Revised Common Rule: What the Changes Mean to Your Research

Teal stethoscope next to blue pen, laying on chart paperwork

The Revised Common Rule compliance date is quickly approaching on January 19, 2018. The Office of Research Integrity and MHRI leadership are working to ensure required changes to our policies and processes are made to comply with the new requirements. And while the implementation date is just around the corner, as with many other governmental changes, many in the research community feel the government will announce a delay in the implementation but until that happens, MHRI is getting prepared.  Here are some frequently asked questions about the common rule.

What are the Key Changes and What Should I Expect?

Exempt Research

Some of the existing categories of exempt research have changed, while a few new ones have been added. For a few of the exempt categories, there will now be a limited Institutional Review Board (IRB) review required. Want more information about the new exemptions? A handout describing the changes is available here.

Continuing Review

Continuing review is no longer required for studies that meet the following conditions: (1) eligible for expedited review, (2) research that underwent “limited review”, and (3) research that has progressed and involves only data analysis and/or accessing follow up clinical data for standard of care procedures. Despite the elimination of the continuing review requirement, institutions have the flexibility to require an accounting of ongoing research.

At MHRI, one final continuing review submission and approval will be required post 1/19/18 and after that, moving forward, there will be an annual check-in process that will require investigators to inform the Office of Research Integrity of the status of their project. More information on the check-in process will follow when the first check-ins are approaching. Investigators will be notified when they are required to check in annually with the IRB.

Informed Consent

Under the revised Common Rule, the informed consent document must provide information a reasonable person would want to have in order to make an informed decision. It must contain a concise and focused presentation of the key information that is most likely to assist a subject in understanding the reasons why one might or might not want to participate in the research. This portion of the informed consent document must be organized and presented in a way that facilitates comprehension. Certain specific statements must also be included in the Informed Consent Form (ICF) if you are working with identifiable private information or biospecimens.

At MHRI, you should expect to see new informed consent form templates coming soon!

Broad Consent

The revised Common Rule gives a new option for consent for the storage/maintenance/future use of identifiable data and biospecimens. Currently, researchers have the options to obtain consent from subjects or ask the IRB for a consent waiver. Broad consent is now an additional consent option for these specific activities. The institution is required to keep track of any individual’s refusal to provide broad consent so that the IRB does not waive consent for that individual in the future.

MHRI supports the broad consent portions of the Common Rule revisions and is working toward adopting a broad consent process once a technical infrastructure is implemented to track which individuals have been approached and whether they denied broad consent. Since broad consent is an additional option for researchers rather than a required change, MHRI is taking this time to evaluate all potential options. More information will follow once it is available.

Single IRB Review

The National Institutes of Health (NIH) is now requiring single IRB review for multi-site studies funded by the agency. The Common Rule revisions adopt a single IRB review requirement for multi-institutional research studies which mirrors the recent changes to the NIH policy. The compliance date for single IRB review is January 2020. MHRI will be releasing information about single IRB review for multi-institutional studies funded by Common Rule agencies in the future.

Any questions about the Common Rule changes? Contact [email protected]