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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
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18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
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23. Vulnerable Populations
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Basic Folder Information

26.3 Involved but not Engaged in UM-Research


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

March 7, 2007



26.3 Involved but not Engaged in UM-Research

When a foreign institution or site is involved but "not-engaged" in UM human subject research, the following policies apply: 

1)  The research requires review and approval by the UM IRB

2)  The UM IRB may approve the study if the foreign entity's procedures afford protections of the rights and welfare of the participants that are at  least equivalent to those provided in 45 CFR 46, 21 CFR 50, 21 CFR 56 and the written policies of the UM IRB and if the resources and facilities are appropriate for the research.

3)  If the foreign institution or site has an established IRB/IEC or equivalent, approval of that panel must be obtained to conduct the research at the "not engaged" site or documentation must be received that the site's IRB/IEC has determined that approval is not necessary for the research to be conducted at the site

4)  If the foreign institution or site does not have an established IRB/IEC, a letter of cooperation must be obtained from that institution or site demonstrating that the appropriate institutional or oversight officials are permitting the research to be conducted at the performance site

5)  The UM IRB may approve the study if documentation is received from the international site's IRB/IEC determination or letter of cooperation, as applicable and if this documentation and other information deemed necessary establishes that the foreign institution’s procedures afford protections of the rights and welfare of the participants that are at least equivalent to those provided in 45 CFR 46, 21 CFR 50, 21 CFR 56 and the written policies of the UM IRB and if the resources and facilities are appropriate for the research.

6)  IRB approval is contingent upon documentation of foreign governmental approvals as applicable.

7)  The study may not commence at the non-engaged, foreign institution or site prior to UM IRB approval



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