[Federal Register Volume 89, Number 180 (Tuesday, September 17, 2024)]
[Rules and Regulations]
[Pages 76280-76309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20814]



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Vol. 89

Tuesday,

No. 180

September 17, 2024

Part IV





Department of Health and Human Services





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42 CFR Part 93





Public Health Service Policies on Research Misconduct; Final Rule

Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / 
Rules and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 93

RIN 0937-AA12


Public Health Service Policies on Research Misconduct

AGENCY: U.S. Department of Health and Human Services (HHS).

ACTION: Final rule.

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SUMMARY: This final rule revises the regulations governing Public 
Health Service Policies on Research Misconduct. The final rule reflects 
both substantive and non-substantive revisions in response to public 
comments and to improve clarity. The purpose of the final rule is to 
implement policy changes and respond to technological changes that 
occurred over the past several years applicable to research misconduct.

DATES: Effective Date: This final rule is effective January 1, 2025.
    Applicability Date: All regulatory requirements are applicable 
beginning on or after January 1, 2026.

ADDRESSES: Address any comments or questions regarding the final rule 
to Sheila R. Garrity, JD, MPH, MBA, Director, Office of Research 
Integrity (ORI), 1101 Wootton Parkway, Suite 240, Rockville, MD 20852. 
Some commonly asked questions and answers will be posted on the ORI 
website prior to the effective date of the final rule. The URL for the 
ORI website is https://ori.hhs.gov.

FOR FURTHER INFORMATION CONTACT: Justina Lawrence, (240) 453-8200.

SUPPLEMENTARY INFORMATION:

I. Background

    The Office of Research Integrity (ORI) within the Department of 
Health and Human Services (HHS) oversees and directs Public Health 
Service (PHS) research integrity activities on behalf of the HHS 
Secretary, with the exception of the regulatory research integrity 
activities of the Food and Drug Administration.
    ORI was established in 1993 by amendment to section 493 of the 
Public Health Service Act (42 U.S.C. 289b). The HHS Secretary has 
authority under section 493 to promulgate a regulation that provides an 
administrative process for entities that apply for or receive PHS 
funding for biomedical or behavioral research to respond to research 
misconduct allegations in connection with such research and to provide 
assurances to the Department that the entities have an administrative 
process in place to respond to research misconduct allegations, 
investigate research misconduct allegations, and comply with the 
Department's regulation. Section 493 also authorizes the HHS Secretary 
to promulgate a regulation addressing ORI's actions, including 
appropriate remedies, with respect to research misconduct.
    In 2005, HHS updated regulations implementing section 493 that 
predated ORI's establishment. Specifically, HHS removed 42 Code of 
Federal Regulations (CFR) part 50, subpart A and added 42 CFR part 93, 
Public Health Service Policies on Research Misconduct. Since 2005, ORI 
and regulated entities experienced policy developments and 
technological changes applicable to research misconduct, such as the 
2008 NIH Public Access policy; the 2023 NIH Data Management and Sharing 
policy; the shift to saving data on the cloud; and the ability to use 
artificial intelligence to detect image falsification, among many other 
developments. Therefore, ORI decided to revise part 93.
    On October 6, 2023, ORI issued a Notice of Proposed Rulemaking 
(NPRM) that proposed revisions to 42 CFR part 93 based on the 
experience ORI and institutions gained with the regulation since it was 
promulgated in 2005 (88 FR 69583). In addition, the NPRM was issued in 
response to increasing public concerns about research integrity in 
science and institutional questions about research misconduct review 
proceedings. The NPRM proposed several changes to provide clarity, 
transparency, and a better streamlined process.
    The NPRM proposed changes to subpart A. These changes included 
requiring grant recipients to take responsibility for the research 
integrity assurances of their subrecipients; adding ORI oversight of 
and increasing reporting requirements for subsequent use exception 
determinations; reducing disclosure limitations; and expanding 
institutional reporting obligations.
    Proposed changes to subpart B in the NPRM included adding or 
revising definitions of commonly used terms such as institutional 
record, administrative record, honest error, intentionally, knowingly, 
recklessly, and accepted practices of the relevant research community.
    Proposed changes to subpart C in the NPRM included clarification 
for maintaining active institutional research integrity assurances and 
addressing apparent or actual conflicts of interest. The NPRM also 
proposed changes to the institutional research misconduct review 
process, including assessments, sequestration of research records, 
inquiries, investigations, and the maintenance of institutional 
records.
    Proposed changes to subpart D in the NPRM included clarification of 
institutional assembly of administrative records and potential ORI 
actions for institutional noncompliance. In addition, ORI proposed 
clarifying that the lack of an ORI finding of research misconduct does 
not overturn an institution's determination of research misconduct. 
Other proposed changes to subpart D included when and how ORI may 
disclose information about a research misconduct proceeding.
    Proposed changes to subpart E in the NPRM included a streamlined 
process for contesting ORI findings of research misconduct and HHS 
administrative actions. The proposed appeals process included 
Administrative Law Judge (ALJ) review of an administrative record, 
rather than a de novo review of evidence presented at a hearing before 
an ALJ.
    The NPRM sought comments 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 the existing regulation.

II. Overview of Comments and Significant Changes in Final Rule

    ORI received 269 comments via Regulations.gov. ORI also received 
comments as part of its interagency review process. ORI received 199 
relevant comments representing the views of two main constituent 
groups: institutions and individuals. In several instances, duplicative 
comments were posted by the same institution or individual. ORI 
received 171 unique comments submitted by 123 institutions and 46 
individuals. In two cases, an institution submitted two separate sets 
of comments; since the content of each submission was distinct, ORI 
counted each submission as a unique comment. In addition, some comments 
were endorsed by multiple individuals or institutions. For example, one 
institutional comment was explicitly supported by 70 separate 
commenters. Another institutional comment was explicitly supported by 
83 separate commenters. Ten commenters supported an additional 
institutional statement, and three commenters supported other 
representative groups' statements.
    Most comments addressed multiple sections of the proposed rule. 
Many commenters made general statements supporting the more efficient 
execution and oversight of research misconduct proceedings proposed in 
the NPRM;

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however, most commenters recommended changes to enhance the clarity of 
the proposed regulation. These comments generally involved maintaining 
the balance between ensuring a complete review of misconduct 
allegations and protecting the rights of respondents and recognizing 
the potential for administrative burden and cost on institutions.
    Most commenters anticipated administrative burden resulting from 
various parts of the NPRM. These comments were divided among five 
topics: burden related to the assessment phase, burden related to 
determining honest error, burden related to transcribing interviews, 
burden related to reporting, and burdens placed on small institutions. 
Several commenters requested more time to implement the final rule, and 
the amount of time requested varied widely. A majority requested one 
year, while others requested different timelines.
    Many commenters recommended revisions to or removal of proposed 
definitions. Commenters also made general comments on the proposed 
rule, with most commenters recommending additions, revisions, or 
removal of various sections.
    Commenters expressed a variety of concerns about potential 
conflicts of interest but did not recommend the removal or revision of 
any particular section of the proposed regulation. Commenters also 
expressed concerns about harm to respondents' reputation; these 
concerns included ORI's access to assessment reports and potential 
breaches of confidentiality when sharing transcripts. Commenters also 
expressed concerns about the effects of the proposed regulation on 
whistleblowers. These concerns included fears of retaliation, negative 
effects on reporting misconduct, and breaches of confidentiality.
    The NPRM proposed several substantive changes in which commenters 
provided feedback that informed the drafting of the final rule. The 
following paragraphs provide an overview of the feedback received from 
commenters. More detailed descriptions of comments on specific sections 
of the proposed regulation are addressed below in section III.

Subpart A Summary of Significant Public Comments and Changes

    Proposed Sec.  93.102(a) would require primary PHS grant recipients 
to take responsibility for the compliance of their subrecipients. A 
number of commenters recommended removing the proposed requirement 
making each PHS funding recipient responsible for the compliance of 
their subrecipients, because institutional responsibility for 
regulatory compliance was not clarified. ORI did not intend to impose a 
new burden on prime funding recipients; in the final rule subrecipients 
are required to have their own assurances filed with ORI. Proposed 
Sec.  93.105(b), which involved time limitations for research 
misconduct proceedings, required more reporting requirements and 
established that ORI makes the final determination of when a subsequent 
use exception can be applied. Commenters recommended revising this 
section to state that institutions should be afforded discretion in 
applying the subsequent use exceptions. ORI agreed institutions should 
be able to determine whether the subsequent use exception applies to a 
given situation. Proposed Sec.  93.106 would require increased 
institutional reporting obligations to ORI related to institutional 
confidentiality obligations. Commenters found the language of the 
proposed regulation in this section overcomplicated institutional 
confidentiality obligations, added problematic provisions, and 
contained information more appropriate for guidance. ORI recognized 
institutions' concerns about implementing the confidentiality 
requirements in the proposed rule and changed the final rule to provide 
latitude for institutions to decide confidentiality requirements for 
themselves. A number of commenters disapproved omitting the 2005 
regulation's Evidentiary Standards section from the NPRM, and asked ORI 
to maintain the burden of proof language from the 2005 regulation. ORI 
had proposed removing this section because evidentiary standards were 
discussed in several other parts of the NPRM; however, ORI concurred 
with commenters, restored and updated aspects of the Evidentiary 
Standards section, and revised the final rule to clarify specific 
situations in which an adverse inference can be made but did not 
address all situations in which an adverse inference can be made. 
Nothing in the final rule precludes an institution or HHS from drawing 
an adverse inference under a different set of facts if appropriate.

Subpart B Summary of Significant Public Comments and Changes

    Proposed Secs. 93.205, 93.211, 93.217, 93.236 and 93.245 set forth 
definitions for Appeal, Difference of Opinion, Honest Error, Research 
Integrity, Suspension and Debarment to provide definitions of commonly 
used terms. Several commenters recommended removing these definitions 
because they did not enhance the clarity of the regulation. ORI agreed 
and removed these definitions. Proposed Secs. 93.223, 93.217, and 
93.234, which set forth definitions for Institutional Record, 
Recklessly, and Small Institution, were also added to provide 
definitions for commonly used terms. Commenters recommended revisions 
to clarify these definitions. ORI concurred and revised these 
definitions, described in detail in the next section.

Subpart C Summary of Significant Public Comments and Changes

    Proposed Sec.  93.304 regarding institutional policies and 
procedures removed a provision that was in the 2005 regulation 
requiring institutions to have policies and procedures in place to 
protect the rights of respondents. Commenters were concerned about 
protecting these rights and ORI restored the language from the 2005 
regulation that institutions provide for all reasonable and practical 
efforts, if requested and as appropriate, to protect or restore the 
reputation of persons alleged to have engaged in research misconduct 
but against whom no finding of research misconduct is made.
    Proposed Sec.  93.305 was meant to provide details on institutional 
responsibilities in the general conduct of misconduct proceedings. Some 
commenters appreciated the provision that permits an institution to add 
respondents to an ongoing misconduct case without conducting a separate 
inquiry for each new respondent. Other commenters were concerned that 
listing the types of researchers the institutions should consider as 
potential respondents created a confusing standard and could be 
detrimental to those individuals. ORI concurred and removed the list of 
potential co-respondents as well as the parenthetical list of 
additional research records to examine, because these lists were 
intended to be exemplary rather than prescriptive. Some commenters 
found the section on pursuing leads overly prescriptive, while others 
found it overly broad. Many commenters were concerned that pursuing all 
leads during an inquiry would be burdensome and costly--as well as 
cause reputational harm to innocent researchers. ORI concurred and 
moved the requirement to pursue all leads to Sec.  93.310(j), which 
details the investigation requirements.
    Commenters also objected to the proposed requirement to transcribe 
all interviews in Sec.  93.305 of the NPRM, especially interviews 
conducted during the assessment or inquiry phase, because it could 
discourage reporting of

