Proposed Rule2023-21746
Public Health Service Policies on Research Misconduct
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 6, 2023
Issuing agencies
Health and Human Services Department
Abstract
In this Notice of Proposed Rulemaking (NPRM), the Department of Health and Human Services (HHS), Office of the Secretary, Office of the Assistant Secretary for Health (OASH), Office of Research Integrity (ORI) proposes to revise the Public Health Service (PHS) Policies on Research Misconduct. The proposed revisions are based on the experience ORI and institutions have gained with the regulation since it was released in 2005. This NPRM seeks comment from individuals, institutional officials, organizations, institutions, research funding agencies, and other members of the public on the proposed revisions and how to improve the clarity of substantive and non-substantive.
Full Text
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[Federal Register Volume 88, Number 193 (Friday, October 6, 2023)]
[Proposed Rules]
[Pages 69583-69604]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-21746]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 93
RIN 0937-AA12
Public Health Service Policies on Research Misconduct
AGENCY: U.S. Department of Health and Human Services (HHS).
ACTION: Notice of proposed rulemaking (NPRM).
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SUMMARY: In this Notice of Proposed Rulemaking (NPRM), the Department
of Health and Human Services (HHS), Office of the Secretary, Office of
the Assistant Secretary for Health (OASH), Office of Research Integrity
(ORI) proposes to revise the Public Health Service (PHS) Policies on
Research Misconduct. The proposed revisions are based on the experience
ORI and institutions have gained with the regulation since it was
released in 2005. This NPRM seeks comment from individuals,
institutional officials, organizations, institutions, research funding
agencies, and other members of the public on the proposed revisions and
how to improve the clarity of substantive and non-substantive.
[[Page 69584]]
DATES: Submit comments on or before December 5, 2023.
ADDRESSES: For efficient management of comments, HHS requests that all
comments be submitted electronically to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
(referred to hereafter as ``<a href="http://regulations.gov">regulations.gov</a>''). In commenting, please
refer to the Regulatory Information Number (RIN) [0937-AA12].
Instructions: Enter the RIN in the search field at <a href="https://www.regulations.gov">https://www.regulations.gov</a> and click on ``Search.'' To view the proposed rule,
click on the title of the rule. To comment, click on ``Comment'' and
follow the instructions. If you are uploading multiple attachments into
<a href="http://regulations.gov">regulations.gov</a>, please number and label all attachments; <a href="https://www.regulations.gov">https://www.regulations.gov</a> will not automatically number them. All relevant
comments will be posted without change to <a href="https://www.regulations.gov">https://www.regulations.gov</a>,
including any personal information provided. For detailed instructions
on submitting comments and additional information on the rulemaking
process, see the ``Public Participation'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read comments received, please
go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
FOR FURTHER INFORMATION CONTACT: Sheila Garrity, JD, MPH, MBA, Office
of Research Integrity, 1101 Wootton Parkway, Suite 240, Rockville, MD
20852; telephone 240-453-8200.
SUPPLEMENTARY INFORMATION: All comments, including any personally
identifiable or confidential business information provided, will be
placed in the public docket without change and will be publicly
available online at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Therefore, HHS
cautions commenters about submitting information they do not want to be
made available to the public.
When submitting comments on this NPRM, the agency requests that
commenters explain their rationale and provide any relevant data and
information to support their comments or rationale, as applicable.
This preamble is organized as follows:
I. Public Participation
II. Authority for These Regulations
III. Proposed Updates to Subpart A
IV. Proposed Updates to Subpart B
V. Proposed Updates to Subpart C
VI. Proposed Updates to Subpart D
VII. Proposed Updates to Subpart E
VIII. Required Regulatory Analyses
I. Public Participation
Interested persons are invited to participate in this rulemaking by
submitting written views, opinions, recommendations, and data. Comments
received, including attachments and other supporting materials, are
part of the public record and subject to public disclosure. Do not
include any information in your comment or supporting materials that
you do not wish to be disclosed publicly. Comments are invited on any
topic within the scope of this NPRM.
II. Authority for These Regulations
The primary authority supporting this rulemaking is 42 U.S.C. 289b
(section 493 of the Public Health Service Act, as amended). This
authority established ORI as an independent entity within HHS and
requires the Secretary to issue regulations to define the term
``research misconduct'' and implement the research misconduct
provisions of the statute. To that end, in 2005 HHS issued Public
Health Service (PHS) Policies on Research Misconduct (the ``2005 Final
Rule'') [42 CFR part 93; 70 FR 28370 (May 17, 2005)]. Since the 2005
Final Rule was issued, ORI has gained extensive experience handling all
aspects of the HHS research integrity program under 42 CFR part 93. ORI
now seeks to capitalize on that experience through the regulatory
revision process.
ORI anticipates release of the final rule in the summer of 2024,
with implementation to begin a minimum of 4 months afterward. ORI will
aim for an effective date of January 1, 2025, to simplify institutional
reporting under proposed Sec. 93.302(b). Once this NPRM is finalized,
ORI recognizes that some institutions may wish to implement the revised
regulation for research misconduct proceedings already underway. As was
done with the 2005 Final Rule, ORI intends that for any allegation of
research misconduct received by HHS or an institution before the
effective date of the revised regulation, regardless of the stage of
the research misconduct proceeding, the proceeding will fall under the
2005 Final Rule. ORI seeks comment on aspects to consider if it were to
entertain individual requests to apply the revised regulation to a
particular ongoing proceeding.
For additional information and an extensive historical background
on the origins of ORI and the development of the PHS policies on
research misconduct, we direct the public to 69 FR 20778 (Apr. 16,
2004) and to ORI's website at <a href="https://ori.hhs.gov/historical-background">https://ori.hhs.gov/historical-background</a>. A basic tenet of the scientific process is that research
constantly evolves as experimental results and analyses inform new
hypotheses. Informed debate and the discourse of ideas is a natural
part of that process. Institutions must foster a research environment
that discourages misconduct in all research and that deals forthrightly
with possible misconduct associated with PHS supported research. ORI
has recognized that the 2005 Final Rule's complexity and missing
definitions may create confusion in some areas. Accordingly, this
proposed rule aims to implement revisions that we believe are necessary
and appropriate while retaining many of the features of the 2005 Final
Rule.
We highlight below the changes in subparts A through E,
particularly to draw attention to areas that represent new approaches.
Briefly, this NPRM follows the structure of the 2005 Final Rule.
Subpart A describes the purpose and fundamental precepts of the
regulation. Subpart B provides definitions. Subpart C lists
institutional responsibilities, and subpart D describes
responsibilities of HHS and ORI. Finally, subpart E covers the process
for respondents who wish to contest the ORI findings of research
misconduct and HHS administrative actions. We invite public comments on
all aspects of this proposed regulation.
III. Proposed Updates to Subpart A
Subpart A establishes the responsibilities of HHS, PHS, ORI, and
institutions in addressing allegations of research misconduct. ORI
proposes refining the language in subpart A to clarify the
applicability of the regulation to allegations of research misconduct.
Subpart A also addresses HHS coordination with other agencies. In
addition, ORI proposes removing reference to evidentiary standards and
burden of proof formerly found at Sec. 93.106 because proposed
revisions throughout part 93, and specifically at Sec. 93.104, address
requirements for a finding of research misconduct, including
preponderance of evidence to prove an allegation.
A proposed substantive addition to subpart A includes clarifying
language about confidentiality, explaining when and how disclosure may
be made to ``those who need to know.'' In the 2005 Final Rule, the
phrase ``those who need to know'' is not defined in Sec. 93.108,
causing uncertainty about what information can be disclosed and to
whom. To address this concern, we propose to add new paragraphs in
Sec. 93.106 to address the situations in which disclosures may need to
occur as well as who is considered as having a ``need to know'' and in
what circumstances. We believe these proposed revisions will balance
the
[[Page 69585]]
rights of all parties while minimizing unnecessary information
disclosure.
ORI recognizes that anonymity is a concern for some complainants
and witnesses. Institutional, state, or other policies may govern the
granting of anonymity to complainants or witnesses in a research
misconduct proceeding, so ORI has not proposed language in the NPRM.
Instead, ORI proposes to issue guidance on protecting anonymity in
transcripts and other materials collected throughout a research
misconduct proceeding. ORI is interested in the public's views on
maintaining anonymity for complainants or witnesses who request it,
including whether to include provisions for such anonymity in the final
rule.
The 2005 Final Rule generally applies only to research misconduct
occurring within six years of the date HHS or an institution receives
an allegation of research misconduct, but it provides a ``subsequent
use'' exception to the six-year limitation in Sec. 93.105(b)(1). From
our experience, this ``subsequent use'' exception has been applied most
often to the citation of questioned paper(s) in a researcher's more
recent publication or PHS grant application which in turn tolls the
six-year time limitation. From our experience the phrase ``other use
for the potential benefit of the respondent of the research record''
also has been viewed as vague and unclear. Therefore, to ensure clarity
within the institutional community, we propose that the six-year time
limitation be maintained, but we propose revising the ``subsequent
use'' exception at Sec. 93.105(b)(1) to include clarifying
information. ORI is interested in public comments on how to further
clarify the expectations and/or requirements related to the
``subsequent use'' exception.
IV. Proposed Updates to Subpart B
ORI is proposing revisions to definitions in subpart B and
introducing new definitions, some of which align with other changes
proposed throughout the regulation. In a few cases, regulatory
principles appeared in the body of the 2005 Final Rule without
definition; these proposed revisions now appear among the 48 proposed
definitions provided in subpart B. We propose moving definitions for
``research misconduct'', ``fabrication'', and ``falsification'' to
subpart B without changes. ORI proposes revising the ``plagiarism''
definition and moving it to subpart B. We believe having all
definitions in one place makes it easier for readers, enabling the text
in subpart C to focus on institutional responsibilities. We are
interested in public comments on all these definitions, their specific
content as well as their inclusion in the listing of definitions in
subpart B.
ORI proposes adding some commonly-used terms to the definitions to
ensure clarity in usage. These additional terms include ``appeal'';
``assessment''; ``difference of opinion''; ``institutional certifying
official'' and ``institutional deciding official''; ``research
integrity''; ``research integrity officer''; and ``small institution.''
Key points of other proposed definitional changes follow, with more
expansive definitions in subpart B. This preamble groups the
conceptually related terms versus providing them alphabetically as they
appear in subpart B.
New Terms and Definitions
Institutional Record. As part of the proposed revisions, we
introduce the concept of a robust and required institutional record as
part of the research misconduct investigative process. Described in
more detail at Sec. 93.223, the proposed institutional record includes
the assessment report, inquiry report, investigation report,
decision(s) made by the institutional deciding official, and the
complete record of any institutional appeal, any other records the
institution used for the research misconduct proceeding, documentation
related to the determination that records are irrelevant or duplicate
and therefore not included, and a single index listing all documents in
the institutional record.
Administrative Record. The administrative record described at
proposed Sec. 93.202 contains information that would be used by ORI in
making findings of research misconduct and identifying administrative
actions, in addition to serving as the basis for the Departmental
Appeals Board (DAB) Administrative Law Judge (ALJ) review and
information considered by the HHS Suspension and Debarment Official
(SDO). The proposed administrative record comprises: the institutional
record; any information provided by the respondent to ORI, including
but not limited to the verbatim transcript of any meetings under
proposed Sec. 93.403 between the respondent and ORI, whether in
person, by phone, or by videoconference; and correspondence between the
respondent and ORI; any additional information provided to ORI while
the case is pending before ORI; and any analysis or additional
information generated or obtained by ORI. Any analysis or additional
information generated or obtained by ORI will also be made available to
respondent.
Honest Error. At times, institutions have raised the issue that
``honest error'' is not defined in the 2005 Final Rule, and that
providing a definition would ensure greater consistency and fairness.
We propose to define the term ``honest error'' in subpart B as a
mistake made in good faith.
Intentionally, Knowingly, and Recklessly. None of these terms were
defined in the 2005 Final Rule. Although ``knowingly'' and
``intentionally'' seem to be more commonly understood than
``recklessly'', we have received requests through the years to provide
explicit definitions for clarity and to ensure uniform application in
the research community. We propose definitions based on those used in
the ALJ's Recommended Decisions in ORI v. Kreipke, Decision No. CR5109
(May 18, 2018) at page 14 and ORI v. Srivastava, Decision No. 5178
(Sept. 5, 2018) at pages 11-12. We propose that to act
``intentionally'' means to act with the aim of carrying out the act. To
act ``knowingly'' means to act with awareness of the act. Finally, to
act ``recklessly'' means to act without proper caution despite a known
risk for harm. These definitions are found at Sec. Sec. 93.224,
93.226, and 93.234, respectively.
Accepted Practices of the Relevant Research Community. From our
experience, many institutions have requested a definition for the
phrase ``accepted practices of the relevant research community'' to
ensure clarity and uniformity in application to research misconduct
proceedings. Therefore, we propose to adopt at Sec. 93.200 a revised
and extended version of the definition provided in the ALJ's
Recommended Decision in ORI v. Kreipke, Decision No. CR5109 (May 18,
2018) at page 17. Specifically, we propose ``accepted practices of the
relevant research community'' to mean those practices established by 42
CFR part 93 and by PHS funding components, as well as commonly accepted
professional codes or norms within the overarching community of
researchers and institutions that apply for and receive PHS grants.
These practices must be consistent with the definition of research
integrity at Sec. 93.236.
This Part. Over the years, institutions and government agencies
have told us that ``this part'' is confusing. We propose to define
``this part'' as meaning 42 CFR part 93 in its entirety, unless
otherwise explicitly noted. We further define how to refer to only a
portion of the regulation.
[[Page 69586]]
Revised Definition
Plagiarism. The 2005 Final Rule states that ``Plagiarism is the
appropriation of another person's ideas, processes, results, or words
without giving appropriate credit.'' In addition to moving the
definition of ``plagiarism'' to Sec. 93.230, we propose to include new
Sec. 93.230(a) and (b). Proposed Sec. 93.230(a) differentiates
unattributed text copied verbatim or nearly verbatim from the limited
use of identical or nearly-identical phrases which describe a commonly-
used methodology. Further, proposed Sec. 93.230(b) addresses self-
plagiarism and authorship or credit disputes. Self-plagiarism and
authorship disputes do not meet the definition of research misconduct
and are outside of ORI's jurisdiction. These issues are better handled
at the institutional level.
