[Federal Register Volume 85, Number 83 (Wednesday, April 29, 2020)]
[Notices]
[Pages 23834-23835]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09086]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Research Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Request for information (RFI).

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SUMMARY: The Department of Health and Human Services (HHS), Office of 
Research Integrity (ORI) is seeking information and comments from 
entities and individuals regarding best practices for sequestering 
evidence during research misconduct proceedings under 42 CFR part 93. 
In particular, ORI is interested in learning about challenges and 
solutions in sequestering digital evidence, such as data stored in 
cloud environments and on personal electronic equipment or storage 
devices. ORI will use this information to prepare guidelines to support 
institutions carrying out research misconduct proceedings.
    Responses to the RFI must be received electronically at the email 
address provided below no later than 5:00 p.m. ET 45 days after the 
publication of this RFI.
    Interested parties are to submit comments electronically to [email protected]. Include ``Sequestration RFI'' in the 
subject line of the email. Mailed paper submissions

[[Page 23835]]

and submissions received after the deadline will not be reviewed.

FOR FURTHER INFORMATION CONTACT:  Elisabeth A. Handley, Director, 
Office of Research Integrity, 1101 Wootton Parkway, Suite 240, 
Rockville, MD 20852, (240) 453-8200.

SUPPLEMENTARY INFORMATION: 
    Background: 42 CFR part 93 establishes several requirements 
regarding the reporting and investigation of research misconduct to 
which institutions must adhere to receive Public Health Service (PHS) 
funding. Per Sec.  93.305(a), an institution must:

    Either before or when the institution notifies the respondent of 
the allegation, inquiry or investigation, promptly take all 
reasonable and practical steps to obtain custody of all the research 
records and evidence needed to conduct the research misconduct 
proceeding, inventory the records and evidence, and sequester them 
in a secure manner, except that where the research records or 
evidence encompass scientific instruments shared by a number of 
users, custody may be limited to copies of the data or evidence on 
such instruments, so long as those copies are substantially 
equivalent to the evidentiary value of the instruments. . . . 
[Emphasis added].

    Failing to properly sequester data can have a significant 
detrimental impact on the outcome of a research misconduct proceeding. 
Common issues that can negatively affect the examination of evidence 
include:

 Notifying a respondent about a misconduct proceeding before 
sequestration
 failing to sequester all relevant evidence, such as digital 
data stored on personal computers and storage devices
 failing to sequester forensic images of hard drives
 failing to fully document the sequestration process and 
maintain a detailed chain of custody for each item sequestered

    To better support institutions in carrying out their responsibility 
for maintenance and custody of research records and evidence, ORI 
intends to publish guidelines that will inform interested parties of 
best practices for sequestering evidence during a research misconduct 
proceeding.
    Request for information and comments: In preparation for producing 
guidelines on sequestration, ORI is interested in learning what major 
challenges exist in the sequestration process and approaches to 
overcome them. ORI is particularly interested in best practices in the 
sequestering of digital evidence. Specific topics of interest include 
but are not limited to the following:
     Digital data can be an important source of evidence for 
research misconduct proceedings. What unique challenges exist when 
collecting digital data and what approaches successfully address them? 
ORI is especially interested in learning the following:
    [rtarr8] How do institutions identify sources of digital data that 
need to be sequestered?
    [rtarr8] Digital data may be located on devices not necessarily 
owned by the institution, such as personal computers and storage 
devices, cloud-based and online services, and personal email. What 
approaches are successful in securing data in these situations? What 
data policies address this issue?
     ORI has observed that sequestration tends to be more 
successful when institutions assemble a team of individuals with 
different expertise to assist in in the gathering and securing of 
evidence. Thus, ORI is interested in learning the following:
    [rtarr8] What is the technical makeup of successful teams, 
especially regarding digital evidence?
    [rtarr8] How are members selected and trained?
     Institutions may have their own specific policies, 
procedures, guidelines, instructions, or other tools to enable them to 
meet their broad obligation under Sec.  93.305(a) to properly sequester 
evidence for research misconduct proceedings. Thus, ORI is interested 
in learning the following:
    [rtarr8] What institutional policies, procedures, and guidelines 
have been effective in ensuring successful sequestration?
    [rtarr8] To assist institutions in formulating their own policies, 
the ORI website provides example Policies and Procedures for Research 
Misconduct at https://ori.hhs.gov/sample-policy-procedures-responding-research-misconduct-allegations. Although institutions are not required 
to adopt the exact text as presented, ORI considers institutions that 
do so to be compliant with their obligation under Sec.  93.302(a)(1) to 
establish policies and procedures in compliance with 42 CFR part 93. 
What additions or changes are appropriate for these sample Policies and 
Procedures to reflect the growing digital landscape, especially 
regarding sequestering digital evidence?
    Collection of Information Requirements: Please note: This RFI is 
issued solely for information and planning purposes; it does not 
constitute a Request for Proposals (RFPs), applications, proposal 
abstracts, or quotations. This RFI does not commit the U.S. Government 
to contract for any supplies or services or to make a grant award. 
Further, ORI is not seeking proposals through this RFI and will not 
accept unsolicited proposals. Responders are advised that the U.S. 
Government will not pay for any information or administrative costs 
incurred in responding to this RFI; all costs associated with 
responding to this RFI will be solely at the expense of the interested 
parties. ORI notes that not responding to this RFI does not preclude 
participation in any future procurement, if conducted. It is the 
responsibility of the potential responders to monitor this RFI 
announcement for additional information pertaining to this request.
    ORI will actively consider all input as our office develops future 
regulatory proposals or future sub-regulatory policy guidance. ORI may 
or may not choose to contact individual responders. Such communications 
would be for the sole purpose of clarifying statements in the 
responders' written responses. Responses to this notice are not offers 
and cannot be accepted by the U.S. Government to form a binding 
contract or to issue a grant. Information obtained as a result of this 
RFI may be used by the U.S. Government for program planning on a non-
attribution basis. Respondents should not include any information that 
might be considered proprietary or confidential. This RFI should not be 
construed as a commitment or authorization to incur cost for which 
reimbursement would be required or sought. All submissions become U.S. 
Government property and will not be returned.

    Dated: April 22, 2022.
Elisabeth A. Handley,
Director, Office of Research Integrity, Office of the Assistant 
Secretary for Health.
[FR Doc. 2020-09086 Filed 4-28-20; 8:45 am]
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