Considerations for Hospital Approval of Human Participant Research
Chanaud, Cheryl M
Journal of hospital medicine : an official publication of the Society of Hospital Medicine 2010 Apr; 5(4): E17-24
Hospitals often accept as sufficient the federal requirement that human participant research studies have Institutional Review Board (IRB) review and approval, but IRBs usually do not consider many practical matters that arise in the implementation and operation of an interventional clinical trial in the complex environment of the modern acute care hospital.
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The Use of Placebo-Controlled Clinical Trials for the Approval of Psychiatric Drugs: Part II-Ethical Considerations Related to the Individual Participant Feifel, David (2009-12)This is Part 2 of a two-part series on the ethical issues surrounding the use of placebo arms in clinical trials for psychiatric drugs. Part 1 discussed the ethical argument from a statistical, population-based perspective. ...