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allegations and contribute to institutional burden. ORI concurred, 
revised the section, and moved it to Sec.  93.310(g), which details the 
investigation requirements. The revised section removes the requirement 
for transcribed interviews during the assessment and inquiry phases. 
Some commenters noted this section may not provide fair procedures to 
respondents. Other commenters recommended removing the section 
entirely, stating that institutions should be allowed to institute best 
practices without regulatory oversight. A few commenters favored 
retaining the section as proposed. ORI removed all portions of the 
proposed subsection that did not specify requirements--that is, 
sections on the institution's choice to use a committee, consortium, or 
person to conduct, support, or participate in proceedings; what a 
consortium might be comprised of; and the institution's choice to allow 
respondents/complainants to object to committee or consortium 
member(s). The information was intended to be exemplary, not 
prescriptive. ORI intends to issue guidance on this topic.
    Proposed Sec.  93.306, which describes the institutional assessment 
of research misconduct allegations, increased reporting requirements, 
and time limitations were added to ensure prompt institutional response 
in addressing allegations of misconduct. Commenters were concerned 
about the burden of increased pre-investigation reporting requirements. 
ORI concurred and revised this section to simplify the assessment phase 
and require institutions to document their assessment process rather 
than write a formal report. The final rule clarifies that, if an 
institution determines to close a research misconduct proceeding after 
the assessment, it must retain documentation of its rationale 
sufficient to permit a later review by ORI.
    Proposed Sec.  93.307, which involves the institutional inquiry, 
increased reporting requirements, and time limitations were added to 
ensure prompt institutional response in addressing allegations of 
misconduct. The NPRM proposed to prohibit an institution from 
determining honest error during the inquiry stage. Some commenters 
requested clarification because the process for notifying additional 
respondents of an institutional inquiry appeared unclear. ORI concurred 
and revised this section to simplify the language. Commenters also 
recommended removing proposed Sec.  93.307(f)(2) because they conveyed 
the requirement that institutions determine honest error only at the 
investigation stage would unfairly burden both respondents and 
institutions. ORI agreed and removed Sec.  93.307(f)(2). Several 
commenters recommended removing proposed Sec.  93.307(h), which set a 
60-day timeframe for completing an inquiry, stating that institutions 
should have more flexibility in the timeframe to thoroughly conduct an 
inquiry. ORI concurred and lengthened the inquiry timeline from 60 to 
90 days. If the inquiry takes longer than 90 days to complete, the 
inquiry report must document the reasons for exceeding the 90-day 
period.
    The institutional investigation phase described in proposed Sec.  
93.310 was meant to provide additional institutional responsibilities 
in the conduct of an institutional investigation of research 
misconduct, including additional reporting and proposed rules about 
sequestration of evidence, multiple respondents, and multiple 
institutions. A few commenters recommended removal of proposed Sec.  
93.310(c)(2) because they conveyed their concern that the regulation 
infringes on the rights of respondents who are added to an ongoing 
investigation without an additional inquiry. ORI clarified Sec.  
93.310(c)(2) that when a new respondent is added to an ongoing 
proceeding, institutions may but are not required to conduct a separate 
inquiry for additional respondents, and additional respondents must be 
notified of allegation(s) and provided an opportunity to respond.
    Proposed Sec.  93.313(k) and (l)(2) describing the institutional 
investigation report was meant to clarify the requirements for an 
investigation report. The section included lists of examples of 
sequestered materials. The section also included a prohibition against 
split decisions by an investigation committee. Commenters recommended 
removing proposed Sec.  93.313(k), which included a requirement that 
institutions identify any research records and other evidence obtained 
and sequestered but not reviewed, because it was deemed resource-
intensive and an unnecessary burden. ORI concurred and removed Sec.  
93.313(k) as duplicative of 93.313(e). ORI notes that the inventory 
requirement described in 93.313(e) does not require identification of 
specific files or emails but allows for a broader summary of the types 
of files or emails sequestered. Commenters also recommended removing 
language in proposed Sec.  93.313(l)(2) prohibiting investigation 
committees from making a split decision. ORI removed that prohibition 
and included language that the report must clearly state the 
investigation committee's conclusions regarding whether research 
misconduct occurred.
    The institutional appeals process described in proposed Sec.  
93.314 would require that institutional appeals be completed within 120 
days or apply for an extension. Commenters recommended deleting or 
significantly revising Sec.  93.314, contending the institutional 
appeal was within the institution's purview, not ORI's. ORI concurred 
and removed most of the requirements in Sec.  93.314 and added Sec.  
93.315 to acknowledge institutional purview. ORI recognizes the 
potential inefficiency of starting oversight review while an 
institutional appeal is ongoing that could reverse or modify the 
institutional findings of research misconduct. The final rule clarifies 
that institutions should not transmit their institutional record until 
the conclusion of any institutional appeals. If an appeal is filed 
after the institution has transmitted the institutional record, the 
institution must promptly notify ORI so the agency can postpone 
oversight review until the institutional appeal is complete.

Subpart D Summary of Significant Public Comments and Changes

    Proposed Sec.  93.410(b) would allow ORI to publish notice of 
institutional research misconduct proceedings that did not result in 
ORI findings. Many commenters urged ORI to remove Sec.  93.410(b), 
which proposed that ORI may publish notice of institutional 
investigations and actions. Commenters cited regulatory overreach, 
breaches of confidentiality, and inconsistency with other agencies' 
policies. ORI removed 93.410(b) from the final rule, ensuring 
institutions have discretion in this area. Proposed Sec.  93.411 would 
require HHS to provide notification and publish final HHS actions that 
result in a finding of research misconduct. One commenter objected to 
replacing ``may'' with ``shall,'' regarding ORI's publication of 
findings and settlements. ORI restored the 2005 regulatory language of 
``may'' to retain flexibility.

Subpart E Summary of Significant Public Comments and Changes

    Proposed Sec.  93.512 provided for a simpler and more expedient 
appeals process, which would entail ALJ review of an administrative 
record 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 provided for the possibility of a limited 
hearing if the

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ALJ determines that there is a genuine dispute over material fact. One 
commenter, in response to the NPRM's request for comments on the scope 
of and need for limited hearings, suggested the research misconduct 
process allows for sufficient procedures to make such limited hearings 
unnecessary. ORI agreed, removed proposed Sec.  93.512 from the final 
rule, made clarifying edits throughout subpart E, including removing 
language concerning suspension and debarment and adding the qualifiers 
``proposed'' or ``HHS'' before the phrase ``administrative actions.''
    ORI made other changes in the final rule to generally provide 
clarity requested by the commenters. In addition to specific changes 
discussed below, ORI changed ``will'' to ``may'' in places throughout 
the final rule, as appropriate, to add flexibility. ORI made 
nonsubstantive edits throughout the final rule in accordance with the 
Plain Writing Act of 2010. ORI also merged or separated content within 
sections of the final rule to improve clarity and readability. ORI 
streamlined language to avoid repeatedly distinguishing research 
misconduct proceedings subject to part 93 from suspension and debarment 
actions governed by regulations separate and distinct from part 93. 
These changes either were nonsubstantive or increased the flexibility 
accorded to regulated entities.

III. Section-by-Section Description of Changes in the Final Rule

A. Application of Effective Date to Research Misconduct Proceedings, 
Final Rule Sec.  93.75

    Commenters suggested delaying the effective date of the final rule, 
citing the time required for institutions to update their policies and 
procedures and train staff, with many commenters recommending an 
effective date 18 months after the publication date. ORI retained the 
proposed effective date of January 1, 2025, but clarified that all 
regulatory requirements are applicable on or after January 1, 2026, in 
order to provide ample time for institutions to prepare for the final 
rule. ORI will not require institutions to implement and submit revised 
policies and procedures that comply with the final rule until the 
submission of their annual report covering 2025, which is due on or 
before April 30, 2026. ORI believes that this approach balances the 
need to promptly implement improvements made by the final rule with the 
time for institutions to update their policies and procedures. ORI 
added Sec.  93.75 to clarify the applicability date, specifying that 
beginning on January 1, 2026, an institution must follow the final rule 
for allegations received by the institution on or after January 1, 
2026. For allegations received by an institution before January 1, 
2026, an institution must follow 42 CFR part 93 as published in the 
2005 edition of the Code of Federal Regulations, unless the respondent 
and institution both elect in writing to follow the new final rule.

B. Applicability, NPRM Sec.  93.102(a)

    A number of commenters recommended removing the proposed 
requirement making each PHS funding recipient responsible for the 
compliance of their subrecipients, because institutional responsibility 
for regulatory compliance was not clarified. A few commenters 
recommended revision for the same reason, adding that subrecipients 
should have assurances on file with ORI to ensure compliance by all 
recipients of PHS funding. ORI removed the sentence, ``Further, each 
recipient of such support is responsible for the compliance of their 
subrecipients with this part,'' because ORI did not intend to impose a 
new burden on prime funding recipients; subrecipients are required to 
have their own assurances filed with ORI.

C. Applicability, NPRM Sec.  93.102(d)

    Revisions clarify that suspension and debarment at HHS are governed 
by regulations separate and distinct from part 93. As noted above, 
corresponding revisions throughout the final rule streamline language 
because there is no need to repeatedly distinguish research misconduct 
proceedings subject to this part from suspension and debarment actions 
subject to separate and distinct regulations. ORI also revised the 
language in this section to confirm that the Suspension and Debarment 
Official (SDO) and ORI may coordinate actions to the extent consistent 
with the SDO's and ORI's respective authorities. Such coordination 
includes jointly issuing notices or seeking settlements of actions and 
proceedings.

D. Research Misconduct, NPRM Secs. 93.103

    Commenters recommended deleting this section, because it duplicated 
information found elsewhere, specifically the definitions of 
fabrication, falsification, and plagiarism. ORI concurred and deleted 
this section in its entirety.

E. Requirements for Findings of Research Misconduct, NPRM Secs. 
93.104(a), (b), and (c)

    Commenters expressed appreciation that the proposed regulation 
clarified the three requirements for findings of research misconduct 
and confirmed three elements must be met. ORI made one change for 
grammatical consistency across all subsections.

F. Time Limitations, NPRM Sec.  93.105(b)

    Commenters recommended revising this section to state that 
institutions should be allowed to determine their own timeframe for 
applying subsequent use exceptions. ORI agreed institutions should be 
able to determine whether the subsequent use exception applies to a 
given case. To have a consistent regulatory standard across all 
institutions, ORI retained the six-year limitation. Commenters also 
expressed concern about the potential cost and burdens of the proposed 
requirement that institutions inform ORI of the relevant facts before 
concluding the subsequent use exception does not apply. ORI concurred 
and revised the section to require institutions to document how they 
determined the exception did or did not apply and to retain that 
information in the institutional record. ORI may address the 
application of the subsequent use exception for institutional reporting 
requirements through future policymaking.

G. Confidentiality, NPRM Sec.  93.106

    In response to commenters mentioning circumstances in which 
institutions may have a legitimate need to inform persons outside the 
institution about a pending research misconduct proceeding, ORI 
clarified that institutions may alert journal editors and others who 
need to know of potentially inaccurate data in a timely manner, and the 
final rule specifies that institutions are not prohibited from managing 
published data or acknowledging that data may be unreliable. In 
addition, to prevent some institutions from keeping research-related 
information confidential longer than necessary, the final rule now 
clarifies the length of time an institution is bound by the 
confidentiality provision. Commenters also stated that the language 
proposed in this section overcomplicated institutional confidentiality 
obligations and contained information more appropriate for guidance. 
ORI recognized institutions' concerns about overly prescriptive 
language and changed the final rule to provide greater latitude for

[[Page 76284]]

institutions to decide how to meet confidentiality requirements. ORI 
also removed the subsections that discussed what constitutes ``those 
who need to know.''

H. Appeal, NPRM Sec.  93.204

    Commenters recommended deleting this definition because it was 
unnecessary. ORI concurred and removed this definition.

I. Charge Letter, NPRM Sec.  93.206

    ORI removed specific language addressing joint charge letters, 
because Sec.  93.102(d) of the final rule addresses situations in which 
ORI and the SDO may jointly issue notices. ORI also revised proposed 
Sec.  93.206 to remove references to the SDO in the definition and 
avoid redundancy in subpart A.

J. Difference of Opinion, NPRM Sec.  93.211

    Several commenters recommended removing this definition because it 
did not enhance the clarity of the regulation. ORI agreed and removed 
this definition.

K. Honest Error, NPRM Sec.  93.217

    Several commenters requested revision of this definition of honest 
error. A minority of commenters asked ORI to add a reference to good 
faith and intent and to provide examples. Most commenters recommended 
removing the definition because they conveyed that it was unnecessary. 
ORI concurred and removed this definition.

L. Institutional Record, NPRM Sec.  93.223

    Commenters generally supported including this definition but 
expressed concerns about the institutional burden of sequestering 
irrelevant records and conveyed that the institutional investigation 
committee should have autonomy to decide which records to consider. 
While ORI understands sequestration imposes an institutional burden, 
ORI has found that records originally not considered by an institution 
may be relevant to the research misconduct proceeding. ORI balanced 
these concerns by revising the proposed definition of institutional 
record and retaining a maintenance requirement in Sec.  93.318 for 
sequestered evidence that is not part of the institutional record. ORI 
revised the proposed definition to clarify that the institutional 
record comprises all records the institution compiled or generated 
during the research misconduct proceeding, except for the records the 
institution did not consider or rely on. The institutional record index 
does not need to include records the institution did not consider or 
rely on. ORI revised the proposed definition to include a requirement 
for a general description of records sequestered but not considered or 
relied on. Additionally, ORI revised wording to clarify that 
assessments are to be documented, but an assessment report is not 
required. ORI intends to issue guidance on this topic.

M. Recklessly, NPRM Sec.  93.234

    Many commenters proposed revisions to this definition. Some 
commenters requested clarification of and distinction between the 
definitions of ``knowingly'' and ``recklessly,'' as well as a 
definition of ``harm.'' Several commenters requested guidance with 
examples to help institutions distinguish between ``careless'' and 
``reckless'' supervision. One commenter approved of the existing 
definition. ORI revised the definition in response to these comments to 
make it easier to apply in the research misconduct context. In 
particular, ORI revised the definition to make it specific to 
proposing, performing, or reviewing research, or reporting research 
results, rather than ``acting'' more generally, and specific to a risk 
of fabrication, falsification, or plagiarism.

N. Investigation, NPRM Sec.  93.225

    Commenters proposed revising this definition to provide further 
clarification. ORI agreed and revised the definition by removing 
unnecessary language for clarity.

O. Research Integrity, NPRM Sec.  93.236

    Many commenters recommended removing this definition because they 
found it narrow, unclear, and inconsistent with the National Academies 
of Sciences, Engineering, and Medicine (NASEM) definition. One 
commenter recommended retaining the proposed definition. ORI decided to 
remove this definition and may provide future guidance on this topic.

P. Research Misconduct Proceedings, NPRM Sec.  93.239

    Regarding the appeals process and involvement of an ALJ, ORI added 
clarifying language, ``appeals under subpart E,'' to avoid ambiguity 
and to distinguish this process from institutional appeals.

Q. Research Record, NPRM Sec.  93.240

    Commenters requested clarification of this definition. ORI added 
``records of'' before ``oral presentations'' to exclude from the 
definition any records of completely internal presentations where 
problems were potentially identified and corrected before outside 
reporting. ORI also changed the phrase ``internal reports'' to ``lab 
meeting reports'' to clarify the meaning of this phrase, which may be 
part of the research record. Additionally, ORI removed ``internet'' 
from ``internet and online'' content because of the repetitive meaning 
of the two words. ORI intends to issue guidance on this definition.

R. Small Institution, NPRM Sec.  93.244

    Several commenters recommended revisions to the definition because 
they conveyed that the criteria used to designate a small institution 
were overly restrictive. ORI agreed and removed the statement that a 
small institution typically has ``a total of 10 or fewer institutional 
members'' and may address this topic through future policymaking.

S. Suspension and Debarment, NPRM Sec.  93.245

    ORI removed this proposed definition of ``suspension and 
debarment'' and merged significant aspects of the definition with 
``Suspension and Debarment Official or SDO'' to reduce redundancy.

T. Institutional Policies and Procedures, NPRM Sec.  93.304

    One commenter commended ORI for requiring all institutions to file 
an assurance to apply for PHS support. Commenters expressed concern 
about omitting the 2005 regulation's requirement to make all reasonable 
and practical efforts to restore the reputation of respondents not 
found to have committed research misconduct. Commenters requested 
restoring proposed Sec.  93.304 to the 2005 wording. ORI concurred and 
restored the 2005 wording regarding policies and procedures to protect 
the reputation of respondents when no finding has been made.

