Federal Register / Vol. 88, No. 193 / Friday, October 6, 2023 / Proposed Rules 69583 

Deputy Director means the Deputy 

Under Secretary of Commerce for 

Intellectual Property and Deputy 

Director of the United States Patent and 

Trademark Office, or an individual 

serving as Acting Deputy Director. 

Commissioner for Patents and 

Commissioner for Trademarks mean the 

positions defined in 35 U.S.C. 3(b)(2), or 

an individual acting in the capacity of 

one of those positions. 

Issuance means the entry of a 

decision into the record of a Board 

proceeding. 

Management Judge means the Chief 

Administrative Patent Judge, the Deputy 

Chief Administrative Patent Judge, a 

Vice Chief Administrative Patent Judge, 

a Senior Lead Administrative Patent 

Judge, a Lead Administrative Patent 

Judge, including individuals who serve 

in these positions in an acting capacity, 

or any other Administrative Patent 

Judge who, as part of their duties, 

supervises the work of other 

Administrative Patent Judges or is 

responsible for reviewing the 

performance of other Administrative 

Patent Judges. 

Panel means the members of the 

Board assigned to a proceeding pursuant 

to the Board’s Standard Operating 

Procedure 1. 

Proceeding means an appeal or 

contested case under Part 41, or trial 

proceeding under Part 42. 

§ 43.3 No Pre-Issuance Director 

Involvement in Panel Decisions. 

(a) Prior to issuance of a decision by 

the panel, the Director, Deputy Director, 

Commissioner for Patents, and 

Commissioner for Trademarks shall not 

communicate, directly or through 

intermediaries, with any member of the 

panel regarding the decision. 

(b) The prohibition of paragraph (a) 

shall not apply to any proceeding in 

which the individual is a member of the 

panel. When sitting as a member of a 

panel, the Director or other individual 

listed in paragraph (a) is a coequal 

member of the panel and exercises no 

review authority over the proceeding 

prior to the issuance of the panel’s 

decision on the merits. 

(c) Nothing in this section shall 

prevent the Director or delegate from 

communicating with a panel as to 

resource needs or the procedural status 

of any proceeding pending before the 

Board. 

(d) The Chief Administrative Patent 

Judge or delegates of the Chief 

Administrative Patent Judge shall 

designate panels of the Board on behalf 

of the Director. The Director may issue 

generally applicable paneling guidance 

to be applied to proceedings before the 

Board. The Director shall not direct or 

otherwise influence the paneling or 

repaneling of any specific proceeding 

prior to issuance of the panel decision. 

When reviewing or rehearing an issued 

panel decision, the Director may direct 

the repaneling of the proceeding in a 

manner consistent with PTAB paneling 

guidance, through an Order entered into 

the record. 

§ 43.4 Limited Pre-Issuance Management 

Involvement in Decisions. 

(a) Except as requested pursuant to 

paragraph (b) or permitted under 

paragraph (d) or (e), prior to issuance of 

a decision by the panel, no Management 

Judge or employee of the Office external 

to the Board shall initiate 

communication, directly or through 

intermediaries, with any member of a 

panel regarding a decision. 

(b) Any individual panel member may 

request that one or more Management 

Judges provide input on a decision prior 

to issuance. The choice to request input 

is optional and solely within the 

discretion of an individual panel 

member. 

(c) It is within the sole discretion of 

the panel to adopt any edits, 

suggestions, or feedback provided to the 

panel by a Management Judge as part of 

a review requested under paragraph (b). 

The panel has final authority and 

responsibility for the content of a 

decision and determines whether and 

how to incorporate any feedback 

requested under paragraph (b). 

(d) The prohibition of paragraph (a) 

shall not apply to any Management 

Judge who is a member of the panel. 

When sitting as a member of a panel, a 

Management Judge is a coequal member 

of the panel and exercises no review 

authority over the proceeding prior to 

the issuance of the panel’s decision on 

the merits. 

(e) Nothing in this section shall 

prevent a Management Judge from 

communicating with a panel as to 

resource needs or the procedural status 

of any case pending before the Board. 

§ 43.5 Review of Decisions by NonManagement Judges. 

If the Office establishes procedures 

governing the internal circulation and 

review of decisions prior to issuance to 

one or more designated members of the 

Board: 

(a) No Management Judge shall 

participate directly or indirectly in any 

such review and the reviewing nonManagement judges shall not discuss 

the substance of any circulated decision 

with a Management Judge prior to 

issuance of the decision, except with a 

Management Judge who is a member of 

the panel; and 

(b) Any edits, suggestions, or feedback 

provided to the panel pursuant to such 

circulation and review are optional and 

in the sole discretion of the panel to 

accept. The panel has final authority 

and responsibility for the content of a 

decision and determines whether and 

how to incorporate any feedback 

provided. 

§ 43.6 Controlling Legal Authority; No 

Unwritten or Non-Public Binding Policy or 

Guidance. 

Notwithstanding any other provision 

of this Part, all decisions of the Board 

are expected to comport with all 

applicable statutes, regulations, binding 

case law, and written agency policy and 

guidance applicable to Board 

proceedings. There shall be no 

unwritten agency or Board policy or 

guidance that is binding on any panel of 

the Board. All written policy and 

guidance binding on panels of the Board 

shall be made public. 

Katherine K. Vidal, 

Under Secretary of Commerce for Intellectual 

Property and Director of the United States 

Patent and Trademark Office. 

[FR Doc. 2023–22218 Filed 10–5–23; 8:45 am] 

BILLING CODE 3510–16–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 93 

RIN 0937–AA12 

Public Health Service Policies on 

Research Misconduct 

AGENCY: U.S. Department of Health and 

Human Services (HHS). 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: In this Notice of Proposed 

Rulemaking (NPRM), the Department of 

Health and Human Services (HHS), 

Office of the Secretary, Office of the 

Assistant Secretary for Health (OASH), 

Office of Research Integrity (ORI) 

proposes to revise the Public Health 

Service (PHS) Policies on Research 

Misconduct. The proposed revisions are 

based on the experience ORI and 

institutions have gained with the 

regulation since it was released in 2005. 

This NPRM seeks comment from 

individuals, institutional officials, 

organizations, institutions, research 

funding agencies, and other members of 

the public on the proposed revisions 

and how to improve the clarity of 

substantive and non-substantive. 


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DATES: Submit comments on or before 

December 5, 2023. 

ADDRESSES: For efficient management of 

comments, HHS requests that all 

comments be submitted electronically to 

https://www.regulations.gov (referred to 

hereafter as ‘‘regulations.gov’’). In 

commenting, please refer to the 

Regulatory Information Number (RIN) 

[0937–AA12]. 

Instructions: Enter the RIN in the 

search field at https://

www.regulations.gov and click on 

‘‘Search.’’ To view the proposed rule, 

click on the title of the rule. To 

comment, click on ‘‘Comment’’ and 

follow the instructions. If you are 

uploading multiple attachments into 

regulations.gov, please number and 

label all attachments; https://

www.regulations.gov will not 

automatically number them. All 

relevant comments will be posted 

without change to https://

www.regulations.gov, including any 

personal information provided. For 

detailed instructions on submitting 

comments and additional information 

on the rulemaking process, see the 

‘‘Public Participation’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read comments received, please go to 

https://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Sheila Garrity, JD, MPH, MBA, Office of 

Research Integrity, 1101 Wootton 

Parkway, Suite 240, Rockville, MD 

20852; telephone 240–453–8200. 

