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May2018

On April 19, HHS and 16 other federal agencies released a new Notice of Proposed Rulemaking (NPRM) that would delay the general compliance date for the revised Federal Policy for the Protection of Human Subjects, or “Common Rule,” an additional six months, to January 21, 2019. The NPRM also proposes to allow institutions to implement three “burden-reducing provisions” during the delay period between July 19, 2018 (the compliance date laid out in the January 2018 Interim Final Rule) and January 21, 2019. For more on the details of the April 2018 NPRM and the specific areas in which the agencies are seeking comment, see our earlier blog post.

Comments on the NPRM are due May 21, and as you consider developing and submitting your comments, I wanted to share the letter PRIM&R has submitted.

PRIM&R endorses the proposal to extend the compliance date for the revised Common Rule an additional six months while allowing institutions to take advantage of three burden-reducing provisions early. But, we make clear that our support is predicated on an understanding that this further delay will give the agencies time to produce guidance and make it available to the regulated community far enough in advance of the compliance date to be useful in guiding institutions’ implementation plans—ideally at least three months in advance. 

In our comments, we remind the agencies that a primary stated reason for the release of an interim final rule in January 2018 delaying the original compliance date six months was to allow the agencies time to publish guidance, and yet no guidance has been published to date. We urge the agencies to take advantage of the additional delay to issue guidance prior to the January 2019 compliance date, and in a timeframe that will allow institutions to make the required changes to their systems, processes, and procedures, and we furthermore encourage the agencies to make use of existing resources, such as the recommendations already developed by SACHRP.

We go on to suggest four areas the agencies should prioritize for guidance, and say a bit more in each case about why guidance is necessary. Those areas are:

  1. The new requirement at §__.116(a)(5)(i) that informed consent begin with a “concise and focused presentation of key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.”
  2. New exemption category 3 at §__.104(d)(3)(i), involving “benign behavioral interventions.”
  3. New exemption category 4 at §__.104(d)(3)(i), the “HIPAA Exemption,” according to which research using identifiable private information may be exempt as long as that information or its collection is covered by HIPAA.
  4. “Limited IRB review,” a new concept introduced in four exemption categories (exemptions 2, 3, 7, and 8), but

Finally, we urge the agencies not to prioritize the creation of guidance on broad consent, as we share the regulated community’s concerns that that option will require mechanisms for tracking consent and refusals to consent that are logistically burdensome or even prohibitive for many institutions. As such, this provision is not likely to be used by most of the regulated community.

PRIM&R believes that, given the complexity of the new rule, successful implementation and compliance requires the availability of guidance within a timeframe that allows institutions to develop plans and change systems and procedures. While our comments emphasize this need for guidance, we do not suggest that if no guidance is forthcoming, the rule should be further delayed. Further delay would lead to more uncertainty of the sort that has frustrated and burdened the research community for the past year and a half (or more—let’s remember this revision process started almost seven years ago). The regulated community needs confirmation of a compliance date, so that it can re-focus its energies on the important business of protecting the rights and welfare of research participants. 

I urge you to submit comments on the NPRM as well, whether you are in favor of the proposed delay or prefer another timeline. You can submit your comments by May 21 at the regulations.gov portal, referencing docket ID HHS-OPHS-2018-0007, and selecting the “Comment Now” button, or just use this link: www.regulations.gov/docket?D=HHS-OPHS-2018-0007.

This is one more opportunity for the community to let the regulators know how and when we would like to see this process completed, and to collectively urge the prompt issuance of guidance.

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