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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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HSRO Forms & Documents
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eProst User Guide
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HIPAA
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Western IRB (WIRB)
About the HSRO


Basic Folder Information

24.4 Privacy (as applicable to ALL studies)


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

August 6, 2008



Policy

The IRB shall review, and base its study approval upon, strategies proposed by the principal investigator to ensure the privacy of  research subjects.  Privacy issues for IRB evaluation should include (as applicable):

  1. the time and place where information is provided by participants to investigators
  2. the nature of information provided by participants
  3. the nature of the experiences the participants will undergo as a result of the study
  4. who shall receive, access and use information provided by participants
  5. factors that may determine what is private to an individual such as gender, ethnicity, age, socio-economic class, education, ability level, social or verbal skill, health status, legal status, nationality, intelligence or personality 
  6. the participant’s relationship to the investigator
  7. the presence of others (such as parents) during data gathering 

Studies requesting the use of existing, identifiable subject information for research other than that contemplated by the originally approved research protocol require IRB examination of the risks involved. The IRB shall determine whether the new use is within the scope of the original consent or whether it is necessary to obtain additional consent.

For studies in which HIPAA regulations apply (see below), the principal investigator must obtain IRB approval and provide the privacy offices of UM and/or JHS and/or other covered entities with copies of:

  1. the IRB’s determination letter; AND
  2. the HIPAA Authorization forms; or documentation of a Waiver and/or Partial Waiver of HIPAA Authorization; OR
  3. the IRB determination letter approving the use of a Limited Data Set; OR
  4. documentation that the requirements for decedent research or research preparatory to a study have been met.

Note – when privacy offices of UM and/or JHS allow an investigator access to PHI to generate his/her limited data set, the investigator will be considered a Business Associate in performing this function and a business associate agreement shall be required with signature by an authorized signatory. 

For all studies involving PHI (with the exception of those creating limited or de-identified data sets) the principal investigator must assure, for IRB approval, that only the minimum necessary information is being requested and that any PHI created for research will be entered into the medical record or Designated Record Set.



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