SUPPLEMENTARY INFORMATION: All 

comments, including any personally 

identifiable or confidential business 

information provided, will be placed in 

the public docket without change and 

will be publicly available online at 

https://www.regulations.gov. Therefore, 

HHS cautions commenters about 

submitting information they do not 

want to be made available to the public. 

When submitting comments on this 

NPRM, the agency requests that 

commenters explain their rationale and 

provide any relevant data and 

information to support their comments 

or rationale, as applicable. 

This preamble is organized as follows: 

I. Public Participation 

II. Authority for These Regulations 

III. Proposed Updates to Subpart A 

IV. Proposed Updates to Subpart B 

V. Proposed Updates to Subpart C 

VI. Proposed Updates to Subpart D 

VII. Proposed Updates to Subpart E 

VIII. Required Regulatory Analyses 

I. Public Participation 

Interested persons are invited to 

participate in this rulemaking by 

submitting written views, opinions, 

recommendations, and data. Comments 

received, including attachments and 

other supporting materials, are part of 

the public record and subject to public 

disclosure. Do not include any 

information in your comment or 

supporting materials that you do not 

wish to be disclosed publicly. 

Comments are invited on any topic 

within the scope of this NPRM. 

II. Authority for These Regulations 

The primary authority supporting this 

rulemaking is 42 U.S.C. 289b (section 

493 of the Public Health Service Act, as 

amended). This authority established 

ORI as an independent entity within 

HHS and requires the Secretary to issue 

regulations to define the term ‘‘research 

misconduct’’ and implement the 

research misconduct provisions of the 

statute. To that end, in 2005 HHS issued 

Public Health Service (PHS) Policies on 

Research Misconduct (the ‘‘2005 Final 

Rule’’) [42 CFR part 93; 70 FR 28370 

(May 17, 2005)]. Since the 2005 Final 

Rule was issued, ORI has gained 

extensive experience handling all 

aspects of the HHS research integrity 

program under 42 CFR part 93. ORI now 

seeks to capitalize on that experience 

through the regulatory revision process. 

ORI anticipates release of the final 

rule in the summer of 2024, with 

implementation to begin a minimum of 

4 months afterward. ORI will aim for an 

effective date of January 1, 2025, to 

simplify institutional reporting under 

proposed § 93.302(b). Once this NPRM 

is finalized, ORI recognizes that some 

institutions may wish to implement the 

revised regulation for research 

misconduct proceedings already 

underway. As was done with the 2005 

Final Rule, ORI intends that for any 

allegation of research misconduct 

received by HHS or an institution before 

the effective date of the revised 

regulation, regardless of the stage of the 

research misconduct proceeding, the 

proceeding will fall under the 2005 

Final Rule. ORI seeks comment on 

aspects to consider if it were to entertain 

individual requests to apply the revised 

regulation to a particular ongoing 

proceeding. 

For additional information and an 

extensive historical background on the 

origins of ORI and the development of 

the PHS policies on research 

misconduct, we direct the public to 69 

FR 20778 (Apr. 16, 2004) and to ORI’s 

website at https://ori.hhs.gov/historicalbackground. A basic tenet of the 

scientific process is that research 

constantly evolves as experimental 

results and analyses inform new 

hypotheses. Informed debate and the 

discourse of ideas is a natural part of 

that process. Institutions must foster a 

research environment that discourages 

misconduct in all research and that 

deals forthrightly with possible 

misconduct associated with PHS 

supported research. ORI has recognized 

that the 2005 Final Rule’s complexity 

and missing definitions may create 

confusion in some areas. Accordingly, 

this proposed rule aims to implement 

revisions that we believe are necessary 

and appropriate while retaining many of 

the features of the 2005 Final Rule. 

We highlight below the changes in 

subparts A through E, particularly to 

draw attention to areas that represent 

new approaches. Briefly, this NPRM 

follows the structure of the 2005 Final 

Rule. Subpart A describes the purpose 

and fundamental precepts of the 

regulation. Subpart B provides 

definitions. Subpart C lists institutional 

responsibilities, and subpart D describes 

responsibilities of HHS and ORI. 

Finally, subpart E covers the process for 

respondents who wish to contest the 

ORI findings of research misconduct 

and HHS administrative actions. We 

invite public comments on all aspects of 

this proposed regulation. 

III. Proposed Updates to Subpart A 

Subpart A establishes the 

responsibilities of HHS, PHS, ORI, and 

institutions in addressing allegations of 

research misconduct. ORI proposes 

refining the language in subpart A to 

clarify the applicability of the regulation 

to allegations of research misconduct. 

Subpart A also addresses HHS 

coordination with other agencies. In 

addition, ORI proposes removing 

reference to evidentiary standards and 

burden of proof formerly found at 

§ 93.106 because proposed revisions 

throughout part 93, and specifically at 

§ 93.104, address requirements for a 

finding of research misconduct, 

including preponderance of evidence to 

prove an allegation. 

A proposed substantive addition to 

subpart A includes clarifying language 

about confidentiality, explaining when 

and how disclosure may be made to 

‘‘those who need to know.’’ In the 2005 

Final Rule, the phrase ‘‘those who need 

to know’’ is not defined in § 93.108, 

causing uncertainty about what 

information can be disclosed and to 

whom. To address this concern, we 

propose to add new paragraphs in 

§ 93.106 to address the situations in 

which disclosures may need to occur as 

well as who is considered as having a 

‘‘need to know’’ and in what 

circumstances. We believe these 

proposed revisions will balance the 


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rights of all parties while minimizing 

unnecessary information disclosure. 

ORI recognizes that anonymity is a 

concern for some complainants and 

witnesses. Institutional, state, or other 

policies may govern the granting of 

anonymity to complainants or witnesses 

in a research misconduct proceeding, so 

ORI has not proposed language in the 

NPRM. Instead, ORI proposes to issue 

guidance on protecting anonymity in 

transcripts and other materials collected 

throughout a research misconduct 

proceeding. ORI is interested in the 

public’s views on maintaining 

anonymity for complainants or 

witnesses who request it, including 

whether to include provisions for such 

anonymity in the final rule. 

The 2005 Final Rule generally applies 

only to research misconduct occurring 

within six years of the date HHS or an 

institution receives an allegation of 

research misconduct, but it provides a 

‘‘subsequent use’’ exception to the sixyear limitation in § 93.105(b)(1). From 

our experience, this ‘‘subsequent use’’ 

exception has been applied most often 

to the citation of questioned paper(s) in 

a researcher’s more recent publication 

or PHS grant application which in turn 

tolls the six-year time limitation. From 

our experience the phrase ‘‘other use for 

the potential benefit of the respondent 

of the research record’’ also has been 

viewed as vague and unclear. Therefore, 

to ensure clarity within the institutional 

community, we propose that the sixyear time limitation be maintained, but 

we propose revising the ‘‘subsequent 

use’’ exception at § 93.105(b)(1) to 

include clarifying information. ORI is 

interested in public comments on how 

to further clarify the expectations and/ 

or requirements related to the 

‘‘subsequent use’’ exception. 

IV. Proposed Updates to Subpart B 

ORI is proposing revisions to 

definitions in subpart B and introducing 

new definitions, some of which align 

with other changes proposed throughout 

the regulation. In a few cases, regulatory 

principles appeared in the body of the 

2005 Final Rule without definition; 

these proposed revisions now appear 

among the 48 proposed definitions 

provided in subpart B. We propose 

moving definitions for ‘‘research 

misconduct’’, ‘‘fabrication’’, and 

‘‘falsification’’ to subpart B without 

changes. ORI proposes revising the 

‘‘plagiarism’’ definition and moving it to 

subpart B. We believe having all 

definitions in one place makes it easier 

for readers, enabling the text in subpart 

C to focus on institutional 

responsibilities. We are interested in 

public comments on all these 

definitions, their specific content as 

well as their inclusion in the listing of 

definitions in subpart B. 

