By Jerry Menikoff Pages: 1-3
How can we appropriately ensure that people who enroll in clinical research understand what they are getting into? The recent revisions to the primary set of U.S. regulations for protecting research subjects (the Common Rule) attempt to better achieve that goal by, in part, providing more useful information to prospective subjects. In this issue of AJOB, Stephanie Morain and her colleagues address another important aspect of informed consent to research: Who should be obtaining consent? They note that although a variety of ethical guidelines warn against having physician-investigators obtain consent from someone who is already their own patient, U.S. regulations do not actually prohibit this. Indeed, as their article states, guidance from the Department of Health and Human Services’ Office for Human Research Protections specifically provides that institutional review boards (IRBs) may use discretion in determining when to allow this.
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