Response to Commenter

From: Klein, Natalie (HHS/OPHS)
Sent: Wednesday, October 20, 2021 12:04 PM
To: MHilliard@ncbcenter.org
Subject: Re: Public Comment - Document Identifier: OS–0990–New: Process, for proposed research
involving: (1) Pregnant women, human fetuses and neonates; (2) prisoners; or, (3) children, as subjects
that are not otherwise approval by an IRB.

Dear Dr. Hilliard,
Thank you for your letter dated September 27, 2021 in response to a Department of Health and Human
Service (HHS) notice published in the July 29, 2021 issue of the Federal Register (FRN) proposing an
information collection request entitled “Institutional Review Board (IRB) Records for HHS/OASH
Consultation Process.” I am writing to respond to your letter.
As stated in the referenced notice, the Office of the Assistant Secretary for Health (OASH), Office for
Human Research Protections (OHRP), is requesting a new approval from the Office of Management and
Budget of an OHRP requirement that IRB records be submitted when an IRB or its institution requests a
Department of Health and Human Services (HHS) consultation process for proposed research involving
any of the following populations as subjects, and the research is not otherwise approvable by an IRB: (1)
pregnant women, human fetuses and neonates; (2) prisoners; or, (3) children.
As permitted in the HHS Protection of Human Subjects Research regulations at 45 CFR part 46, subparts
B, C, and D, respectively, the Assistant Secretary of Health, on behalf of the Secretary of HHS, may
determine that such research can be conducted or supported by HHS after consulting with experts and
allowing for public review of, and comment on, the proposed research. The new information collection
request relates to obtaining the relevant IRB records when an IRB or its institution requests a HHS
consultation process under these regulations. The annual burden estimated for collecting this
information is 10 hours.
The notice invited interested persons to send comments on the proposed information collection on or
before September 27, 2021, regarding this burden estimate or any other aspect of this collection of
information, including any of the following subjects: (1) The necessity and utility of the proposed
information collection for the proper performance of the agency’s functions; (2) the accuracy of the
estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected;
and (4) the use of automated collection techniques or other forms of information technology to
minimize the information collection burden.
You stated the following in your September 27, 2021 letter: “NCBC wishes to focus on policies pertaining
to the accuracy of the estimated burden of proposed research on human subjects who are pregnant
women, human fetuses and neonates, prisoners, or children. Such accuracies are essential to assure
that the proposed research information to be collected represents the requisite quality, utility, and
clarity to justify the proposal. We understand HHS may determine that such research can be conducted
or supported by a revised HHS policy, after consulting with experts and allowing for future public
comment on a more detailed presentation of proposed public policy,” and, “We look forward to a later
more detailed policy proposal to provide further public comment.”

You expressed comments about the burden of research on human subjects and the provisions in the
HHS Protection of Human Subjects Research regulations at 45 CFR part 46, subparts B, C, and D,
respectively, which permit IRBs to refer certain categories of proposed research to OHRP (on behalf of
HHS) for HHS consultation and approval consideration. Your comments do not pertain to the subject of
the July 29, 2021 FRN, which relates to the estimated burden for IRB records to be provided to OHRP
when an IRB or its institution requests a HHS consultation process under these regulations .
OHRP thanks you for your comments and will convey them to the OHRP staff working to interpret these
provisions.

Respectfully,
Natalie

Natalie M. Klein, PhD
Director, Division of Policy and Assurances
DHHS Of f ice for Human Research Protections
Email: Natalie.Klein@hhs.gov
Desk: (301) 284-2272
Web: https://www.hhs.gov/ohrp/