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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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eProst User Guide
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Western IRB (WIRB)
About the HSRO


Basic Folder Information

24.3 General Principles of IRB Review of Privacy, Security and Confidentiality


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

August 6, 2008



Policy

The protection of subjects in ALL STUDIES requires the assurance that privacy, security and confidentiality are appropriately managed.  Principal investigators must ensure that studies include provisions for security and for ensuring the privacy and confidentiality of participants.  The strategies to ensure privacy, security and confidentiality during and after the research shall be evaluated by the IRB which acts as the Privacy Board for HIPAA-related purposes, and the appropriateness of these strategies shall be a prerequisite for its study approval. 

Strategies for privacy must ensure each participant’s right to be free from unauthorized or unreasonable intrusion into his/her private life and the right to control access to personal information.  Research procedures should be carefully designed to limit the personal information to be acquired to that which is minimally necessary and should be administered using procedures that will protect the subject's privacy.



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