On Jan. 19, 2017, the Department of Health and Human Services and fifteen other federal agencies issued revisions to the regulations governing human subjects research. The regulations are referred to as the Common Rule. All of these changes go into effect on July 19, 2018, with the exception of a staged implementation on single Institutional Review Board (IRB) requirements, discussed below. The federal Office of Human Research Protections (OHRP) describes the purpose of the regulatory changes:
OHRP posts a copy of the new rule and related information at: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html
This presentation provides a detailed examination of new exemption criteria, changes to continuing review, mandate for single IRB review and significant changes to the structure and content of informed consent documents. The presentation may benefit study personnel who conduct research and individuals who prepare IRB submissions.
This session of Research and Discovery Grand Rounds provides an overview of the upcoming changes to the federal Common Rule that governs human subjects research. The presentation may benefit faculty and staff in understanding the broad themes and potential impacts of the regulatory changes
Exempt Research - The Revised Common Rule broadens the types of research that qualify for exemption. Several exempt categories have been revised, and there are new categories of exemptions. The exemption comparison chart shows how the categories have changed. Note that some exemption categories require limited IRB review, which is a new type of review.
Continuing Review - The Revised Common Rule removes the requirement for continuing review for minimal risk research and for full-board research that is in long-term follow-up or data analysis only, unless the research is FDA-regulated.
Even when continuing review is not required, investigators remain responsible for updating the IRB about adverse events and other unanticipated problems, seeking IRB approval for changes to personnel, protocol amendments, recruitment materials, etc., and informing the IRB when the research is complete.
Informed Consent - When the new regulations go into effect, changes will be required to the structure and content of informed consent documents. Consent forms must begin with a concise summary of "key information" that is most likely to assist a prospective subject in understanding the reasons why one might or might not want to join the research. This section must be organized in a way that facilitates understanding. Additional guidance about this concise summary is forthcoming.
There are also new requirements for additional consent elements related to the use of de-identified information, the use of biospecimens, potential for commercial profit and return of clinically-relevant results. KUMC consent form templates will be updated to reflect these new elements. The KUMC IRB will be applying these changes to all federally-funded/supported studies and to other studies involving greater than minimal risk.
The 2018 regulations require that certain clinical trial consent forms be posted on a government website. This requirement applies to studies that are conducted or supported by a federal agency. The posting must occur no more than 60 days after the last study visit by any subject. The specific government website has not yet been named.
Single IRB Review - Beginning Jan. 25, 2018, all multi-center NIH-funded studies will be required to use single IRB review for the domestic sites. Additional information is posted at: https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm Single IRB review for studies conducted or supported by other federal agencies will be required starting in January 2020.
Impact of the Changes on Ongoing Research - In most cases, ongoing research will remain under the pre-2018 regulations (those issued in 1991). The KUMC IRB will maintain two sets of Standard Operating Procedures. Investigators are not required to make any changes to ongoing research. The IRB will issue guidance on how to request transition to the new rules, if desired, and the circumstances where transition might be beneficial. Investigators should be aware that transitioned studies might need additional IRB review and re-consenting of subjects. Final determination on whether to transition an individual study is made by the IRB.
eIRB System - The IRB's electronic submission system is being updated by the vendor to reflect the revised regulations. Changes to the system are anticipated by mid-January. Additional information on electronic IRB submissions will be posted on this page.
Next Steps - Investigators should refer to this page for updates about the Revised Common Rule. Updated application forms, standard operating procedures, templates and guidance are under development. The new rules will apply to human subjects research that is approved on or after July 19, 2018.