When OPRR Comes Calling: Enforcing Federal Research Regulations
McCarthy, Charles R.
Kennedy Institute of Ethics Journal. 1995 Mar; 5(1): 51-55.
In an update following this article, Ruth Macklin responds to the revelation that the controversial Hall-Stillman embryo-splitting experiment at George Washington University was conducted -- contrary to federal regulations -- without prior institutional review board (IRB) review. This revelation altered Dr. Macklin's view of the ethical status of the research. Undoubtedly such revelations also raise general questions for administrators and researchers in many institutions, including, for example: How do allegations of noncompliance with federal regulations arise? When should allegations of infractions of the regulations be reported? Who has an obligation to report? To whom should reports be made? What sort of inquiry should take place? Who should conduct the inquiry? If a determination is made that infractions have occurred, what sanctions are appropriate? And, what publicity is given to the allegations, before, during, and after an evaluation? Some of these questions can be answered in a straightforward manner, while the answers to others depend on the circumstances of the case. This article provides some general answers to these questions.
Accountability; Administrators; Cloning; Confidentiality; Due Process; Ethical Review; Ethics; Evaluation; Federal Government; Fraud; Government; Government Regulation; Health; Human Experimentation; Institutional Policies; IRB; Misconduct; Punishment; Regulation; Research; Research Ethics; Research Institutes; Researchers; Review; Scientific Misconduct; Universities; Whistleblowing;
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