V. Proposed Updates to Subpart C
Compliance and Assurances. Information and guidance for
institutions about compliance and research integrity assurances is
provided at Sec. Sec. 93.300 through 304. We propose clarifying the
requirements for establishing and maintaining an active research
integrity assurance, in addition to providing specific guidance for
small institutions.
Conflict of interest. The 2005 Final Rule requires that
institutions ``ensure that individuals responsible for carrying out any
part of the research misconduct proceeding do not have unresolved
personal, professional or financial conflicts of interest with the
complainant, respondent or witnesses'' at Sec. 93.300(b). This
requirement has been interpreted by many institutions as a requirement
to provide respondents with an opportunity to object to committee
members' participation prior to their appointments to an inquiry
committee, if one is used, or an investigation committee. This approach
to conflict issues is not required by the 2005 Final Rule although some
institutions have apparently made it an unwritten standard. We propose
to add clarifying language at Sec. 93.305(h)(5) that addresses how an
institution may provide respondents or complainants the opportunity to
object to the person or to one or more committee or consortium members,
chosen to conduct, support, or participate in the research misconduct
proceedings. If an institution chooses to provide one respondent in a
proceeding the opportunity to object, it must provide all respondents
in that proceeding the opportunity to object. If an institution chooses
to provide one complainant the opportunity to object in a proceeding,
it must provide all complainants the opportunity to object in that
proceeding. We believe this is fair and will maintain uniformity in the
processing of research misconduct allegations.
Sequestration of research records and other evidence. ORI is aware
of concerns that, in the current research environment and with the use
of cloud-based storage, it may not be possible to obtain ``custody'' of
the original research records and other evidence that will be needed to
conduct a research misconduct proceeding. We propose to move away from
the use of the term ``custody'' and focus on the institution's
obligation to obtain and sequester all research records and other
evidence that will be needed to conduct the research misconduct
proceeding (see Sec. Sec. 93.305(a), 93.306(c)(2)(ii), 93.307(d), and
93.310(d)). We also propose adding new language at Sec. 93.305(a)
indicating that when it is not possible to obtain the original research
records or other evidence, an institution may obtain copies of the data
or other evidence so long as those copies are substantially equivalent
in evidentiary value.
Institutional Assessment. New language is added at Sec. 93.306 to
describe the institutional assessment. We have provided criteria for an
assessment to proceed to inquiry at Sec. 93.306(1)(i) through (iii),
and we have described reporting requirements as well as a timeline for
completion of assessments.
Institutional Inquiry. ORI has observed that institutions often
convene a committee to conduct a robust, investigation-like process at
the inquiry stage. These processes may include interviewing witnesses
and reviewing research records, only to repeat them at the
investigation stage. ORI plans to issue guidance indicating that an
interview conducted at the inquiry phase can be carried forward into
investigation and need not be repeated, unless it might reveal further
information. We propose a revision at Sec. 93.307(e)(2), to allow
institutional discretion in convening committees of experts to conduct
reviews at the inquiry stage to determine whether an investigation is
warranted. We further provide options for who may do the inquiry
review, noting that the institution may use one or more subject matter
experts to assist them. For more information on using a committee,
consortium, or other person for research misconduct proceedings, see
proposed Sec. 93.305(h).
We propose to clarify for institutions in a new section, Sec.
93.307(f)(1)(i), that proceeding to an investigation requires that they
have a reasonable basis for concluding that an allegation falls within
the definition of research misconduct under 42 CFR part 93 and involves
PHS supported biomedical or behavioral research, research training or
activities related to that research or research training, as provided
in Sec. 93.102. We also propose including language at Sec. 93.309(c)
to clearly indicate that institutions are required to keep sufficiently
detailed documentation of each inquiry to permit a later assessment by
ORI of the reasons the institution decided not to conduct an
investigation.
We propose adding new language to Sec. Sec. 93.307(f)(2)(ii) and
93.307(g)(2) to describe the inquiry results and inquiry report after
an inquiry has been conducted. We have learned over time that the
phrase ``the allegation may have substance'' in current Sec.
93.307(d)(2), may lack the clarity an institution would find helpful to
delineate an inquiry from an investigation. By nature, an inquiry is
preliminary. An inquiry would not be expected to identify sufficient
basis for differentiating honest error or difference of opinion from
research misconduct committed intentionally, knowingly, or recklessly,
absent an admission of research misconduct. We do not believe such a
determination can be made at the inquiry phase to support dismissal of
an allegation. However, we propose that the institution should note in
the inquiry report any evidence of honest error or a difference of
opinion, for full consideration at the investigation stage.
Institutional Investigation. From our experience, there has been
some confusion about the extent to which institutions must continue to
pursue leads at the institutional investigation stage under Sec.
93.310(h). To address this concern, we propose that Sec. 93.310(h) be
revised to indicate that, at the investigation stage, the institution
may choose to add to or expand the ongoing investigation by including
any new allegations pertaining to the same respondent or research
records in question (e.g., manuscripts or funding proposals) that come
to the institution's attention during the pendency of the
investigation, rather than opening an inquiry to review those new
allegations. We believe this will address an institution's
administrative efficiency concern(s) while providing that new
allegations are addressed as they are identified.
Institutional Record. As defined in proposed Sec. 93.223 and
further described at proposed Sec. Sec. 93.305 through 93.316, ORI
proposes that institutions be required to develop, maintain, and
provide an institutional record. The institutional record would
ultimately be
[[Page 69587]]
part of a more expansive administrative record that would form the
basis of any ORI decision regarding whether research misconduct has
occurred, any decision by the Departmental Appeals Board ALJ, or any
decision by the HHS Suspension and Debarment Official (SDO). ORI may
provide additional guidance on how to organize and submit the
institutional record.
VI. Proposed Updates to Subpart D
ORI proposes changes to its processes that align with changes for
institutions in subpart C, specifically how ORI assembles the
administrative record of a research misconduct proceeding. Further,
1. We propose to add paragraph (b) in Sec. 93.404 that would
provide even more clarity by indicating that the lack of an ORI finding
of research misconduct does not overturn an institution's determination
that the conduct constituted professional or research misconduct
warranting remediation under the institution's policy.
2. We clarify actions ORI may take for institutional noncompliance.
3. We indicate when and how ORI may disclose information about a
research misconduct proceeding. We propose, at Sec. 93.410(b), a
revision that would permit ORI to publish notice of institutional
research misconduct findings and implemented institutional actions.
This notice would inform the public and research community that
allegations of research misconduct have been addressed under the
regulation and help to protect the health and safety of the public,
promote the integrity of PHS supported research and the research
process, or conserve public funds. ORI is interested in public comment
on this proposed change, particularly on the opportunity for a
respondent to provide comment or information prior to the posting of
such a notice.
VII. Proposed Updates to Subpart E
From our experience and interactions with institutions and
professional organizations, there is a strong desire for a simpler and
more expedient appeals process than the approach provided in the 2005
Final Rule. Under the 2005 Final Rule, a Departmental Appeals Board
(DAB) ALJ undertakes a de novo review of ORI findings of research
misconduct and proposed HHS administrative actions, based on evidence
(including witness testimony) presented by ORI and the respondent at a
hearing. Therefore, we propose a major revision to 42 CFR part 93,
subpart E which will provide a streamlined process for contesting ORI
findings of research misconduct and HHS administrative actions. The
proposed appeals process would entail ALJ review of the administrative
record, which includes all information provided by the respondent to
ORI, to determine whether ORI's findings and HHS's proposed
administrative actions other than suspension or debarment are
reasonable and not based on a material error of law or fact. The
proposed appeals process also provides for the possibility of a limited
hearing if the ALJ determines that there is a genuine dispute over
material fact. There would be no further opportunity to appeal ORI's
findings and HHS's proposed administrative actions (other than
suspension or debarment) within HHS. This proposal does not change that
respondents may request reconsideration of a final debarment decision
with the SDO. We believe this approach is advantageous to all parties,
providing finality in a more expedient manner. ORI specifically seeks
comment on the scope of and need, or lack of need, for the limited
hearing in proposed Sec. 93.511, as well as comment on the other
proposed revisions to subpart E.
VIII. Required Regulatory Analyses
All recipients of PHS biomedical and behavioral research awards
must continue to comply with reporting and record keeping requirements
in this NPRM. As shown below in the Paperwork Reduction Act analysis,
those burdens on institutions encompass essentially all the activities
required under the proposed rule.
We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, Executive Order 14094, and the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders
12866, 13563, and 14094 direct us to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). We do not believe that
this proposed rule, if finalized, would result in significant effects
as described below.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
state, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold described in
Executive Order 14094 is $200 million. This proposed rule, if
finalized, would not result in an expenditure in any year that meets or
exceeds this amount.
Summary of Impacts and Threshold Analysis
This proposed rule would result in costs associated with covered
institutions updating their policies and procedures for responding to
allegations of research misconduct; costs associated with covered
entities filing an annual statement of assurance (research integrity
assurance) and an annual report on allegations received; costs
associated with submitting reports and evidence to support their
results and conclusions of inquiries or investigations of research
misconduct; and costs associated with obtaining all research records
and other evidence when there is an allegation of research misconduct
and engaging persons to handle the process for addressing the
allegations of research misconduct. We anticipate that the proposed
rule would likely reduce the burden of compliance by states or other
institutions through reduced confusion and uncertainty.
We performed an initial threshold analysis to assess the
approximate magnitude of the impacts of the proposed rule to determine
whether it would result in significant effects as per section 3(f)(1)
of Executive Order 12866. We identified the costs associated with
covered institutions updating their policies and procedures for
responding to allegations of research misconduct as the largest impact
under the proposed rule. For this impact, we anticipate that 5,910
institutions holding research integrity assurances would update their
policies and procedures. For the purposes of this threshold analysis,
we adopt 16 hours as an estimate for the average time across all
covered entities for these tasks. Across all covered entities, this is
94,560 total hours spent updating policies and procedures.
To monetize the change in time use associated with these
activities, we adopt an hourly value of time based on the cost of
labor, including wages and benefits, and also indirect costs, which
``reflect resources necessary for the administrative oversight of
employees and generally include time spent on administrative personnel
issues (e.g., human resources activities such as hiring, performance
reviews, personnel transfers, affirmative action programs), writing
administrative guidance documents, office expenses (e.g., space
[[Page 69588]]
rental, utilities, equipment costs), and outreach and general training
(e.g., employee development).'' \1\
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\1\ U.S. Department of Health and Human Services, Office of the
Assistant Secretary for Planning and Evaluation. 2017. ``Valuing
Time in U.S. Department of Health and Human Services Regulatory
Impact Analyses: Conceptual Framework and Best Practices.'' <a href="https://aspe.hhs.gov/reports/valuing-time-us-department-health-human-services-regulatory-impact-analyses-conceptual-framework">https://aspe.hhs.gov/reports/valuing-time-us-department-health-human-services-regulatory-impact-analyses-conceptual-framework</a>. Page v.
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For these tasks, we identify a pre-tax hourly wage for Education
Administrators, Postsecondary. According to the U.S. Bureau of Labor
Statistics, the mean hourly wage for these individuals is $53.49 per
hour.\2\ We assume that benefits plus indirect costs equal
approximately 100 percent of pre-tax wages, and adjust this hourly rate
by multiplying by two, for a fully loaded hourly wage rate of $106.98.
We multiply this fully loaded hourly wage rate by the 94,560 total
hours across covered entities spent updating policies and procedures
and estimate a total cost in the first year of about $10.1 million.
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\2\ U.S. Bureau of Labor Statistics. Occupational Employment and
Wages, May 2021. 11-9033 Education Administrators, Postsecondary.
Mean hourly wage. <a href="https://www.bls.gov/oes/current/oes119033.htm">https://www.bls.gov/oes/current/oes119033.htm</a>.
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Regulatory Flexibility Act
The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires
agencies to prepare a regulatory flexibility analysis describing the
impact of the proposed rule on small entities (named ``institutions''
in the proposed rule), permits agency heads to certify that a proposed
rule will not, if promulgated, have a significant economic impact on a
substantial number of small entities. The primary effect of this
proposed rule would be to require covered institutions to implement
policies and procedures for responding to allegations of research
misconduct. The Secretary proposes to certify that this proposed rule
would not have a significant impact on a substantial number of small
entities, as defined by the Regulatory Flexibility Act, based on the
following facts.
1. As of March 1, 2023, approximately 30 percent (1,785) of 5,910
institutions holding research integrity assurances are small
institutions. The primary impact of the NPRM on covered institutions
results from the reporting and record keeping provisions which are
analyzed in detail under the heading ``The Paperwork Reduction Act.''
Significant annual burdens apply only if an institution learns of
possible research misconduct and begins an inquiry, investigation, or
both.
2. Institutions covered by 42 CFR part 93 reported having conducted
a total of 114 inquiries and 101 investigations during the 2021
reporting period. Two inquiries and two investigations were conducted
by small institutions. Small institutions may be able to avoid
developing and filing the full policies and procedures for addressing
allegations of research misconduct required by Sec. 93.304 by filing a
Small Institution Statement. Under the 2005 Final Rule, this is called
a Small Organization Statement. ORI or another appropriate HHS office
will work with small institutions to develop and/or advise on a process
for handling allegations of research misconduct consistent with 42 CFR
part 93. The burden of filing the Small Institution Statement is .5
hour. Thus, the burden of developing and filing the full policies and
procedures for addressing allegations of research misconduct required
by Sec. 93.304 will not fall on a substantial number of small
entities.
A small entity that files the Small Institution Statement must
still report allegations of research misconduct to ORI and comply with
all provisions of the proposed rule except as described in Sec.
93.303. The most significant burden that could fall on an entity filing
a Small Institution Statement is in addressing allegations of research
misconduct which would include obtaining all research records and other
evidence when there is an allegation of research misconduct, engaging
persons to handle the process for addressing the allegations of
research misconduct, and submitting reports and evidence to support the
small institution's results and conclusions of inquiries or
investigations of research misconduct. The average burden per response
is estimated at 40 hours. Based on reports of research misconduct over
the last 5 years, fewer than 5 small institutions would have to incur
that burden in any year. Based on this analysis, HHS concludes that the
regulations set forth in the NPRM will not impose a significant burden
on a substantial number of small entities. However, HHS will carefully
consider comments on the analysis and conclusion.
