RECENTLY, WE have received a number of manuscripts at the ARCHIVES that were troubling because of the lack of institutional review board (IRB) examination and approval. These have included studies by physicians in private practice, physicians employed by state health departments, and pediatricians in academic medicine. The rationale in each case was that since patients were not being contacted, IRB review was unnecessary. We strongly disagree.
The medical research community is under markedly increased scrutiny by the public for the ethics of the research that we conduct. The death of 18-year-old Jesse Gelsinger in a gene therapy trial at the University of Pennsylvania raised the issues not only of informed consent but also of financial conflicts of interest by the investigators conducting the trial.1,2 The death of a volunteer in a study of asthma temporarily shut down all federal funding for medical research at Johns Hopkins Hospital, the top recipient of National Institutes of Health funding for research and rated by some as the best hospital in America.3 The ethics issues in these cases have been widely discussed in both the lay and medical literature.
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