Human Research Protection

www.fda.gov

www.hhs.gov/ohrp

How will MHRI address Revised Common Rule consent form requirements?

• Investigators generally will have to comply with the revised common rule requirements for informed consent after the January 21, 2019 compliance date. These requirements will be enforced at the time of continuing review or modification, whichever comes first. The ORI will work with investigative sites to help review and edit consent forms for studies submitted under the new Common Rule. In addition, MHRI has revised our consent form templates (available through the link above and in the eIRB system library) to accommodate the new consent elements (e.g., concise summary of key information).

Will MHRI be responsible for posting consent forms to the public federal website as required for federally funded studies?

• No, the research sponsor is ultimately responsible for compliance with this requirement; however, MHRI will be happy to work with investigators and sponsors to ensure that consent forms meet the criteria for posting (e.g., contain the requisite information and suggestions for redaction).

What is broad consent?

• Broad consent is a non-study specific consenting avenue that can be utilized for both exempt and non-exempt secondary research use of identifiable private information or identifiable specimens (including storage and maintenance of specimens for such use). 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.

What is limited IRB review?

• Limited IRB review is focused on reviewing studies (certain categories of exempt research) to ensure adequate privacy and confidentiality safeguards, especially for exempt research utilizing individually identifiable information/biospecimens.

Will MHRI offer review for all categories of exempt research as promulgated in the revised Common Rule?

• Yes, MHRI will provide review for all categories of exempt research as promulgated in the revised Common Rule.

Will MHRI apply the new Common Rule criteria when conducting a continuing review?

• Yes, MHRI will conduct continuing review under the new Common Rule criteria for continuing reviews that take place after January 21, 2019. Continuing review will no longer be 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 and 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.