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Institutional Review Board

Policy and Guidance

 Guidances 

Humanitarian Use Devices (HUD)

I. Informed Consent Guidance

II. Informed Consent Guidance - How to Prepare a Readable Consent Form

III. Informed Consent Guidance - FDA Regulated Studies

Investigational Medical Devices

Investigators as Study Participants (Self-Experimentation)

Reporting Protocol Deviations

Research Using FDA Test Articles

Policies

Organization Policy on Complaints from Research Participants, Investigators and Research Staff, the Community, etc. (Policy No. 109.3)

Organization Policy on Monitoring the Consent Process and Research Procedures in Ongoing Research (Policy No. 109.8)