The revised Common Rule is effective as of January 21, 2019. The Common Rule is the Federal Policy for the Protection of Human Subjects. All new human-subjects research submitted for review on or after Jan. 21 is subject to the revised regulations.
Changes Include the Following:
- Most research that is determined by the IRB to pose ‘minimal risk’ to participants is no longer required to be re-approved annually. In January 2018, we removed the re-approval requirement for unfunded minimal risk research. The revised Common Rule regulations now allow us to also remove re-approval requirements for research funded by agencies that are signatories to the Common Rule (e.g. NSF, NIH, DoE, DoD). Research subject to FDA regulation and research funded by non-Common Rule agencies will continue to require re-approval on an annual basis.
- Expansion of the categories of research eligible for "exemption". Some types of research that was previously required to be reviewed through the expedited process may now qualify for exempt-level IRB review. Note: Exempt studies are still "human subjects research" and require IRB review prior to implementation.
- Changes to the informed consent process. Consent language must be organized in a fashion that facilitates understanding of risks and benefits and provides prospective participants with sufficient information in order to make a fully-informed decision about whether to participate. Additionally, there are new required & additional elements of informed consent. Updated informed consent templates have been provided that incorporate these changes.
- Updated application forms can be found on IRBNet under "Forms and Templates." The new consent form template and application form must be used for all IRB submissions beginning January 21, 2019.
The PowerPoint available here details changes to the Common Rule regulations as well as related updates to Lehigh University's IRB policy.
A summary of earlier changes to IRB policy implemented in Jan. 2018 can be found here.
Single IRB-review of multi-site NIH-supported research is NIH policy and is required beginning January 25, 2018.
Please contact us for more information or with questions.