ORI proposes adding some 

commonly-used terms to the definitions 

to ensure clarity in usage. These 

additional terms include ‘‘appeal’’; 

‘‘assessment’’; ‘‘difference of opinion’’; 

‘‘institutional certifying official’’ and 

‘‘institutional deciding official’’; 

‘‘research integrity’’; ‘‘research integrity 

officer’’; and ‘‘small institution.’’ Key 

points of other proposed definitional 

changes follow, with more expansive 

definitions in subpart B. This preamble 

groups the conceptually related terms 

versus providing them alphabetically as 

they appear in subpart B. 

New Terms and Definitions 

Institutional Record. As part of the 

proposed revisions, we introduce the 

concept of a robust and required 

institutional record as part of the 

research misconduct investigative 

process. Described in more detail at 

§ 93.223, the proposed institutional 

record includes the assessment report, 

inquiry report, investigation report, 

decision(s) made by the institutional 

deciding official, and the complete 

record of any institutional appeal, any 

other records the institution used for the 

research misconduct proceeding, 

documentation related to the 

determination that records are irrelevant 

or duplicate and therefore not included, 

and a single index listing all documents 

in the institutional record. 

Administrative Record. The 

administrative record described at 

proposed § 93.202 contains information 

that would be used by ORI in making 

findings of research misconduct and 

identifying administrative actions, in 

addition to serving as the basis for the 

Departmental Appeals Board (DAB) 

Administrative Law Judge (ALJ) review 

and information considered by the HHS 

Suspension and Debarment Official 

(SDO). The proposed administrative 

record comprises: the institutional 

record; any information provided by the 

respondent to ORI, including but not 

limited to the verbatim transcript of any 

meetings under proposed § 93.403 

between the respondent and ORI, 

whether in person, by phone, or by 

videoconference; and correspondence 

between the respondent and ORI; any 

additional information provided to ORI 

while the case is pending before ORI; 

and any analysis or additional 

information generated or obtained by 

ORI. Any analysis or additional 

information generated or obtained by 

ORI will also be made available to 

respondent. 

Honest Error. At times, institutions 

have raised the issue that ‘‘honest error’’ 

is not defined in the 2005 Final Rule, 

and that providing a definition would 

ensure greater consistency and fairness. 

We propose to define the term ‘‘honest 

error’’ in subpart B as a mistake made 

in good faith. 

Intentionally, Knowingly, and 

Recklessly. None of these terms were 

defined in the 2005 Final Rule. 

Although ‘‘knowingly’’ and 

‘‘intentionally’’ seem to be more 

commonly understood than 

‘‘recklessly’’, we have received requests 

through the years to provide explicit 

definitions for clarity and to ensure 

uniform application in the research 

community. We propose definitions 

based on those used in the ALJ’s 

Recommended Decisions in ORI v. 

Kreipke, Decision No. CR5109 (May 18, 

2018) at page 14 and ORI v. Srivastava, 

Decision No. 5178 (Sept. 5, 2018) at 

pages 11–12. We propose that to act 

‘‘intentionally’’ means to act with the 

aim of carrying out the act. To act 

‘‘knowingly’’ means to act with 

awareness of the act. Finally, to act 

‘‘recklessly’’ means to act without 

proper caution despite a known risk for 

harm. These definitions are found at 

§§ 93.224, 93.226, and 93.234, 

respectively. 

Accepted Practices of the Relevant 

Research Community. From our 

experience, many institutions have 

requested a definition for the phrase 

‘‘accepted practices of the relevant 

research community’’ to ensure clarity 

and uniformity in application to 

research misconduct proceedings. 

Therefore, we propose to adopt at 

§ 93.200 a revised and extended version 

of the definition provided in the ALJ’s 

Recommended Decision in ORI v. 

Kreipke, Decision No. CR5109 (May 18, 

2018) at page 17. Specifically, we 

propose ‘‘accepted practices of the 

relevant research community’’ to mean 

those practices established by 42 CFR 

part 93 and by PHS funding 

components, as well as commonly 

accepted professional codes or norms 

within the overarching community of 

researchers and institutions that apply 

for and receive PHS grants. These 

practices must be consistent with the 

definition of research integrity at 

§ 93.236. 

This Part. Over the years, institutions 

and government agencies have told us 

that ‘‘this part’’ is confusing. We 

propose to define ‘‘this part’’ as meaning 

42 CFR part 93 in its entirety, unless 

otherwise explicitly noted. We further 

define how to refer to only a portion of 

the regulation. 


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Revised Definition 

Plagiarism. The 2005 Final Rule states 

that ‘‘Plagiarism is the appropriation of 

another person’s ideas, processes, 

results, or words without giving 

appropriate credit.’’ In addition to 

moving the definition of ‘‘plagiarism’’ to 

§ 93.230, we propose to include new 

§ 93.230(a) and (b). Proposed § 93.230(a) 

differentiates unattributed text copied 

verbatim or nearly verbatim from the 

limited use of identical or nearlyidentical phrases which describe a 

commonly-used methodology. Further, 

proposed § 93.230(b) addresses selfplagiarism and authorship or credit 

disputes. Self-plagiarism and authorship 

disputes do not meet the definition of 

research misconduct and are outside of 

ORI’s jurisdiction. These issues are 

better handled at the institutional level. 

V. Proposed Updates to Subpart C 

Compliance and Assurances. 

Information and guidance for 

institutions about compliance and 

research integrity assurances is 

provided at §§ 93.300 through 304. We 

propose clarifying the requirements for 

establishing and maintaining an active 

research integrity assurance, in addition 

to providing specific guidance for small 

institutions. 

Conflict of interest. The 2005 Final 

Rule requires that institutions ‘‘ensure 

that individuals responsible for carrying 

out any part of the research misconduct 

proceeding do not have unresolved 

personal, professional or financial 

conflicts of interest with the 

complainant, respondent or witnesses’’ 

at § 93.300(b). This requirement has 

been interpreted by many institutions as 

a requirement to provide respondents 

with an opportunity to object to 

committee members’ participation prior 

to their appointments to an inquiry 

committee, if one is used, or an 

investigation committee. This approach 

to conflict issues is not required by the 

2005 Final Rule although some 

institutions have apparently made it an 

unwritten standard. We propose to add 

clarifying language at § 93.305(h)(5) that 

addresses how an institution may 

provide respondents or complainants 

the opportunity to object to the person 

or to one or more committee or 

consortium members, chosen to 

conduct, support, or participate in the 

research misconduct proceedings. If an 

institution chooses to provide one 

respondent in a proceeding the 

opportunity to object, it must provide 

all respondents in that proceeding the 

opportunity to object. If an institution 

chooses to provide one complainant the 

opportunity to object in a proceeding, it 

must provide all complainants the 

opportunity to object in that proceeding. 

We believe this is fair and will maintain 

uniformity in the processing of research 

misconduct allegations. 

