Findings of Research Misconduct, 23834-23835 [2020-09086]
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Federal Register / Vol. 85, No. 83 / Wednesday, April 29, 2020 / Notices
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data sets’’ to updating digital data
streams for analyses?
c. As we move into increased sharing
and integrated data sets, how might
FDA manage data in a way that avoids
unnecessary duplication?
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a. How can FDA modernize its data
strategy to continue ensuring privacy
and security of data?
b. What should FDA do to promote
the management and organization of
data assets across the Agency, as the
amount and complexity of data (e.g., in
regulatory submissions to FDA) is
rapidly increasing?
3. Data strategies and data sharing,
including:
a. How can FDA’s data strategy
facilitate broader goals of integration
and interoperability of health care data
and scientific data/virtual patient data
generated using scientific models?
b. How can FDA design its data
strategy to reflect a global marketplace
and promote clarity to data providers
like regulated industry and other
stakeholders?
c. How can FDA design its data
strategy and policy development to
facilitate appropriate data access, data
sharing within the Agency and via data
sharing agreements, as well as the
appropriate reuse and repurposing of
data to advance Agency regulatory
science priorities?
d. For stakeholders, including
regulated industry that submit data to
FDA, how can FDA enhance the
efficiency of the preparation and
submission of data to FDA?
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Dated: April 23, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–09045 Filed 4–28–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Request for information (RFI).
AGENCY:
ACTION:
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 OASH-ORIPublic-Comments@hhs.gov. Include
‘‘Sequestration RFI’’ in the subject line
of the email. Mailed paper submissions
SUMMARY:
E:\FR\FM\29APN1.SGM
29APN1
Federal Register / Vol. 85, No. 83 / Wednesday, April 29, 2020 / Notices
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 § 93.305(a), an institution
must:
jbell on DSKJLSW7X2PROD with NOTICES
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
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20:00 Apr 28, 2020
Jkt 250001
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:
➢ How do institutions identify
sources of digital data that need to be
sequestered?
➢ 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:
➢ What is the technical makeup of
successful teams, especially regarding
digital evidence?
➢ 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 § 93.305(a) to properly
sequester evidence for research
misconduct proceedings. Thus, ORI is
interested in learning the following:
➢ What institutional policies,
procedures, and guidelines have been
effective in ensuring successful
sequestration?
➢ 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-policyprocedures-responding-researchmisconduct-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
§ 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
PO 00000
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Fmt 4703
Sfmt 4703
23835
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]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0990-new]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
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
SUMMARY:
E:\FR\FM\29APN1.SGM
29APN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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).
-----------------------------------------------------------------------
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]
BILLING CODE 4150-31-P
