[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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