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Diane Publishing Books
Human Subjects Research: Undercover Tests Show the Institutional Review Board System is Vulnerable to Unethical Manipulation: Congressional Testimony
Gregory D. Kutz (au)
Millions of Americans enroll in clinical studies of experimental drugs and medical devices each year. The HHS and the FDA are responsible for overseeing independent institutional review boards (IRB), which review and monitor human subjects research, with the intended purpose of protecting the rights and welfare of the research subjects. Kutz investigated 3 key aspects of the IRB system: (1) the process for estab. an IRB; (2) the process through which researchers wishing to apply for fed. funding assure HHS their human subjects research activities follow ethical principles and fed. reg.; and (3) the process that medical research co. follow to get approval for conducting research on human subjects.
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