In announcing the upcoming guidance, Department of Health and Human Services (HHS) official Irene Stith-Coleman did not specify what the topic would be or whether the HHS Office for Human Research Protections (OHRP) would be releasing draft or final guidance.
But her announcement comes about two months before research institutions have to comply with a major overhaul to the Common Rule, a set of regulations adopted by nearly 20 federal agencies to protect research volunteers from undue harm.
To date, the OHRP has issued three draft guidance documents on how to transition from the old to new regulations, but none has been finalized.
Those who must follow the rule have been clamoring for help on implementing the changes, which include updating consent forms and data management systems.
While not specifying what the forthcoming document would address, Stith-Coleman posted a slide that she said lists what guidance documents the OHRP is working on.
At the top of the list were the three draft guidance documents on transitioning to the new rule, followed by one on broad consent. Broad consent is an alternative option for storing and using identifiable, private information in future, unspecified research. A number of those in the regulated community have said broad consent is not worth adopting because it is too cumbersome.
The OHRP is also working on guidance describing what key information should go at the top of the informed consent form. This is a new requirement in the revised Common Rule, but the OHRP has not yet defined what “key information” means and how institutions can be sure they have met that threshold.
The OHRP is updating two dozen existing guidance documents and working on about 18 new ones, Stith-Coleman said.
Learn more in the OHRP announcement and the Federal Register notice (83 Fed. Reg. 58,261).
Selected information in the "Pharmaceutical Science Update" is compiled from summaries and articles from Bloomberg BNA.