Some wise words on the Final* Final Rule

No rule is every truly final — in fact, the Office for Human Research Protections (OHRP) issued a Final Rule on the protection of human subjects back in 1991, and now the agency’s back at it with the new Final* Final Rule, issued just last month. Elisa A. Hurley, the director of PRIM&R, one of the big professional organizations in our field, has some wise words on what the revised rule may mean for those of us involved in overseeing research.

Some items to note include:

–OHRP had indicated, in an earlier draft rule, it was considering subjecting research involving non-identified biospecimens to the Common Rule. After a great hue and cry, that provision was dropped, so research involving non-identified specimens remains outside the scope of human subject research (except in certain FDA-regulated research, but that’s another blog post). Dr. Hurley does note that the new rule includes language that the notion of what is “identifiable,” and of the evolving technologies yielding identifiable information, will be reviewed every few years. So OHRP is noticing that things that might not be identifiable now, might become so in a few years, and their treatment under the regulations may change.

–Informed consent gets another look in the new rule. We’ve all been challenged by how to transmit information during the informed consent process. What gets conveyed must be thorough and accurate, and it must also be in transmitted in a way that potential subjects can understand. The revised rule sets out some more specific requirements for how that information must be presented.

Be sure to click on the link above to read Dr. Hurley’s complete comments. Her post also contains links to more commentary and information about the rule.