Paperwork Reduction Act
ORI currently holds OMB-Control-Number 0937-0198 for the collection
of information from institutions. The information is needed to fulfill
section 493 of the Public Health Service Act (42 U.S.C. 289b), which
requires assurances from institutions that apply for PHS funding for
any project or program that involves the conduct of biomedical or
behavioral research. In addition, the information is required to
fulfill the assurance and annual reporting requirements of 42 CFR part
93. ORI uses the information to monitor institutional compliance with
the regulation. Lastly, the information may be used to respond to
congressional requests for information to prevent misuse of Federal
funds and to protect the public interest. The Institutional Assurance
and Annual Report on Possible Research Misconduct, PHS-6349, and the
Assurance of Compliance by Sub-Award Recipients, PHS-6315, are covered
by OMB 0937-0198. The OMB approvals expire August 31, 2026, and ORI has
applied for renewal with only minor changes to language in the forms.
Estimated Annualized Burden Hour Table
[3/16/2023]
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Forms (if necessary) Type of Number of responses per hours per Total burden
respondent respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
PHS-6349...................... Awardee 5,770 1 10/60 961
Institutions.
PHS-6315...................... Sub-Awardee 156 1 5/60 13
Institutions.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 974
----------------------------------------------------------------------------------------------------------------
[[Page 69589]]
Estimated Annualized Cost to Respondents
[3/16/2023]
----------------------------------------------------------------------------------------------------------------
Total
Forms (if necessary) Type of respondent Total burden Hourly wage respondent
hours rate cost
----------------------------------------------------------------------------------------------------------------
PHS-6349.............................. Awardee Institutions.... 961 $107.00 $102,827.00
PHS-6315.............................. Sub-Awardee Institutions 13 107.00 1,391.00
----------------------------------------------------------------------------------------------------------------
For the reasons discussed in the preamble, HHS proposes to revise
42 CFR part 93 to read as follows:
PART 93--PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT
Sec.
93.25 Organization of this part.
93.50 Special terms.
Subpart A--General
93.100 General policy.
93.101 Purpose.
93.102 Applicability.
93.103 Research misconduct.
93.104 Requirements for findings of research misconduct.
93.105 Time limitations.
93.106 Confidentiality.
93.107 Coordination with other agencies.
Subpart B--Definitions
93.200 Accepted practices of the relevant research community.
93.201 Administrative action.
93.202 Administrative record.
93.203 Allegation.
93.204 Appeal.
93.205 Assessment.
93.206 Charge letter.
93.207 Complainant.
93.208 Contract.
93.209 Day.
93.210 Departmental Appeals Board or DAB.
93.211 Difference of opinion.
93.212 Evidence.
93.213 Fabrication.
93.214 Falsification.
93.215 Funding component.
93.216 Good faith.
93.217 Honest error.
93.218 Inquiry.
93.219 Institution.
93.220 Institutional certifying official.
93.221 Institutional deciding official.
93.222 Institutional member.
93.223 Institutional record.
93.224 Intentionally.
93.225 Investigation.
93.226 Knowingly.
93.227 Notice.
93.228 Office of Research Integrity or ORI.
93.229 Person.
93.230 Plagiarism.
93.231 Preponderance of the evidence.
93.232 Public Health Service or PHS.
93.233 PHS support.
93.234 Recklessly.
93.235 Research.
93.236 Research integrity.
93.237 Research Integrity Officer or RIO.
93.238 Research misconduct.
93.239 Research misconduct proceeding.
93.240 Research record.
93.241 Respondent.
93.242 Retaliation.
93.243 Secretary or HHS.
93.244 Small institution.
93.245 Suspension and debarment.
93.246 Suspension and Debarment Official or SDO.
93.247 This part.
Subpart C--Responsibilities of Institutions
Compliance and Assurances
93.300 General responsibilities for compliance.
93.301 Research integrity assurances.
93.302 Maintaining active research integrity assurances.
93.303 Research integrity assurances for small institutions.
93.304 Institutional policies and procedures.
93.305 General conduct of research misconduct proceedings.
The Institutional Assessment
93.306 Institutional assessment.
The Institutional Inquiry
93.307 Institutional inquiry.
93.308 Notice of the results of the inquiry.
93.309 Reporting to ORI on the decision to initiate an
investigation.
The Institutional Investigation
93.310 Institutional investigation.
93.311 Investigation time limits.
93.312 Opportunity to comment on the investigation report.
93.313 Investigation report.
93.314 Institutional appeals.
93.315 Transmittal of the institutional record to ORI.
93.316 Completing the research misconduct process.
Other Institutional Responsibilities
93.317 Retention and custody of the institutional record.
93.318 Institutional standards of conduct.
Subpart D--Responsibilities of the U.S. Department of Health and Human
Services
General Information
93.400 General statement of ORI authority.
93.401 Interaction with other entities and interim actions.
Research Misconduct Issues
93.402 ORI allegation assessments.
93.403 ORI review of research misconduct proceedings.
93.404 Findings of research misconduct and proposed administrative
actions.
93.405 Notifying the respondent of findings of research misconduct
and HHS administrative actions.
93.406 Final HHS actions.
93.407 HHS administrative actions.
93.408 Mitigating and aggravating factors in HHS administrative
actions.
93.409 Settlement of research misconduct proceedings.
93.410 Final HHS action with no settlement or finding of research
misconduct.
93.411 Final HHS action with a settlement or finding of misconduct.
Institutional Compliance Issues
93.412 Making decisions on institutional noncompliance.
93.413 HHS compliance actions.
Disclosure of Information
93.414 Notice.
Subpart E--Opportunity To Contest ORI Findings of Research Misconduct
and HHS Administrative Actions
General Information
93.500 General policy.
Process for Contesting Research Misconduct Findings and/or
Administrative Actions
93.501 Notice of appeal.
93.502 Appointment of the Administrative Law Judge.
93.503 Filing of the administrative record.
93.504 Standard of review.
93.505 Rights of the parties.
93.506 Authority of the Administrative Law Judge.
93.507 Ex parte communications.
93.508 Filing, format, and service.
93.509 Filing motions.
93.510 Conferences.
93.511 Hearing to resolve genuine factual dispute.
93.512 The Administrative Law Judge's ruling.
Authority: 42 U.S.C. 216, and 289b.
Sec. 93.25 Organization of this part.
This part is subdivided into five subparts. Each subpart contains
sections related to a broad topic or specific audience with special
responsibilities as shown in the following table.
[[Page 69590]]
------------------------------------------------------------------------
You will find sections related to .
In subpart . . . . .
------------------------------------------------------------------------
A................................. General information about this rule.
B................................. Definitions of terms used in this
part.
C................................. Responsibilities of institutions
with PHS support.
D................................. Responsibilities of the U.S.
Department of Health and Human
Services and the Office of Research
Integrity.
E................................. Information on how to contest ORI
research misconduct findings and
HHS administrative actions.
------------------------------------------------------------------------
Sec. 93.50 Special terms.
This part uses terms throughout the text that have special meaning.
Those terms are defined in subpart B of this part.
Subpart A--General
Sec. 93.100 General policy.
(a) Research misconduct involving Public Health Service (PHS)
support is contrary to the interests of the PHS and the Federal
Government, to the health and safety of the public, to the integrity of
research, and to the conservation of public funds.
(b) The U.S. Department of Health and Human Services (HHS) and
institutions that apply for or receive PHS support for biomedical or
behavioral research, biomedical or behavioral research training, or
activities related to that research or research training share
responsibility for the integrity of the research process. HHS has
ultimate oversight authority for PHS supported research, and for taking
other actions as appropriate or necessary, including the right to
assess allegations and perform inquiries or investigations at any time.
Institutions and institutional members have an affirmative duty to
protect PHS funds from misuse by ensuring the integrity of all PHS
supported work, and primary responsibility for responding to and
reporting allegations of research misconduct, as provided in this part.
Sec. 93.101 Purpose.
The purpose of this part is to:
(a) Establish the responsibilities of HHS, the Office of Research
Integrity (ORI), and institutions in addressing allegations of research
misconduct;
(b) Define what constitutes research misconduct in PHS supported
research;
(c) Establish the requirements for a finding of research
misconduct;
(d) Define the general types of administrative actions HHS may take
in response to research misconduct;
(e) Require institutions to:
(1) Develop and implement policies and procedures for reporting and
addressing allegations of research misconduct covered by this part;
(2) Provide HHS with the assurances necessary to permit the
institutions to participate in PHS supported research.
(f) Protect the health and safety of the public, promote the
integrity of PHS supported research and the research process, and
conserve public funds.
Sec. 93.102 Applicability.
(a) Every extramural or intramural institution (see Sec. 93.219)
that applies for or receives PHS support for biomedical or behavioral
research, biomedical or behavioral research training, or activities
related to that research or research training must comply with this
part. Further, each recipient of such support is responsible for the
compliance of their subrecipients with this part.
(b) This part applies to allegations of research misconduct
involving:
(1) Applications or proposals for PHS support for biomedical or
behavioral extramural or intramural research, biomedical or behavioral
research training, or activities related to that research or research
training;
(2) PHS supported biomedical or behavioral extramural or intramural
research;
(3) PHS supported biomedical or behavioral extramural or intramural
research training programs;
(4) PHS supported extramural or intramural activities that are
related to biomedical or behavioral research or research training, such
as, but not limited to, the operation of tissue and data banks or the
dissemination of research information;
(5) Research records produced during PHS supported research,
research training, or activities related to that research or research
training; and
(6) Research proposed, performed, reviewed, or reported, as well as
any research record generated from that research, regardless of whether
an application or proposal for PHS funds resulted in an awarded grant,
contract, cooperative agreement, sub-award, or other form of PHS
support.
(c) This part does not supersede or establish an alternative to any
applicable statutes, regulations, policies, or procedures for handling
fiscal improprieties, the ethical treatment of human or animal
subjects, criminal matters, personnel actions against Federal
employees, or addressing whistleblowers and/or retaliation.
(d) This part does not supersede or establish an alternative to the
HHS suspension and debarment regulations as set forth under the
Nonprocurement Common Rule (NCR) at 2 CFR part 180 for nonprocurement
transactions (as further implemented by HHS at 2 CFR part 376) or the
Federal Acquisition Regulation (FAR) at 48 CFR 9.406 and 9.407 for
procurement transactions (as further supplemented by HHS at 48 CFR
309.4).
(e) This part does not prohibit or otherwise limit how institutions
handle allegations of misconduct that do not fall within this part's
definition of research misconduct or that do not involve PHS support.
Sec. 93.103 Research misconduct.
(a) As defined below, research misconduct is fabrication,
falsification, or plagiarism in proposing, performing, or reviewing
research, or in reporting research results (see Sec. 93.238).
(b) Research misconduct does not include honest error or
differences of opinion.
Sec. 93.104 Requirements for findings of research misconduct.
A finding of research misconduct made under this part requires
that:
(a) There be a significant departure from accepted practices of the
relevant research community; and
(b) The misconduct be committed intentionally, knowingly, or
recklessly; and
(c) The allegation must be proven by a preponderance of the
evidence.
Sec. 93.105 Time limitations.
(a) Six-year limitation. This part applies only to research
misconduct occurring within six years of the date HHS or an institution
receives an allegation of research misconduct.
(b) Exceptions to the six-year limitation. Paragraph (a) of this
section does not apply in the following instances:
(1) Subsequent use exception. The respondent continues or renews
any incident of alleged research misconduct that occurred before the
six-year limitation through the use of, republication of, or citation
to the portion(s) of the research record (e.g., processed data, journal
articles, funding
[[Page 69591]]
proposals, data repositories) that is alleged to have been fabricated,
falsified, or plagiarized, for the potential benefit of the respondent.
(i) When the respondent uses, republishes, or cites to the
portion(s) of the research record that is alleged to have been
fabricated, falsified, or plagiarized, in submitted or published
manuscripts, submitted PHS grant applications, progress reports
submitted to PHS funding components, posters, presentations, or other
research records within six years of when the allegations were received
by HHS or an institution, this exception applies.
(ii) For allegations which may fall under this exception, an
institution must inform ORI of the relevant facts before concluding the
exception does not apply. ORI will make the final decision about the
subsequent use exception for each allegation.
(2) Exception for the health or safety of the public. If ORI or the
institution, following consultation with ORI, determines that the
alleged research misconduct, if it occurred, would possibly have a
substantial adverse effect on the health or safety of the public, this
exception applies.
Sec. 93.106 Confidentiality.
(a) Disclosure of the identity of respondents, complainants, and
witnesses in research misconduct proceedings is limited, to the extent
possible, to those who need to know, consistent with a thorough,
competent, objective, and fair research misconduct proceeding, and as
allowed by law. Institutions must inform respondents, complainants, and
witnesses, before they are interviewed, if and how their identity may
be disclosed. Provided, however, that the institution must disclose the
identity of respondents, complainants, or other relevant persons to ORI
pursuant to an ORI review of research misconduct proceedings under this
part.
(b) Except as may otherwise be prescribed by applicable law,
confidentiality must be maintained for any records or evidence from
which research subjects might be identified. Disclosure is limited to
those who need to know to carry out a research misconduct proceeding.
(c) Disclosure of ongoing research misconduct proceedings under
this part is limited, to the extent possible, to those who need to
know, consistent with a thorough, competent, objective, and fair
research misconduct proceeding, or the purpose of this part as
described in Sec. 93.101(f). In this context, ``those who need to
know'' may include public and private entities.
(d) Disclosure of concerns related to the reliability of the
research record that is alleged to have been fabricated, falsified, or
plagiarized is limited, to the extent possible, to those who need to
know, consistent with a thorough, competent, objective, and fair
research misconduct proceeding, or the purpose of this part as
described in Sec. 93.101(f). In this context, ``those who need to
know'' may include journals, editors, publishers, and public and
private entities.
(e) For officials at institutions other than the institution where
the research misconduct proceedings are being conducted, their need to
know occurs when the institution:
(1) May possess records relevant to allegations under review;
(2) Employs a respondent alleged or found to have committed
research misconduct; or
(3) Funds research being conducted by a respondent alleged or found
to have committed research misconduct.
Sec. 93.107 Coordination with other agencies.
(a) When more than one agency of the Federal Government has
jurisdiction over the subject misconduct allegation, HHS will cooperate
in designating a lead agency to coordinate the response of the agencies
to the allegation. Where HHS is not the lead agency, it may, in
consultation with the lead agency, take appropriate action.
(b) In research misconduct proceedings involving more than one
agency, HHS may refer to the other agency's (or agencies') evidence or
reports if HHS determines that the evidence or reports will assist in
resolving HHS issues. In appropriate cases, HHS will seek to resolve
allegations jointly with the other agency or agencies.