U. General Conduct of Research Misconduct Proceedings--Sequestration of 
Research Records and Other Evidence, NPRM Sec.  93.305(a)

    ORI noted the requirement to sequester all research records and 
other evidence was mentioned more than once in the NPRM. To reduce 
redundancy, this requirement is explained in full only once in the 
final rule, under General Conduct of Research Misconduct Proceedings.

V. General Conduct of Research Misconduct Proceedings--Multiple 
Respondents, NPRM Sec.  93.305(d)

    Some commenters appreciated the provision that permits an 
institution to add respondents to an ongoing research misconduct case 
without conducting a separate inquiry for each new

[[Page 76285]]

respondent. Others expressed the provision could set a precedent that 
infringes on respondents' rights. To address this concern, the final 
rule specifies that each additional respondent must be provided notice 
of the allegations and an opportunity to respond, consistent with 
subpart C. Some commenters were also concerned that listing the types 
of researchers the institutions should consider as potential 
respondents created a confusing standard and could be detrimental to 
those individuals. ORI concurred and removed the list of potential co-
respondents as well as the parenthetical list of additional research 
records to examine, because these lists were intended to be exemplary 
rather than prescriptive. Some commenters suggested changing ``must 
consider whether any additional researchers are responsible'' to ``may 
consider whether any additional researchers are responsible.'' ORI 
revised this section to allow institutions the flexibility to use their 
own judgment.

W. General Conduct of Research Misconduct Proceedings--Pursue Leads, 
NPRM Sec.  93.305(f)

    Some commenters found this section overly prescriptive while others 
found it overly broad. Many commenters were concerned that pursuing all 
leads during an inquiry would be burdensome and costly--as well as 
cause reputational harm to innocent researchers. ORI concurred and 
moved the requirement to pursue all leads to Sec.  93.310(j), which 
details the investigation requirements. ORI also removed the 
parenthetical list of additional research records to examine, because 
it was intended to be exemplary, not prescriptive. ORI intends to 
provide further guidance specifying recommended practices for pursuing 
leads.

X. General Conduct of Research Misconduct Proceedings--Interviews, NPRM 
Sec.  93.305(g)

    Commenters objected to the proposed requirement to transcribe all 
interviews, especially interviews conducted during the assessment or 
inquiry phase, because it could discourage reporting of allegations and 
contribute to institutional burden. Some commenters expressed that if 
transcriptions are mandatory, they should be required only during the 
investigation. ORI concurred, revised the proposed section, and moved 
it to Sec.  93.310(g), which details the investigation requirements. 
The revised section removes the requirement for transcribed interviews 
during the assessment and inquiry phases.

Y. Conduct of Research Misconduct Proceedings--Using a Committee, 
Consortium, or Other Person for Research Misconduct Proceedings, NPRM 
Sec.  93.305(h)

    Some commenters noted a concern that this section may not provide 
fair procedures to respondents. Other commenters recommended removing 
the section entirely, stating that institutions should be allowed to 
institute best practices without regulatory oversight. A few commenters 
favored retaining the section as proposed. ORI removed all portions of 
the proposed subsection that did not specify requirements--that is, 
sections on the institution's choice to use a committee, consortium, or 
person to conduct, support, or participate in proceedings; what a 
consortium might be comprised of; and the institution's choice to allow 
respondents/complainants to object to committee or consortium 
member(s). The information was intended to be exemplary, not 
prescriptive.

Z. Institutional Assessment, NPRM Sec.  93.306

    A number of commenters were concerned about the burden of increased 
pre-investigation reporting requirements. ORI concurred and revised 
this section to simplify the assessment phase and require institutions 
to document their assessment process rather than write a formal report. 
Commenters also expressed concern about potential harm to respondents' 
reputations if ORI is permitted to read an institution's assessment 
documentation. In response to the concern about reputational harm, ORI 
notes that any assessment documentation obtained by ORI will be subject 
to the Privacy Act, 5 U.S.C. 552a. Many commenters asked ORI to remove 
Sec.  93.306(e), which proposed requiring institutions to complete the 
assessment within 30 days. Commenters expressed that this timeline was 
unrealistic, would be burdensome for institutions, and could undermine 
the rigor and utility of the sequestration process. One commenter was 
concerned about the impact of this assessment timeframe on respondents' 
mental health. ORI concurred and removed the 30-day assessment timeline 
requirement.

AA. Institutional Inquiry, NPRM Sec.  93.307

    Some commenters requested clarification because the process for 
notifying additional respondents of an institutional inquiry appeared 
unclear. ORI concurred and revised this section to simplify the 
language. Commenters also recommended removing proposed Sec.  
93.307(f)(2) because they conveyed that the requirement that 
institutions determine honest error only at the investigation stage 
would unfairly burden both respondents and institutions. ORI agreed and 
removed proposed Sec.  93.307(f)(2). Several commenters recommended 
removing proposed Sec.  93.307(h), which set a 60-day timeframe for 
completing an inquiry, stating that institutions should have more 
flexibility in the timeframe to thoroughly conduct an inquiry. ORI 
concurred and lengthened the inquiry timeline from 60 to 90 days. If 
the inquiry takes longer than 90 days to complete, the inquiry report 
must document the reasons for exceeding the 90-day period. ORI also 
revised references to ``research records'' throughout the final rule to 
ensure consistency with Sec.  93.307(d), which describes ``research 
records and other evidence.'' In addition, ORI removed proposed Sec.  
93.307(e)(5) in the final rule to eliminate redundancy, because Sec.  
93.310(j) specifically addresses the institutional responsibility to 
pursue all leads.

BB. Reporting to ORI on the Decision To Initiate an Investigation, NPRM 
Sec.  93.309

    ORI removed the proposed requirement that the Institutional 
Deciding Official review the inquiry report and provide a written 
decision to proceed to an investigation, to eliminate potential 
administrative burden.

CC. Institutional Investigation, NPRM Sec.  93.310

    A few commenters recommended removal of Sec.  93.310(c)(2) because 
they expressed a concern that the regulation infringes on the rights of 
respondents who are added to an ongoing investigation without an 
additional inquiry. ORI clarified in Sec.  93.310(c)(2) that when a new 
respondent is added to an ongoing proceeding, institutions may but are 
not required to conduct a separate inquiry for additional respondents, 
and additional respondents must be notified of allegation(s) and 
provided an opportunity to respond consistent with subpart C. In 
response to commenters requesting additional clarity for regulated 
entities, ORI moved proposed Sec.  93.310(h) regarding the 
institutional responsibility to pursue leads to Sec.  93.310(j) and 
streamlined the language, including clarifying the respondent 
notification requirement.

[[Page 76286]]

DD. Investigation Report, NPRM Sec.  93.313(k)

    Commenters requested clarity on how the investigation report should 
identify sequestered evidence. Commenters also recommended removing 
Sec.  93.313(k), which included a requirement that institutions 
identify any research records and other evidence obtained and 
sequestered but not reviewed, because it was deemed resource-intensive 
and an unnecessary burden. ORI revised Sec.  93.313 to replace proposed 
Secs. 93.313(e) and (k) with a single requirement in Sec.  93.313(e) to 
include in the investigation report an inventory of sequestered 
research records and other evidence, except records the institution did 
not consider or rely on. ORI made a corresponding revision to Sec.  
93.220(c) of the final rule requiring that the institutional record 
include a general description of the records that were sequestered but 
not considered or relied on. ORI notes that the general description in 
Sec.  93.220(c) does not require identification of specific files or 
emails but allows for a broader summary of the types of files or emails 
sequestered.

EE. Investigation Report, NPRM Sec.  93.313(l)(2)

    Commenters recommended removing language in proposed Sec.  
93.313(l)(2) prohibiting investigation committees from making a split 
decision. ORI removed that prohibition and included language that the 
report must clearly state the investigation committee's conclusions 
regarding whether research misconduct occurred for each separate 
allegation.

FF. Institutional Appeals, NPRM Sec.  93.314

    Commenters recommended deleting or significantly revising proposed 
Sec.  93.314, which requires institutions to complete any institutional 
appeals within 120 days or seek an extension, contending the 
institutional appeal was within the institution's purview, not ORI's. 
ORI concurred and removed most of the requirements in Sec.  93.314. ORI 
recognizes the potential inefficiency of starting oversight review 
while an institutional appeal is ongoing that could reverse or modify 
the institutional findings of research misconduct. The final rule 
clarifies that institutions should not transmit their institutional 
record until the conclusion of any institutional appeals. If an appeal 
is filed after the institution has transmitted the institutional 
record, the institution must promptly notify ORI so the agency can 
postpone oversight review until the institutional appeal is complete.

GG. Decision by the Institutional Deciding Official, Final Rule Sec.  
93.314

    ORI added this section to clearly identify the responsibilities of 
the Institutional Deciding Official at the conclusion of an 
investigation and to respond to commenters generally requesting 
additional clarity.

HH. Completing the Research Misconduct Process, NPRM Sec.  93.316(a)

    ORI revised the requirement that institutions notify ORI in advance 
if an institution plans to close research misconduct proceedings to 
omit ``or for any other reason'' to eliminate unnecessary burden.

II. Institutional Standards of Conduct, NPRM Sec.  93.318

    This section was intended to indicate that ORI findings of research 
misconduct or HHS settlements of research misconduct proceedings, or 
the absence thereof, do not affect institutional findings or actions 
taken based on an institution's standards of conduct. ORI combined (a) 
and (b) of this section and clarified language accordingly.

JJ. Interaction With Other Entities and Interim Actions, NPRM Sec.  
93.401

    ORI added language to clarify the relationship between ORI and the 
HHS official authorized to impose suspension and debarment.

KK. Final HHS Actions, NPRM Sec.  93.406

    ORI removed unnecessary language regarding suspension and 
debarment.

LL. HHS Administrative Actions, NPRM Sec.  93.407

    ORI revised this section to clarify that, for purposes of this 
regulation, HHS administrative actions do not include suspension and 
debarment. However, the HHS official authorized to impose suspension 
and debarment remains free to pursue those actions under applicable 
regulations, as stated in Sec.  93.407(d).

MM. Mitigating and Aggravating Factors in HHS Administrative Actions, 
NPRM Sec.  93.408

    ORI removed unnecessary language regarding suspension and 
debarment.

NN. Final HHS Action With No Settlement or Finding of Research 
Misconduct, NPRM Sec.  93.410(a)

    ORI removed the phrase ``as it deems necessary'' in Sec.  93.410(a) 
because it does not add further meaning to the section.

OO. Final HHS Action With No Settlement or Finding of Research 
Misconduct, NPRM Sec.  93.410(b)

    Many commenters urged ORI to remove Sec.  93.410(b), which proposed 
that ORI publish notice of institutional investigations and actions. 
Commenters cited regulatory overreach, breaches of confidentiality, and 
inconsistency with other agencies' policies. One commenter noted that 
ORI's publication of institutional reports and findings would be 
inconsistent with the confidentiality provisions established in the 
clinical research context. A minority of commenters recommended 
revising the section to redact respondents' identifying information to 
ensure confidentiality. A few commenters recommended retaining the 
section as proposed. ORI removed proposed Sec.  93.410(b) from the 
final rule, ensuring institutions have discretion in this area.

PP. Final HHS Action With a Settlement or Finding of Misconduct, NPRM 
Sec.  93.411

    One commenter objected to replacing ``may'' with ``shall,'' 
regarding ORI's publication of findings and settlements. ORI restored 
the 2005 regulatory language of ``may'' to retain flexibility.

QQ. HHS Compliance Actions, NPRM Sec.  93.413

    ORI revised this section to clarify the process for making a 
discretionary referral to the HHS official authorized to impose 
suspension and debarment under separate and distinct regulations. In 
addition, ORI changed the section's name to ``ORI compliance actions'' 
for accuracy.

RR. Notice, NPRM Sec.  93.414

    One commenter objected to replacing ``may'' with ``shall'' 
regarding ORI's publication of findings and settlements. ORI restored 
the 2005 regulatory language of ``may'' to retain flexibility. 
Commenters were concerned this portion of the proposed regulation 
weakens respondents' confidentiality protections and runs counter to 
the remedial purpose of regulations and HHS administrative actions. One 
commenter requested adding language to protect the institution's 
confidentiality in subsection (b). Numerous commenters recommended 
requiring ORI to notify the relevant institution when it closes a case 
without a settlement or a finding of research misconduct. One commenter 
expressed that ORI should attempt to restore the reputation of 
respondents not found to have committed research misconduct; they also 
expressed that if a complainant is found to have conflicts

[[Page 76287]]

of interest with the respondent, ORI should consider taking action 
against the complainant. Another commenter was concerned about Sec.  
93.414(f), which provides that any publications or disclosures pursuant 
to this section are not considered appealable ``administrative 
actions.'' ORI revised this section for clarity and removed proposed 
subsections 93.414(c)-(f) in response to the comments.

SS. General Policy, NPRM Sec.  93.500

    ORI revised this section to clarify that a respondent must exhaust 
administrative remedies under this part prior to seeking judicial 
review in Federal court.

TT. Conferences, NPRM Sec.  93.510

    ORI revised this section to restore in subsection 93.510(e) the 
phrase ``Whenever possible'' from the 2005 regulation to retain 
flexibility for the ALJ.

UU. Hearing To Resolve Genuine Factual Dispute, NPRM Sec.  93.511

    One commenter, in response to the NPRM's request for comments on 
the scope of and need for limited hearings, suggested the research 
misconduct process allows for sufficient procedures to make such 
limited hearings unnecessary. ORI agreed, removed proposed Sec.  93.511 
from the final rule, and made corresponding edits throughout subpart E.

VV. The Administrative Law Judge's Ruling, NPRM Sec.  93.512

    To promote consistency in agency decision making, ORI reinstated 
and updated from the 2005 regulation an opportunity for the Assistant 
Secretary for Health (ASH) to review the ALJ's decision under subpart 
E. Although Sec.  93.511 in the final rule explicitly provides that the 
ASH may review the ALJ's recommended decision before it becomes final, 
the ASH and the Secretary also have the ability to review ORI findings 
of research misconduct and/or proposed HHS administrative actions 
before a charge letter is issued under Sec.  93.405 and to act as final 
decision maker before a charge letter is issued, if either of them so 
chooses.

