any intellectual property rights such as patents (actual, planned or applied for) or a copyright or license fees or royalties in connection with the technology or product related to the study or the sponsoring agency(s)

IRB members, alternate members, ad hoc members, consultants and guests may not participate in IRB deliberations and they may not vote or serve as a reviewer of studies in which they, their spouses or dependent children serve as Principal Investigator, co-investigator or key personnel.  At the request of the IRB Chair or Chair-designee, such individuals may be present at an IRB meeting to answer questions but may not be present during deliberations or voting on the study. 

IRB members, alternate members, ad hoc members, consultants and guests are expected to inform the IRB Chair or Chair-designee whenever a conflict of interest is applicable by policies defined above or by reasonable perceptions that financial or other considerations may compromise or have the appearance of compromising the individual's professional judgment and the independence of his/her input into the review process. 

In addition, there may be no undue influence by University administrators, Principal Investigators, key personnel or other employees of the University on the selection of IRB reviewers.

Members having any potential conflict of interest regarding the discharging of duties as voting IRB members should:

1.  Announce the conflict and recuse themselves from participation during review of that research study except to provide information on request

2.  Leave the meeting during the discussion and not vote on any motion to approve or disapprove the study in question

[NOTE:  When a person with a conflict of interest leaves the meeting, he/she cannot be counted towards a quorum.  If the quorum is lost, the review of the study shall be tabled.]



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