The impact of the IRB on medical centers

The role of the IRB in a Medical Center is presented with respect to investigations of medical device safety and effectiveness involving human subjects. The prime points presented and discussed are: the reasons (governmental, social, economic, legal-liability, scientific and moral) for the existence of an IRB; the analytical and descriptive documentation which should always precede experimentation; the concepts governing an application to a "typical" IRB; a practical, detailed outline of some special facts and circumstances typically most important to an IRB; and, the question of confidentiality of trade secrets.