IV. Significant Comments Not Resulting in Changes

A. Accepted Practices of the Relevant Research Community, NPRM Sec.  
93.200

    Commenters supported retaining this proposed definition but found 
it overly expansive. Commenters recommended revised language, including 
practices specific to PHS-funded research. ORI left this definition 
unchanged to acknowledge the expanding universe of research 
disciplines.

B. Allegation, NPRM Sec.  93.203

    Commenters supported revising this definition to clarify purposeful 
disclosure of possible research misconduct. After consideration, ORI 
left the definition as proposed, to avoid adding another element to the 
definition that may discourage reporting possible research misconduct.

C. Assessment, NPRM Sec.  93.205

    Many commenters recommended deleting this definition because they 
conveyed that it was unnecessary. Some commenters' recommended 
revisions were related to concerns about the proposed description of 
the assessment phase in subpart C. A minority of commenters supported 
the inclusion of the definition but sought clarification for what 
constitutes readily available information. ORI made changes to subpart 
C and left the definition of ``assessment'' as proposed because there 
was no consensus among the comments and because it was satisfied that 
the proposed definition served the purpose of explaining the term to 
those who may be unfamiliar with the term in the research misconduct 
context. ORI may address this topic through future policymaking.

D. Complainant, NPRM Sec.  93.207

    Commenters recommended revising this definition to add details 
about complainant anonymity. ORI agreed on the importance of anonymity 
and addressed confidentiality elsewhere in subpart A of the final rule. 
ORI left the definition of complainant unchanged.

E. Contract, NPRM Sec.  93.208

    One commenter proposed removing this definition because it is a 
commonly understood term. ORI opted to leave the definition as 
proposed, because it is helpful to those who are not familiar with 
contracts under the Federal Acquisition Regulation.

F. Day, NPRM Sec.  93.209

    Some commenters recommended removing or revising this definition to 
factor in academic calendars. Since academic calendars vary, ORI 
retained the definition in its proposed form.

G. Departmental Appeals Board, NPRM Sec.  93.210

    One commenter recommended removing this definition because it is a 
commonly understood term. ORI retained the definition in its proposed 
form because it is helpful to those who are not familiar with that 
organization.

H. Evidence, NPRM Sec.  93.212

    A small number of commenters provided contradictory recommendations 
about removing or enhancing the definition. ORI retained the definition 
in its proposed form because there was no consensus among the comments 
and because it was satisfied that the proposed definition served the 
purpose of explaining the term to those who may be unfamiliar with the 
term in the research misconduct context.

I. Falsification, NPRM Sec.  93.214

    One commenter recommended revising this definition to include 
allegations of misconduct and intent. ORI retained the definition in 
its proposed form because it is consistent with the definition found in 
the 2000 Office of Science and Technology Policy's Federal Policy on 
Research Misconduct, 65 FR 76260 (Dec. 6, 2000).

J. Good Faith, NPRM Sec.  93.216

    Some commenters recommended revising this definition to express 
nuance without fundamentally altering its meaning. ORI retained the 
definition in its proposed form because commenters were not opposed to 
the meaning expressed in the definition.

K. Institution, NPRM Sec.  93.219

    One commenter recommended revising this definition to clarify that 
institutions are not persons. ORI retained the definition in its 
proposed form. While the definition refers to ``any person,'' the term 
``person'' is defined in Sec.  93.226 of the final rule to include both 
individuals and other legal entities that are not individuals.

L. Institutional Deciding Official, NPRM Sec.  93.221

    Commenters recommended revising this definition to permit the 
Research Integrity Officer, or RIO, to serve as the Institutional 
Deciding Official. ORI retained the definition in its proposed form, 
because requiring a different individual to serve in each role will 
better ensure a fair and unbiased outcome.

M. Institutional Member, NPRM Sec.  93.222

    Commenters recommended revising the definition to remove the 
inclusion of subcontractors and subrecipients. ORI retained the 
definition in its proposed form and clarified related wording under 
``Applicability'' in subpart A, because an individual's duty to protect 
PHS funds from misuse should not depend on the individual's employment 
status with a specific institution.

[[Page 76288]]

N. Intentionally, NPRM Sec.  93.224

    Commenters suggested revising this definition to provide further 
clarification. One commenter also suggested better harmonization with 
definitions used by other Federal agencies. ORI retained the definition 
in its proposed form to avoid including additional terms that could 
introduce ambiguity. ORI intends to explore opportunities to harmonize 
policy across Federal entities.

O. Knowingly, NPRM Sec.  93.226

    Many commenters generally supported retaining this proposed 
definition; however, several commenters requested clarification on 
distinctions among ``knowingly,'' ``recklessly,'' and 
``intentionally.'' ORI retained the definition in its proposed form to 
avoid including additional terms that could introduce ambiguity.

P. Notice, NPRM Sec.  93.227

    One commenter recommended removing this definition. Another 
commenter recommended revision to remove the word ``serve.'' ORI 
retained the definition because it describes an essential part of the 
process of notifying respondents. ORI retained the word ``serve'' for 
clarity and notes that the definition does not require the use of a 
process server.

Q. Office of Research Integrity or ORI, NPRM Sec.  93.228

    One commenter recommended removing this definition because it is a 
commonly understood term. ORI retained the definition in its proposed 
form because it is helpful to the public.

R. Plagiarism, NPRM Sec.  93.230

    Commenters recommended revising this definition, particularly to 
clarify ``self-plagiarism.'' ORI retained the definition in its 
proposed form. Because ``plagiarism'' is defined as the appropriation 
of ``another person's'' ideas, processes, results, or words, without 
giving appropriate credit, the exclusion of a ``self-plagiarism'' 
definition was intended to confirm that the appropriation must be of 
``another person's'' rather than one's own ideas, processes, results, 
or words. Thus, ORI does not believe it necessary to further define 
``self-plagiarism'' in its regulation, but ORI may address this topic 
through future policymaking.

S. Preponderance of Evidence, NPRM Sec.  93.231

    One commenter supported the inclusion of the definition. Another 
commenter recommended revision to clarify the definition. ORI retained 
the definition because there was no consensus among the comments and 
because it was satisfied that the proposed definition served the 
purpose of explaining the term to those who may be unfamiliar with the 
term in the research misconduct context.

T. Research Integrity Officer or RIO, NPRM Sec.  93.237

    Several commenters provided feedback on this definition. Many 
commenters supported the inclusion of this definition. A minority of 
commenters recommended its removal because they conveyed that it was 
unnecessary or confusing. ORI retained the definition in its proposed 
form because it is helpful to the public and clarifies the specific 
responsibilities of this role.

U. Research Misconduct, NPRM Sec.  93.238

    Commenters recommended revision of the definition to include 
questionable research practices. One commenter conveyed that the 
definition was unnecessary. One commenter requested retention of the 
proposed definition. ORI decided to retain this definition because it 
is consistent with the definition found in the 2000 Office of Science 
and Technology Policy's Federal Policy on Research Misconduct, 65 FR 
76260 (Dec. 6, 2000).

V. Retaliation, NPRM Sec.  93.242

    Commenters recommended revision of this definition to make it more 
expansive. ORI retained the definition in its proposed form as a more 
limited definition is needed to accommodate HHS components that address 
retaliation in other contexts.

W. General Responsibilities for Compliance, NPRM Sec.  93.300(g)

    Commenters proposed removing the portion of Sec.  93.300(g) that 
requires institutions to address deficiencies or additional 
allegations, noting that ORI already has a broad mandate to ensure 
compliance. One commenter asked ORI to add a requirement that 
institutions take precautions to ensure that complainants do not have 
unresolved conflicts of interest with the respondent. Some commenters 
recommended retaining the section as proposed. Commenters also 
requested more guidance on fostering an environment of research 
integrity and developing and evaluating effective training programs; 
one commenter offered suggestions about how to improve Responsible 
Conduct of Research training. ORI acknowledges the compliance process 
can be complex. ORI left this section unchanged because providing 
guidance rather than stipulating additional regulatory requirements 
reduces institutional burden. ORI intends to issue further guidance on 
these topics.

X. Research Integrity Assurances, NPRM Sec.  93.301

    One commenter noted changing the title of this section from 
``Institutional Assurances'' to ``Research Integrity Assurances'' was 
confusing and could be misread as materially altering the nature of 
institutional assurances. One commenter expressed it was inappropriate 
to require the person who coordinates an institution's compliance 
assurances and Responsible Conduct of Research program to also be 
responsible for fostering an environment that supports research 
integrity, because that is a leadership-level responsibility. There was 
a request for more specific guidance on how institutions can foster 
research integrity, with examples focused not only on research but also 
the concept of ``research integrity'' more broadly. ORI acknowledges 
the compliance process can be complex. ORI left this section unchanged 
because providing guidance rather than stipulating additional 
regulatory requirements reduces institutional burden. ORI intends to 
issue further guidance on these topics.

Y. Maintaining Active Research Integrity Assurances, NPRM Sec.  
93.302(a)

    One commenter requested greater clarity in proposed Sec.  
93.302(a)(4)(ii) on the scope of policies and procedures that 
institutions are required to make publicly available. ORI intends to 
issue guidance on this topic.

Z. General Conduct of Research Misconduct Proceedings--Sequestration of 
Research Records and Other Evidence, NPRM Sec.  93.305(a)

    Most commenters approved of proposed Sec.  93.305(a) and expressed 
appreciation that institutions may sequester copies of records if they 
are substantially equivalent in evidentiary value. ORI retained the 
language as proposed.

AA. General Conduct of Research Misconduct Proceedings--Multiple 
Institutions, NPRM Sec.  93.305(e)

    Commenters appreciated ORI's addition of this subsection because 
there has been an increase in complex cases involving more than one 
institution. However, they requested further guidance on how to handle 
such cases, including how to determine a lead institution. ORI intends 
to issue further guidance on this topic.

[[Page 76289]]

BB. General Conduct of Research Misconduct Proceedings--Interviews, 
NPRM Sec.  93.305(g)

    Some commenters suggested revising NPRM section Sec.  93.305(g)(5) 
to require institutions to redact all interview transcripts before 
forwarding them to the respondent, to protect interviewees' identities. 
ORI left this section unchanged and moved it to Sec.  93.310(g) because 
policies regarding interview transcriptions prior to the investigation 
phase should be left to the discretion of institutions.

CC. Institutional Investigation, NPRM Sec.  93.310

    Commenters recommended revising Sec.  93.310(a) to extend the time 
to begin an investigation. ORI retained the proposed language because 
it is important to proceed promptly after an institution decides an 
investigation is warranted.

DD. Investigation Time Limits, NPRM Sec.  93.311

    Several commenters approved of ORI's increasing the investigation 
period from 120 to 180 days; however, a significant number of 
commenters expressed that 180 days is inadequate to conduct a thorough 
investigation. These commenters requested timeframes ranging up to a 
year or more. ORI retained the proposed 180-day timeline, because the 
timeframe balances the needs of institutions and the need of 
respondents to have investigations conclude within a reasonable amount 
of time, and institutions have the opportunity to request extensions. 
ORI will continue to work closely with institutions that request and 
substantiate the need for an extension.

EE. Interaction With Other Entities and Interim Actions, NPRM Sec.  
93.401(b)

    Commenters recommended revising Sec.  93.401(b) to require ORI to 
notify the RIO or the Institutional Deciding Official if ORI makes a 
determination to refer a case to the Department of Justice or other 
Federal agencies while the institution's research misconduct 
proceedings are pending. ORI retained the language of this section 
because such referrals are nonpublic.

FF. ORI Allegation Assessments, NPRM Sec.  93.402

    One commenter was concerned about the removal of language that was 
in the 2005 regulation specifying the requirements for ORI to conduct 
an assessment. ORI did not restore the language because it is redundant 
with Sec.  93.204 of the final rule.

GG. Final HHS Action With No Settlement or Finding of Research 
Misconduct, NPRM Sec.  93.410(b)

    One commenter stated that the institutional investigation report is 
part of a PHS-supported research process and should be made public; 
they suggested copies of or links to all institutional investigation 
reports should be posted on the ORI website. ORI retained the language 
as proposed because the institutional investigation report is not a 
public document and is protected by the Privacy Act, 5 U.S.C. 552a.

HH. Rights of the Parties, NPRM Sec.  93.505

    One commenter suggested that discovery and de novo review are not 
needed; all that should be required is consideration of all the 
evidence available to the ALJ, including the institutional record and 
additional testimony and other evidence provided during the appeal. ORI 
did not make further changes because ORI already proposed removing the 
discovery and de novo review provisions in the NPRM.

V. Effective Date

    The final rule will become effective January 1, 2025, and all 
regulatory requirements will be applicable on January 1, 2026, which 
will apply prospectively. The effect of the prospective application to 
research misconduct proceedings will depend on when allegations are 
received by institutions. The final rule applies to research misconduct 
proceedings based on allegations received by institutions on or after 
January 1, 2026. For allegations received by an institution prior to 
January 1, 2026, an institution must follow 42 CFR part 93 as published 
in the 2005 edition of the Code of Federal Regulations, unless a 
respondent and institution agree in writing to apply the final rule to 
a particular research misconduct proceeding. Institutions must 
implement and submit revised policies and procedures that comply with 
the final rule along with their annual report covering 2025, which must 
be received by ORI on or before April 30, 2026.