Subpart B--Definitions
Sec. 93.200 Accepted practices of the relevant research community.
Accepted practices of the relevant research community means those
practices established by 42 CFR part 93 and by PHS funding components,
as well as commonly accepted professional codes or norms within the
overarching community of researchers and institutions that apply for
and receive PHS grants. These practices must be consistent with the
definition of research integrity.
Sec. 93.201 Administrative action.
Administrative action means an HHS action, consistent with Sec.
93.407, taken in response to a research misconduct proceeding to
protect the health and safety of the public, to promote the integrity
of PHS supported biomedical or behavioral research, biomedical or
behavioral research training, or activities related to that research or
research training, or to conserve public funds.
Sec. 93.202 Administrative record.
Administrative record comprises: the institutional record; any
information provided by the respondent to ORI, including but not
limited to the verbatim transcript of any meetings under Sec. 93.403
between the respondent and ORI, whether in person, by phone, or by
videoconference, and correspondence between the respondent and ORI; any
additional information provided to ORI while the case is pending before
ORI; and any analysis or additional information generated or obtained
by ORI. Any analysis or additional information generated or obtained by
ORI will also be made available to the respondent.
Sec. 93.203 Allegation.
Allegation means a disclosure of possible research misconduct
through any means of communication and brought directly to the
attention of an institutional or HHS official.
Sec. 93.204 Appeal.
Appeal means a request that is made by a respondent to the
institution or HHS, consistent with Sec. 93.314 and subpart E, to
reverse or modify findings, decisions, and/or actions related to
allegations of research misconduct, against the respondent.
Sec. 93.205 Assessment.
Assessment means a consideration of whether an allegation of
research misconduct appears to fall within the definition of research
misconduct; appears to involve PHS supported biomedical or behavioral
research, biomedical or behavioral research training, or activities
related to that research or research training, as provided in Sec.
93.102; and is sufficiently credible and specific so that potential
evidence of research misconduct may be identified. The assessment only
involves the review of readily accessible information relevant to the
allegation.
Sec. 93.206 Charge letter.
Charge letter means the written notice, as well as any amendments
to the notice, that are sent to the respondent stating the findings of
research misconduct and any proposed HHS administrative actions. If the
charge letter includes a suspension or debarment action, it may be
issued jointly by ORI and the Suspension and Debarment Official (SDO).
[[Page 69592]]
Sec. 93.207 Complainant.
Complainant means an individual who in good faith makes an
allegation of research misconduct.
Sec. 93.208 Contract.
Contract means an acquisition instrument awarded under the Federal
Acquisition Regulation (FAR), 48 CFR chapter 1.
Sec. 93.209 Day.
Day means calendar day unless otherwise specified. If a deadline
falls on a Saturday, Sunday, or Federal holiday, the deadline will be
extended to the next day that is not a Saturday, Sunday, or Federal
holiday.
Sec. 93.210 Departmental Appeals Board or DAB.
Departmental Appeals Board or DAB means the organization, within
the HHS Office of the Secretary, established to conduct hearings and
provide impartial review of disputed decisions made by HHS operating
components.
Sec. 93.211 Difference of opinion.
Difference of opinion means an alternative view held by a
researcher who is substantively engaged in the scientific subject area.
It generally contrasts with a prevailing opinion included in a
published research record or generally accepted by the relevant
scientific community. The differing opinion must concern scientific
data, methodology, analysis, interpretations, or conclusions, not
policy opinions or decisions unrelated to data practices.
Sec. 93.212 Evidence.
Evidence means anything offered or obtained during a research
misconduct proceeding that tends to prove or disprove the existence of
an alleged fact. Evidence includes documents, whether in hard copy or
electronic form, information, tangible items, and testimony.
Sec. 93.213 Fabrication.
Fabrication means making up data or results and recording or
reporting them.
Sec. 93.214 Falsification.
Falsification means manipulating research materials, equipment, or
processes, or changing or omitting data or results such that the
research is not accurately represented in the research record.
Sec. 93.215 Funding component.
Funding component means any organizational unit of the PHS
authorized to award grants, contracts, or cooperative agreements for
any activity covered by this part involving research or research
training; funding components may be agencies, bureaus, centers,
institutes, divisions, offices, or other awarding units within the PHS.
Sec. 93.216 Good faith.
(a) Good faith as applied to a complainant or witness means having
a reasonable belief in the truth of one's allegation or testimony,
based on the information known to the complainant or witness at the
time. An allegation or cooperation with a research misconduct
proceeding is not in good faith if made with knowing or reckless
disregard for information that would negate the allegation or
testimony.
(b) Good faith as applied to an institutional or committee member
means cooperating with the research misconduct proceeding by
impartially carrying out the duties assigned for the purpose of helping
an institution meet its responsibilities under this part. An
institutional or committee member does not act in good faith if their
acts or omissions during the research misconduct proceedings are
dishonest or influenced by personal, professional, or financial
conflicts of interest with those involved in the research misconduct
proceeding.
(c) Good faith as applied to a respondent means acting with
reasonable belief that respondent's actions are consistent with
accepted practices of the relevant research community.
Sec. 93.217 Honest error.
Honest error means a mistake made in good faith.
Sec. 93.218 Inquiry.
Inquiry means preliminary information-gathering and preliminary
fact-finding that meets the criteria and follows the procedures of
Sec. Sec. 93.307 through 93.309.
Sec. 93.219 Institution.
Institution means any person that applies for or receives PHS
support for any activity or program that involves the conduct of
biomedical or behavioral research, biomedical or behavioral research
training, or activities related to that research or training. This
includes, but is not limited to, colleges and universities, PHS
intramural biomedical or behavioral research laboratories, research and
development centers, national user facilities, industrial laboratories
or other research institutes, small research institutions, and
independent researchers.
Sec. 93.220 Institutional certifying official.
Institutional certifying official means the institutional official
responsible for assuring on behalf of an institution that the
institution has written policies and procedures for addressing
allegations of research misconduct, in compliance with this part; and
complies with its own policies and procedures and the requirements of
this part. The institutional certifying official also is responsible
for certifying the content of the institution's annual report, which
contains information specified by ORI on the institution's compliance
with this part, and ensuring the report is submitted to ORI, as
required.
Sec. 93.221 Institutional deciding official.
Institutional deciding official means the institutional official
who makes final determinations on allegations of research misconduct
and any institutional actions. The same individual cannot serve as the
institutional deciding official and the research integrity officer.
Sec. 93.222 Institutional member.
Institutional member or members means an individual (or
individuals) who is employed by, is an agent of, or is affiliated by
contract or agreement with an institution. Institutional members may
include, but are not limited to, officials, tenured and untenured
faculty, teaching and support staff, researchers, research
coordinators, technicians, postdoctoral and other fellows, students,
volunteers, subject matter experts, consultants, or attorneys, or
employees or agents of contractors, subcontractors, or sub-awardees.
Sec. 93.223 Institutional record.
The institutional record comprises:
(a) The records that the institution compiled during the research
misconduct proceeding pursuant to Sec. Sec. 93.305 through 93.316,
except to the extent the institution subsequently determines and
documents that those records are not relevant to the proceeding or that
the records duplicate other records that are being retained. These
records include, but are not limited to:
(1) The assessment report as required by Sec. 93.306(d);
(2) If an inquiry is conducted, the inquiry report and all records
(other than drafts of the report) in support of that report, including,
but not limited to, research records and the transcripts of any
interviews conducted during the inquiry, information the respondent
provided to the institution, and the documentation of any decision not
to investigate as required by Sec. 93.309(c);
(3) If an investigation is conducted, the investigation report and
all records (other than drafts of the report) in
[[Page 69593]]
support of that report, including, but not limited to, research
records, the transcripts of each interview conducted pursuant to Sec.
93.310(g), and information the respondent provided to the institution;
(4) Decision(s) by the institutional deciding official, such as the
written decision from the institutional deciding official with the
final determination of research misconduct findings (whether the
institution found research misconduct, and if so, who committed the
misconduct) and implemented institutional actions; and
(5) The complete record of any institutional appeal under Sec.
93.314;
(b) The documentation of the determination of irrelevant or
duplicate records; and
(c) A single index listing all documents in the institutional
record.
Sec. 93.224 Intentionally.
To act intentionally means to act with the aim of carrying out the
act.
Sec. 93.225 Investigation.
Investigation means the formal development of a factual record and
the examination of that record that meets the criteria and follows the
procedures of Sec. Sec. 93.310 through 93.316 and leads to a decision
not to make a finding of research misconduct or to a recommendation for
a finding of research misconduct which may include a recommendation for
other appropriate actions, including institutional and administrative
actions.
Sec. 93.226 Knowingly.
To act knowingly means to act with the awareness of the act.
Sec. 93.227 Notice.
Notice means a written or electronic communication served in person
or sent by mail or its equivalent to the last known street address,
facsimile number, or email address of the addressee.
Sec. 93.228 Office of Research Integrity or ORI.
Office of Research Integrity or ORI means the office established by
Public Health Service Act section 493 (42 U.S.C. 289b) and to which the
HHS Secretary has delegated responsibility for addressing research
integrity and misconduct issues related to PHS supported activities.
Sec. 93.229 Person.
Person means any individual, corporation, partnership, institution,
association, unit of government, or legal entity, however organized.
Sec. 93.230 Plagiarism.
Plagiarism means the appropriation of another person's ideas,
processes, results, or words, without giving appropriate credit.
(a) Plagiarism includes the unattributed verbatim or nearly
verbatim copying of sentences and paragraphs from another's work, which
materially mislead the reader regarding the contributions of the
author. It does not include the limited use of identical or nearly-
identical phrases which describe a commonly-used methodology.
(b) Plagiarism does not include self-plagiarism or authorship or
credit disputes including disputes among former collaborators who
participated jointly in the development or conduct of a research
project. Self-plagiarism and authorship disputes do not meet the
definition of research misconduct.
Sec. 93.231 Preponderance of the evidence.
Preponderance of the evidence means proof by evidence that,
compared with evidence opposing it, leads to the conclusion that the
fact at issue is more likely true than not.
Sec. 93.232 Public Health Service or PHS.
Public Health Service or PHS consists of the following components
within the HHS: the Office of the Assistant Secretary for Health, the
Office of Global Affairs, the Administration for Strategic Preparedness
and Response, the Advanced Research Projects Agency for Health, the
Agency for Healthcare Research and Quality, the Agency for Toxic
Substances and Disease Registry, the Centers for Disease Control and
Prevention, the Food and Drug Administration, the Health Resources and
Services Administration, the Indian Health Service, the National
Institutes of Health, the Substance Abuse and Mental Health Services
Administration, and any other components of HHS designated or
established as components of the Public Health Service.
Sec. 93.233 PHS support.
PHS support means PHS funding, or applications or proposals
therefor, for biomedical or behavioral research, biomedical or
behavioral research training, or activities related to that research or
training, that may be provided through funding for PHS intramural
research; PHS grants, cooperative agreements, contracts; or subawards,
contracts, or subcontracts under those PHS funding instruments; or
salary or other payments under PHS grants, cooperative agreements, or
contracts.
Sec. 93.234 Recklessly.
To act recklessly means to act without proper caution despite a
known risk for harm.
Sec. 93.235 Research.
Research means a systematic experiment, study, evaluation,
demonstration, or survey designed to develop or contribute to general
knowledge (basic research) or specific knowledge (applied research) by
establishing, discovering, developing, elucidating, or confirming
information or underlying mechanisms related to biological causes,
functions, or effects; diseases; treatments; or related matters to be
studied.
Sec. 93.236 Research integrity.
Research integrity refers to the use of honest and verifiable
methods in proposing, performing, and evaluating research; reporting
research results and maintaining the research record with particular
attention to adherence to rules, regulations, and guidelines; and
following accepted practices of the relevant research community.
Sec. 93.237 Research Integrity Officer or RIO.
Research Integrity Officer or RIO refers to the institutional
official responsible for administering the institution's written
policies and procedures for addressing allegations of research
misconduct in compliance with this part.
Sec. 93.238 Research misconduct.
Research misconduct means fabrication, falsification, or plagiarism
in proposing, performing, or reviewing research, or in reporting
research results. Research misconduct does not include honest error or
differences of opinion.
Sec. 93.239 Research misconduct proceeding.
Research misconduct proceeding means any actions related to alleged
research misconduct taken under this part, including but not limited
to, allegation assessments, inquiries, investigations, ORI oversight
reviews, and appeals.
Sec. 93.240 Research record.
Research record means the record of data or results that embody the
facts resulting from scientific inquiry. Data or results may be in
physical or electronic form. Examples of items, materials, or
information that may be considered part of the research record include,
but are not limited to, research proposals, raw data, processed data,
clinical research records, laboratory records, study records,
laboratory notebooks, progress
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reports, manuscripts, abstracts, theses, oral presentations, internet
and online content, internal reports, and journal articles.
Sec. 93.241 Respondent.
Respondent means the individual against whom an allegation of
research misconduct is directed or who is the subject of a research
misconduct proceeding.
Sec. 93.242 Retaliation.
Retaliation means an adverse action taken against a complainant,
witness, or committee member by an institution or one of its members in
response to:
(a) A good faith allegation of research misconduct; or
(b) Good faith cooperation with a research misconduct proceeding.
Sec. 93.243 Secretary or HHS.
Secretary or HHS means the Secretary of HHS or any other official
or employee of the HHS to whom the Secretary delegates authority.
Sec. 93.244 Small institution.
Small institution means an institution that receives PHS research
funds but may be too small to conduct an inquiry or investigation into
an allegation of research misconduct as required by this part without
actual or apparent conflicts of interest. A small institution typically
has a total of 10 or fewer institutional members.
Sec. 93.245 Suspension and debarment.
Suspension and debarment mean the actions that Federal agencies
take to disqualify persons deemed not presently responsible from doing
business with the government.
(a) Suspension refers to the temporary disqualification of a person
or entity for up to 18 months, typically during the pendency of an
investigation and ensuing legal proceedings.
(b) Debarment, meanwhile, refers to a final decision to disqualify
a person or entity for a fixed period of time. Both suspension and
debarment have government-wide effect: if an entity is suspended or
debarred by one agency, it is prohibited from obtaining any Federal
contracts or participating in nonprocurement transactions.
(c) Policies and procedures governing suspension and debarment from
procurement programs are set forth in the Federal Acquisition
Regulation (FAR) at 48 CFR 9.406 and 9.407 (as further supplemented by
HHS at 48 CFR 309.4).
