[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