VI. Required Regulatory Analyses

    We examined the impacts of the final rule under Executive Order 
12866, Executive Order 13563, Executive Order 14094, the Regulatory 
Flexibility Act (5 U.S.C. 601-612), the Unfunded Mandates Reform Act of 
1995 (Pub. L. 104-4), and the Congressional Review Act (5 U.S.C. 801-
808).
    Executive Orders 12866, 13563, and 14094 direct us to assess all 
benefits, costs, and transfers 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). A ``significant regulatory action'' under Executive Order 
12866 Section 3(f)(1) (as amended by Executive Order 14094) includes a 
``regulatory action likely to result in a rule that may have an annual 
effect on the economy of $200 million or more (adjusted every 3 years 
by the Administrator of [the Office of Information and Regulatory 
Affairs (OIRA)] for changes in gross domestic product); or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, territorial, or tribal governments or 
communities.'' The analysis below concludes that this final rule is not 
a significant regulatory action under Executive Order 12866 Section 
3(f)(1). OIRA has determined that this final rule is a significant 
regulatory action, but that it does not meet the criteria set forth in 
5 U.S.C. 804(2) under the Congressional Review Act.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
institutions. The analysis below concludes that the final rule will not 
have a significant economic impact on a substantial number of small 
institutions.
    The Unfunded Mandates Reform Act of 1995 (UMRA) generally requires 
that each agency conduct a cost-benefit analysis, identify and consider 
a reasonable number of regulatory alternatives, and select the least 
costly, most cost-effective, or least burdensome alternative that 
achieves the objectives of the rule before promulgating any proposed or 
final rule that includes a Federal mandate that may result in 
expenditures of more than $100 million (adjusted for inflation) in at 
least one year by State, local, and tribal governments, or by the 
private sector. Each agency must also seek input from State, local, and 
tribal governments. The current threshold after adjustment for 
inflation using the Implicit Price Deflator for the Gross Domestic 
Product is $183 million, reported in 2023 dollars. Per the analysis 
below, this final rule will not result in an unfunded mandate in any 
year that meets or exceeds this amount.

Baseline and Summary of Impacts

    Under the current regulatory requirements, all recipients of PHS

[[Page 76290]]

support for biomedical or behavioral research, biomedical or behavioral 
research training, or activities related to that research or research 
training must comply with certain reporting and record keeping 
requirements. However, since many of these impacts have not been 
comprehensively quantified and monetized in a previously published 
regulatory impact analysis, when considering the potential impacts of 
this final rule, we adopt an analytic baseline that excludes many 
ongoing activities associated with the existing requirements. For 
example, absent any further regulatory action, we anticipate that 
covered entities would continue to incur costs (inclusive of the 
opportunity costs of staff time and other resources) associated with 
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 final rule will likely reduce the burden of 
compliance by institutions through reduced confusion and uncertainty. 
Thus, the benefits of this final rule stem from reduced confusion for 
research institutions to understand the requirements that apply to 
them. This final rule will reduce the potential for lengthy back-and-
forth discussions between ORI and institutions to ensure that 
institutions conduct complete and fair investigations of allegations of 
research misconduct. It will also streamline the process for 
respondents to appeal ORI findings of research misconduct and proposed 
HHS administrative actions. We anticipate that these revisions will 
reduce the burden across the affected research community. This final 
rule will also help foster an environment of responsible conduct of 
research.
    We anticipate that this final rule will likely result in one-time 
costs associated with covered institutions updating their policies and 
procedures for responding to allegations of research misconduct. For 
institutions that undertake proceedings to address allegations of 
research misconduct, we identify and monetize additional recurring 
costs associated with documenting aspects of those proceedings. We 
quantify and monetize these costs in the next section.

One-Time Costs Associated With Updating Policies and Procedures

    In support of the NPRM, 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 a significant regulatory action 
per section 3(f)(1) of Executive Order 12866. We identified the 
potential 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. To quantify 
this impact, we adopted a count of 5,910 institutions holding research 
integrity assurances that would update their policies and procedures. 
For the purposes of the initial threshold analysis, we adopted 16 hours 
as an estimate for the average time across all covered entities for 
these tasks. Across all covered entities, this was 94,560 total hours 
spent updating policies and procedures.
    To monetize the change in time use associated with these 
activities, we adopted 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 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. 
Accessed March 29, 2024.
---------------------------------------------------------------------------

    For these tasks, we identified 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 was $53.49 per 
hour.\2\ We assumed that benefits plus indirect costs equal 
approximately 100 percent of pre-tax wages, and adjusted this hourly 
rate by multiplying by two, for a fully loaded hourly wage rate of 
$106.98. We multiplied this fully loaded hourly wage rate by the 94,560 
total hours across covered entities spent updating policies and 
procedures and estimated 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. 
Accessed March 29, 2024.
---------------------------------------------------------------------------

    We received public comments suggesting it will take institutions 
more than 16 hours to update their policies and procedures,\3\ with 
alternative estimates including between 17-26 hours, between 27-40 
hours, or more than 40 hours. We appreciate these comments, and in 
response, we present an additional threshold analysis, following the 
same approach described above, but adopting several revised assumptions 
and updated data. This threshold analysis helps to determine whether it 
will result in a significant regulatory action per section 3(f)(1) of 
Executive Order 12866 and to determine whether any effects will exceed 
the UMRA threshold. For this analysis, we adopt a more recent estimate 
that 6,394 institutions holding research integrity assurances. 
Consistent with an upper-bound estimate from public comments, we adopt 
40 hours as the average hours per covered entity. We updated the pre-
tax hourly wage to $55.38 per hour,\4\ for a fully loaded hourly wage 
rate of $110.76. The modified assumptions indicate that, across all 
covered entities, 255,760 hours would be spent updating policies and 
procedures. Monetizing this impact using the fully loaded hourly wage 
rate, this would represent a cost in the first year of about $28.3 
million. Thus, our modified threshold analysis indicates that the 
largest economic impact of the final rule would not exceed the monetary 
threshold for significant regulatory actions per section 3(f)(1) of 
Executive Order 12866 or the UMRA threshold. We emphasize that this 
estimate corresponds to an upper-bound estimate of the potential 
impacts based on public comments to the proposed rule.
---------------------------------------------------------------------------

    \3\ For example, see ``Comment from COGR, HHS-OASH-2023-0014, 
HHS-OASH-2023-0014-0001, 2023-21746.'' https://www.regulations.gov/comment/HHS-OASH-2023-0014-0074. Accessed March 29, 2024.
    \4\ U.S. Bureau of Labor Statistics. Occupational Employment and 
Wages, May 2022. 11-9033 Education Administrators, Postsecondary. 
Mean hourly wage. https://www.bls.gov/oes/current/oes119033.htm. 
Accessed March 29, 2024.
---------------------------------------------------------------------------

    As discussed in greater detail in the Preamble, this final rule 
includes several revisions that generally reduce the burden on the 
institutions covered, compared to the proposed rule. To estimate the 
costs associated with covered institutions updating their policies and 
procedures, we adopt 16 hours as an estimate for the average time per 
covered entity and apply the updated fully loaded hourly wage

[[Page 76291]]

estimate ($110.76) and covered entity count (6,394 institutions). 
Combining these assumptions results in an estimate of the total cost 
associated with updating policies and procedures in the first year of 
about $11.3 million.

Recurring Costs Attributable to the Final Rule

    For institutions that address allegations of research misconduct, 
we identify additional recurring costs associated with the final rule's 
reporting, recordkeeping, and third-party disclosure requirements 
related to institutions responding to allegations of research 
misconduct. To quantify these impacts, we adopt an estimate of 230 
cases per year, matching the most recent annual count of cases reported 
to HHS.
    Consistent with our estimates in the Paperwork Reduction Act 
section of this Preamble, we believe that institutions will spend a 
total of 221,030 hours per year on these requirements, which is about 
961 hours per case. To monetize these impacts, we adopt the fully 
loaded hourly value of time of $110.76 per hour for postsecondary 
education administrators. Across all 230 cases, we compute an annual 
cost associated with these regulatory requirements of $24,481,283 per 
year. The Paperwork Reduction Act section of this Preamble contains 
additional details on the annual burden estimates and total costs 
associated with each of these requirements.

Summary and Timing of Costs of the Final Rule

    Across all covered institutions, we anticipate that the final rule 
will result in about $11.3 million in one-time costs associated with 
institutions updating policies and procedures. We account for timing of 
these impacts by assuming they will occur in 2025. We also identify 
incremental costs of about $24.5 million associated with the final 
rule's reporting, recordkeeping, and third-party disclosure 
requirements related to institutions responding to allegations of 
research misconduct. Consistent with the implementation schedule of the 
final rule, we account for timing of these recurring impacts by 
assuming they will occur in 2026 and in subsequent years. Over a 5-year 
time horizon, we report a present value of total costs attributable to 
the final rule of about $102.5 million, or annualized costs of about 
$21.7 million, both calculated using a constant 2% real discount rate.

                    Table 1--Costs of the Final Rule
                [Constant 2023 dollars, 2% discount rate]
------------------------------------------------------------------------
                         Year                                 Cost
------------------------------------------------------------------------
2025..................................................       $11,331,191
2026..................................................        24,481,283
2027..................................................        24,481,283
2028..................................................        24,481,283
2029..................................................        24,481,283
                                                       -----------------
    Present Value.....................................       102,499,288
    Annualized........................................        21,746,084
------------------------------------------------------------------------

Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601-612) requires agencies 
to prepare a regulatory flexibility analysis describing the impact of 
the final rule on small entities (``institutions'' for purposes of the 
final rule) unless they certify that a final rule will not, if 
promulgated, have a significant economic impact on a substantial number 
of small institutions. HHS generally considers a rule to have a 
significant impact on a substantial number of small institutions if it 
has at least a 3% impact on revenue on at least 5% of small 
institutions. We considered whether the final rule would result in 
effects that exceed these thresholds. This analysis below concludes, 
and the Secretary certifies that this final rule will not have a 
significant impact on a substantial number of small institutions, as 
defined by the Regulatory Flexibility Act, based on the following 
facts.
    As of March 1, 2024, approximately 22 percent (1,412) of 6,394 
institutions holding research integrity assurances are small 
institutions. The primary impact of the final rule on covered 
institutions results from the reporting and record keeping provisions, 
which are analyzed in detail under the heading ``The Paperwork 
Reduction Act.'' Potentially significant annual burdens apply only if 
an institution learns of possible research misconduct and begins an 
inquiry, investigation, or both.
    Institutions covered by 42 CFR part 93 reported having conducted a 
total of 124 inquiries and 121 investigations during the 2023 reporting 
period. In total, one inquiry and three 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 regulation, 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 0.5 
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 final 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 past five years, fewer than five small institutions will have to 
incur that burden in any year. Based on this analysis, HHS concludes 
that the regulations set forth in the final rule will not impose a 
significant burden on a substantial number of small institutions.

Paperwork Reduction Act

    Sections 104, 301-303, 305-313, and 315-318 of this final rule 
contain information collection requirements that are subject to review 
and approval by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521). These 
provisions involve the following institutional activities in addressing 
allegations of misconduct involving PHS-funded research:
    Title: The title of the section of the Public Health Service 
Policies on Research Misconduct involving institutional activities.
    Description: The relevant passage(s) of the section describing the 
institutional information collection requirements.
    Description of Respondents: The ``respondents'' for the collection 
of information described in this regulation are institutions that apply 
for or receive PHS support through grants, contracts, or cooperative 
agreements for any project or program that involves the conduct of 
biomedical or behavioral research, biomedical or behavioral research 
training, or activities related to

[[Page 76292]]

that research or training (see definition of ``Institution'' at Sec.  
93.216).

Subpart A--General

Section 93.104
    (ii) For research misconduct that appears subject to the subsequent 
use exception, institutions must document their determination that the 
subsequent use exception does not apply. Such documentation must be 
retained in accordance with Sec.  93.318.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--40 hours.
    Total Annual Burden--9,200 hours.

Subpart C--Responsibilities of Institutions

Compliance and Assurances

Section 93.305
    (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 paragraph 
(a) of this section.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--25 hours.
    Total Annual Burden--5,750 hours.
    (c) Maintenance of sequestered research records and other evidence. 
An institution must maintain the sequestered research records and other 
evidence as required by Sec.  93.318.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--80 hours.
    Total Annual Burden--18,400 hours.
    (g) Notifying ORI of special circumstances. At any time during a 
research misconduct proceeding, as defined in Sec.  93.235, 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.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--1 hour.
    Total Annual Burden--230 hours.

The Institutional Assessment

Section 93.306
    (c) Assessment results.
    (2) If the RIO or another designated institutional official 
determines that requirements for an inquiry are met, they must: (i) 
document the assessment;
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--80 hours.
    Total Annual Burden--18,400 hours.
    (ii) promptly sequester all research records and other evidence, 
consistent with Sec.  93.305(a), and promptly initiate the inquiry.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--160 hours.
    Total Annual Burden--36,800 hours.
    (3) 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 did not conduct an 
inquiry. Such documentation must be retained in accordance with Sec.  
93.318.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--10 hours.
    Total Annual Burden--2,300 hours.

The Institutional Inquiry

Section 93.307
    (d) Sequestration of records. An institution must obtain all 
research records and other evidence needed to conduct the research 
misconduct proceeding, consistent with Sec.  93.305(a).
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--80 hours.
    Total Annual Burden--18,400 hours.
Section 93.308
    (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.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--2 hours.
    Total Annual Burden--460 hours.
Section 93.309
    (a) Within 30 days of determining that an investigation is 
warranted, the institution must provide ORI with 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, if used, 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 any transcribed interviews;
    (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 an 
investigation;
    (11) Any comments on the inquiry report by the respondent or the 
complainant; and
    (12) Any institutional actions implemented, including 
communications with journals or funding agencies.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--4 hours.
    Total Annual Burden--920 hours.
    (b) Institutions must keep detailed documentation of inquiries to 
permit a later assessment by ORI of the reasons why the institution 
decided not to investigate. Such documentation must be retained in 
accordance with Sec.  93.318.
    Number of Respondents--230.
    Number of Responses per Respondent--1.

[[Page 76293]]

    Annual Average Burden per Response--0 hours. Burden accounted for 
in Sec.  93.316(a)(2).
    Total Annual Burden--0 hours.
    (c) In accordance with Sec.  93.305(g), institutions must notify 
ORI of any special circumstances that may exist.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--2 hours.
    Total Annual Burden--460 hours.