(d) Policies and procedures governing suspension and debarment from
nonprocurement programs are set forth in the Nonprocurement Common Rule
(NCR) at 2 CFR part 180 (as further implemented by HHS at 2 CFR part
376).
(e) Actions undertaken under the FAR and NCR have reciprocal
effect; exclusions issued under one system will result in ineligibility
for all government procurement and nonprocurement programs.
Sec. 93.246 Suspension and Debarment Official or SDO.
Suspension and Debarment Official or SDO means the HHS official
authorized to impose suspension and debarment.
Sec. 93.247 This part.
This part means 42 CFR part 93 in its entirety, unless otherwise
explicitly noted. When referring to only a portion of 42 CFR part 93,
that portion may be described as ``subpart'' (see Sec. 93.25), or as
``section'' (text within a specific portion of the subpart).
Subpart C--Responsibilities of Institutions Compliance and
Assurances
Sec. 93.300 General responsibilities for compliance.
Institutions must:
(a) Have written policies and procedures for addressing allegations
of research misconduct that meet the requirements of this part;
(b) Respond to each allegation of research misconduct for which the
institution is responsible under this part in a thorough, competent,
objective, and fair manner, including precautions to ensure that
individuals responsible for carrying out any part of the research
misconduct proceeding do not have unresolved personal, professional, or
financial conflicts of interest with the complainant, respondent, or
witnesses;
(c) Foster a research environment that promotes research integrity
and the responsible conduct of research, discourages research
misconduct, and deals promptly with allegations or evidence of possible
research misconduct;
(d) Take all reasonable and practical steps to protect the
positions and reputations of good faith complainants, witnesses, and
committee members and protect these individuals from retaliation by
respondents and/or other institutional members;
(e) Provide confidentiality to the extent required by Sec. 93.106
to all respondents, complainants, and witnesses in a research
misconduct proceeding, and to research subjects identifiable from
research records or other evidence;
(f) Take all reasonable and practical steps to ensure the
cooperation of respondents and other institutional members with
research misconduct proceedings, including, but not limited to, their
providing information, research records, and other evidence;
(g) Cooperate with HHS during any research misconduct proceeding or
compliance review, including addressing deficiencies or additional
allegations in the institutional record if directed by ORI;
(h) Assist in administering and enforcing any HHS administrative
actions imposed on its institutional members; and
(i) Have an active research integrity assurance.
Sec. 93.301 Research integrity assurances.
(a) General policy. (1) An institution that applies for or receives
PHS support for biomedical or behavioral research, biomedical or
behavioral research training, or activities related to that research or
research training, must provide HHS with an assurance of compliance
with this part by establishing and then maintaining an active research
integrity assurance.
(2) PHS funding components may only authorize release of funds for
extramural biomedical and behavioral research, biomedical and
behavioral research training, or activities related to that research or
research training, to institutions that have an active research
integrity assurance on file with ORI.
(b) Research integrity assurance. The Institutional Certifying
Official must assure on behalf of the institution, initially and then
annually thereafter, that the institution:
(1) Has written policies and procedures for addressing allegations
of research misconduct, in compliance with this part;
(2) Complies with its policies and procedures for addressing
allegations of research misconduct; and
(3) Complies with all provisions of this part.
Sec. 93.302 Maintaining active research integrity assurances.
(a) Compliance with this part. ORI considers an institution in
compliance with this part when it:
(1) Has policies and procedures for addressing allegations of
research misconduct according to this part, keeps them in compliance
with this part, and upon request, provides them to ORI and other HHS
personnel;
(2) Complies with its policies and procedures for addressing
allegations of research misconduct;
(3) Complies with all provisions of this part; and
(4) Takes all reasonable and practical specific steps to foster
research integrity
[[Page 69595]]
consistent with Sec. 93.300, including, but not limited to:
(i) Informing the institution's members about its policies and
procedures for addressing allegations of research misconduct, and the
institution's commitment to compliance with the policies and
procedures; and
(ii) Making its policies and procedures for addressing allegations
of research misconduct publicly available.
(b) Annual report. An institution must file an annual report with
ORI, which contains information specified by ORI, on the institution's
compliance with this part. The Institutional Certifying Official is
responsible for certifying the content of this report and for ensuring
the report is submitted as required.
(c) Additional information. Along with its research integrity
assurance or annual report, an institution must send ORI such other
information as ORI may request on the institution's research misconduct
proceedings covered by this part and the institution's compliance with
the requirements of this part.
Sec. 93.303 Research integrity assurances for small institutions.
(a) Small institutions may file a ``Small Institution Statement''
with ORI in place of the institutional policies and procedures required
by Sec. Sec. 93.300(a), 93.301, and 93.304, upon approval by ORI.
(b) The Small Institution Statement does not relieve the
institution from complying with any other provision of this part.
(c) By submitting a Small Institution Statement, the institution
agrees to report all allegations of research misconduct to ORI. ORI or
another appropriate HHS office will work with the institution to
develop and/or advise on a process for handling allegations of research
misconduct consistent with this part.
(d) If a small institution has or believes it has a conflict of
interest during any phase of a research misconduct proceeding, the
small institution should contact ORI for guidance.
Sec. 93.304 Institutional policies and procedures.
Institutions seeking an approved research integrity assurance must
have written policies and procedures for addressing allegations of
research misconduct. Such policies and procedures must:
(a) Address and be consistent with all applicable requirements
pertaining to institutional responsibilities included in this part;
(b) Include and be consistent with applicable definitions in this
part; and
(c) Be made available to ORI in English.
Sec. 93.305 General conduct of research misconduct proceedings.
(a) Sequestration of research records and other evidence. An
institution must promptly take all reasonable and practical steps to
obtain all research records and other evidence, which may include
copies of the data or other evidence so long as those copies are
substantially equivalent in evidentiary value, needed to conduct the
research misconduct proceeding; inventory the records and other
evidence; and sequester them in a secure manner. Where the research
records or other evidence are located on or encompass scientific
instruments shared by multiple users, institutions may obtain copies of
the data or other evidence from such instruments, so long as those
copies are substantially equivalent to the evidentiary value of the
instruments. Whenever possible, the institution must obtain the
research records or other evidence:
(1) Before or at the time the institution notifies the respondent
of the allegation(s); and
(2) Whenever additional items become known or relevant to the
inquiry or investigation.
(b) Access to research records. Where appropriate, an institution
must give the respondent copies of, or reasonable supervised access to,
the research records that are sequestered in accordance with Sec.
93.305(a).
(c) Maintenance of the institutional record. An institution, as the
responsible legal entity for the PHS supported research, has a
continuing obligation under this part to ensure that it maintains an
adequate institutional record for a research misconduct proceeding. An
institution must maintain the institutional record as required by Sec.
93.317.
(d) Multiple respondents. Institutions must consider whether any
additional researchers are responsible for the alleged research
misconduct. Notably, the principal investigator, other coauthors on the
publication(s), co-investigators on the funding proposal(s),
collaborators, and laboratory members who were involved in conducting
the experiments that generated the primary data or in generating the
text and figures in the research records (e.g., published papers and
funding proposals) must be considered as potential respondents during
the assessment, inquiry, and/or subsequent investigation. If any
additional respondent(s) are identified throughout the inquiry/
investigation, they must be notified of the allegations, in accordance
with Sec. Sec. 93.307(c), 93.308(a), and 93.310(c).
(e) Multiple institutions. When multiple institutions are involved
in the allegations, one institution must be designated as the lead
institution if a joint research misconduct proceeding (inquiry and/or
investigation) is conducted. In a joint research misconduct proceeding,
the lead institution should obtain research records pertinent to the
inquiry/investigation and witness' testimonies from the other relevant
institutions. By mutual agreement, the joint research misconduct
proceeding may include committee members from the institutions
involved. The determination of whether further inquiry and/or
investigation is warranted, whether research misconduct occurred, and
which institutional actions are to be taken may be made by the
institutions jointly or the responsibilities tasked to the lead
institution.
(f) Pursue leads. An institution must diligently pursue all
significant issues and leads discovered in information obtained from
evidence and/or testimony during the inquiry and/or investigation that
are determined relevant to the inquiry and/or investigation, including
any evidence of additional instances of possible research misconduct.
The pursuit of any such issues and/or leads may extend to the
examination of additional research records (e.g., published papers,
grant applications) of the respondent(s) that contain similar data
elements as that of the initial allegation(s). If additional
allegations are raised during the inquiry or investigation, the
respondent(s) must be notified in writing of the additional allegations
raised against them.
(g) Interviews. An institution must interview each respondent,
complainant, and any other available person who has been reasonably
identified as having information regarding any relevant aspects of the
investigation, including witnesses identified by the respondent.
Institutions may, but are not required to, conduct interviews during
the assessment or inquiry. Interviews conducted during an assessment,
inquiry, and/or investigation must be consistent with the requirements
of this section.
(1) Interviews must be transcribed.
(2) Any exhibits shown to the interviewee during the interview must
be numbered and referred to by that number in the interview.
(3) The transcript of the interview must be made available to the
relevant interviewee for correction.
[[Page 69596]]
(4) The transcript(s) with any corrections and numbered exhibits
must be included in the record of the investigation.
(5) The respondent must not be present during the witnesses'
interviews but must be provided a transcribed copy of the interview.
Using a committee, consortium, or other person for research
misconduct proceedings. (1) An institution may use the services of a
committee, consortium, or person that the institution reasonably
determines to be qualified by practice and/or experience to conduct,
support, or participate in the research misconduct proceedings. An
institution may choose to use the same committee, consortium, or person
for the assessment, inquiry, and/or investigation.
(2) An institution must address any potential, perceived, or actual
personal, professional, or financial conflicts of interest between
members of the committee or consortium, or the qualified person and the
complainant, respondent, or witnesses.
(3) A consortium may be a group of institutions, professional
organizations, mixed groups, or individuals that will conduct research
misconduct proceedings for other institutions.
(4) An institution must ensure that a committee, consortium, or
person acting on its behalf conducts research misconduct proceedings in
compliance with the requirements of this part.
(5) An institution is not required to provide respondents or
complainants the opportunity to object to the person or to one or more
committee or consortium members chosen to conduct, support, or
participate in the research misconduct proceedings. If an institution
chooses to provide one respondent the opportunity to object in a
proceeding, it must provide all respondents the opportunity to object
in that proceeding. If an institution chooses to provide one
complainant the opportunity to object in a proceeding, it must provide
all complainants the opportunity to object in that proceeding.
(i) Notifying ORI of special circumstances. At any time during a
research misconduct proceeding, as defined in Sec. 93.239, an
institution must notify ORI immediately if it has reason to believe
that any of the following conditions exist:
(1) Health or safety of the public is at risk, including an
immediate need to protect human or animal subjects.
(2) HHS resources or interests are threatened.
(3) Research activities should be suspended.
(4) There is reasonable indication of possible violations of civil
or criminal law.
(5) Federal action is required to protect the interests of those
involved in the research misconduct proceeding.
(6) HHS may need to take appropriate steps to safeguard evidence
and protect the rights of those involved.
The Institutional Assessment
Sec. 93.306 Institutional assessment.
(a) Purpose. An assessment's purpose is to decide if an allegation
warrants an inquiry.
(b) Conducting the institutional assessment. (1) Upon receiving an
allegation of research misconduct, the RIO or another designated
institutional official must promptly assess the allegation to determine
whether the allegation:
(i) Falls within the definition of research misconduct under this
part,
(ii) Is within the jurisdictional criteria of 42 CFR 93.102, and
(iii) Is sufficiently credible and specific so that potential
evidence of research misconduct may be identified.
(2) In conducting the assessment, the RIO or another designated
institutional official must review readily accessible information
relevant to the allegation. The RIO or another designated institutional
official does not need to interview the complainant, respondent, or
other witnesses, or gather information beyond what may have been
submitted with the allegation, except as necessary to determine whether
the allegation is sufficiently credible and specific so that potential
evidence of research misconduct may be identified. Should it be
necessary to conduct interviews or gather information, such interviews
must be conducted according to the requirements of Sec. 93.305(g).
Assessment results. (1) An inquiry must be conducted if the
allegation meets the three assessment criteria at Sec. 93.306(b)(1).
(2) If the RIO or another designated institutional official
determines that requirements for an inquiry are met, they must:
(i) Document the assessment, in the form of an assessment report
(see Sec. 93.306(d)); and
(ii) Promptly take all reasonable and practical steps to obtain all
research records and other evidence that are needed, before or at the
time the institution notifies the respondent of the allegation(s),
consistent with Sec. 93.305, and promptly initiate the inquiry.
(2) If the RIO or another designated institutional official
determines that requirements for an inquiry are not met, they must keep
sufficiently detailed documentation of the assessment to permit a later
review by ORI of the reasons why the institution decided not to conduct
an inquiry.
(d) Assessment report. (1) The RIO or another designated
institutional official must document the process undertaken and the
outcome of the assessment, including:
(i) The allegation(s) assessed;
(ii) The name(s), professional alias(es), and position(s) of the
respondent(s);
(iii) Any evidence reviewed;
(iv) Whether the allegation falls within the definition of research
misconduct under this part;
(v) Whether the allegation is within the jurisdictional criteria of
Sec. 93.102;
(vi) Whether the allegation is sufficiently credible and specific
so that potential evidence of research misconduct may be identified;
and
(vii) Whether the institution will proceed to inquiry. If the
assessment automatically moves to inquiry as required by Sec.
93.306(e)(2), the assessment report must document this action.
(2) The assessment report must be completed within 15 days of when
the decision is made to move to inquiry under Sec. 93.306(c) or the
institution moves to inquiry under Sec. 93.306(e)(2).
(3) Institutions must keep these records in a secure manner for at
least 7 years after the assessment was conducted, and upon request,
provide them to ORI.
(e) Time for completion. (1) The institution must complete the
assessment within 30 days of its initiation.
(2) If the assessment will take longer than 30 days, the
institution must initiate an inquiry consistent with Sec. 93.307.
The Institutional Inquiry
Sec. 93.307 Institutional inquiry.
(a) Criteria warranting an inquiry. An inquiry is warranted if the
allegation:
(1) Was not assessed within the 30-day period for review provided
in Sec. 93.306(e); or
(2) Meets the following three criteria:
(i) Falls within the definition of research misconduct under this
part;
(ii) Is within the jurisdictional criteria of Sec. 93.102; and
(iii) Is sufficiently credible and specific so that potential
evidence of research misconduct may be identified.
