Agencies delay revisions to human subject policy
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January 26, 2018
Agencies delay revisions to human subject policy

Sixteen federal agencies, including the EPA, have jointly published a final interim rule delaying by 6 months last year’s revisions to the Federal Policy for the Protection of Human Subjects. According to the agencies, the delay was requested by the regulated community, which cited the complexity of the revisions, the absence of needed guidance, and the need to revamp institutional procedures and electronic systems to come into compliance. The interim final rule, which was issued without a proposal, extends the January 19, 2018, effective date of the revisions to July 19, 2018. The agencies also announced plans to publish a proposed rule that would further delay implementation of the revisions.

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Responding to changes in research

The Federal Policy for the Protection of Human Subjects was originally promulgated as the Common Rule in 1991. The Common Rule was amended in 2005 and remained unchanged until the agencies published their revisions in 2017 (January 19, 2017, FR).

“The volume and landscape of research involving human subjects have changed considerably,” the agencies stated. “Research with human subjects has grown in scale and become more diverse. Examples of developments include: an expansion in the number and types of clinical trials, as well as observational studies and cohort studies; a diversification of the types of social and behavioral research being used in human subjects research; increased use of sophisticated analytic techniques to study human biospecimens; and the growing use of electronic health data and other digital records to enable very large datasets [sic] to be rapidly analyzed and combined in novel ways. Yet these developments have not been accompanied by major change in the human subjects research oversight system, which has remained largely unaltered over the past two decades.”

Better informed subjects

Primarily, the revisions established new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process. For example, consent forms must provide potential research subjects with a better understanding of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate. Consent forms for certain federally funded clinical trials must be posted on a public website. Also, the revisions included establishment of new exempt categories of research based on the level of risk they pose to participants.

Avoiding mistakes

“We agree that regulated entities need additional time for implementation and compliance, which would be furthered by the issuance of guidance by the Common Rule agencies,” the agencies now state. “Without a delay, and without guidance, institutions that have expected a delay that hastily attempt to implement the revised rule without adequate preparation are bound to make mistakes, the consequences of which may jeopardize the proper conduct of research and the safety and wellbeing [sic] of human subjects.”

Research subject to one set of rules

Before July 19, 2018, regulated entities will continue to comply with the pre-2018 requirements.

“To clarify, regulated entities are not allowed, prior to July 19, 2018, to comply with the 2018 requirements in lieu of the pre-2018 requirements,” say the agencies. “Unless further regulatory action is taken, studies initiated on or after July 19, 2018, will be required to comply with the 2018 requirements. Studies initiated prior to July 19, 2018, or studies determined to be exempt, before July 19, 2018, would, as a default, continue to be subject to the pre-2018 requirements for their duration. This will maintain the ability of institutions to hold such studies to the same set of standards throughout the studies’ duration, and will avoid a requirement that such research be subject to two sets of rules. However, on or after July 19, 2018, institutions may elect instead to conduct such studies in compliance with the 2018 requirements.”

The interim final rule was published in the January 22, 2018, FR.

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