The Institutional Investigation

Section 93.310
    Institutions conducting research misconduct investigations must: 
(b) 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.  93.307 and Sec.  93.309.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--0 hours. Burden accounted for 
in Sec.  93.309(a).
    Total Annual Burden--0 hours.
    (d) 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.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--0 hours. Burden accounted for 
in Sec.  93.308(a).
    Total Annual Burden--0 hours.
    (g) Interviews. During the investigation, 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. (1) Interviews during the investigation must be 
recorded and transcribed.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--300 hours.
    Total Annual Burden--69,000 hours.
    (3) The transcript of the interview must be made available to the 
relevant interviewee for correction.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--4 hours.
    Total Annual Burden--920 hours.
    (5) The respondent must be provided a transcript of the interview.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--4 hours.
    Total Annual Burden--920 hours.
    (j) Pursue leads. If additional allegations are raised, the 
respondent(s) must be notified in writing of the additional allegations 
raised against them.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--2 hours.
    Total Annual Burden--460 hours.
Section 93.310
    (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.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--1 hour.
    Total Annual Burden--230 hours.
    (c) Progress reports. If ORI grants an extension, it may direct the 
institution to file periodic progress reports.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--1 hour.
    Total Annual Burden--230 hours.
Section 93.312
    (a) The institution must give the respondent a copy of the draft 
investigation report and, concurrently, a copy of, or supervised access 
to, the research records and other evidence that the investigation 
committee considered or relied on. The respondent must submit any 
comments on the draft report to the institution within 30 days of 
receiving the draft investigation report.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--2 hours.
    Total Annual Burden--460 hours.
Section 93.313
    A final investigation report for each respondent must be in writing 
and include:
    (a) Description of the nature of the allegation(s) of research 
misconduct, including any additional allegation(s) addressed during the 
research misconduct proceeding.
    (b) Description and documentation of the PHS support, including, 
for example, any grant numbers, grant applications, contracts, and 
publications listing PHS support.
    (c) Description of the specific allegation(s) of research 
misconduct for consideration in the investigation of the respondent.
    (d) Composition of investigation committee, including name(s), 
position(s), and subject matter expertise.
    (e) Inventory of sequestered research records and other evidence, 
except records the institution did not consider or rely on; and a 
description of how any sequestration was conducted during the 
investigation. This inventory must include manuscripts and funding 
proposals that were considered or relied on during the investigation.
    (f) Transcripts of all interviews conducted, as described in Sec.  
93.310(g).
    (g) Identification of the specific published papers, manuscripts 
submitted but not accepted for publication (including online 
publication), PHS funding applications, progress reports, 
presentations, posters, or other research records that allegedly 
contained the falsified, fabricated, or plagiarized material.
    (h) Any scientific or forensic analyses conducted.
    (i) If not already provided to ORI, the institutional policies and 
procedures under which the investigation was conducted.
    (j) Any comments made by the respondent and complainant on the 
draft investigation report and the investigation committee's 
consideration of those comments.
    (k) A statement for each separate allegation of whether the 
investigation committee recommends a finding of research misconduct.
    (1) If the investigation committee recommends a finding of research 
misconduct for an allegation, the investigation report must, for that 
allegation:
    (i) Identify the individual(s) who committed the research 
misconduct.
    (ii) Indicate whether the research misconduct was falsification, 
fabrication, and/or plagiarism.
    (iii) Indicate whether the research misconduct was committed 
intentionally, knowingly, or recklessly.
    (iv) State whether the other requirements for a finding of research 
misconduct, as described in Sec.  93.103, have been met.
    (v) Summarize the facts and the analysis which support the 
conclusion

[[Page 76294]]

and consider the merits of any explanation by the respondent.
    (vi) Identify the specific PHS support.
    (vii) Identify whether any publications need correction or 
retraction.
    (2) If the investigation committee does not recommend a finding of 
research misconduct for an allegation, the investigation report must 
provide a detailed rationale.
    (l) List of any current support or known applications or proposals 
for support that the respondent has pending with PHS and non-PHS 
Federal agencies.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--160 hours.
    Total Annual Burden--36,800 hours.
Section 93.315
    (a) If a respondent appeals an institution's finding(s) of research 
misconduct or institutional actions, the institution must promptly 
notify ORI.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--1 hour.
    Total Annual Burden--230 hours.
    (b) If the institution has not transmitted its institutional record 
to ORI in accordance with Sec.  93.316 prior to the appeal, the 
institution must wait until the appeal is concluded to transmit its 
institutional record. The institution must ensure that the complete 
record of the appeal is included in the institutional record consistent 
with Sec.  93.220(a)(5).
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--0 hours. Burden accounted for 
in Sec.  93.316(a).
    Total Annual Burden--0 hours.
    (c) If the institution has transmitted its institutional record to 
ORI in accordance with Sec.  93.316 prior to the appeal, the 
institution must provide ORI a complete record of the appeal once the 
appeal is concluded.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--2 hours.
    Total Annual Burden--460 hours.
Section 93.316
    After the Institutional Deciding Official has made a final 
determination of research misconduct findings in accordance with Sec.  
93.314, the institution must transmit the institutional record to ORI. 
The institutional record must be consistent with Sec.  93.220 and 
logically organized.
    Per Sec.  93.220: The institutional record comprises:
    (a) The records that the institution compiled or generated during 
the research misconduct proceeding, except records the institution did 
not consider or rely on. These records include, but are not limited to:
    (1) Documentation of the assessment as required by Sec.  93.306(c).
    (2) If an inquiry is conducted, the inquiry report and all records 
(other than drafts of the report) considered or relied on during the 
inquiry, including, but not limited to, research records and the 
transcripts of any transcribed 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) considered or relied on 
during the investigation, 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 under Sec.  
93.314.
    (5) The complete record of any institutional appeal consistent with 
Sec.  93.315.
    (b) A single index listing all the research records and evidence 
that the institution compiled during the research misconduct 
proceeding, except records the institution did not consider or rely on.
    (c) A general description of the records that were sequestered but 
not considered or relied on.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--4 hours.
    Total Annual Burden--920 hours.
Section 93.317
    (a) 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 or a 
settlement with the respondent has been reached.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--1 hour.
    Total Annual Burden--230 hours.
    (b) The [respondent's written] admission statement must meet all 
elements required for a research misconduct finding under Sec.  93.103 
and must be provided to ORI before the institution closes its research 
misconduct proceeding.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--10 hours.
    Total Annual Burden--2,300 hours.
    (b--continued): 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.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--10 hours.
    Total Annual Burden--2,300 hours.
Section 93.318
    (a) Maintenance of institutional record and all sequestered 
evidence. An institution must maintain the institutional record and all 
sequestered evidence including physical objects (regardless of whether 
the evidence is part of the institutional record) in a secure manner 
for seven years after completion of the proceeding or the completion of 
any HHS proceeding involving the research misconduct allegation under 
subparts D and E of this part, whichever is later, unless custody has 
been transferred to HHS under paragraph (b) of this section or ORI 
advises otherwise in writing.
    Number of Respondents--230.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--8 hours.
    Total Annual Burden--1,840 hours.

[[Page 76295]]



                                Estimated Annualized Burden Hour Table (9/3/2024)
----------------------------------------------------------------------------------------------------------------
                                                                   Number of        Average
     Forms (If necessary)          Type of         Number of     responses per   burden hours     Total burden
                                  respondent      respondents     respondent     per response         Hours
----------------------------------------------------------------------------------------------------------------
Sec.   93.104................  Institutions...             230               1              40             9,200
Sec.   93.305.b..............  Institutions...             230               1              25             5,750
Sec.   93.305.c..............  Institutions...             230               1              80            18,400
Sec.   93.325................  Institutions...             230               1               1               230
Sec.   93.306.c.2.i..........  Institutions...             230               1              80            18,400
Sec.   93.306.c.2.ii.........  Institutions...             230               1             160            36,800
Sec.   93.306.c.2.iii........  Institutions...             230               1              10             2,300
Sec.   93.307................  Institutions...             230               1              80            18,400
Sec.   93.308................  Institutions...             230               1               2               460
Sec 93.309.a.................  Institutions...             230               1               4               920
Sec 93.309.c.................  Institutions...             230               1               2               460
Sec.   93.310.g.1............  Institutions...             230               1             300            69,000
Sec.   93.310.g.3............  Institutions...             230               1               4               920
Sec.   93.310.g.5............  Institutions...             230               1               4               920
Sec.   93.310.j..............  Institutions...             230               1               2               460
Sec.   93.310.b..............  Institutions...             230               1               1               230
Sec.   93.310.c..............  Institutions...             230               1               1               230
Sec.   93.312................  Institutions...             230               1               2               460
Sec.   93.313................  Institutions...             230               1             160            36,800
Sec.   93.315.a..............  Institutions...             230               1               1               230
Sec.   93.315.c..............  Institutions...             230               1               2               460
                              ----------------------------------------------------------------------------------
    Total....................  ...............  ..............  ..............  ..............           221,030
----------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
    Estimated annualized cost to
  respondents (9/3/2024) Forms (If      Type of  respondent     Total burden     Hourly wage    Total respondent
             necessary)                                             hours           rate              cost
----------------------------------------------------------------------------------------------------------------
Sec.   93.104.......................  Institutions...........           9,200            $111         $1,018,992
Sec.   93.305.b.....................  Institutions...........           5,750             111            636,870
Sec.   93.305.c.....................  Institutions...........          18,400             111          2,037,984
Sec.   93.325.......................  Institutions...........             230             111             25,475
Sec.   93.306.c.2.i.................  Institutions...........          18,400             111          2,037,984
Sec.   93.306.c.2.ii................  Institutions...........          36,800             111          4,075,968
Sec.   93.306.c.2.iii...............  Institutions...........           2,300             111            254,748
Sec.   93.307.......................  Institutions...........          18,400             111          2,037,984
Sec.   93.308.......................  Institutions...........             460             111             50,950
Sec 93.309.a........................  Institutions...........             920             111            101,899
Sec 93.309.c........................  Institutions...........             460             111             50,950
Sec.   93.310.g.1...................  Institutions...........          69,000             111          7,642,440
Sec.   93.310.g.3...................  Institutions...........             920             111            101,899
Sec.   93.310.g.5...................  Institutions...........             920             111            101,899
Sec.   93.310.j.....................  Institutions...........             460             111             50,950
Sec.   93.310.b.....................  Institutions...........             230             111             25,475
Sec.   93.310.c.....................  Institutions...........             230             111             25,475
Sec.   93.312.......................  Institutions...........             460             111             50,950
Sec.   93.313.......................  Institutions...........          36,800             111          4,075,968
Sec.   93.315.a.....................  Institutions...........             230             111             25,475
Sec.   93.315.c.....................  Institutions...........             460             111             50,950
                                     ---------------------------------------------------------------------------
    Total...........................  .......................  ..............  ..............         24,481,283
----------------------------------------------------------------------------------------------------------------

    Following publication of the final rule, ORI will publish 60-day 
and 30-day notices in the Federal Register seeking public comment on 
these information collection requirements and associated burden 
estimates, and ORI will submit an Information Collection Request (ICR) 
to OMB seeking approval for these requirements under existing OMB 
Control Number 0937-0198, which currently covers the assurance and 
annual reporting requirements of 42 CFR part 93 (the Institutional 
Assurance and Annual Report on Possible Research Misconduct, PHS-6349, 
and the Assurance of Compliance by Sub-Award Recipients, PHS-6315). 
Before the applicability date of this final rule, ORI anticipates 
publishing a notice in the Federal Register announcing OMB's decision 
to approve, modify, or disapprove this ICR. This final rule does not 
make any substantive revisions to the Assurance or Annual Report that 
would require clearance under the PRA, but ORI anticipates making minor 
updates to these forms as part of the upcoming revision to 0937-0198.
    An Agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number.

List of Subjects in 42 CFR Part 93

    Government contracts, Grant programs, Reporting and recordkeeping 
requirements, Research, Science and technology.

0
For reasons discussed in the preamble, HHS is revising 42 CFR part 93 
to read as follows:

[[Page 76296]]

PART 93--PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT

Sec.
93.25 Organization of this part.
93.50 Special terms.
93.75 Application of effective date to research misconduct 
proceedings.
Subpart A--General
93.100 General policy.
93.101 Purpose.
93.102 Applicability.
93.103 Requirements for findings of research misconduct.
93.104 Time limitations.
93.105 Evidentiary standards.
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 Assessment.
93.205 Charge letter.
93.206 Complainant.
93.207 Contract.
93.208 Day.
93.209 Departmental Appeals Board or DAB.
93.210 Evidence.
93.211 Fabrication.
93.212 Falsification.
93.213 Funding Component.
93.214 Good Faith.
93.215 Inquiry.
93.216 Institution.
93.217 Institutional Certifying Official.
93.218 Institutional Deciding Official.
93.219 Institutional member.
93.220 Institutional record.
93.221 Intentionally.
93.222 Investigation.
93.223 Knowingly.
93.224 Notice.
93.225 Office of Research Integrity or ORI.
93.226 Person.
93.227 Plagiarism.
93.228 Preponderance of the evidence.
93.229 Public Health Service or PHS.
93.230 PHS support.
93.231 Recklessly.
93.232 Research.
93.233 Research Integrity Officer or RIO.
93.234 Research misconduct.
93.235 Research misconduct proceeding.
93.236 Research record.
93.237 Respondent.
93.238 Retaliation.
93.239 Secretary or HHS.
93.240 Small institution.
93.241 Suspension and Debarment Official or SDO.
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 draft investigation report.
93.313 Investigation report.
93.314 Decision by the Institutional Deciding Official.
93.315 Institutional appeals.
93.316 Transmittal of the institutional record to ORI.
93.317 Completing the research misconduct process.

Other Institutional Responsibilities

93.318 Retention and custody of the institutional record and all 
sequestered evidence.
93.319 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 HHS 
administrative actions.
93.405 Notifying the respondent of findings of research misconduct 
and proposed 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 ORI compliance actions.

Disclosure of Information

93.414 Notice.
Subpart E--Opportunity to Contest ORI Findings of Research Misconduct 
and Proposed HHS Administrative Actions

General Information

93.500 General policy.

Process for Contesting Research Misconduct Findings and/or Proposed HHS 
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 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 
information related to a broad topic or specific audience with special 
responsibilities as shown in the following table.

                         Table 1 to Sec.   93.25
------------------------------------------------------------------------
                                     You will find sections related to .
         In subpart . . .                            . .
------------------------------------------------------------------------
A.................................  General information about this part.
B.................................  Definitions 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
                                     proposed 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.