(b) Purpose. An inquiry's purpose is to conduct an initial review
of the evidence to decide if an allegation warrants an investigation.
[[Page 69597]]
(c) Notice to respondent. At the time of or before beginning an
inquiry, an institution must make a good faith effort to notify in
writing the presumed respondent, if any. If the inquiry subsequently
identifies additional respondents, the institution must notify them.
Only allegations specific to a particular respondent are to be included
in the notification to that respondent.
(d) Sequestration of the records. An institution must obtain all
research records and other evidence needed to conduct the research
misconduct proceeding, consistent with Sec. 93.305(a).
(e) Conducting the inquiry--(1) Multiple institutions. A joint
research misconduct proceeding must be conducted consistent with Sec.
93.305(e).
(2) Person conducting the inquiry. Institutions may, but are not
required to, convene committees of experts to conduct reviews at the
inquiry stage to determine whether an investigation is warranted. The
inquiry review may be done by a RIO or another designated institutional
official in lieu of a committee, with the caveat that if needed, these
individuals may utilize one or more subject matter experts to assist
them in the inquiry review.
(3) Review of evidence. The purpose of an inquiry is to conduct an
initial review of the evidence to determine whether to conduct an
investigation. Therefore, an inquiry does not require a full review of
all the evidence related to the allegation.
(4) Interviews. Institutions may, but are not required to, call
witnesses or respondents for interviews that would provide additional
information for the institution's review. Any interviews conducted must
follow the requirements of Sec. 93.305(g).
(5) Pursue leads. Institutions must diligently pursue all
significant issues and leads, consistent with the requirements of Sec.
93.305(f).
(f) Inquiry results--(1) Criteria warranting an investigation. An
investigation is warranted if:
(i) There is a reasonable basis for concluding that the allegation
falls within the definition of research misconduct under this part and
involves PHS supported biomedical or behavioral research, biomedical or
behavioral research training, or activities related to that research or
research training, as provided in Sec. 93.102; and
(ii) Preliminary information-gathering and fact-finding from the
inquiry indicates that the allegation may have substance.
(2) Honest error and difference of opinion. (i) A conclusion of
honest error or difference of opinion must not be made at the inquiry
stage.
(ii) An inquiry cannot determine that an allegation lacks
sufficient substance based solely on a respondent's unsubstantiated
claim that the alleged research misconduct was a result of honest error
or difference of opinion.
(3) Findings of research misconduct. Findings of research
misconduct, including the determination of whether the alleged
misconduct is intentional, knowing, or reckless, cannot be made at the
inquiry stage.
(g) Inquiry report. (1) The institution must prepare a written
report that meets the requirements of this section and Sec. 93.309.
(2) If there is potential evidence of honest error or difference of
opinion, the institution must note this in the inquiry report.
(3) The institution must provide the respondent an opportunity to
review and comment on the inquiry report and attach any comments
received to the report.
(h) Time for completion. (1) The institution must complete the
inquiry within 60 days of its initiation unless circumstances clearly
warrant a longer period.
(2) If the inquiry will take longer than 60 days, the institution
must notify ORI and request an extension. As part of the request, the
institution must describe the particular circumstances or issues that
would warrant additional time to complete the inquiry.
(3) If the inquiry takes longer than 60 days to complete, the
inquiry report must document the reasons for exceeding the 60-day
period.
Sec. 93.308 Notice of the results of the inquiry.
(a) Notice to respondent. The institution must notify the
respondent whether the inquiry found that an investigation is
warranted. The notice must include a copy of the inquiry report and
include a copy of or refer to this part and the institution's policies
and procedures adopted under its research integrity assurance.
(b) Notice to complainants. The institution is not required to
notify the complainant(s) whether the inquiry found that an
investigation is warranted. The institution may, but is not required
to, provide relevant portions of the report to the complainant(s) for
comment. If an institution provides notice to one complainant in a
case, it must provide notice, to the extent possible, to all
complainants in the case.
Sec. 93.309 Reporting to ORI on the decision to initiate an
investigation.
(a) Within 30 days of deciding that an investigation is warranted,
the institution must provide ORI with the written decision by the
institutional deciding official and a copy of the inquiry report which
includes the following information:
(1) The names, professional aliases, and positions of the
respondent and complainant;
(2) A description of the allegation(s) of research misconduct;
(3) The PHS support, including, for example, grant numbers, grant
applications, contracts, and publications listing PHS support;
(4) The composition of the inquiry committee, including name(s),
position(s), and subject matter expertise;
(5) Inventory of sequestered research records and other evidence
and description of how sequestration was conducted;
(6) Transcripts of interviews, if conducted;
(7) Timeline and procedural history;
(8) Any scientific or forensic analyses conducted;
(9) The basis for recommending that the allegation(s) warrant an
investigation;
(10) The basis on which any allegation(s) do not merit further
investigation;
(11) Any comments on the inquiry report by the respondent or the
complainant;
(12) Any institutional actions implemented, including
communications with journals or funding agencies; and
(13) Written decision from the institutional deciding official that
an investigation is warranted.
(b) The institution must provide the following information to ORI
whenever requested:
(1) The institutional policies and procedures under which the
inquiry was conducted;
(2) The research records and other evidence reviewed, transcripts
of any interviews, and copies of all relevant documents; and
(3) The charges for the investigation to consider.
(c) Institutions must keep sufficiently detailed documentation of
inquiries to permit a later assessment by ORI of the reasons why the
institution decided not to conduct an investigation. Consistent with
Sec. 93.317, institutions must keep these records in a secure manner
for at least 7 years after the termination of the inquiry, and upon
request, provide them to ORI.
(d) In accordance with Sec. 93.305(i), institutions must notify
ORI and other PHS agencies, as relevant, of any special circumstances
that may exist.
[[Page 69598]]
The Institutional Investigation
Sec. 93.310 Institutional investigation.
Institutions conducting research misconduct investigations must:
(a) Time. Begin the investigation within 30 days after deciding
that an investigation is warranted.
(b) Notice to ORI. Notify ORI of the decision to begin an
investigation on or before the date the investigation begins and
provide an inquiry report that meets the requirements of Sec. Sec.
93.307 and 93.309.
(c) Notice to the respondent. Notify the respondent in writing of
the allegation(s) within a reasonable amount of time after determining
that an investigation is warranted, but before the investigation
begins.
(1) The institution must give the respondent written notice of any
allegation(s) of research misconduct not addressed during the inquiry
or in the initial notice of investigation within a reasonable amount of
time of deciding to pursue such allegation(s).
(2) If the institution identifies additional respondents during the
investigation that were not identified during the inquiry, the
institution is not required to conduct a separate inquiry. If any
additional respondent(s) are identified during the investigation, the
institution must notify them of the allegation(s).
(3) While an investigation into multiple respondents can convene
with the same investigation committee members, separate investigation
reports and research misconduct determinations are required for each
respondent.
(d) Sequestration of the records. An institution must obtain all
research records and other evidence needed to conduct the research
misconduct proceeding, consistent with Sec. 93.305(a).
(e) Documentation. Use diligent efforts to ensure that the
investigation is thorough and sufficiently documented and includes
examination of all research records and other evidence relevant to
reaching a decision on the merits of the allegation(s).
(f) Ensuring a fair investigation. Take reasonable steps to ensure
an impartial and unbiased investigation to the maximum extent
practicable, including participation of persons with appropriate
scientific expertise who do not have unresolved personal, professional,
or financial conflicts of interest relevant to the investigation. An
institution may use the same committee members from the inquiry in
their subsequent investigation.
(g) Interviews. Conduct interviews, consistent with Sec.
93.305(g).
(h) Pursue leads. Pursue diligently all significant issues and
leads, consistent with the requirements of Sec. 93.305(f), and
continue the investigation to completion. Once a proceeding reaches the
investigation stage, the institution may choose to add to or expand the
ongoing investigation by including any allegation(s) pertaining to the
same respondent or research records in question (e.g., manuscripts or
funding proposals) that come to the institution's attention during the
investigation, rather than opening an inquiry to review those
allegation(s).
(i) Multiple respondents. Consider, consistent with Sec.
93.305(d), the prospect of additional researchers being responsible for
the alleged research misconduct.
(j) Multiple institutions. A joint research misconduct proceeding
must be conducted consistent with Sec. 93.305(e).
Sec. 93.311 Investigation time limits.
(a) Time limit for completing an investigation. An institution must
complete all aspects of an investigation within 180 days of beginning
it, including conducting the investigation, preparing the draft
investigation report for each respondent, providing the draft report to
each respondent for comment in accordance with Sec. 93.312, and
sending the final institutional record including the final report to
ORI under Sec. 93.315.
(b) Extension of time limit. If unable to complete the
investigation in 180 days, the institution must ask ORI for an
extension in writing that includes the circumstances or issues
warranting additional time.
(c) Progress reports. If ORI grants an extension, it may direct the
institution to file periodic progress reports.
(d) Investigation report. If the investigation takes longer than
180 days to complete, the investigation report must include the reasons
for exceeding the 180-day period.
Sec. 93.312 Opportunity to comment on the draft investigation
report.
(a) The institution must give the respondent a copy of the draft
investigation report and, concurrently, a copy of, or supervised access
to, the records on which the report is based. The respondent must
submit any comments on the draft report to the institution within 30
days of the date on which the respondent received the draft
investigation report.
(b) The institution is not required to provide the complainant(s) a
copy of the draft investigation report or relevant portions of that
report. Should the institution choose to do so, all complainants must
be treated in the same way--absent extenuating circumstances. The
complainant must submit any comments on the draft report to the
institution within 30 days of the date on which the complainant
received the draft investigation report or relevant portions of it.
Sec. 93.313 Investigation report.
A final investigation report for each respondent must be in writing
and include:
(a) Describe the nature of the allegation(s) of research
misconduct, including any additional allegation(s) addressed during the
research misconduct proceeding.
(b) Describe and document the PHS support, including, for example,
any grant numbers, grant applications, contracts, and publications
listing PHS support.
(c) Describe the specific allegation(s) of research misconduct for
consideration in the investigation for each respondent.
(d) Composition of investigation committee, including name(s),
position(s), and subject matter expertise.
(e) Inventory of sequestered research records/other evidence and
how sequestration was conducted during the investigation, if
applicable.
(f) Listing of all manuscripts, funding proposals, and research
records that were examined during the investigation.
(g) Transcripts of all interviews conducted, as described in Sec.
93.305(g).
(h) Identification of the specific published papers, manuscripts
submitted but not accepted for publication (including online
publication), PHS grant/contract applications, progress reports,
presentations, posters, or other research records that allegedly
contained the falsified, fabricated, or plagiarized material.
(i) Any scientific or forensic analyses conducted.
(j) If not already provided to ORI with the inquiry report, include
the institutional policies and procedures under which the investigation
was conducted.
(k) Identify and summarize the research records and other evidence
reviewed and identify any evidence obtained and sequestered but not
reviewed.
(l) For each separate allegation of research misconduct identified
during the investigation, provide a finding as to whether research
misconduct did or did not occur, and if so:
(1) Identify the individual(s) responsible for the misconduct;
[[Page 69599]]
(2) Indicate whether the research misconduct was falsification,
fabrication, and/or plagiarism; and if the requirements for a finding
of research misconduct, as described in Sec. 93.104, have been met.
Voting or split decisions by the investigation committee members are
not permitted in the final recommendation in the investigation report.
(3) Summarize the facts and the analysis which support the
conclusion and consider the merits of any explanation by the
respondent;
(4) Identify the specific PHS support;
(5) Identify whether any publications need correction or
retraction; and
(6) List any current support or known applications or proposals for
support that the respondent has pending with PHS and non-PHS Federal
agencies.
Include and consider any comments made by the respondent and
complainant on the draft investigation report.
(n) The basis on which allegation(s) did not result in a research
misconduct determination.
(o) Any institutional actions recommended or implemented including
communications with journals or funding agencies.
Sec. 93.314 Institutional appeals.
(a) While not required by this part, if the institution's policies
and procedures provide for an appeal by the respondent that could
result in a reversal or modification of the findings of research
misconduct in the investigation report, the institution must notify ORI
of and complete any such appeal within 120 days of its initiation.
Appeals of institutional personnel actions or other actions that would
not result in a reversal or modification of the findings of research
misconduct are excluded from the 120-day limit.
(b) If unable to complete any appeals within 120 days, the
institution must ask ORI for an extension in writing that includes the
circumstances or issues warranting additional time.
(c) ORI may grant requests for extension for good cause. If ORI
grants an extension, it may direct the institution to file periodic
progress reports.
Sec. 93.315 Transmittal of the institutional record to ORI.
The institution must transmit to ORI the institutional record. The
institutional record must be consistent with Sec. 93.223 and logically
organized.
Sec. 93.316 Completing the research misconduct process.
(a) ORI expects institutions to carry inquiries and investigations
through to completion and to pursue diligently all significant issues
and credible allegations of research misconduct. Institutions must
notify ORI in advance if the institution plans to close a research
misconduct proceeding at the assessment, inquiry, investigation, or
appeal stage on the basis that the respondent has admitted to
committing research misconduct, a settlement with the respondent has
been reached, or for any other reason.
(b) A respondent's admission of research misconduct must be made in
writing and signed by the respondent. An admission must specify the
falsification, fabrication, and/or plagiarism that occurred and which
research records were affected. The admission statement must meet all
the elements required for a research misconduct finding under Sec.
93.104 and must be provided to ORI before the institution closes its
research misconduct proceeding. The institution must also provide a
statement to ORI describing how it determined that the scope of the
misconduct was fully addressed by the admission and confirmed the
respondent's culpability.
(c) After consulting with the institution on its basis for closing
a case under paragraph (a) of this section, ORI may conduct an
oversight review of the institution's handling of the case and take
appropriate action including:
(1) Approving or conditionally approving closure of the case;
(2) Directing the institution to complete its process;
(3) Directing the institution to address deficiencies in the
institutional record;
(4) Referring the matter for further investigation by HHS; or,
(5) Taking a compliance action.
Other Institutional Responsibilities
Sec. 93.317 Retention and custody of the institutional record.
(a) Maintenance of institutional record. Unless custody has been
transferred to HHS under paragraph (b) of this section, or ORI has
advised the institution in writing that it no longer needs to retain
the institutional record, an institution must maintain the
institutional record in a secure manner for 7 years after completion of
the proceeding or the completion of any PHS proceeding involving the
research misconduct allegation under subparts D and E of this part,
whichever is later.
