Revised Common Rule: What the Changes Mean to Your Research

Open calendar book with pen and three green paper clips

The Revised Common Rule went into effect on January 21, 2019. 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. 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 formal continuing review submission and approval will be required post 1/21/19 and after that, moving forward, the IRB will make a risk determination based on the nature of the protocol and history of review whether to require an additional check in for studies that fall into the above categories of review.

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.

When submitting to the MHRI IRB, you should use the new informed consent templates available in the library section of the new eIRB system. Note, that in addition to the above common rule requirements, this new consent template also folds the HIPAA authorization into the consent form for a combined consent/HIPAA authorization. If you need access to a consent template and do not yet have a Huron login please contact ORI.

Broad Consent
The revised Common Rule provides a new voluntary 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. Once implemented, 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 concept behind the broad consent portions of the Common Rule revisions and will support a broad consent process once a technical infrastructure is implemented to track which individuals have been approached and whether they denied broad consent. Since the technical aspects of broad consent have not yet been addressed nationally or locally, MHRI has opted NOT to adopt the broad consent provisions. 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 Common Rule 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]