eConsent for Research Sites

by Jim Gearhart

Common Rule Delayed to January 2019

The effective date for changes to the Common Rule will most likely change again. The signatories to the Common Rule first agreed in January 2017 that the collection of changes would come into effect in January 2018. Then, the agencies pushed implementation back to July of this year. Now, the Common Rule signatories are suggesting another six-month delay for all but three elements of the Common Rule.

In January the Common Rule signatories made a six-month extension look easy, but this new proposal comes as a formal Notice of Proposed Rulemaking (NPRM), which gives the public an opportunity to comment. The title of the NPRM, which was released on April 20, doesn’t quite say it all, but it says most of it: “Federal Policy for the Protection of Human Subjects: Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions.”

The formality this time around may come from the title’s last phrase, “While Allowing the Use of Three Burden-Reducing Provisions.” The Common Rule signatories want to move ahead with three parts of the Common Rule in July while waiting on the rest. As justification for the delay, the NPRM cites three high-profile recommendations: a letter from the Association of American Medical Colleges, Association of American Universities, Association of Public & Land-grant

Universities, and the Council on Governmental Relations; a letter from the American Medical Informatics Association, and a recommendation from the HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP).

With dates for the Common Rule now spreading across three calendar years (an announcement in 2017, an original effective date scheduled for January 2018, a revised effective date of July 2018, and the latest proposal for a staggered implementation across 2018 and 2019), the timing and description of implementations could be confusing. This NPRM introduces three terms to try clarifying matters:

Pre-2018 Requirements: The requirements that have been in place since 1991, and that will remain effective until at least July 19, 2018,

2018 Requirements: The changes that were announced in 2017, scheduled to be effective in January 2018, delayed to July 2018, and most likely – for the bulk of the requirements – now will be delayed to January 2019.

Three specified burden-reducing provisions of the 2018 Requirements: The NPRM argues that three changes are easy enough to introduce by July and will save enough time or effort that that they should be:

  1. Redefining “research,” to reduce the number of activities that will fall under the Common Rule (at §__.102 of the 2018 Requirements)
  2. Eliminating the requirement that IRBs review grant applications along with study protocols (§__.103(d)) and
  3. Discontinuing continuing review for some categories of research (mainly minimal risk research; at §__.109(f)(1)(i) and (iii))

The NPRM acknowledges that most of the 2018 requirements are too complex to complete by July. The changes will require new systems, new capabilities, and official guidance that has not yet been released. The three exceptions, however, offer an appealing blend of ease of implementation and significant savings in time or effort. These three provisions will –the reasoning goes– save time, can more or less stand alone without the rest of the new requirements, and will need relatively little guidance between now and July.

(At the risk of confusing matters, if they aren’t already, note that timing for one revision has not changed. The effective date for cooperative review –that is, single IRB review of multisite studies– is still January 20, 2020)

The NPRM would largely leave it up to each institution how to adopt the three specified burden-reducing provisions of the 2018 Requirements. Organizations can adopt all three wholesale, take them on piecemeal, or they can decide to wait until January 2019. The cost and benefit analysis of the NPRM assumes that half of the organizations covered by the Common Rule would try out the three burden-reducing provisions of the 2018 requirements in July.

The NPRM invited responses to some specific questions:

  • Should the Common Rule signatories implement all of the 2018 Requirements in July 2018, as currently scheduled?
  • Should the signatories delay all of the 2018 Requirements to January 2019?
  • Should the signatories introduce the three specified burden-reducing provisions of the 2018 Requirements in July 2018, and delay the rest of the 2018 Requirements to January, 2019?
  • Should they delay implementation beyond January 2019?

The comment period on this NPRM is open for 30 days, so you have until May 20 to let the Common Rule signatories know whether you agree that these three provisions will reduce work burdens enough to introduce them separately.

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