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  Welcome
Ethical Research Practice
Institutional Review Board

IRB Review Criteria
--Definition of Research
--Is It Research?
--Human Subjects
--Case Study 1
--Case Study 2
--Study Design
--Minimal Risk
--Risks & Benefits
--Confidentiality
--HIPAA
--Subject Selection
--Vulnerable Subjects
--Incentives
--Quiz

Informed Consent
Genetic Testing
Types of Review
Continuation & Final Reports
Serious Adverse Events
Frequently Asked Questions
Conclusion

HIPAA

The Health Insurance Portability and Accountability Act (HIPAA) was passed by Congress in 1996 and took effect April 14, 2003. The HIPAA Privacy Rule is intended to give patients more control over their health information and to protect their personal privacy. The IRB will serve as the Privacy Board for research.

When conducting research, we often share patient information to organizations outside of Henry Ford health System, including sponsors and collaborators, laboratories, the FDA, and subcontractors. Subjects must give permission for this information to be used for research. In order to comply with HIPAA regulations:

  • Privacy language must be incorporated into all consent forms.
  • Patients participating in research must be informed why and how certain private health information is collected.
  • Subjects must also be informed what is done with their personal health information.
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