The federal policies mandating the protection of human subjects are known as the “Common Rule,” and on January 19, 2018, a substantial revision to the Common Rule will take effect*. These changes are meant to ease some researcher burden while enhancing the protection of human subjects. These changes apply only to new studies submitted on or after January 19, 2018. Please note: the revised Common Rule does NOT apply to FDA-regulated and Department of Justice studies.
Recommendations for Researchers
The Office for Research Protections is working to implement the revised Common Rule changes, and no action is required by researchers at this time. However, it’s important to note that researchers submitting their studies to the IRB on or after January 19, 2018 will be reviewed under the revised Common Rule. If you have flexibility in the timing of your study and are starting a new study, we recommend waiting to submit on or after January 19 to have your study reviewed under the revised Common Rule. New templates to use for review under the revised Common Rule will be available later this year. Alternately, you may want to submit well in advance of January 19 to be reviewed under the current regulations; submissions to the IRB often require revisions that take time, and we want to help researchers avoid being caught in Common Rule "limbo." We are continuing to evaluate whether, in the future, we will apply the revised Common Rule to studies existing prior to January 19.
Common Rule Changes: Highlights
Of particular interest to many Penn State researchers are changes in three areas: expanded exemption categories, continuing review changes, and consent form changes. Below are a few highlights regarding the changes in these areas.
New Exempt Categories
The Common Rule defines three levels of review for human subjects research: exempt, expedited, and full (committee). The new Common Rule broadens the types of research that may be determined to be exempt from IRB review. For example, starting January 19, benign behavioral interventions conducted with adults may be determined to be exempt. Researchers must submit to the IRB program for a determination that activities are exempt from IRB review. Another example: the collection of identifiable, sensitive information from adults may also be exempt; however, this new category requires a limited IRB review to determine that appropriate privacy and confidentiality protections are in place.
Continuing Review Changes
Some minimal risk studies will no longer be required to renew their IRB approval on an annual basis (continuing review). Investigators conducting eligible studies will be informed of post-approval requirements at the time of initial approval.
Consent Form Changes
Consent forms will need to include a brief summary that explains the research to potential participants in an easy-to-understand and clear manner. It is now mandated that consent forms be concise while also giving the full context of a study, including its risks and benefits, so potential participants have all the information they need to make an informed decision. Consent forms will also need to include information regarding the potential for future use of de-identified data and biospecimens.
In addition, there is a new requirement that cooperative research studies involving more than one institution to use a single IRB for review. The implementation date for this requirement is January 19, 2020.
For updates related to the Common Rule or to learn more about the changes, visit our Common Rule and Other Changes page. Sara Horn, IRB Program Director, will also be presenting a talk, "The Revised Common Rule: What Researchers Need to Know," December 6, 4-5 PM in 312 BBH Building as part of the Prevention Research Center's seminar series. For information about recent changes specific to NIH-funded research, see this recent article.
*A one-year delay for the general implementation of the Common Rule was proposed on October 7. This delay is currently being reviewed by the U.S. Office of Management and Budget. We will post any updates about the implementation date and further details as soon as they are known.