(b) Provision for HHS custody. On request, institutions must
transfer custody of or provide copies to HHS of the institutional
record or any component of the institutional record and any sequestered
physical objects, such as a computer hard drive, for ORI to conduct its
oversight review, to develop the administrative record, or to present
the administrative record in any proceeding under subparts D and E of
this part.
Sec. 93.318 Institutional standards of conduct.
(a) Institutions may have standards of conduct different from the
standards for research misconduct under this part. Therefore, an
institution may find conduct to be actionable under its standards even
if the conduct does not meet this part's definition of research
misconduct.
(b) An HHS or ORI finding or settlement on research misconduct
findings does not affect institutional findings or actions taken based
on an institution's standards of conduct.
Subpart D--Responsibilities of the U.S. Department of Health and
Human Services
General Information
Sec. 93.400 General statement of ORI authority.
(a) ORI review. ORI may respond directly to any allegation of
research misconduct at any time before, during, or after an
institution's response to the matter. The ORI response may include, but
is not limited to:
(1) Conducting allegation assessments;
(2) Determining independently if jurisdiction exists under this
part;
(3) Forwarding allegations of research misconduct to the
appropriate institution or HHS component for inquiry or investigation;
(4) Requesting clarification or additional information,
documentation, research records, or other evidence as necessary from an
institution or its members or other persons or sources to carry out
ORI's review;
(5) Notifying or requesting assistance and information from PHS
funding components or other affected Federal and state offices and
agencies or institutions;
(6) Reviewing the institutional record and directing the
institution to address deficiencies or additional allegations in the
institutional record;
(7) Making a finding of research misconduct; and
(8) Proposing or taking administrative actions.
(b) ORI assistance to institutions. ORI will:
(1) Provide information, technical assistance, and procedural
advice to institutional officials as needed regarding an institution's
research
[[Page 69600]]
misconduct proceedings and the sufficiency of the institutional record.
(2) Issue guidance and provide information to support institutional
implementation of and/or compliance with the requirements of this part.
(c) Review of institutional research integrity assurances. ORI will
review institutional research integrity assurances and policies and
procedures for compliance with this part.
(d) Institutional compliance. ORI may make findings and impose HHS
compliance actions related to an institution's compliance with this
part and with its policies and procedures, including an institution's
participation in research misconduct proceedings.
Sec. 93.401 Interaction with other entities and interim actions.
(a) ORI may notify and consult with other entities including
government funding agencies, institutions, private organizations,
journals, publishers, and editors at any time if those entities have a
need to know about or have information relevant to a research
misconduct proceeding.
(b) If ORI believes that a criminal or civil fraud violation may
have occurred, it shall promptly refer the matter to the Department of
Justice (DOJ), the HHS Inspector General (OIG), or other appropriate
investigative body. ORI may provide expertise and assistance to the
DOJ, OIG, PHS offices, other Federal offices, and state or local
offices involved in investigating or otherwise pursuing research
misconduct allegations or related matters.
(c) ORI may notify affected PHS offices and funding components at
any time to enable them to take appropriate interim actions.
(d) The information provided will not be disclosed as part of the
peer review and advisory committee review processes but may be used by
the Secretary in making decisions about the award or continuation of
funding.
Research Misconduct Issues
Sec. 93.402 ORI allegation assessments.
(a) When ORI receives an allegation, it may conduct an assessment
or refer the matter to the relevant institution for an assessment,
inquiry, or other appropriate actions.
(b) If ORI decides that an inquiry is warranted, it forwards the
matter to the appropriate institution or HHS component.
(c) If ORI decides that an inquiry is not warranted it will close
the case and forward the allegation in accordance with paragraph (d) of
this section.
(d) ORI may forward allegations that do not fall within the
jurisdiction of this part to the appropriate HHS component, Federal or
state agency, institution, organization, journal, or other appropriate
entity.
Sec. 93.403 ORI review of research misconduct proceedings.
(a) In conducting its review of research misconduct proceedings,
ORI will:
(1) Determine whether PHS has jurisdiction under this part;
(2) Consider the institutional record and decide whether the
institutional record is sufficient, provide instructions to the
institution(s) if ORI determines that revisions are needed or
additional allegations of research misconduct should be addressed, and
require institutions to provide the respondent with an opportunity to
respond to information or allegations added to the institutional
record;
(3) Determine if the institution conducted the proceedings in a
timely and fair manner in accordance with this part with sufficient
thoroughness, objectivity, and competence to support the conclusions;
and
(4) After reviewing in accordance with paragraphs (a)(1) through
(3) of this section, decide whether to close the case without further
action or proceed with the case.
(b) If ORI decides to proceed with the case, ORI will:
(1) Obtain additional information or materials from the
institution, the respondent, complainants, or other sources, as needed;
(2) Conduct additional analyses, as needed;
(3) Provide the respondent the opportunity to access the
institutional record, any additional information provided to ORI while
the case is pending before ORI, and any analysis or additional
information generated or obtained by ORI;
(4) Provide the respondent the opportunity to submit information to
ORI;
(5) Allow the respondent and the respondent's attorney, if
represented, to meet virtually or in person with ORI to discuss the
information that the respondent has provided to ORI and have ORI's
meetings with the respondent transcribed, with a copy of the transcript
provided to the respondent for review and suggested correction;
(6) Close the administrative record following paragraphs (b)(3)
through (5) of this section;
(7) Provide the respondent the opportunity to access the complete
administrative record; and
(8) Take any other actions necessary to complete ORI's review.
Sec. 93.404 Findings of research misconduct and proposed
administrative actions.
(a) After completing its review of the administrative record, ORI
can:
(1) Close the case without a separate ORI finding of research
misconduct;
(2) Make findings of research misconduct and propose and take
administrative actions based on the administrative record; or
(3) Seek to settle the case.
(b) The lack of an ORI finding of research misconduct does not
overturn an institution's determination that the conduct constituted
professional or research misconduct warranting remediation under the
institution's policy.
Sec. 93.405 Notifying the respondent of findings of research
misconduct and HHS administrative actions.
(a) When ORI makes a finding of research misconduct or seeks to
impose HHS administrative actions, other than suspension or debarment,
it notifies the respondent in a charge letter. The charge letter
includes the ORI findings of research misconduct, including the basis
for such findings in the administrative record, and any proposed
administrative actions. The charge letter also advises the respondent
how they can access the administrative record and of the opportunity to
contest the findings and administrative actions under subpart E of this
part. In cases involving a suspension or debarment action, the HHS SDO
issues a notice of suspension or proposed debarment to the respondent
as part of the charge letter. The notice of suspension or proposed
debarment issued by the HHS SDO will include instructions on how the
respondent can contest the suspension and/or proposed debarment.
(b) ORI sends the charge letter by certified mail, private delivery
service, or electronic mail to the last known address of the respondent
or the last known principal place of business of the respondent's
attorney, if represented.
Sec. 93.406 Final HHS actions.
(a) Unless the respondent contests the findings and/or the
administrative actions, other than suspension and/or proposed
debarment, contained in the charge letter within the 30-day period
prescribed in Sec. 93.501, the ORI finding of and HHS administrative
actions, other than suspension and/or proposed debarment, proposed for
research misconduct issues are final.
(b) Unless the respondent contests a suspension and/or proposed
debarment within the 30-day period prescribed in the NCR or FAR,
respectively, the SDO may close the record and issue a final
[[Page 69601]]
debarment decision in the matter. Respondents may request
reconsideration of a final debarment decision with the SDO.
Sec. 93.407 HHS administrative actions.
(a) Based on the administrative record, HHS may impose
administrative actions that include but are not limited to:
(1) Clarification, correction, or retraction of the research
record.
(2) Letters of reprimand.
(3) Imposition of special certification or research integrity
assurance requirements to ensure compliance with applicable regulations
or terms of PHS grants, contracts, or cooperative agreements.
(4) Suspension or termination of a PHS grant, contract, or
cooperative agreement.
(5) Restriction on specific activities or expenditures under an
active PHS grant, contract, or cooperative agreement.
(6) Special review of all requests for PHS funding.
(7) Imposition of supervision requirements on a PHS grant,
contract, or cooperative agreement.
(8) Certification of attribution or authenticity in all requests
for support and reports to the PHS.
(9) Prohibition on participating in any advisory capacity to the
PHS.
(10) Adverse personnel action if the respondent is a Federal
employee, in compliance with relevant Federal personnel policies and
laws.
(11) Suspension or debarment administrative actions under the
Nonprocurement Common Rule (NCR) at 2 CFR part 180 for nonprocurement
transactions (as further implemented by HHS at 2 CFR part 376) or under
the Federal Acquisition Regulation (FAR) at 48 CFR 9.406 and 9.407 for
procurement transactions (as further supplemented by HHS at 48 CFR
309.4). Such administrative actions have reciprocal effect; exclusions
issued under one system will result in ineligibility for all government
procurement and nonprocurement programs.
(b) In connection with findings of research misconduct, HHS also
may seek to recover PHS funds spent in support of the activities that
involved research misconduct.
(c) Any authorized HHS component may impose, administer, or enforce
administrative actions separately or in coordination with other HHS
components, including, but not limited to ORI, OIG, the PHS funding
component, and the SDO.
Sec. 93.408 Mitigating and aggravating factors in HHS administrative
actions.
The purpose of HHS administrative actions is remedial. The
appropriate administrative action is commensurate with the seriousness
of the misconduct and the need to protect the health and safety of the
public, promote the integrity of the PHS supported research and
research process, and conserve public funds. ORI considers the
following aggravating and mitigating factors in determining appropriate
HHS administrative actions and their terms. Distinct from ORI's
process, the SDO considers the aggravating and mitigating factors
listed in the NCR or FAR, whichever is appropriate to the funding
mechanism, when considering suspension and debarment actions. The
existence or nonexistence of any factor is not determinative.
(a) Knowing, intentional, or reckless. Were the respondent's
actions knowing or intentional or were the actions reckless?
(b) Pattern. Was the research misconduct an isolated event or part
of a continuing or prior pattern of dishonest conduct?
(c) Impact. Did the misconduct have significant impact on the
proposed or reported research record, research subjects, other
researchers, institutions, or the public health or welfare?
(d) Acceptance of responsibility. Has the respondent accepted
responsibility for the misconduct by:
(1) Admitting the conduct;
(2) Cooperating with the research misconduct proceedings;
(3) Demonstrating remorse and awareness of the significance and
seriousness of the research misconduct; and
(4) Taking steps to correct or prevent the recurrence of the
research misconduct?
(e) Failure to accept responsibility. Does the respondent blame
others rather than accepting responsibility for the actions?
(f) Retaliation. Did the respondent retaliate against complainants,
witnesses, committee members, or other individuals?
(g) Continued risk to PHS funding. Does the respondent demonstrate
responsible stewardship of research resources?
(h) Other factors. Are other factors relevant to the circumstances
of a particular case?
Sec. 93.409 Settlement of research misconduct proceedings.
(a) HHS may settle a research misconduct proceeding at any time it
concludes that settlement is in the best interests of the Federal
Government and the public health or welfare.
(b) A settlement agreement precludes the respondent from contesting
any ORI findings of research misconduct, HHS administrative actions
(other than a suspension or debarment decision), or ORI's jurisdiction
in handling the research misconduct proceeding.
(c) Settlement agreements are publicly available, regardless of
whether ORI made a finding of research misconduct.
Sec. 93.410 Final HHS action with no settlement or finding of
research misconduct.
When the final HHS action does not result in a settlement or
finding of research misconduct, ORI may:
(a) Provide written notice to the respondent, the relevant
institution, the complainant, and HHS officials, as it deems necessary.
(b) To the extent permitted by the Privacy Act, 5 U.S.C. 552a, and
ORI's system of records notice for research misconduct proceedings,
publish notice of institutional research misconduct findings and
implemented institutional actions related to the falsified, fabricated,
or plagiarized material in the research record, but not the names or
other identifying information of the respondent(s), if doing so is
within the best interests of HHS to protect the health and safety of
the public, to promote the integrity of the PHS supported research and
research process, or to conserve public funds.
Sec. 93.411 Final HHS action with a settlement or finding of
misconduct.
When a final HHS action results in a settlement or research
misconduct finding, ORI:
(a) Shall provide final notification of any research misconduct
findings and HHS administrative actions to the respondent, the relevant
institution, and HHS officials, including the SDO. The SDO shall
provide a separate notice of final HHS action on any suspension or
debarment actions.
(b) May provide final notification of any research misconduct
findings and HHS administrative actions to the complainant(s).
(c) Shall send a notice to the relevant journal, publisher, data
repository, or other similar entity identifying publications or
research records which require correction or retraction.
(d) Shall publish notice of the research misconduct findings.
(e) Shall notify the respondent's current employer, if the employer
is an institution subject to this part.
[[Page 69602]]
Institutional Compliance Issues
Sec. 93.412 Making decisions on institutional noncompliance.
ORI may decide that an institution is not compliant with this part
if the institution does not implement and follow the requirements of
this part and its own research integrity assurance. In making this
decision, ORI may consider, but is not limited to the following
factors:
(a) Failure to establish and comply with policies and procedures
under this part;
(b) Failure to respond appropriately when allegations of research
misconduct arise;
(c) Failure to report to ORI all investigations and findings of
research misconduct under this part;
(d) Failure to cooperate with ORI's review of research misconduct
proceedings; or
(e) Other actions or omissions that have a material, adverse effect
on reporting and responding to allegations of research misconduct.
Sec. 93.413 HHS compliance actions.
(a) An institution's failure to comply with the requirements of
this part may result in enforcement action against the institution.
(b) If an institution fails to comply with the requirements of this
part, HHS may take some or all of the following compliance actions:
(1) Require the institution to accept and/or implement technical
assistance provided by HHS.
(2) Issue a letter of reprimand.
(3) Require the institution to take corrective actions.
(4) Place the institution on special review status. For a
designated period, ORI will closely monitor the institution's
activities for compliance with this part. Monitoring may consist of,
but is not limited to, compliance reviews and/or audits.
(5) Direct that research misconduct proceedings be handled by HHS.
(6) Recommend that HHS debar or suspend the institution.
(7) Any other action appropriate to the circumstances.
(c) If the institution's actions constitute a substantial or
recurrent failure to comply with this part, ORI may revoke the
institution's research integrity assurance under Sec. 93.301 or Sec.
93.303.
(d) ORI may make public any findings of institutional noncompliance
and HHS compliance actions.