Sequestration of research records and 

other evidence. ORI is aware of concerns 

that, in the current research 

environment and with the use of cloudbased storage, it may not be possible to 

obtain ‘‘custody’’ of the original 

research records and other evidence that 

will be needed to conduct a research 

misconduct proceeding. We propose to 

move away from the use of the term 

‘‘custody’’ and focus on the institution’s 

obligation to obtain and sequester all 

research records and other evidence that 

will be needed to conduct the research 

misconduct proceeding (see 

§§ 93.305(a), 93.306(c)(2)(ii), 93.307(d), 

and 93.310(d)). We also propose adding 

new language at § 93.305(a) indicating 

that when it is not possible to obtain the 

original research records or other 

evidence, an institution may obtain 

copies of the data or other evidence so 

long as those copies are substantially 

equivalent in evidentiary value. 

Institutional Assessment. New 

language is added at § 93.306 to describe 

the institutional assessment. We have 

provided criteria for an assessment to 

proceed to inquiry at § 93.306(1)(i) 

through (iii), and we have described 

reporting requirements as well as a 

timeline for completion of assessments. 

Institutional Inquiry. ORI has 

observed that institutions often convene 

a committee to conduct a robust, 

investigation-like process at the inquiry 

stage. These processes may include 

interviewing witnesses and reviewing 

research records, only to repeat them at 

the investigation stage. ORI plans to 

issue guidance indicating that an 

interview conducted at the inquiry 

phase can be carried forward into 

investigation and need not be repeated, 

unless it might reveal further 

information. We propose a revision at 

§ 93.307(e)(2), to allow institutional 

discretion in convening committees of 

experts to conduct reviews at the 

inquiry stage to determine whether an 

investigation is warranted. We further 

provide options for who may do the 

inquiry review, noting that the 

institution may use one or more subject 

matter experts to assist them. For more 

information on using a committee, 

consortium, or other person for research 

misconduct proceedings, see proposed 

§ 93.305(h). 

We propose to clarify for institutions 

in a new section, § 93.307(f)(1)(i), that 

proceeding to an investigation requires 

that they have a reasonable basis for 

concluding that an allegation falls 

within the definition of research 

misconduct under 42 CFR part 93 and 

involves PHS supported biomedical or 

behavioral research, research training or 

activities related to that research or 

research training, as provided in 

§ 93.102. We also propose including 

language at § 93.309(c) to clearly 

indicate that institutions are required to 

keep sufficiently detailed 

documentation of each inquiry to permit 

a later assessment by ORI of the reasons 

the institution decided not to conduct 

an investigation. 

We propose adding new language to 

§§ 93.307(f)(2)(ii) and 93.307(g)(2) to 

describe the inquiry results and inquiry 

report after an inquiry has been 

conducted. We have learned over time 

that the phrase ‘‘the allegation may have 

substance’’ in current § 93.307(d)(2), 

may lack the clarity an institution 

would find helpful to delineate an 

inquiry from an investigation. By 

nature, an inquiry is preliminary. An 

inquiry would not be expected to 

identify sufficient basis for 

differentiating honest error or difference 

of opinion from research misconduct 

committed intentionally, knowingly, or 

recklessly, absent an admission of 

research misconduct. We do not believe 

such a determination can be made at the 

inquiry phase to support dismissal of an 

allegation. However, we propose that 

the institution should note in the 

inquiry report any evidence of honest 

error or a difference of opinion, for full 

consideration at the investigation stage. 

Institutional Investigation. From our 

experience, there has been some 

confusion about the extent to which 

institutions must continue to pursue 

leads at the institutional investigation 

stage under § 93.310(h). To address this 

concern, we propose that § 93.310(h) be 

revised to indicate that, at the 

investigation stage, the institution may 

choose to add to or expand the ongoing 

investigation by including any new 

allegations pertaining to the same 

respondent or research records in 

question (e.g., manuscripts or funding 

proposals) that come to the institution’s 

attention during the pendency of the 

investigation, rather than opening an 

inquiry to review those new allegations. 

We believe this will address an 

institution’s administrative efficiency 

concern(s) while providing that new 

allegations are addressed as they are 

identified. 

Institutional Record. As defined in 

proposed § 93.223 and further described 

at proposed §§ 93.305 through 93.316, 

ORI proposes that institutions be 

required to develop, maintain, and 

provide an institutional record. The 

institutional record would ultimately be 


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part of a more expansive administrative 

record that would form the basis of any 

ORI decision regarding whether 

research misconduct has occurred, any 

decision by the Departmental Appeals 

Board ALJ, or any decision by the HHS 

Suspension and Debarment Official 

(SDO). ORI may provide additional 

guidance on how to organize and submit 

the institutional record. 

VI. Proposed Updates to Subpart D 

ORI proposes changes to its processes 

that align with changes for institutions 

in subpart C, specifically how ORI 

assembles the administrative record of a 

research misconduct proceeding. 

Further, 

1. We propose to add paragraph (b) in 

§ 93.404 that would provide even more 

clarity by indicating that the lack of an 

ORI finding of research misconduct 

does not overturn an institution’s 

determination that the conduct 

constituted professional or research 

misconduct warranting remediation 

under the institution’s policy. 

2. We clarify actions ORI may take for 

institutional noncompliance. 

3. We indicate when and how ORI 

may disclose information about a 

research misconduct proceeding. We 

propose, at § 93.410(b), a revision that 

would permit ORI to publish notice of 

institutional research misconduct 

findings and implemented institutional 

actions. This notice would inform the 

public and research community that 

allegations of research misconduct have 

been addressed under the regulation 

and help to protect the health and safety 

of the public, promote the integrity of 

PHS supported research and the 

research process, or conserve public 

funds. ORI is interested in public 

comment on this proposed change, 

particularly on the opportunity for a 

respondent to provide comment or 

information prior to the posting of such 

a notice. 

VII. Proposed Updates to Subpart E 

From our experience and interactions 

with institutions and professional 

organizations, there is a strong desire for 

a simpler and more expedient appeals 

process than the approach provided in 

the 2005 Final Rule. Under the 2005 

Final Rule, a Departmental Appeals 

Board (DAB) ALJ undertakes a de novo 

review of ORI findings of research 

misconduct and proposed HHS 

administrative actions, based on 

evidence (including witness testimony) 

presented by ORI and the respondent at 

a hearing. Therefore, we propose a 

major revision to 42 CFR part 93, 

subpart E which will provide a 

streamlined process for contesting ORI 

findings of research misconduct and 

HHS administrative actions. The 

proposed appeals process would entail 

ALJ review of the administrative record, 

which includes all information 

provided by the respondent to ORI, to 

determine whether ORI’s findings and 

HHS’s proposed administrative actions 

other than suspension or debarment are 

reasonable and not based on a material 

error of law or fact. The proposed 

appeals process also provides for the 

possibility of a limited hearing if the 

ALJ determines that there is a genuine 

dispute over material fact. There would 

be no further opportunity to appeal 

ORI’s findings and HHS’s proposed 

administrative actions (other than 

suspension or debarment) within HHS. 

This proposal does not change that 

respondents may request 

reconsideration of a final debarment 

decision with the SDO. We believe this 

approach is advantageous to all parties, 

providing finality in a more expedient 

manner. ORI specifically seeks comment 

on the scope of and need, or lack of 

need, for the limited hearing in 

proposed § 93.511, as well as comment 

on the other proposed revisions to 

subpart E. 

VIII. Required Regulatory Analyses 

All recipients of PHS biomedical and 

behavioral research awards must 

continue to comply with reporting and 

record keeping requirements in this 

NPRM. As shown below in the 

Paperwork Reduction Act analysis, 

those burdens on institutions 

encompass essentially all the activities 

required under the proposed rule. 

