The Federal Policy for the Protection of Human Subjects, also known as the “Common Rule,” specifies the requirements for the protection of human subjects in U.S. Department of Health and Human Services (HHS) sponsored clinical trials. A final rule published to the Federal Register in January 2017 revised the Common Rule, which has a compliance date of January 21, 2019. The revised Common Rule requirements are also known as the “2018 Requirements.” The revisions were intended as a step toward harmonizing the human subject protection regulations between HHS and FDA as required under the 21st Century Cures Act (Cures Act).
The Revised Common Rule has created some differences in the regulations for human subject protections between HHS and FDA regulated studies. The FDA has not yet updated its regulations and so has released the guidance, “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations,” which can be found here. The guidance is intended to clarify the effects of the 2018 Requirements and reduce the burden due to two sets of requirements for human subject protections.
Changes to Informed Consent:
Clarification that the elements of Informed Consent for the 2018 Requirements are similar enough to the current standards for FDA so that only one consent form is required for studies under both HHS and FDA.
An interesting new element in the 2018 Requirements is that an informed consent must contain a statement describing whether identifiable private information or biospecimens will or will not be used or distributed for future research even if it is deidentified.
Interesting additional elements in the 2018 Requirements include disclosing:
that biospecimens may be sold for profit,
if clinically relevant results will be shared with the subjects, and
if research involving a biospecimen may include genomic sequencing.
The 2018 Requirements allow IRBs to follow expedited procedures for research from the expedited review list.
The IRB must still determine that the research poses no more than minimal risk for it to be eligible.
FDA regulated studies:
must follow the FDA regulations for IRB review of no more than minimal risk studies and
use FDA’s 1998 list of categories of research that is eligible for expedited review procedures published in the Federal Register.
The IRB needs to determine that the research on the list poses no more than minimal risk.
IRB Continuing Review:
The 2018 Requirements removed the requirement for continuing review when expedited review is permitted or when only access to subject data from routine follow-up or data analysis is required.
FDA regulated studies must follow the current continuing review requirements, which includes a schedule according to risk but at least once a year.
The Revised Common Rule and this guidance move the HHS and FDA closer to harmonizing human subject protection regulations as required under the Cures Act. Once the regulations are harmonized, the regulatory burdens of two requirements for human subject protections will be lifted. For now, if the study is subject to both sets of regulations and they differ, the stricter regulations must be followed. The FDA intends to harmonize its regulations with the Revised Common Rule, but for now hopes this guidance will clarify the impact.
To ask questions or request further clarification from the FDA, add electronic comments here.
-The Clinical Pathways Team
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