Sec.  93.75  Application of effective date to research misconduct 
proceedings.

    (a) An institution must follow this part for allegations received 
by the institution on or after January 1, 2026, except for the policies 
and procedures required under Sec. Sec.  93.300(a) and 93.302(b), which 
must be implemented and submitted by due date of the annual report 
covering the 2025 reporting year, as specified by ORI.
    (b) For allegations received by an institution before January 1, 
2026, unless the institution and the respondent both elect in writing 
to follow this part, an institution must follow this part as published 
in the 2005 edition of the Code of Federal Regulations.

[[Page 76297]]

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 to 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 
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 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.
    (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, subaward, 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 set forth at 2 CFR part 180, 
as implemented by HHS at 2 CFR part 376; and 48 CFR part 9, subpart 
9.4, as supplemented by HHS at 48 CFR part 309, subpart 309.4. The 
Suspension and Debarment Official SDO and ORI may coordinate actions to 
the extent consistent with the SDO's and ORI's respective authorities. 
Such coordination includes jointly issuing notices or seeking 
settlements of actions and proceedings.
    (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  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 be proven by a preponderance of the evidence.


Sec.  93.104  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 proposals, data repositories) 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 research misconduct that appears subject to the subsequent 
use exception, institutions must document their determination that the 
subsequent use exception does not apply. Such documentation must be 
retained in accordance with Sec.  93.318.
    (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.  93.105  Evidentiary standards.

    (a) Standard of proof. An institutional or HHS finding of research 
misconduct must be proved by a preponderance of the evidence.
    (b) Burden of proof. (1) The institution or HHS has the burden of 
proof for making a finding of research misconduct. A respondent's 
destruction of research records documenting the questioned research is 
evidence of research misconduct where the institution or HHS 
establishes by a

[[Page 76298]]

preponderance of the evidence that the respondent intentionally or 
knowingly destroyed records after being informed of the research 
misconduct allegations. A respondent's failure to provide research 
records documenting the questioned research is evidence of research 
misconduct where the respondent claims to possess the records but 
refuses to provide them upon request.
    (2) The respondent has the burden of going forward with and 
proving, by a preponderance of the evidence, all affirmative defenses 
raised. In determining whether HHS or the institution has carried the 
burden of proof imposed by this part, the finder of fact shall give due 
consideration to admissible, credible evidence of honest error or 
difference of opinion presented by the respondent.
    (3) The respondent has the burden of going forward with and 
proving, by a preponderance of the evidence, any mitigating factors 
relevant to a decision to impose administrative actions after a 
research misconduct proceeding.


Sec.  93.106  Confidentiality.

    (a) Disclosure of the identity of respondents, complainants, and 
witnesses while conducting the research misconduct proceedings is 
limited, to the extent possible, to those who need to know, as 
determined by the institution, consistent with a thorough, competent, 
objective, and fair research misconduct proceeding, and as allowed by 
law. Those who need to know may include institutional review boards, 
journals, editors, publishers, co-authors, and collaborating 
institutions. This limitation on disclosure of the identity of 
respondents, complainants, and witnesses no longer applies once an 
institution has made a final determination of research misconduct 
findings. The institution, however, 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) This section does not prohibit institutions from managing 
published data or acknowledging that data may be unreliable.


Sec.  93.107  Coordination with other agencies.

    (a) When more than one agency of the Federal Government has 
jurisdiction over a research misconduct allegation, HHS will cooperate 
with the other agencies 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 may 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 awards.


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 transcript of any virtual or in-person meetings under 
Sec.  93.403(b) between the respondent and ORI, 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  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; 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.  93.205  Charge letter.

    Charge letter means the written notice, as well as any amendments 
to the notice, sent to the respondent stating the findings of research 
misconduct and any proposed HHS administrative actions.


Sec.  93.206  Complainant.

    Complainant means an individual who in good faith makes an 
allegation of research misconduct.


Sec.  93.207  Contract.

    Contract means an acquisition instrument awarded under the Federal 
Acquisition Regulation (FAR), 48 CFR chapter 1.


Sec.  93.208  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.  93.209  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.  93.210  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.  93.211  Fabrication.

    Fabrication means making up data or results and recording or 
reporting them.

[[Page 76299]]

Sec.  93.212  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.  93.213  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.  93.214  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 knowledge of 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.


Sec.  93.215  Inquiry.

    Inquiry means preliminary information-gathering and preliminary 
fact-finding that meets the criteria and follows the procedures of 
Sec.  93.307 through Sec.  93.309.


Sec.  93.216  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, research institutions, and independent 
researchers.


Sec.  93.217  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 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.  93.218  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.  93.219  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.  93.220  Institutional record.

    The institutional record comprises:
    (a) The records that the institution compiled or generated during 
the research misconduct proceeding, except records the institution did 
not consider or rely on. These records include, but are not limited to:
    (1) Documentation of the assessment as required by Sec.  93.306(c).
    (2) If an inquiry is conducted, the inquiry report and all records 
(other than drafts of the report) considered or relied on during the 
inquiry, including, but not limited to, research records and the 
transcripts of any transcribed 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) considered or relied on 
during the investigation, 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 under Sec.  
93.314.
    (5) The complete record of any institutional appeal consistent with 
Sec.  93.315.
    (b) A single index listing all the research records and evidence 
that the institution compiled during the research misconduct 
proceeding, except records the institution did not consider or rely on.
    (c) A general description of the records that were sequestered but 
not considered or relied on.


Sec.  93.221  Intentionally.

    To act intentionally means to act with the aim of carrying out the 
act.


Sec.  93.222  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 93.317.


Sec.  93.223  Knowingly.

    To act knowingly means to act with awareness of the act.


Sec.  93.224  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.  93.225  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.  93.226  Person.

    Person means any individual, corporation, partnership, institution, 
association, unit of government, or other legal entity, however 
organized.


Sec.  93.227  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 that

[[Page 76300]]

materially misleads the reader regarding the contributions of the 
author. It does not include the limited use of identical or nearly 
identical phrases that 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.  93.228  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.  93.229  Public Health Service or PHS.

    Public Health Service or PHS consists of the following components 
within 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.  93.230  PHS support.

    PHS support means PHS funding, or applications or proposals for PHS 
funding, 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, or contracts; subawards, 
contracts, or subcontracts under those PHS funding instruments; or 
salary or other payments under PHS grants, cooperative agreements, or 
contracts.


Sec.  93.231  Recklessly.

    To act recklessly means to propose, perform, or review research, or 
report research results, with indifference to a known risk of 
fabrication, falsification, or plagiarism.


Sec.  93.232  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.  93.233  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.  93.234  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.  93.235  Research misconduct proceeding.

    Research misconduct proceeding means any actions related to alleged 
research misconduct taken under this part, including allegation 
assessments, inquiries, investigations, ORI oversight reviews, and 
appeals under subpart E of this part.


Sec.  93.236  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 reports, manuscripts, abstracts, theses, 
records of oral presentations, online content, lab meeting reports, and 
journal articles.


Sec.  93.237  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.  93.238  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.  93.239  Secretary or HHS.

    Secretary or HHS means the Secretary of HHS or any other official 
or employee of HHS to whom the Secretary delegates authority.


Sec.  93.240  Small institution.

    Small institution means an institution that 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.


Sec.  93.241  Suspension and Debarment Official or SDO.

    Suspension and Debarment Official (SDO) means the HHS official 
authorized to impose suspension and debarment, which are the actions 
that Federal agencies take to disqualify persons deemed not presently 
responsible from doing business with the Federal Government.

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 taking 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 to protect these individuals from retaliation by 
respondents and/or other institutional members;
    (e) Provide confidentiality consistent with Sec.  93.106 to all 
respondents, complainants, and witnesses in a research misconduct 
proceeding, and to

[[Page 76301]]

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 with 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.
    (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 those policies in 
compliance with this part, and upon request, provides them to ORI and 
other HHS components.
    (2) Complies with its policies and procedures for addressing 
allegations of research misconduct.
    (3) Complies with all provisions of this part.
    (4) Takes all reasonable and practical specific steps to foster 
research integrity 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 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 may 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) Provide for all reasonable and practical efforts, if requested 
and as appropriate, to protect or restore the reputation of persons 
alleged to have engaged in research misconduct but against whom no 
finding of research misconduct is made.


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 research 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 in evidentiary value 
to 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 paragraph 
(a) of this section.
    (c) Maintenance of sequestered research records and other evidence. 
An institution must maintain the sequestered research records and other 
evidence as required by Sec.  93.318.
    (d) Multiple respondents. If an institution identifies additional 
respondents during an inquiry or investigation, the institution is not 
required to conduct a separate inquiry for each new respondent. 
However, each additional respondent must be provided notice of and an 
opportunity to respond to the allegations, consistent with this 
subpart.
    (e) Multiple institutions. When allegations involve research 
conducted at multiple institutions, one institution must be designated 
as the lead

[[Page 76302]]

institution if a joint research misconduct proceeding is conducted. In 
a joint research misconduct proceeding, the lead institution should 
obtain research records and other evidence pertinent to the proceeding, 
including witness testimony, 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 the institutional actions to be taken 
may be made by the institutions jointly or tasked to the lead 
institution.
    (f) Using a committee, consortium, or other person for research 
misconduct proceedings. (1) An institution must address any potential, 
perceived, or actual personal, professional, or financial conflicts of 
interest between members of the committee or consortium, or other 
person, and the complainant, respondent, or witnesses.
    (2) 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.
    (g) Notifying ORI of special circumstances. At any time during a 
research misconduct proceeding, as defined in Sec.  93.235, 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 determine whether an 
allegation warrants an inquiry.
    (b) Conducting the institutional assessment. Upon receiving an 
allegation of research misconduct, the RIO or another designated 
institutional official must promptly assess the allegation to determine 
whether the allegation:
    (1) Falls within the definition of research misconduct under this 
part;
    (2) Is within the applicability criteria of Sec.  93.102; and
    (3) Is sufficiently credible and specific so that potential 
evidence of research misconduct may be identified.
    (c) Assessment results. (1) An inquiry must be conducted if the 
allegation meets the three assessment criteria in paragraph (b) of this 
section.
    (2) If the RIO or another designated institutional official 
determines that requirements for an inquiry are met, they must:
    (i) Document the assessment; and
    (ii) Promptly sequester all research records and other evidence, 
consistent with Sec.  93.305(a), and promptly initiate the inquiry.
    (3) 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 did not conduct an 
inquiry. Such documentation must be retained in accordance with Sec.  
93.318.

The Institutional Inquiry


Sec.  93.307  Institutional inquiry.

    (a) Criteria warranting an inquiry. An inquiry is warranted if the 
allegation meets the following three criteria:
    (1) Falls within the definition of research misconduct under this 
part;
    (2) Is within the applicability criteria of Sec.  93.102; and
    (3) 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 determine whether an allegation warrants an 
investigation. An inquiry does not require a full review of the 
evidence related to the allegation.
    (c) Notice to the 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. If additional allegations are 
raised, the respondent(s) must be notified in writing of the additional 
allegations raised against them.
    (d) Sequestration of 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 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.
    (3) Interviews. Institutions may interview witnesses or respondents 
that would provide additional information for the institution's review.
    (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) 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 90 days of its initiation unless circumstances warrant a 
longer period.
    (2) If the inquiry takes longer than 90 days to complete, the 
inquiry report must document the reasons for exceeding the 90-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

[[Page 76303]]

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 complainant. The institution is not required to 
notify a complainant whether the inquiry found that an investigation is 
warranted. The institution may, but is not required to, provide 
relevant portions of the report to a complainant 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 determining that an investigation is 
warranted, the institution must provide ORI with 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, if used, 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 any transcribed interviews;
    (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 an 
investigation;
    (11) Any comments on the inquiry report by the respondent or the 
complainant; and
    (12) Any institutional actions implemented, including 
communications with journals or funding agencies.
    (b) The institution must provide the following information to ORI 
whenever requested:
    (1) The institutional policies and procedures under which the 
inquiry was conducted; and
    (2) The research records and other evidence reviewed, and copies of 
all relevant documents.
    (c) Institutions must keep detailed documentation of inquiries to 
permit a later assessment by ORI of the reasons why the institution 
decided not to investigate. Such documentation must be retained in 
accordance with Sec.  93.318.
    (d) In accordance with Sec.  93.305(g), institutions must notify 
ORI of any special circumstances that may exist.

The Institutional Investigation


Sec.  93.310  Institutional investigation.

    Institutions conducting research misconduct investigations must:
    (a) Time. Begin the investigation within 30 days after deciding 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 Sec.  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, the institution may but is not required to conduct a 
separate inquiry for each new respondent. If any additional 
respondent(s) are identified during the investigation, the institution 
must notify them of the allegation(s) and provide them an opportunity 
to respond consistent with this subpart.
    (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 records. Obtain all research records and other 
evidence needed to conduct the investigation, 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. During the investigation, 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.
    (1) Interviews during the investigation must be recorded and 
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.
    (4) The transcript(s) with any corrections and numbered exhibits 
must be included in the institutional record of the investigation.
    (5) The respondent must not be present during the witnesses' 
interviews but must be provided a transcript of the interview.
    (h) Multiple respondents. Consider, consistent with Sec.  
93.305(d), the prospect of additional researchers being responsible for 
the alleged research misconduct.
    (i) Multiple institutions. A research misconduct proceeding 
involving multiple institutions must be conducted consistent with Sec.  
93.305(e).
    (j) Pursue leads. Pursue diligently all significant issues and 
leads discovered that are determined relevant to the investigation, 
including any evidence of additional instances of possible research 
misconduct, and continue the investigation to completion. If additional 
allegations are raised, the respondent(s) must be notified in writing 
of the additional allegations raised against them.


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 
transmitting the institutional record including the final investigation 
report and decision by the Institutional Deciding Official to ORI in 
accordance with Sec.  93.316.