We have examined the impacts of the 

proposed rule under Executive Order 

12866, Executive Order 13563, 

Executive Order 14094, and the 

Unfunded Mandates Reform Act of 1995 

(Pub. L. 104–4). Executive Orders 

12866, 13563, and 14094 direct us to 

assess all costs and benefits of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). We do 

not believe that this proposed rule, if 

finalized, would result in significant 

effects as described below. 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires us to 

prepare a written statement, which 

includes an assessment of anticipated 

costs and benefits, before proposing 

‘‘any rule that includes any Federal 

mandate that may result in the 

expenditure by state, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted annually for inflation) in any 

one year.’’ The current threshold 

described in Executive Order 14094 is 

$200 million. This proposed rule, if 

finalized, would not result in an 

expenditure in any year that meets or 

exceeds this amount. 

Summary of Impacts and Threshold 

Analysis 

This proposed rule would result in 

costs associated with covered 

institutions updating their policies and 

procedures for responding to allegations 

of research misconduct; costs associated 

with covered entities filing an annual 

statement of assurance (research 

integrity assurance) and an annual 

report on allegations received; costs 

associated with submitting reports and 

evidence to support their results and 

conclusions of inquiries or 

investigations of research misconduct; 

and costs associated with obtaining all 

research records and other evidence 

when there is an allegation of research 

misconduct and engaging persons to 

handle the process for addressing the 

allegations of research misconduct. We 

anticipate that the proposed rule would 

likely reduce the burden of compliance 

by states or other institutions through 

reduced confusion and uncertainty. 

We performed an initial threshold 

analysis to assess the approximate 

magnitude of the impacts of the 

proposed rule to determine whether it 

would result in significant effects as per 

section 3(f)(1) of Executive Order 12866. 

We identified the costs associated with 

covered institutions updating their 

policies and procedures for responding 

to allegations of research misconduct as 

the largest impact under the proposed 

rule. For this impact, we anticipate that 

5,910 institutions holding research 

integrity assurances would update their 

policies and procedures. For the 

purposes of this threshold analysis, we 

adopt 16 hours as an estimate for the 

average time across all covered entities 

for these tasks. Across all covered 

entities, this is 94,560 total hours spent 

updating policies and procedures. 

To monetize the change in time use 

associated with these activities, we 

adopt an hourly value of time based on 

the cost of labor, including wages and 

benefits, and also indirect costs, which 

‘‘reflect resources necessary for the 

administrative oversight of employees 

and generally include time spent on 

administrative personnel issues (e.g., 

human resources activities such as 

hiring, performance reviews, personnel 

transfers, affirmative action programs), 

writing administrative guidance 

documents, office expenses (e.g., space 


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69588 Federal Register / Vol. 88, No. 193 / Friday, October 6, 2023 / Proposed Rules 

1U.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-departmenthealth-human-services-regulatory-impact-analysesconceptual-framework. Page v. 

2U.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. 

rental, utilities, equipment costs), and 

outreach and general training (e.g., 

employee development).’’ 1

For these tasks, we identify a pre-tax 

hourly wage for Education 

Administrators, Postsecondary. 

According to the U.S. Bureau of Labor 

Statistics, the mean hourly wage for 

these individuals is $53.49 per hour.2

We assume that benefits plus indirect 

costs equal approximately 100 percent 

of pre-tax wages, and adjust this hourly 

rate by multiplying by two, for a fully 

loaded hourly wage rate of $106.98. We 

multiply this fully loaded hourly wage 

rate by the 94,560 total hours across 

covered entities spent updating policies 

and procedures and estimate a total cost 

in the first year of about $10.1 million. 

Regulatory Flexibility Act 

The Regulatory Flexibility Act (5 

U.S.C. 601 et seq.) requires agencies to 

prepare a regulatory flexibility analysis 

describing the impact of the proposed 

rule on small entities (named 

‘‘institutions’’ in the proposed rule), 

permits agency heads to certify that a 

proposed rule will not, if promulgated, 

have a significant economic impact on 

a substantial number of small entities. 

The primary effect of this proposed rule 

would be to require covered institutions 

to implement policies and procedures 

for responding to allegations of research 

misconduct. The Secretary proposes to 

certify that this proposed rule would not 

have a significant impact on a 

substantial number of small entities, as 

defined by the Regulatory Flexibility 

Act, based on the following facts. 

1. As of March 1, 2023, approximately 

30 percent (1,785) of 5,910 institutions 

holding research integrity assurances 

are small institutions. The primary 

impact of the NPRM on covered 

institutions results from the reporting 

and record keeping provisions which 

are analyzed in detail under the heading 

‘‘The Paperwork Reduction Act.’’ 

Significant annual burdens apply only if 

an institution learns of possible research 

misconduct and begins an inquiry, 

investigation, or both. 

2. Institutions covered by 42 CFR part 

93 reported having conducted a total of 

114 inquiries and 101 investigations 

during the 2021 reporting period. Two 

inquiries and two investigations were 

conducted by small institutions. Small 

institutions may be able to avoid 

developing and filing the full policies 

and procedures for addressing 

allegations of research misconduct 

required by § 93.304 by filing a Small 

Institution Statement. Under the 2005 

Final Rule, this is called a Small 

Organization Statement. ORI or another 

appropriate HHS office will work with 

small institutions to develop and/or 

advise on a process for handling 

allegations of research misconduct 

consistent with 42 CFR part 93. The 

burden of filing the Small Institution 

Statement is .5 hour. Thus, the burden 

of developing and filing the full policies 

and procedures for addressing 

allegations of research misconduct 

required by § 93.304 will not fall on a 

substantial number of small entities. 

A small entity that files the Small 

Institution Statement must still report 

allegations of research misconduct to 

ORI and comply with all provisions of 

the proposed rule except as described in 

§ 93.303. The most significant burden 

that could fall on an entity filing a Small 

Institution Statement is in addressing 

allegations of research misconduct 

which would include obtaining all 

research records and other evidence 

when there is an allegation of research 

misconduct, engaging persons to handle 

the process for addressing the 

allegations of research misconduct, and 

submitting reports and evidence to 

support the small institution’s results 

and conclusions of inquiries or 

investigations of research misconduct. 

The average burden per response is 

estimated at 40 hours. Based on reports 

of research misconduct over the last 5 

years, fewer than 5 small institutions 

would have to incur that burden in any 

year. Based on this analysis, HHS 

concludes that the regulations set forth 

in the NPRM will not impose a 

significant burden on a substantial 

number of small entities. However, HHS 

will carefully consider comments on the 

analysis and conclusion. 

Paperwork Reduction Act 

ORI currently holds OMB-ControlNumber 0937–0198 for the collection of 

information from institutions. The 

information is needed to fulfill section 

493 of the Public Health Service Act (42 

U.S.C. 289b), which requires assurances 

from institutions that apply for PHS 

funding for any project or program that 

involves the conduct of biomedical or 

behavioral research. In addition, the 

information is required to fulfill the 

assurance and annual reporting 

requirements of 42 CFR part 93. ORI 

uses the information to monitor 

institutional compliance with the 

regulation. Lastly, the information may 

be used to respond to congressional 

requests for information to prevent 

misuse of Federal funds and to protect 

the public interest. The Institutional 

Assurance and Annual Report on 

Possible Research Misconduct, PHS– 

6349, and the Assurance of Compliance 

by Sub-Award Recipients, PHS–6315, 

are covered by OMB 0937–0198. The 

OMB approvals expire August 31, 2026, 

and ORI has applied for renewal with 

only minor changes to language in the 

forms. 

