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Series of adverse outcomes in clinical trials

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Question

There have been a series of adverse outcomes in clinical trials being conducted at your hospital. The Medical Director who has headed the Institutional Review Board (IRB) has been doing so for the past 20 years. After further investigation, legal counsel has informed you that the protocols have not been followed, and in many instances, patients have not been provided adequate informed consent. You have also heard rumors that the Medical Director, now aged 71, has noticeably slowed in recent years and at times seems forgetful.

Describe steps to address the issues with IRB as presented in the scenario.

Explain what steps are needed to make an IRB valid and how to ensure that research in a health services organization conforms to proper IRB protocol. Be specific and provide examples.

Reference no: EM133522146

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