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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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About the HSRO

Basic Folder Information

25.3 Agreements for non-UM Institutions or Individuals "INVOLVED" in UM Research

Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

September 18, 2006

25.3 Agreement for non-UM Institutions or Individuals "INVOLVED" in UM Research

OUTSIDE FACILITY AGREEMENT: (For Template of an Outside Facility Agreement, CLICK HERE)
This template agreement shall apply if the non-UM institution or investigator is involved but not engaged in UM research.  NOTE – it is recognized that in certain circumstances, this agreement may not be suitable.  In such situations, alternative documentation may be approved by the Associate Vice Provost for Human Subject Research.  Investigators are encouraged   to consult with the HSRO when drafting such an agreement. 

An example of a non-UM institution being "involved" in UM human subject research occurs when the non-UM institution provides a facility in which the research is being conducted or provides a pool of research participants.  This is in contrast to a non-UM institution being "engaged" in UM research because, in the former circumstance, the employees or agents of the outside facility are not intervening or interacting with living individuals for research purposes or are not obtaining identifiable private information for research purposes [45 CFR 46.102(d),(f); 21 CFR 56.102(c),(e); 21 CFR 50.3(c)(g)].

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