OHRP Guidance on Maintaining Consistency Regarding the Applicability of the 2018 or Pre-2018 Requirements

Options for How New Sites Added to Ongoing Cooperative Research Can Follow the Same Version of the Common Rule  

NOTE: This guidance is consistent with the 2018 Requirements (i.e., the revised Common Rule)

This guidance represents the current thinking of the Office for Human Research Protections (OHRP) on this topic. This guidance does not create or confer any rights for or on any person and does not operate to bind OHRP or the public.

OHRP guidance should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word “must” in OHRP guidance means that something is required under the Department of Health and Human Services (HHS) regulations at 45 CFR part 46. The use of the word “should” in OHRP guidance means that something is recommended or suggested, but not required. An institution may use an alternative approach if the approach satisfies the requirements of 45 CFR part 46. OHRP is available to discuss alternative approaches by telephone at 240-453-8237 or 866-447-4777, or by email at ohrp@hhs.gov.

Date: November 12, 2020

OHRP has received questions from the regulated community on how institutions can maintain consistency in the version of the Common Rule that applies to a cooperative research project in situations where an Institutional Review Board (IRB) approved the study at one or more sites before the general compliance date of the 2018 Requirements (i.e., the revised Common Rule), and other sites are added after the general compliance date of the 2018 Requirements. The individuals posing these questions indicated that there are many benefits (administrative and scientific) of ensuring that all sites in a cooperative research project are subject to the same version of the Common Rule.  In particular, it is OHRP’s understanding that those individuals desire to further improve a study’s validity by reducing differences across sites, where this can easily be achieved.

In response to these questions, OHRP is clarifying the options with regard to whether the pre-2018 Requirements or 2018 Requirements apply to institutions added as new sites for ongoing cooperative research.  This document describes permissible options, under 45 CFR §46.101(l), in cooperative research projects for which:

  1. (1) the research was initially approved by an Institutional Review Board (IRB) for at least one study site prior to January 21, 2019 (the general compliance date of the 2018 Requirements); and
  2. (2) at least one new site is added to the research on or after January 21, 2019.

If the above two criteria are met, the following options are permissible:

  • The pre-2018 Requirements can apply to the cooperative research at any subsequently added site, without further action by any institution involved in the research. 45 CFR §46.101(l)(3).

    If the initial study sites are conducting the research under the pre-2018 Requirements, this approach will allow all institutions involved in the cooperative research to conduct the research under the pre-2018 Requirements.
  • Any subsequently added site that prefers to conduct the cooperative research under the 2018 Requirements instead may transition the study at that site.  45 CFR §46.101(l)(3), (4). (For more information about transition, see https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-revised-common-rule-compliance-dates-transition-provision-45-cfr-46-1011/index.html.)  Transitioned studies must comply with the single IRB review provision at §46.114(b)(1), unless an exception applies. See 45 CFR §46.114(b)(2)(i) and (ii).
  • If the initial study sites are conducting the research under the 2018 Requirements (e.g., because of a decision at those sites to transition the study conducted at those sites to the 2018 Requirements), this approach will allow all institutions involved in the cooperative research to conduct the research under the 2018 Requirements. (Note that a site’s decision to transition a study is limited to the conduct of the study at that institution, and no other site.)

Please note that these are not the only possible approaches to how the 2018 Requirements at 45 CFR §46.101(l) can allow all sites in a cooperative research project to follow the same version of the Common Rule.  If regulated entities would like to discuss other possible approaches, please feel free to contact OHRP staff at OHRP@HHS.gov.

Content created by Office for Human Research Protections (OHRP)
Content last reviewed on November 11, 2020