[Federal Register Volume 89, Number 28 (Friday, February 9, 2024)]
[Notices]
[Page 9163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-02649]



[[Page 9163]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-new]


Agency Information Collection Request. 60-Day Public Comment 
Request

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: In compliance with the requirement of the Paperwork Reduction 
Act of 1995, the Office of the Secretary (OS), Department of Health and 
Human Services, is publishing the following summary of a proposed 
collection for public comment.

DATES: Comments on the ICR must be received on or before April 9, 2024.

ADDRESSES: Submit your comments to [email protected] or by calling 
(202) 264-0041 and [email protected].

FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting 
information, please include the document identifier 0990-New-60D and 
project title for reference, to Sherrette A. Funn, email: 
[email protected], [email protected] or call (202) 264-0041 the Reports 
Clearance Officer.

SUPPLEMENTARY INFORMATION: Interested persons are invited to send 
comments 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.
    Title of the Collection: Research Misconduct and Noncompliance in 
Clinical Trials and Translational Research.
    Type of Collection: New.
    OMB No.: 0990-XXXX.
    Abstract: The Department of Health and Human Services (HHS) Office 
of Research Integrity (ORI) has partnered with the Office for Human 
Research Protections (OHRP) to launch this data collection effort to 
better understand how to serve those who might benefit from additional 
education and resources to improve research integrity. ORI and OHRP 
have found that researchers, Institutional Review Board (IRB) Chairs, 
Research Integrity Officers (RIOs), Human Protections and Compliance 
Officers, and Human Protections Administrators, who oversee the conduct 
of research involving human research subjects, may struggle with 
identifying reportable noncompliance or unanticipated problems, 
protocol violations, protocol deficiencies, and falsifications and 
fabrications of data and methods in that research. Failure to recognize 
these concerns may result in noncompliance, protocol violations and 
research misconduct not being adequately addressed; falsified and/or 
fabricated methods, data, and results that may be published or used to 
obtain federal funding; human research subjects being harmed; and/or 
Public Health Service (PHS) funds not being protected.
    This data collection is a new request and includes an online survey 
instrument used with stakeholders holding positions at institutions 
holding a Federalwide Assurance (FWA) and/or operating an IRB, and is 
designed to identify barriers in the identification, evaluation, and 
reporting of potential research misconduct, protocol violations, 
reportable noncompliance, and unanticipated problems in research that 
involves human subjects. This data collection is intended to assist ORI 
and OHRP in developing approaches to improve how to identify and 
distinguish incidents that are reportable to ORI and OHRP from those 
that do not require reporting to these offices. This information is 
also intended to give RIOs, IRBs, human protections administrators, 
compliance officers, and other institutional officials involved with 
human subjects' research insight into how they can strengthen their 
policies and procedures for identifying, evaluating, and/or 
communicating potential research misconduct and reportable 
noncompliance and unanticipated problems by identifying gaps, barriers, 
and areas in which communication and education may need to be enhanced 
within their institution.

                                                              Annualized Burden Hour Table
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                                                                                                          Number of
                       Forms  (If necessary)                           Respondents       Number of      responses per   Average  burden   Total  burden
                                                                      (If necessary)    respondents      respondents     per  response        hours
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ORI/OHRP Survey....................................................  ...............            1165                1            20/60              388
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Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the 
Secretary.
[FR Doc. 2024-02649 Filed 2-8-24; 8:45 am]
BILLING CODE 4150-36-P