ESTIMATED ANNUALIZED BURDEN HOUR TABLE

[3/16/2023] 

Forms 

(if necessary) Type of respondent Number of respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden hours 

PHS–6349 ......................................... Awardee Institutions ......................... 5,770 1 10/60 961 

PHS–6315 ......................................... Sub-Awardee Institutions ................. 156 1 5/60 13 

Total ........................................... ........................................................... ........................ ........................ ........................ 974 


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ESTIMATED ANNUALIZED COST TO RESPONDENTS

[3/16/2023] 

Forms 

(if necessary) Type of respondent Total burden hours 

Hourly wage 

rate 

Total 

respondent 

cost 

PHS–6349 ....................................................... Awardee Institutions ....................................... 961 $107.00 $102,827.00 

PHS–6315 ....................................................... Sub-Awardee Institutions ............................... 13 107.00 1,391.00 

For the reasons discussed in the 

preamble, HHS proposes to revise 42 

CFR part 93 to read as follows: 

PART 93—PUBLIC HEALTH SERVICE 

POLICIES ON RESEARCH 

MISCONDUCT 

Sec. 

93.25 Organization of this part. 

93.50 Special terms. 

Subpart A—General 

93.100 General policy. 

93.101 Purpose. 

93.102 Applicability. 

93.103 Research misconduct. 

93.104 Requirements for findings of 

research misconduct. 

93.105 Time limitations. 

93.106 Confidentiality. 

93.107 Coordination with other agencies. 

Subpart B—Definitions 

93.200 Accepted practices of the relevant 

research community. 

93.201 Administrative action. 

93.202 Administrative record. 

93.203 Allegation. 

93.204 Appeal. 

93.205 Assessment. 

93.206 Charge letter. 

93.207 Complainant. 

93.208 Contract. 

93.209 Day. 

93.210 Departmental Appeals Board or 

DAB. 

93.211 Difference of opinion. 

93.212 Evidence. 

93.213 Fabrication. 

93.214 Falsification. 

93.215 Funding component. 

93.216 Good faith. 

93.217 Honest error. 

93.218 Inquiry. 

93.219 Institution. 

93.220 Institutional certifying official. 

93.221 Institutional deciding official. 

93.222 Institutional member. 

93.223 Institutional record. 

93.224 Intentionally. 

93.225 Investigation. 

93.226 Knowingly. 

93.227 Notice. 

93.228 Office of Research Integrity or ORI. 

93.229 Person. 

93.230 Plagiarism. 

93.231 Preponderance of the evidence. 

93.232 Public Health Service or PHS. 

93.233 PHS support. 

93.234 Recklessly. 

93.235 Research. 

93.236 Research integrity. 

93.237 Research Integrity Officer or RIO. 

93.238 Research misconduct. 

93.239 Research misconduct proceeding. 

93.240 Research record. 

93.241 Respondent. 

93.242 Retaliation. 

93.243 Secretary or HHS. 

93.244 Small institution. 

93.245 Suspension and debarment. 

93.246 Suspension and Debarment Official 

or SDO. 

93.247 This part. 

Subpart C—Responsibilities of Institutions 

Compliance and Assurances 

93.300 General responsibilities for 

compliance. 

93.301 Research integrity assurances. 

93.302 Maintaining active research integrity 

assurances. 

93.303 Research integrity assurances for 

small institutions. 

93.304 Institutional policies and 

procedures. 

93.305 General conduct of research 

misconduct proceedings. 

The Institutional Assessment 

93.306 Institutional assessment. 

The Institutional Inquiry 

93.307 Institutional inquiry. 

93.308 Notice of the results of the inquiry. 

93.309 Reporting to ORI on the decision to 

initiate an investigation. 

The Institutional Investigation 

93.310 Institutional investigation. 

93.311 Investigation time limits. 

93.312 Opportunity to comment on the 

investigation report. 

93.313 Investigation report. 

93.314 Institutional appeals. 

93.315 Transmittal of the institutional 

record to ORI. 

93.316 Completing the research misconduct 

process. 

Other Institutional Responsibilities 

93.317 Retention and custody of the 

institutional record. 

93.318 Institutional standards of conduct. 

Subpart D—Responsibilities of the U.S. 

Department of Health and Human Services 

General Information 

93.400 General statement of ORI authority. 

93.401 Interaction with other entities and 

interim actions. 

Research Misconduct Issues 

93.402 ORI allegation assessments. 

93.403 ORI review of research misconduct 

proceedings. 

93.404 Findings of research misconduct 

and proposed administrative actions. 

93.405 Notifying the respondent of findings 

of research misconduct and HHS 

administrative actions. 

93.406 Final HHS actions. 

93.407 HHS administrative actions. 

93.408 Mitigating and aggravating factors in 

HHS administrative actions. 

93.409 Settlement of research misconduct 

proceedings. 

93.410 Final HHS action with no settlement 

or finding of research misconduct. 

93.411 Final HHS action with a settlement 

or finding of misconduct. 

Institutional Compliance Issues 

93.412 Making decisions on institutional 

noncompliance. 

93.413 HHS compliance actions. 

Disclosure of Information 

93.414 Notice. 

Subpart E—Opportunity To Contest ORI 

Findings of Research Misconduct and HHS 

Administrative Actions 

General Information 

93.500 General policy. 

Process for Contesting Research Misconduct 

Findings and/or Administrative Actions 

93.501 Notice of appeal. 

93.502 Appointment of the Administrative 

Law Judge. 

93.503 Filing of the administrative record. 

93.504 Standard of review. 

93.505 Rights of the parties. 

93.506 Authority of the Administrative Law 

Judge. 

93.507 Ex parte communications. 

93.508 Filing, format, and service. 

93.509 Filing motions. 

93.510 Conferences. 

93.511 Hearing to resolve genuine factual 

dispute. 

93.512 The Administrative Law Judge’s 

ruling. 

Authority: 42 U.S.C. 216, and 289b. 

§ 93.25 Organization of this part. 

This part is subdivided into five 

subparts. Each subpart contains sections 

related to a broad topic or specific 

audience with special responsibilities as 

shown in the following table. 


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In subpart . . . You will find sections related to . . . 

A ...................................................... General information about this rule. 

B ...................................................... Definitions of terms used in this part. 

C ...................................................... Responsibilities of institutions with PHS support. 

D ...................................................... Responsibilities of the U.S. Department of Health and Human Services and the Office of Research Integrity. 

E ...................................................... Information on how to contest ORI research misconduct findings and HHS administrative actions. 

§ 93.50 Special terms. 

This part uses terms throughout the 

text that have special meaning. Those 

terms are defined in subpart B of this 

part. 

Subpart A—General 

§ 93.100 General policy. 

(a) Research misconduct involving 

Public Health Service (PHS) support is 

contrary to the interests of the PHS and 

the Federal Government, to the health 

and safety of the public, to the integrity 

of research, and to the conservation of 

public funds. 

(b) The U.S. Department of Health and 

Human Services (HHS) and institutions 

that apply for or receive PHS support for 

biomedical or behavioral research, 

biomedical or behavioral research 

training, or activities related to that 

research or research training share 

responsibility for the integrity of the 

research process. HHS has ultimate 

oversight authority for PHS supported 

research, and for taking other actions as 

appropriate or necessary, including the 

right to assess allegations and perform 

inquiries or investigations at any time. 

Institutions and institutional members 

have an affirmative duty to protect PHS 

funds from misuse by ensuring the 

integrity of all PHS supported work, and 

primary responsibility for responding to 

and reporting allegations of research 

misconduct, as provided in this part. 

