HOW CAN I TELL THAT AN IRB HAS REVIEWED AND APPROVED THIS STUDY OR ANY STUDY?

 

The stamp on your documents reflects that the designated IRB has approved the study.  It is an FDA requirement that the study design (protocol), informed consent, any advertisement, and other instructions to the subject (Subject Instructions) be reviewed and approved by an IRB.


FDA regulations require that the committee have at least five members with varying backgrounds to promote complete and adequate review of research activities.


To fulfill these requirements the IRB may include physicians, pharmacists, Ph.D’s, a toxicologist, a psychologist, an oral surgeon and lay members (non-scientific).


The name and telephone number of the Chairperson is available in every informed consent document.  You may contact the Chairperson with concerns regarding your rights as a subject.

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