[[Page 76304]]

    (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 research records and other evidence that the investigation 
committee considered or relied on. The respondent must submit any 
comments on the draft report to the institution within 30 days of 
receiving the draft investigation report.
    (b) The institution may provide the complainant a copy of the draft 
investigation report or relevant portions of that report. The comments 
of the complainant, if any, must be submitted 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) Description of the nature of the allegation(s) of research 
misconduct, including any additional allegation(s) addressed during the 
research misconduct proceeding.
    (b) Description and documentation of the PHS support, including, 
for example, any grant numbers, grant applications, contracts, and 
publications listing PHS support.
    (c) Description of the specific allegation(s) of research 
misconduct for consideration in the investigation of the respondent.
    (d) Composition of investigation committee, including name(s), 
position(s), and subject matter expertise.
    (e) Inventory of sequestered research records and other evidence, 
except records the institution did not consider or rely on; and a 
description of how any sequestration was conducted during the 
investigation. This inventory must include manuscripts and funding 
proposals that were considered or relied on during the investigation.
    (f) Transcripts of all interviews conducted, as described in Sec.  
93.310(g).
    (g) Identification of the specific published papers, manuscripts 
submitted but not accepted for publication (including online 
publication), PHS funding applications, progress reports, 
presentations, posters, or other research records that allegedly 
contained the falsified, fabricated, or plagiarized material.
    (h) Any scientific or forensic analyses conducted.
    (i) If not already provided to ORI, the institutional policies and 
procedures under which the investigation was conducted.
    (j) Any comments made by the respondent and complainant on the 
draft investigation report and the investigation committee's 
consideration of those comments.
    (k) A statement for each separate allegation of whether the 
investigation committee recommends a finding of research misconduct.
    (1) If the investigation committee recommends a finding of research 
misconduct for an allegation, the investigation report must, for that 
allegation:
    (i) Identify the individual(s) who committed the research 
misconduct.
    (ii) Indicate whether the research misconduct was falsification, 
fabrication, and/or plagiarism.
    (iii) Indicate whether the research misconduct was committed 
intentionally, knowingly, or recklessly.
    (iv) State whether the other requirements for a finding of research 
misconduct, as described in Sec.  93.103, have been met.
    (v) Summarize the facts and the analysis which support the 
conclusion and consider the merits of any explanation by the 
respondent.
    (vi) Identify the specific PHS support.
    (vii) Identify whether any publications need correction or 
retraction.
    (2) If the investigation committee does not recommend a finding of 
research misconduct for an allegation, the investigation report must 
provide a detailed rationale.
    (3) List of any current support or known applications or proposals 
for support that the respondent has pending with PHS and non-PHS 
Federal agencies.


Sec.  93.314  Decision by the Institutional Deciding Official.

    The Institutional Deciding Official is responsible for making a 
final determination of research misconduct findings. This determination 
must be provided in a written decision that includes:
    (a) Whether the institution found research misconduct and, if so, 
who committed the misconduct; and
    (b) A description of relevant institutional actions taken or to be 
taken.


Sec.  93.315  Institutional appeals.

    (a) If a respondent appeals an institution's finding(s) of research 
misconduct or institutional actions, the institution must promptly 
notify ORI.
    (b) If the institution has not transmitted its institutional record 
to ORI in accordance with Sec.  93.316 prior to the appeal, the 
institution must wait until the appeal is concluded to transmit its 
institutional record. The institution must ensure that the complete 
record of the appeal is included in the institutional record consistent 
with Sec.  93.220(a)(5).
    (c) If the institution has transmitted its institutional record to 
ORI in accordance with Sec.  93.316 prior to the appeal, the 
institution must provide ORI a complete record of the appeal once the 
appeal is concluded.


Sec.  93.316  Transmittal of the institutional record to ORI.

    After the Institutional Deciding Official has made a final 
determination of research misconduct findings in accordance with Sec.  
93.314, the institution must transmit the institutional record to ORI. 
The institutional record must be consistent with Sec.  93.220 and 
logically organized.


Sec.  93.317  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 or a settlement with the respondent has 
been reached.
    (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 
elements required for a research misconduct finding under Sec.  93.103 
and must be provided to ORI before the institution closes its research 
misconduct proceeding. The institution must also provide a statement to 
ORI

[[Page 76305]]

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.  93.318  Retention and custody of the institutional record and all 
sequestered evidence.

    (a) Maintenance of institutional record and all sequestered 
evidence. An institution must maintain the institutional record and all 
sequestered evidence including physical objects (regardless of whether 
the evidence is part of the institutional record) in a secure manner 
for seven years after completion of the proceeding or the completion of 
any HHS proceeding involving the research misconduct allegation under 
subparts D and E of this part, whichever is later, unless custody has 
been transferred to HHS under paragraph (b) of this section or ORI 
advises otherwise in writing.
    (b) Provision for HHS custody. On request, institutions must 
transfer custody, or provide copies, to HHS of the institutional record 
or any component of the institutional record and any sequestered 
evidence (regardless of whether the evidence is included in the 
institutional record) for ORI to conduct its oversight review, develop 
the administrative record, or present the administrative record in any 
proceeding under subparts D and E of this part.


Sec.  93.319  Institutional standards of conduct.

    Institutions may have standards of conduct different from the 
standards for research misconduct under this part. ORI findings of 
research misconduct or HHS settlements of research misconduct 
proceedings, or the absence thereof, do 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 whether 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, 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) Taking actions as necessary 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.
    (b) ORI assistance to institutions. ORI may:
    (1) Provide information, technical assistance, and procedural 
advice to institutional officials as needed regarding an institution's 
research misconduct proceedings and the sufficiency of the 
institutional record; and
    (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 ORI 
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, 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 Office of Inspector General (OIG), or other 
appropriate investigative body.
    (c) 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.
    (d) ORI may notify affected PHS offices and funding components at 
any time to enable them to take appropriate interim actions.
    (e) 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.
    (f) ORI may refer a research misconduct matter to the SDO at any 
time for consideration under the HHS suspension and debarment 
regulations. ORI may provide technical assistance and share other 
information that the SDO needs to know to consider the referred matter.

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 conducts an assessment and determines an inquiry is 
warranted, it forwards the matter to the appropriate institution or HHS 
component.
    (c) If ORI conducts an assessment and determines an inquiry is not 
warranted, it will close the case and forward the allegation in 
accordance with paragraph (d) in this section.
    (d) ORI may refer 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.

[[Page 76306]]

Sec.  93.403  ORI review of research misconduct proceedings.

    (a) In conducting its review of research misconduct proceedings, 
ORI will:
    (1) Determine whether this part applies;
    (2) Consider the institutional record and determine 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 whether 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, determine whether to close the case without 
further action or proceed with the case.
    (b) If ORI determines 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;
    (6) Have ORI's virtual or in-person meeting(s) with the respondent 
transcribed and provide a copy of the transcript to the respondent for 
review and suggested correction;
    (7) Close the administrative record following paragraphs (b)(3) 
through (6) of this section;
    (8) Provide the respondent the opportunity to access the complete 
administrative record; and
    (9) Take any other actions necessary to complete ORI's review of 
the research misconduct proceedings.


Sec.  93.404  Findings of research misconduct and proposed HHS 
administrative actions.

    (a) After completing its review of the administrative record, ORI 
may:
    (1) Close the case without a separate ORI finding of research 
misconduct;
    (2) Make findings of research misconduct and propose and take HHS 
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 proposed HHS administrative actions.

    (a) When ORI makes a finding of research misconduct or proposes HHS 
administrative actions, it notifies the respondent in a charge letter. 
The charge letter:
    (1) Includes ORI's findings of research misconduct, including the 
basis for such findings in the administrative record, and any proposed 
HHS administrative actions;
    (2) Advises the respondent how to access the administrative record; 
and
    (3) Informs the respondent of the opportunity to contest the 
findings and proposed HHS administrative actions under subpart E of 
this part.
    (b) ORI sends the charge letter by certified mail, private delivery 
service, or electronic mail or other electronic means 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.

    Unless the respondent contests the findings and/or the proposed HHS 
administrative actions contained in the charge letter within the 30-day 
period prescribed in Sec.  93.501(a), the ORI findings and HHS 
administrative actions are final.


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) Letter(s) of reprimand.
    (3) Imposition of special certification or research integrity 
assurance requirements to ensure compliance with applicable regulations 
or terms of HHS grants, contracts, or cooperative agreements.
    (4) Suspension of award activities under, 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 the respondent's 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 PHS.
    (9) Prohibition of the respondent in participating in any advisory 
capacity with the PHS.
    (10) Recommending that the relevant agency take adverse personnel 
action(s), if the respondent is a Federal employee, in compliance with 
relevant Federal personnel policies and laws.
    (b) In connection with research misconduct findings, HHS also may 
seek to recover PHS funds spent supporting activities involving 
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, and the PHS funding 
component.
    (d) HHS administrative actions under this part do not include 
suspension or debarment. Regardless of whether HHS administrative 
actions are imposed under this part, HHS may pursue suspension and 
debarment under the HHS suspension and debarment regulations.


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. 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

[[Page 76307]]

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 
determines that settlement is in the best interests of the Federal 
Government and the public health or welfare.
    (b) Settlement agreements are publicly available, regardless of 
whether ORI made a finding of research misconduct.
    (c) A settlement agreement precludes the respondent from contesting 
any ORI findings of research misconduct, HHS administrative actions, or 
ORI's jurisdiction in handling the research misconduct proceeding.


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 provide written notice to the 
respondent, the relevant institution, the complainant, and HHS 
officials.


Sec.  93.411  Final HHS action with a settlement or finding of research 
misconduct.

    When a final HHS action results in a settlement or research 
misconduct finding(s), ORI may:
    (a) Provide final notification of any research misconduct findings 
and HHS administrative actions to the respondent, the relevant 
institution, and appropriate HHS officials.
    (b) Provide final notification of any research misconduct findings 
and HHS administrative actions to the complainant(s).
    (c) Send a notice to the relevant journal, publisher, data 
repository, or other similar entity identifying publications or 
research records that require correction or retraction.
    (d) Publish notice of the research misconduct findings.
    (e) Notify the respondent's current employer if the employer is an 
institution subject to this part.

Institutional Compliance Issues


Sec.  93.412  Making decisions on institutional noncompliance.

    ORI may determine 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  ORI compliance actions.

    (a) If ORI determines an institution is not compliant with this 
part, it may take a compliance action against the institution.
    (b) If ORI determines an institution is not compliant with this 
part, ORI may take any or all of the following compliance actions:
    (1) Require the institution to accept and/or implement technical 
assistance provided by ORI.
    (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) Any other action appropriate to the circumstances.
    (c) If an institution fails to comply with the requirements of this 
part, ORI may refer the institution to the SDO for consideration under 
the HHS suspension and debarment regulations.
    (d) 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.
    (e) ORI may make public any findings of institutional noncompliance 
and ORI 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 may disclose or publish a notice regarding settlements, ORI 
findings of research misconduct, 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.

Subpart E--Opportunity To Contest ORI Findings of Research 
Misconduct and Proposed 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 proposed HHS administrative 
actions included in a charge letter.
    (b) A respondent may contest ORI's research misconduct findings and 
proposed HHS administrative actions 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 
whether ORI's research misconduct findings and any proposed HHS 
administrative actions are reasonable and not based on a material error 
of law or fact. The ALJ's ruling constitutes a recommended decision to 
the Assistant Secretary for Health (ASH) in accordance with Sec.  
93.511(b).
    (d) A respondent must exhaust all available administrative remedies 
under this subpart before seeking judicial review of ORI's findings 
and/or HHS administrative actions. The contested findings and/or 
administrative actions shall be inoperative while the

[[Page 76308]]

respondent is pursuing administrative remedies under this subpart.

Process for Contesting Research Misconduct Findings and/or Proposed HHS 
Administrative Actions


Sec.  93.501  Notice of appeal.

    (a) Time to file. A respondent may contest ORI's findings of 
research misconduct and/or proposed HHS administrative actions 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 to ORI by certified mail, electronic mail, or 
other equivalent (i.e., with a verified method of delivery).
    (c) Contents of a notice of appeal. The notice of appeal must:
    (1) Admit or deny each ORI finding of research misconduct and each 
factual assertion made in support of each finding;
    (2) Accept or challenge each proposed HHS 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; and
    (5) Identify any mitigating factors in the administrative record.


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 proposed HHS 
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 the 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 the ORI research misconduct findings and proposed HHS 
administrative actions 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.


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; and
    (3) File motions or briefs in writing before the ALJ.
    (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) 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;
    (2) Rule on motions and other procedural matters;
    (3) 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;
    (4) Upon motion of a party, decide cases, in whole or in part, by 
summary judgment where there is no disputed issue of material fact;
    (5) Regulate the course of the appeal and the conduct of 
representatives and parties; and
    (6) Take action against any party for failing to follow an order or 
procedure or for disruptive conduct.
    (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 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

[[Page 76309]]

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.
    (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. 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.


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 proposed HHS 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; 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) Whenever possible, the ALJ shall memorialize in writing any 
oral rulings within 10 days after a conference is held.


Sec.  93.511  The Administrative Law Judge's ruling.

    (a) Based on the administrative record, the ALJ shall issue a 
ruling in writing within 60 days after the last submission by the 
parties in the case, setting forth whether ORI's research misconduct 
findings and proposed HHS administrative actions reflected in the 
charge letter are reasonable and not based on a material error of law 
or fact. If the ALJ is unable to meet the 60-day deadline, the ALJ must 
set a new deadline and promptly notify the parties. The ALJ shall serve 
a copy of the ruling upon the parties and the ASH.
    (b) The ruling of the ALJ constitutes a recommended decision to the 
ASH. The ASH may review the ALJ's recommended decision and adopt, 
modify, or reject it (in whole or in part) as needed to ensure that the 
decision is reasonable and not based on a material error of law or 
fact. Within 30 days after service of the ALJ's recommended decision, 
the ASH shall notify the parties of the ASH's intent to review or not 
to review the ALJ's recommended decision. If the ASH does not provide 
notice of intent within the 30-day period or notifies the parties that 
the ASH does not intend to review the ALJ's recommended decision, the 
ALJ's recommended decision shall become final. An ALJ's recommended 
decision that becomes final in that manner or the ASH's decision after 
review constitutes the final HHS action on both ORI's findings of 
research misconduct and any HHS administrative actions.

    Dated: September 9, 2024.
Xavier Becerra,
Secretary.
[FR Doc. 2024-20814 Filed 9-12-24; 8:45 am]
BILLING CODE 4150-31-P