§ 93.101 Purpose. 

The purpose of this part is to: 

(a) Establish the responsibilities of 

HHS, the Office of Research Integrity 

(ORI), and institutions in addressing 

allegations of research misconduct; 

(b) Define what constitutes research 

misconduct in PHS supported research; 

(c) Establish the requirements for a 

finding of research misconduct; 

(d) Define the general types of 

administrative actions HHS may take in 

response to research misconduct; 

(e) Require institutions to: 

(1) Develop and implement policies 

and procedures for reporting and 

addressing allegations of research 

misconduct covered by this part; 

(2) Provide HHS with the assurances 

necessary to permit the institutions to 

participate in PHS supported research. 

(f) Protect the health and safety of the 

public, promote the integrity of PHS 

supported research and the research 

process, and conserve public funds. 

§ 93.102 Applicability. 

(a) Every extramural or intramural 

institution (see § 93.219) that applies for 

or receives PHS support for biomedical 

or behavioral research, biomedical or 

behavioral research training, or 

activities related to that research or 

research training must comply with this 

part. Further, each recipient of such 

support is responsible for the 

compliance of their subrecipients with 

this part. 

(b) This part applies to allegations of 

research misconduct involving: 

(1) Applications or proposals for PHS 

support for biomedical or behavioral 

extramural or intramural research, 

biomedical or behavioral research 

training, or activities related to that 

research or research training; 

(2) PHS supported biomedical or 

behavioral extramural or intramural 

research; 

(3) PHS supported biomedical or 

behavioral extramural or intramural 

research training programs; 

(4) PHS supported extramural or 

intramural activities that are related to 

biomedical or behavioral research or 

research training, such as, but not 

limited to, the operation of tissue and 

data banks or the dissemination of 

research information; 

(5) Research records produced during 

PHS supported research, research 

training, or activities related to that 

research or research training; and 

(6) Research proposed, performed, 

reviewed, or reported, as well as any 

research record generated from that 

research, regardless of whether an 

application or proposal for PHS funds 

resulted in an awarded grant, contract, 

cooperative agreement, sub-award, or 

other form of PHS support. 

(c) This part does not supersede or 

establish an alternative to any 

applicable statutes, regulations, policies, 

or procedures for handling fiscal 

improprieties, the ethical treatment of 

human or animal subjects, criminal 

matters, personnel actions against 

Federal employees, or addressing 

whistleblowers and/or retaliation. 

(d) This part does not supersede or 

establish an alternative to the HHS 

suspension and debarment regulations 

as set forth under the Nonprocurement 

Common Rule (NCR) at 2 CFR part 180 

for nonprocurement transactions (as 

further implemented by HHS at 2 CFR 

part 376) or the Federal Acquisition 

Regulation (FAR) at 48 CFR 9.406 and 

9.407 for procurement transactions (as 

further supplemented by HHS at 48 CFR 

309.4). 

(e) This part does not prohibit or 

otherwise limit how institutions handle 

allegations of misconduct that do not 

fall within this part’s definition of 

research misconduct or that do not 

involve PHS support. 

§ 93.103 Research misconduct. 

(a) As defined below, research 

misconduct is fabrication, falsification, 

or plagiarism in proposing, performing, 

or reviewing research, or in reporting 

research results (see § 93.238). 

(b) Research misconduct does not 

include honest error or differences of 

opinion. 

§ 93.104 Requirements for findings of 

research misconduct. 

A finding of research misconduct 

made under this part requires that: 

(a) There be a significant departure 

from accepted practices of the relevant 

research community; and 

(b) The misconduct be committed 

intentionally, knowingly, or recklessly; 

and 

(c) The allegation must be proven by 

a preponderance of the evidence. 

§ 93.105 Time limitations. 

(a) Six-year limitation. This part 

applies only to research misconduct 

occurring within six years of the date 

HHS or an institution receives an 

allegation of research misconduct. 

(b) Exceptions to the six-year 

limitation. Paragraph (a) of this section 

does not apply in the following 

instances: 

(1) Subsequent use exception. The 

respondent continues or renews any 

incident of alleged research misconduct 

that occurred before the six-year 

limitation through the use of, 

republication of, or citation to the 

portion(s) of the research record (e.g., 

processed data, journal articles, funding 


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proposals, data repositories) that is 

alleged to have been fabricated, 

falsified, or plagiarized, for the potential 

benefit of the respondent. 

(i) When the respondent uses, 

republishes, or cites to the portion(s) of 

the research record that is alleged to 

have been fabricated, falsified, or 

plagiarized, in submitted or published 

manuscripts, submitted PHS grant 

applications, progress reports submitted 

to PHS funding components, posters, 

presentations, or other research records 

within six years of when the allegations 

were received by HHS or an institution, 

this exception applies. 

(ii) For allegations which may fall 

under this exception, an institution 

must inform ORI of the relevant facts 

before concluding the exception does 

not apply. ORI will make the final 

decision about the subsequent use 

exception for each allegation. 

(2) Exception for the health or safety 

of the public. If ORI or the institution, 

following consultation with ORI, 

determines that the alleged research 

misconduct, if it occurred, would 

possibly have a substantial adverse 

effect on the health or safety of the 

public, this exception applies. 

§ 93.106 Confidentiality. 

(a) Disclosure of the identity of 

respondents, complainants, and 

witnesses in research misconduct 

proceedings is limited, to the extent 

possible, to those who need to know, 

consistent with a thorough, competent, 

objective, and fair research misconduct 

proceeding, and as allowed by law. 

Institutions must inform respondents, 

complainants, and witnesses, before 

they are interviewed, if and how their 

identity may be disclosed. Provided, 

however, that the institution must 

disclose the identity of respondents, 

complainants, or other relevant persons 

to ORI pursuant to an ORI review of 

research misconduct proceedings under 

this part. 

(b) Except as may otherwise be 

prescribed by applicable law, 

confidentiality must be maintained for 

any records or evidence from which 

research subjects might be identified. 

Disclosure is limited to those who need 

to know to carry out a research 

misconduct proceeding. 

(c) Disclosure of ongoing research 

misconduct proceedings under this part 

is limited, to the extent possible, to 

those who need to know, consistent 

with a thorough, competent, objective, 

and fair research misconduct 

proceeding, or the purpose of this part 

as described in § 93.101(f). In this 

context, ‘‘those who need to know’’ may 

include public and private entities. 

(d) Disclosure of concerns related to 

the reliability of the research record that 

is alleged to have been fabricated, 

falsified, or plagiarized is limited, to the 

extent possible, to those who need to 

know, consistent with a thorough, 

competent, objective, and fair research 

misconduct proceeding, or the purpose 

of this part as described in § 93.101(f). 

In this context, ‘‘those who need to 

know’’ may include journals, editors, 

publishers, and public and private 

entities. 

(e) For officials at institutions other 

than the institution where the research 

misconduct proceedings are being 

conducted, their need to know occurs 

when the institution: 

(1) May possess records relevant to 

allegations under review; 

(2) Employs a respondent alleged or 

found to have committed research 

misconduct; or 

(3) Funds research being conducted 

by a respondent alleged or found to 

have committed research misconduct. 

§ 93.107 Coordination with other agencies. 

(a) When more than one agency of the 

Federal Government has jurisdiction 

over the subject misconduct allegation, 

HHS will cooperate in designating a 

lead agency to coordinate the response 

of the agencies to the allegation. Where 

HHS is not the lead agency, it may, in 

consultation with the lead agency, take 

appropriate action. 

