[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Rules and Regulations]
[Pages 64432-64433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25358]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 46


HHS Policy for the Protection of Human Research Subjects

AGENCY: Office for Human Research Protections (OHRP), Office of the 
Assistant Secretary for Health (OASH), Department of Health and Human 
Services (HHS)

ACTION: Determination of Exception: required use of single 
institutional review board for cooperative research.

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SUMMARY: The Office for Human Research Protections (OHRP), Office of 
the Assistant Secretary for Health (OASH), Department of Health and 
Human Services (HHS), excepts two categories of research from the 
required use of a single institutional review board (IRB) to review 
cooperative research under the HHS regulations for the protection of 
human subjects. This determination is specific to research conducted or 
supported by HHS.

DATES: This exception is applicable as of November 22, 2019.

FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, Director, 
Division of Policy and Assurances, Office for Human Research 
Protections (OHRP), Department of Health and Human Services, 1101 
Wootton Parkway, Suite 200, Rockville, MD 20852; telephone: 240-453-
6900 or 1-866-447-4777; facsimile: 240-453-8409; email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

Regulatory History

    In a final rule published on January 19, 2017, HHS and other 
Federal departments and agencies revised the Federal Policy for the 
Protection of Human Subjects (the ``Common Rule''), codified with 
respect to HHS at subpart A of 45 CFR part 46. The Common Rule is 
followed by 19 other Federal departments and agencies, either as Common 
Rule signatories, or as required by Executive Order or statute. The 
revised Common Rule, including amendments made by a January 22, 2018 
interim final rule (83 FR 2885) and June 19, 2018 final rule (83 FR 
28497) (also referred to as the ``2018 Requirements''), became 
effective on July 19, 2018.
    The revised Common Rule requires that U.S. institutions engaged in 
cooperative research must rely on a single institutional review board 
(IRB) to review and approve the portion of the research conducted at 
domestic sites. See 45 CFR 46.114(b). The compliance date for the 
single IRB requirement is January 20, 2020.
    The revised Common Rule applies to all research initially approved 
by an IRB on or after January 21, 2019. See 45 CFR 46.101(l)(5). As of 
January 20, 2020, the compliance date for the single IRB requirement, 
all cooperative research subject to the revised Common Rule will be 
required to use a single IRB, whether the research was initially 
approved by a single IRB or multiple IRBs.

Regulatory Allowance of Exceptions to Single IRB Review Requirement

    The revised Common Rule provides that the agency conducting or 
supporting cooperative research may except the research from the single 
IRB mandate. To do so, the agency must both determine and document that 
using a single IRB is not appropriate in the particular context. See 45 
CFR 46.114(b)(2).

Research Contexts Qualifying for Exception

    With respect to HHS-conducted or supported research, OHRP has 
determined that the following research is excepted from the single IRB 
mandate: (1) Cooperative research conducted or supported by HHS 
agencies other than the National Institutes of Health (NIH), if an IRB 
approved the research before January 20, 2020, or (2) cooperative 
research conducted or supported by NIH if either (a) the NIH single IRB 
policy \1\ does not apply, and the research was initially approved by 
an IRB before January 20, 2020, or (b) NIH excepted the research from 
its single IRB policy before January 20, 2020.
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    \1\ See ``Guidance on Exceptions to the NIH Single IRB Policy'' 
released October 11, 2017. Available at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-003.html.
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Cooperative Research Approved Before January 20, 2020
    In May 2019, the Association of American Medical Colleges (AAMC), 
the Council on Governmental Relations (COGR), the Association of 
American Universities (AAU), and the Association of Public Land-Grant 
Universities (APLGU) wrote to the director of OHRP expressing concern 
regarding the application of the single IRB requirement to cooperative 
research subject to the revised Common Rule when the research was 
approved before January 20, 2020 (available at https://www.aamc.org/download/497410/data/finaljointassociationlettertoohrponsingleirb.pdf). 
The organizations asserted that much of the research community did not 
fully understand the way this requirement would operate, and informed 
OHRP that shifting a multisite study in midstream to a single IRB 
review system would be difficult and expensive. On this basis, the 
organizations requested that OHRP issue an exception to the single IRB 
requirement for cooperative research conducted under the revised Common

[[Page 64433]]

