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Information for Research Participants
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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
Other Policies
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About the HSRO


Basic Folder Information

28.1 General Principles


approval date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

September 15, 2008



policy

As defined within Section 24 of these policies, all records and documents relating to research studies and participants must be kept confidential to the extent permitted by law; however, records and documents shall be available in a timely manner to University authorized employees or other agents authorized by the University including IRB members and HSRO staff and appropriate governmental agencies including but not limited to  the DHHS, OHRP and the FDA.  All others requesting access to or copies of confidential study records and documents must obtain written approval from the Principal Investigator or the Associate Vice Provost for Human Subject Research.  The Principal Investigator must describe in study documents for review by the IRB, and in consent forms,  the  extent, if any, to which confidentiality of study records identifying the subject will be maintained. 

Although principal investigators are responsible for the creation and maintenance of research records and documents, such records and documents (including data collected pursuant to research) are the property of the University.  Until the temporal requirements for record/document retention are met (c.f. Section 28.2- below), investigators or others may not remove or destroy research records or documents (or copies of such records or documents) without written permission from an authorized representative of the University.  This permission requirement extends to investigators leaving the University even if they plan to continue the research at another institution.



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