2018 Revised Common Rule
Revisions to the Common Rule
On January 19, 2017, the Department of Health and Human Services and fifteen other federal agencies issued revisions to the regulations governing human subjects research (called the Common Rule). These changes go into effect on January 21, 2019 with the exception of a staged implementation on single IRB requirements, discussed below.
Please note: KUMC will implement these new rules for all research that is federally funded or supported or is subject to FDA regulations. Minimal risk research that is not federally funded or supported and is not subject to FDA regulations may be eligible for review under the KUMC Policy for Flexible IRB Review. Please refer to our webpage on flexible review for additional information.
Training session for the Revised Common Rule are now complete. Please review our training slides found here. Feel free to contact the HRPP to arrange department-specific training sessions.
The federal Office of Human Research Protections (OHRP) describes the purpose of the regulatory changes:
- The new rule strengthens protections for people who volunteer to participate in research, while ensuring that the oversight system does not add inappropriate administrative burdens, particularly to low-risk research. It also allows more flexibility in keeping with today's dynamic research environment.
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
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. These changes to exemption will apply to research that is federally funded or supported. For other low and minimal risk research, investigators are encouraged to consult the page on the KUMC Policy for Flexible IRB Review to learn more about streamlined options. Below are additional guidance documents on select topics which will effect exempt research:
- Guidance on Exempt research 01/2019
- Guidance on Benign Interventions 01/2019
- Guidance on Limited IRB review 01/2019
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.
When the new rules go into effect, new minimal risk research will not automatically undergo continuing review by the IRB unless it is FDA-regulated. The IRB may require continuing review for special circumstances such as studies involving conflict of interest, IRB reliance or prior compliance concerns.
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.
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. The KUMC IRB will provide guidance and sample language to assist study teams with this requirement.
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 consent form changes to all federally-funded/supported studies and to any study that involves 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.
KUMC informed consent templates and examples for the Key Information section have been posted on the Forms and Template KUMC IRB webpage here.
Single IRB Review
Beginning January 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.
For assistance, you can email IRBreliance@kumc.edu
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.
The IRB's electronic submission system will be 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.
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.