Rule and initiated before January 20, 2020.
    OHRP has considered this request. One of the objectives of the 
revised Common Rule's single IRB requirement is to reduce 
administrative costs of cooperative research. For cooperative research 
that already has been initially approved by multiple IRBs, the cost 
savings associated with reduced IRB reviews would not be achieved by 
making the single IRB requirement applicable to such cooperative 
research. Members of the regulated community report that transitioning 
cooperative research from multiple IRBs to a single IRB would, 
conversely, be costly for most institutions. Further, excepting such 
research from the single IRB mandate would not adversely affect the 
rights and welfare of the research subjects. For these reasons, OHRP 
has decided to except cooperative research approved before January 20, 
2020, from the single IRB mandate. This general exception does not 
apply to NIH research; an NIH-specific exception is discussed infra.
    OHRP has determined that a relatively small number of HHS protocols 
(other than NIH research) will be eligible for exception. OHRP surveyed 
the HHS agency, other than NIH, that OHRP expects conducts or supports 
the majority of such human subjects research. Based on the information 
provided by that agency, OHRP understands that this agency is 
supporting five ongoing cooperative research studies that are subject 
to the revised Common Rule. Approximately three to five additional 
cooperative research studies supported by this agency that would be 
subject to the revised Common Rule are expected to be initiated before 
January 20, 2020.
Cooperative Research Conducted or Supported by NIH
    The NIH policy on the use of a single IRB for multi-site research 
has been in effect since January 25, 2018. It requires all U.S. sites 
participating in NIH-funded multi-site (i.e., two or more sites) 
studies involving non-exempt human subjects research where the sites 
are following the same protocol to use a single IRB for the review. 
Exceptions to this policy are made where review by the proposed IRB is 
prohibited by a federal, tribal, or state law, regulation, or policy, 
or if there is a compelling justification for the exception. NIH 
determines whether to grant an exception after an assessment of the 
need. NIH's single IRB policy is largely coextensive with the Common 
Rule single IRB requirement, although NIH designed its policy to 
exclude certain categories of cooperative research (e.g., training 
protocols for activities that do not involve human subjects research at 
initiation). NIH also has issued case-specific exceptions to its single 
IRB policy for particular research studies. However, on January 20, 
2020, the revised Common Rule single IRB requirement will take effect 
for certain studies, regardless of whether they are subject to NIH's 
policy, which would require this NIH-conducted or supported research to 
use a single IRB review structure.
    As stated above, if more than one IRB initially reviewed and 
approved cooperative research, imposition of the single IRB mandate in 
mid-stream could result in increased costs and burdens to regulated 
entities, rather than cost savings. Excepting such NIH-conducted or 
supported research from mandated single IRB review will not adversely 
affect the rights and welfare of the research subjects. Further, NIH 
has given thoughtful consideration to these research contexts, and 
already determined that single IRB review should not be required. NIH 
deliberately structured its single IRB policy such that certain 
research would fall outside the scope of coverage. Likewise, in issuing 
case-by-case exceptions to its single IRB policy, NIH concluded that 
single IRB review is not appropriate for those particular research 
contexts. Thus, OHRP has decided to except NIH cooperative research 
from the Common Rule single IRB mandate if either (a) the NIH single 
IRB policy does not apply, and the research was initially approved by 
an IRB before January 20, 2020, or (b) NIH excepted the research from 
its single IRB policy before January 20, 2020. For more information on 
the NIH single IRB policy, see: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html.
    This exception is an exercise of OHRP's enforcement discretion, as 
specifically permitted by 45 CFR 46.114(b)(2), that affects relatively 
few research protocols for a limited time. As required by 45 CFR 
46.114(b)(2), OHRP determines and documents that using a single IRB is 
not appropriate for the described categories of research, and, for the 
reasons stated above, OHRP excepts this research from the single IRB 
mandate. The full text of the exception is listed below, and may also 
be found in the ``Single IRB Requirement'' tab in the ``Regulations, 
Policy, & Posting'' section of the OHRP website (see https://www.hhs.gov/ohrp/regulations-and-policy/index.html).

II. Determination of Exception: Required Use of Single Institutional 
Review Board for Cooperative Research

    The Office for Human Research Protections (OHRP) has determined 
that for HHS cooperative research subject to the 2018 Requirements, and 
for purposes of 45 CFR 46.114(b)(2)(ii), an institution may continue to 
use multiple IRBs, in lieu of a single IRB, for the following research:
    (1) Cooperative research conducted or supported by HHS agencies 
other than the National Institutes of Health (NIH), if an IRB initially 
approved the research before January 20, 2020.
    (2) Cooperative research conducted or supported by NIH if either:
    a. The NIH single IRB policy does not apply, and the research was 
initially approved by an IRB before January 20, 2020, or
    b. NIH excepted the research from its single IRB policy before 
January 20, 2020.
    Note that this determination is only made for purposes of section 
46.114(b)(2)(ii)--namely, for determining whether certain cooperative 
research may be excepted from the single IRB mandate. This 
determination does not prevent, nor should it be viewed as 
discouraging, the voluntary use of a single IRB in cooperative research 
subject to the 2018 Requirements that would fall within the above two 
categories. Further, note that category (2)(b), above, applies for the 
duration of NIH's exception from its policy for the particular research 
study; categories (1) and (2)(a) apply for the duration of the 
research.

    Dated: November 12, 2019.
Jerry Menikoff,
Director, Office for Human Research Protections.
[FR Doc. 2019-25358 Filed 11-21-19; 8:45 am]
 BILLING CODE 4150-36-P