The Department of Health and Human Services and 15 other agencies have announced revisions to the Federal Policy for the Protection of Human Subjects, otherwise known as the Common Rule. The final rule can be found here and will be officially published in the Federal Register on January 19, 2017.
The changes to the rule that will have a significant impact on the conduct of pragmatic clinical trials and embedded research include:
- New requirements regarding the information that must be given to patients as part of the informed consent process, including
- Key information that is most important to the subject and likely to help a patient (or legal representative) make a decision about participation
- An opportunity to discuss the information
- An approach that emphasizes the fostering of overall understanding (as opposed to specific length requirements)
- Allowing the use of broad consent for the use of identifiable information or identifiable biospecimens for other research studies (other than the proposed one) for
- Storage and maintenance for secondary research use
- Secondary research (including future uses)
- New exempt categories of research based on risk profile
- A requirement for U.S.-based institutions engaged in cooperative research to use a single Institution Review Board (IRB)
- A removal of the requirement for continuing review of ongoing research for studies that undergo expedited review.