New Guidelines for Human Research: Common Rule and NIH Confidentiality Updates
The Department of Health and Human Services released a final rule earlier this year revising the federal regulations for the ethical conduct of research with human subjects, called the Common Rule. The updates, which will take effect on January 19, reduce the regulatory burden on researchers conducting low-risk research, while continuing to protect research subjects participating in high-risk studies.
The updated rule will revise the format of a consent form – highlighting certain “key information” at the front of the form in a clear and concise manner. The regulations require researchers to begin consent forms with a brief, focused summary of the information that will best help prospective subjects decide whether or not to participate in a study. The University of Rochester Research Subjects Review Board is currently revising its consent form template which includes prompts for researchers to complete the “key information”. The OHSP Informed Consent policy and related guidance documents will also be revised in the near future to reflect these changes.
The updates will also allow the option for researchers to obtain broad consent to store, maintain, and use research subjects’ identifiable information and/or specimens for future studies – even if those future studies are not yet planned. Broad consent will be obtained in conjunction with informed consent and researchers will be responsible for tracking broad consent responses for their own studies. At this time, broad consent will only be implemented within the context of research at the University of Rochester, not for clinical purposes. However, researchers will still be able to access patient data or biospecimens collected in clinic through the traditional route of submitting a protocol to RSRB.
The updated Common Rule is designed to focus resources for research oversight to the studies that pose the greatest risk to subjects. The new rule expands the type of studies that are exempt from the regulations and no longer requires continuing review for many studies that are minimal risk.
Finally, the revised regulations will require multi-site research studies to use a single Institutional Review Board (sIRB), which will reduce redundancy of multiple IRB reviews and potentially save time. However, exceptions may be made if federal agencies determine that using multiple IRBs is better for a specific clinical trial or context. The single IRB requirement under the Common Rule will take effect in January of 2020 and the policy requiring NIH-funded studies to use an sIRB takes effect January 25, 2018.
In addition, the National Institutes of Health updated its Certificate of Confidentiality policy, which protects researchers from having to disclose research subject data in response to legal demands. Researchers who collect or use identifiable subject information and are funded wholly or in part by the NIH, will no longer need to request a Certificate of Confidentiality, they will be covered automatically. The policy took effect on October 1, and will be applied to all NIH-funded research that started or was ongoing on or after December 31, 2016. For ongoing research, studies will be evaluated individually by the RSRB at the time of continuing review or when an amendment is submitted to determine if changes to the consent form are necessary.
Overall, these changes are meant to foster creativity and innovation of our nation’s clinical researchers as well as engender trust in the research establishment from the general public.
Read a summary of the Common Rule updates.
Read an article about the Certificate of Confidentiality changes.
Watch a presentation by RSRB Senior Regulatory Specialist, Emily Flagg.
Or contact Kelley O’Donoghue in the University’s Office for Human Subject Protection.
Susanne Pritchard Pallo |