Disclosure of Information
Sec. 93.414 Notice.
(a) ORI may disclose information to other persons for the purpose
of providing or obtaining information about research misconduct as
permitted under the Privacy Act, 5 U.S.C. 552a and ORI's system of
records notice for research misconduct proceedings.
(b) ORI shall disclose or publish a notice regarding settlements
and HHS administrative actions, and release or withhold information as
permitted by the Privacy Act and the Freedom of Information Act, 5
U.S.C. 552.
(c) ORI shall disclose or publish final findings of research
misconduct when they become final.
(1) HHS may publish the respondent's name, professional alias,
respondent's current and/or former position, a detailed summary of the
findings, and corrective actions imposed, in any venue it deems
appropriate.
(2) Such venues include, but are not limited to, Federal Government
exclusionary lists (if relevant), the Federal Register, ORI's website,
other HHS publications, professional journals and other publications,
and media outlets.
(d) To the extent allowed by law, ORI will not release information
that would reveal a confidential source.
(e) When ORI closes a case without a settlement or a finding of
research misconduct, disclosure may be made to the respondent, relevant
institution, and complainant(s). Prior to making any disclosure, ORI
will first consider the privacy interests of respondent(s),
complainant(s), witnesses, research subjects or others who may be
identified in the disclosure and determine whether limited disclosures
or confidentiality agreements are needed to protect those interests.
(f) Any publications or disclosures pursuant to this section are
not considered appealable ``administrative actions'' under this part.
Subpart E--Opportunity To Contest ORI Findings of Research
Misconduct and HHS Administrative Actions
General Information
Sec. 93.500 General policy.
(a) This subpart provides a respondent an opportunity to contest
ORI findings of research misconduct and/or HHS administrative actions,
other than suspension or proposed debarment, included in a charge
letter. To contest a suspension or proposed debarment included in a
charge letter, the respondent must provide the SDO directly with
information and argument in opposition to the suspension or proposed
debarment in accordance with 2 CFR part 180 (or successor regulation)
or with 48 CFR 9.406 and 9.407, as governed by the mechanism of PHS
funding involved. A respondent may contest ORI findings and/or HHS
administrative actions other than suspension and proposed debarment
under this subpart; contest only the suspension or proposed debarment
action under 2 CFR part 180 or 48 CFR 9.406 and 9.407; or both.
(b) A respondent may contest ORI research misconduct findings and
HHS administrative actions, other than suspension and proposed
debarment, by filing a notice of appeal with an Administrative Law
Judge (ALJ) at the DAB.
(c) Based on the administrative record, the ALJ shall rule on the
reasonableness of the ORI research misconduct findings and the HHS
administrative actions other than suspension or debarment.
(d) The ALJ's ruling made under Sec. 93.512 is the final HHS
action with respect to the research misconduct findings and
administrative actions, other than suspension or proposed debarment.
Where a respondent contests a suspension or proposed debarment, the ALJ
shall provide a copy of the ruling to the SDO to be included in the
official record under 2 CFR part 180 or 48 CFR 9.406 and 9.407; the SDO
decides the debarment action under the appropriate regulation.
Process for Contesting Research Misconduct Findings and/or
Administrative Actions
Sec. 93.501 Notice of appeal.
(a) Time to file. A respondent may contest ORI findings of research
misconduct and/or HHS administrative actions other than suspension and
proposed debarment by filing a notice of appeal within 30 days of
receipt of the charge letter provided under Sec. 93.405.
(b) Form of a notice of appeal. The respondent's notice of appeal
must be:
(1) In writing;
(2) Signed by the respondent or by the respondent's attorney; and
(3) Submitted to the DAB Chair through the DAB electronic filing
system with a copy sent by certified mail, electronic mail, or other
equivalent (i.e., with a verified method of delivery), to ORI. If the
respondent is also contesting suspension or proposed debarment under 2
CFR part 180, the respondent must send a courtesy copy of the notice of
appeal to the SDO.
(c) Contents of a notice of appeal. The notice of appeal must:
[[Page 69603]]
(1) Admit or deny each finding of research misconduct and each
factual assertion made in support of each finding;
(2) Accept or challenge each proposed administrative action;
(3) Provide detailed, substantive reasons for each denial or
challenge with references to the administrative record;
(4) Identify any legal issues or defenses that the respondent
intends to raise during the proceeding with references to the
administrative record;
(5) Identify any mitigating factors in the administrative record;
and
(6) State whether a suspension or proposed debarment is also being
contested under 2 CFR part 180 or 48 CFR 9.406 and 9.407.
Sec. 93.502 Appointment of the Administrative Law Judge.
(a) Within 30 days of receiving a notice of appeal, the DAB Chair,
in consultation with the Chief ALJ, must designate an ALJ to determine
whether the notice of appeal is timely filed and within the ALJ's
jurisdiction under this subpart. If the appeal is determined to be
timely and within the ALJ's jurisdiction, the ALJ shall decide the
reasonableness of the ORI research misconduct findings and
administrative actions in accordance with this subpart. The ALJ shall
dismiss an appeal if it is untimely or not within the ALJ's
jurisdiction under this subpart.
(b) No ALJ may serve in any proceeding under this subpart if they
have any actual or apparent conflict of interest, bias, or prejudice
that might reasonably impair their objectivity in the proceeding.
(c) Any party to the proceeding may request the ALJ to withdraw
from the proceeding because of an actual or apparent conflict of
interest, bias, or prejudice under paragraph (b) of this section. The
motion to disqualify must be timely and state with particularity the
grounds for disqualification. The ALJ may rule upon the motion or
certify it to the Chief ALJ for decision. If the ALJ rules upon the
motion, either party may appeal the decision to the Chief ALJ.
(d) An ALJ must withdraw from any proceeding for any reason found
by the ALJ or Chief ALJ to be disqualifying.
Sec. 93.503 Filing of the administrative record.
(a) For appeals that are not dismissed under Sec. 93.502(a), ORI
will file the administrative record for this appeal.
(b) The ALJ's review will be based on the administrative record.
(c) The parties have no right to supplement the administrative
record.
Sec. 93.504 Standard of review.
(a) The ALJ shall review the administrative record to determine
whether ORI's findings and HHS's proposed administrative actions, other
than suspension and debarment, reflected in the charge letter are
reasonable and not based on a material error of law or fact.
(b) The ALJ may permit the parties to file briefs making legal and
factual arguments based on the administrative record.
(c) If the ALJ determines that there is a genuine dispute over
facts material to the ORI findings of research misconduct or HHS
administrative actions other than suspension and debarment, the ALJ may
hold a limited hearing to resolve that genuine factual dispute.
Sec. 93.505 Rights of the parties.
(a) The parties to the appeal are the respondent and ORI. The
investigating institution is not a party to the case unless it is a
respondent.
(b) Except as otherwise limited by this subpart, the parties may:
(1) Be accompanied, represented, and advised by an attorney;
(2) Participate in any case-related conference held by the ALJ;
(3) File motions or briefs in writing before the ALJ;
(4) Present evidence relevant to the factual issues at a hearing,
if applicable; and
(5) Present and cross-examine witnesses at a hearing, if
applicable.
(c) The parties have no right to discovery before the ALJ.
Sec. 93.506 Authority of the Administrative Law Judge.
(a) The ALJ assigned to the case must conduct a fair and impartial
proceeding, avoid unnecessary delay, maintain order, and assure that a
complete and accurate record of the proceeding is properly made. The
ALJ is bound by, and may not refuse to follow or find invalid, all
Federal statutes and regulations, Secretarial delegations of authority,
and applicable HHS policies, as provided in paragraph (c)(5) of this
section.
(b) Subject to review as provided elsewhere in this subpart, the
ALJ may:
(1) Review the administrative record and issue a ruling without
convening a hearing;
(2) Hold conferences with the parties to identify or simplify the
issues, or to consider other matters that may aid in the prompt
disposition of the proceeding;
(3) Rule on motions and other procedural matters;
(4) Except for the respondent's notice of appeal, modify the time
for the filing of any document required or authorized under the rules
in this subpart.
(5) Upon motion of a party, decide cases, in whole or in part, by
summary judgment where there is no disputed issue of material fact;
(6) Regulate the course of the appeal and the conduct of
representatives, parties, and witnesses;
(7) Take action against any party for failing to follow an order or
procedure or for disruptive conduct;
(8) Set and change the date, time, schedule, and place of the
hearing, if applicable, upon reasonable notice to the parties;
(9) Continue or recess the hearing, if applicable, in whole or in
part for a reasonable period of time;
(10) Administer oaths and affirmations at the hearing, if
applicable;
(11) Require each party before the hearing, if applicable, to
provide the other party and the ALJ with copies of any exhibits that
the party intends to introduce into evidence; and
(12) Examine witnesses and receive evidence presented at the
hearing, if applicable.
(c) The ALJ does not have the authority to:
(1) Enter an order in the nature of a directed verdict;
(2) Compel settlement negotiations;
(3) Enjoin any act of the Secretary;
(4) Review suspension or proposed debarment;
(5) Find invalid or refuse to follow Federal statutes or
regulations, Secretarial delegations of authority, or HHS policies;
(6) Authorize the parties to engage in discovery; and
(7) Modify the time for filing the respondent's notice of appeal.
(d) The Federal Rules of Evidence and the Federal Rules of Civil
Procedure do not govern the proceedings under this subpart.
Sec. 93.507 Ex parte communications.
(a) No party, attorney, or other party representative may
communicate ex parte with the ALJ on any matter at issue in a case,
unless both parties have notice and an opportunity to participate in
the communication.
(b) If an ex parte communication occurs, the ALJ will disclose it
to the other party and offer the other party an opportunity to comment.
(c) The provisions of this section do not apply to communications
between an employee or contractor of the DAB and the ALJ.
Sec. 93.508 Filing, format, and service.
(a) Filing. (1) Unless the ALJ provides otherwise, all submissions
required or
[[Page 69604]]
authorized to be filed in the proceeding must be filed with the ALJ.
(2) Submissions are considered filed when they are filed with the
DAB according to the DAB's filing guidance.
(b) Format. (1) The ALJ may designate the format for copies of
nondocumentary materials such as videotapes, computer disks, or
physical evidence. This provision does not apply to the charge letter
or other written notice provided under Sec. 93.405.
(2) Every submission filed in the proceeding must include the title
of the case, the docket number, and a designation of the nature of the
submission.
(3) Every submission filed in the proceeding must be signed by and
contain the address and telephone number of the party on whose behalf
the document or paper was filed, or the attorney of record for the
party.
(c) Service. Service of a submission on other parties is
accomplished by filing the submission with the ALJ through the DAB
electronic filing system.
Sec. 93.509 Filing motions.
(a) Parties must file all motions and requests for an order or
ruling with the ALJ, serve them on the other party, state the nature of
the relief requested, provide the legal authority relied upon, and
state the facts alleged in support of the motion or request.
(b) All motions must be in writing except for those made during a
prehearing conference or at a hearing.
(c) Within 10 days after being served with a motion, or other time
as set by the ALJ, a party may file a response to the motion. The
moving party may not file a reply to the response unless allowed by the
ALJ.
(d) The ALJ may not grant a motion before the time for filing a
response has expired, except with the parties' consent or after a
hearing on the motion. However, the ALJ may overrule or deny any motion
without awaiting a response.
(e) The ALJ must make a reasonable effort to dispose of all motions
promptly, and, whenever possible, dispose of all outstanding motions
before the hearing.
Sec. 93.510 Conferences.
(a) The ALJ must schedule an initial conference with the parties
within 30 days of the DAB Chair's assignment of the case.
(b) The ALJ may use the initial conference to discuss:
(1) Identification and simplification of the issues, specification
of genuine disputes of fact and their materiality to the ORI findings
of research misconduct and any administrative actions;
(2) Identification of material legal issues and any need for
briefing;
(3) Scheduling dates for the filing of briefs based on the
administrative record or the hearing, if applicable; and
(4) Other matters that may encourage the fair, just, and prompt
disposition of the proceedings.
(c) The ALJ may schedule additional conferences as appropriate,
upon reasonable notice to or request of the parties.
(d) All conferences will be recorded with copies provided to the
parties upon request.
(e) The ALJ shall memorialize in writing any oral rulings within 10
days after a conference is held.
(f) By 15 days before the scheduled hearing date, if applicable,
the ALJ must hold a prehearing conference to resolve to the maximum
extent possible all outstanding issues about evidence, witnesses,
motions and all other matters that may encourage the fair, just, and
prompt resolution of genuine factual disputes.
Sec. 93.511 Hearing to resolve genuine factual dispute.
(a) The ALJ may hold a virtual or in-person hearing that is limited
to resolving a genuine factual dispute.
(b) The ALJ shall permit the parties to call witnesses and to
question witnesses. The ALJ may also question witnesses.
(c) The parties are not required to submit prehearing briefs.
(d) The parties are not required to give opening or closing
statements at the hearing.
(e) The hearing will be transcribed, and the parties will have an
opportunity to review the transcript and submit proposed corrections to
the ALJ.
(f) Following receipt of the transcript and proposed corrections to
the transcript, the ALJ may permit the parties to file briefs with
suggested factual findings based on the transcript.
(g) The ALJ will issue findings of fact to the parties that
resolves the genuine factual dispute.
Sec. 93.512 The Administrative Law Judge's ruling.
(a) Based on the administrative record and any findings of fact as
a result of a hearing, if applicable, the ALJ shall issue a ruling in
writing setting forth whether ORI's findings and HHS's proposed
administrative actions, other than suspension and debarment, reflected
in the charge letter are reasonable and not based on a material error
of law or fact within 60 days after the last submission by the parties
in the case. If unable to meet the 60-day deadline, the ALJ must set a
new deadline and promptly notify the parties and the SDO if a
suspension or proposed debarment is contested. The ALJ shall serve a
copy of the ruling upon the parties. If a suspension or proposed
debarment is contested, the ALJ shall provide a copy of the ruling to
the SDO to be included in the official record under 2 CFR part 180.
(b) The ruling of the ALJ constitutes the final HHS action on the
findings of research misconduct and administrative actions other than
suspension or debarment. The decision of the SDO constitutes the final
HHS action regarding suspension or debarment under 2 CFR part 180.
Dated: September 27, 2023.
Xavier Becerra,
Secretary.
[FR Doc. 2023-21746 Filed 10-5-23; 8:45 am]
BILLING CODE 4150-31-P
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</html>Indexed from Federal Register on October 6, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.