Public Health Service Policies on Research Misconduct, 69583-69604 [2023-21746]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[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 [www.gpo.gov]
[FR Doc No: 2023-21746]


=======================================================================
-----------------------------------------------------------------------

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).

-----------------------------------------------------------------------

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 https://www.regulations.gov 
(referred to hereafter as ``regulations.gov''). In commenting, please 
refer to the Regulatory Information Number (RIN) [0937-AA12].
    Instructions: Enter the RIN in the search field at https://www.regulations.gov 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 
regulations.gov, please number and label all attachments; https://www.regulations.gov will not automatically number them. All relevant 
comments will be posted without change to https://www.regulations.gov, 
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 https://www.regulations.gov.

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 https://www.regulations.gov. 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 https://ori.hhs.gov/historical-background. 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\
---------------------------------------------------------------------------

    \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.'' https://aspe.hhs.gov/reports/valuing-time-us-department-health-human-services-regulatory-impact-analyses-conceptual-framework. Page v.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \2\ U.S. Bureau of Labor Statistics. Occupational Employment and 
Wages, May 2021. 11-9033 Education Administrators, Postsecondary. 
Mean hourly wage. https://www.bls.gov/oes/current/oes119033.htm.
---------------------------------------------------------------------------

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

[[Page 69594]]

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