General Principles of IRB Review
In the preceding chapters, we have discussed the historical, legal, and ethical background that led to the formation of the IRB system, and we have outlined how such committees should be constituted and financed. In Section II, we discuss in greater detail the principles and mechanisms of IRB review, the preparation and evaluation of informed consent procedures and forms, the procedures applicable to new drugs and medical devices, and the continuing review of approved research. These chapters are directed to a diverse audience—lay members of IRB committees, nonscientific professionals, and administrative staff—and, thus, the discussions will cover a broad range of issues as befits the multidisciplinary nature of IRB review.
KeywordsChief Executive Officer National Commission Human Subject Research Scientific Merit Investigator Competence
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