By Jill Drachenberg, AHC Media Editor
The U.S. Department of Health and Human Services (HHS) on Wednesday released its final rule pertaining to changes in human subjects protections, also known as the Common Rule.
The highly anticipated final rule comes more than a year after the September 2015 Notice of Proposed Rulemaking (NPRM). The public comment period for the NPRM drew more than 2,100 comments, mostly critical of the proposed changes. (For more information on the NPRM, see stories in the November 2015 issue of IRB Advisor.)
One significant bone of contention with IRBs and researchers was a proposal that would have required researchers to obtain consent for future research use of biospecimens — a provision that could create administrative nightmares for researchers to track down study participants years later. The final rule does not require such consent to be obtained, and allows researchers to maintain current practice.
The final rule also makes the following Common Rule changes:
- Consent forms must contain a concise summary — at the beginning of the forms — that describe the study’s purpose, risks and benefits, alternative treatments, and other key information to aid participants in making informed choices.
- Central IRB review will be required for federally funded multisite studies — but the proposal is modified to “add substantial increased flexibility in now allowing broad groups of studies (instead of just specific studies) to be removed from this requirement,” according to HHS.
- Researchers can rely on broad consent for future research use of identifiable biospecimens, rather than obtaining an IRB waiver of consent. Consent will still not be needed for research on de-identified specimens and data.
- Establishes new categories of exempt research, based on risk profile, in order to reduce regulatory and administrative burden on researchers. Some categories will require limited IRB review.
- Certain ongoing studies will no longer have to undergo continuing review if such review is of little benefit to human subjects protection.
HHS also decided to walk back originally proposed changes, including the following:
- The final rule will not cover studies and clinical trials that are not federally funded, as was previously considered.
- The rule does not adopt proposals and standards that have not yet been proposed. For example, “items that were not included in the final rule include a template to be used for broad consent forms, and a decision tool to be used for making exemption determinations,” according to the rule.
- The NPRM’s concept of “excluded” activities was not adopted. “Generally, activities proposed to be excluded are now described as not satisfying the definition of what constitutes research under the regulations or are classified as exempt,” the rule stated.
- The rule, for the most part, retains current practice in privacy standards and does not include proposed standardized privacy safeguards for identifiable data and biospecimens.
“We are very hopeful that these changes and all the others that reduce unnecessary administrative burdens will be beneficial to both researchers and research participants,” said Office of Human Research Protections Director Jerry Menikoff, MD, in a statement.
More information on the HHS final Common Rule changes, including expert analysis and commentary, will appear in the March issue of IRB Advisor.