(b) In research misconduct 

proceedings involving more than one 

agency, HHS may refer to the other 

agency’s (or agencies’) evidence or 

reports if HHS determines that the 

evidence or reports will assist in 

resolving HHS issues. In appropriate 

cases, HHS will seek to resolve 

allegations jointly with the other agency 

or agencies. 

Subpart B—Definitions 

§ 93.200 Accepted practices of the 

relevant research community. 

Accepted practices of the relevant 

research community means those 

practices established by 42 CFR part 93 

and by PHS funding components, as 

well as commonly accepted professional 

codes or norms within the overarching 

community of researchers and 

institutions that apply for and receive 

PHS grants. These practices must be 

consistent with the definition of 

research integrity. 

§ 93.201 Administrative action. 

Administrative action means an HHS 

action, consistent with § 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. 

§ 93.202 Administrative record. 

Administrative record comprises: the 

institutional record; any information 

provided by the respondent to ORI, 

including but not limited to the 

verbatim transcript of any meetings 

under § 93.403 between the respondent 

and ORI, whether in person, by phone, 

or by videoconference, and 

correspondence between the respondent 

and ORI; any additional information 

provided to ORI while the case is 

pending before ORI; and any analysis or 

additional information generated or 

obtained by ORI. Any analysis or 

additional information generated or 

obtained by ORI will also be made 

available to the respondent. 

§ 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. 

§ 93.204 Appeal. 

Appeal means a request that is made 

by a respondent to the institution or 

HHS, consistent with § 93.314 and 

subpart E, to reverse or modify findings, 

decisions, and/or actions related to 

allegations of research misconduct, 

against the respondent. 

§ 93.205 Assessment. 

Assessment means a consideration of 

whether an allegation of research 

misconduct appears to fall within the 

definition of research misconduct; 

appears to involve PHS supported 

biomedical or behavioral research, 

biomedical or behavioral research 

training, or activities related to that 

research or research training, as 

provided in § 93.102; and is sufficiently 

credible and specific so that potential 

evidence of research misconduct may be 

identified. The assessment only 

involves the review of readily accessible 

information relevant to the allegation. 

§ 93.206 Charge letter. 

Charge letter means the written 

notice, as well as any amendments to 

the notice, that are sent to the 

respondent stating the findings of 

research misconduct and any proposed 

HHS administrative actions. If the 

charge letter includes a suspension or 

debarment action, it may be issued 

jointly by ORI and the Suspension and 

Debarment Official (SDO). 


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§ 93.207 Complainant. 

Complainant means an individual 

who in good faith makes an allegation 

of research misconduct. 

§ 93.208 Contract. 

Contract means an acquisition 

instrument awarded under the Federal 

Acquisition Regulation (FAR), 48 CFR 

chapter 1. 

§ 93.209 Day. 

Day means calendar day unless 

otherwise specified. If a deadline falls 

on a Saturday, Sunday, or Federal 

holiday, the deadline will be extended 

to the next day that is not a Saturday, 

Sunday, or Federal holiday. 

§ 93.210 Departmental Appeals Board or 

DAB. 

Departmental Appeals Board or DAB 

means the organization, within the HHS 

Office of the Secretary, established to 

conduct hearings and provide impartial 

review of disputed decisions made by 

HHS operating components. 

§ 93.211 Difference of opinion. 

Difference of opinion means an 

alternative view held by a researcher 

who is substantively engaged in the 

scientific subject area. It generally 

contrasts with a prevailing opinion 

included in a published research record 

or generally accepted by the relevant 

scientific community. The differing 

opinion must concern scientific data, 

methodology, analysis, interpretations, 

or conclusions, not policy opinions or 

decisions unrelated to data practices. 

§ 93.212 Evidence. 

Evidence means anything offered or 

obtained during a research misconduct 

proceeding that tends to prove or 

disprove the existence of an alleged fact. 

Evidence includes documents, whether 

in hard copy or electronic form, 

information, tangible items, and 

testimony. 

§ 93.213 Fabrication. 

Fabrication means making up data or 

results and recording or reporting them. 

§ 93.214 Falsification. 

Falsification means manipulating 

research materials, equipment, or 

processes, or changing or omitting data 

or results such that the research is not 

accurately represented in the research 

record. 

§ 93.215 Funding component. 

Funding component means any 

organizational unit of the PHS 

authorized to award grants, contracts, or 

cooperative agreements for any activity 

covered by this part involving research 

or research training; funding 

components may be agencies, bureaus, 

centers, institutes, divisions, offices, or 

other awarding units within the PHS. 

§ 93.216 Good faith. 

(a) Good faith as applied to a 

complainant or witness means having a 

reasonable belief in the truth of one’s 

allegation or testimony, based on the 

information known to the complainant 

or witness at the time. An allegation or 

cooperation with a research misconduct 

proceeding is not in good faith if made 

with knowing or reckless disregard for 

information that would negate the 

allegation or testimony. 

(b) Good faith as applied to an 

institutional or committee member 

means cooperating with the research 

misconduct proceeding by impartially 

carrying out the duties assigned for the 

purpose of helping an institution meet 

its responsibilities under this part. An 

institutional or committee member does 

not act in good faith if their acts or 

omissions during the research 

misconduct proceedings are dishonest 

or influenced by personal, professional, 

or financial conflicts of interest with 

those involved in the research 

misconduct proceeding. 

(c) Good faith as applied to a 

respondent means acting with 

reasonable belief that respondent’s 

actions are consistent with accepted 

practices of the relevant research 

community. 

§ 93.217 Honest error. 

Honest error means a mistake made in 

good faith. 

§ 93.218 Inquiry. 

Inquiry means preliminary 

information-gathering and preliminary 

fact-finding that meets the criteria and 

follows the procedures of §§ 93.307 

through 93.309. 

§ 93.219 Institution. 

Institution means any person that 

applies for or receives PHS support for 

any activity or program that involves the 

conduct of biomedical or behavioral 

research, biomedical or behavioral 

research training, or activities related to 

that research or training. This includes, 

but is not limited to, colleges and 

universities, PHS intramural biomedical 

or behavioral research laboratories, 

research and development centers, 

national user facilities, industrial 

laboratories or other research institutes, 

small research institutions, and 

independent researchers. 

§ 93.220 Institutional certifying official. 

Institutional certifying official means 

the institutional official responsible for 

assuring on behalf of an institution that 

the institution has written policies and 

procedures for addressing allegations of 

research misconduct, in compliance 

with this part; and complies with its 

own policies and procedures and the 

requirements of this part. The 

institutional certifying official also is 

responsible for certifying the content of 

the institution’s annual report, which 

contains information specified by ORI 

on the institution’s compliance with 

this part, and ensuring the report is 

submitted to ORI, as required. 

§ 93.221 Institutional deciding official. 

Institutional deciding official means 

the institutional official who makes 

final determinations on allegations of 

research misconduct and any 

institutional actions. The same 

individual cannot serve as the 

institutional deciding official and the 

research integrity officer. 

§ 93.222 Institutional member. 

Institutional member or members 

means an individual (or individuals) 

who is employed by, is an agent of, or 

is affiliated by contract or agreement 

with an institution. Institutional 

members may include, but are not 

limited to, officials, tenured and 

untenured faculty, teaching and support 

staff, researchers, research coordinators, 

technicians, postdoctoral and other 

fellows, students, volunteers, subject 

matter experts, consultants, or attorneys, 

or employees or agents of contractors, 

subcontractors, or sub-awardees. 

§ 93.223 Institutional record. 

The institutional record comprises: 

(a) The records that the institution 

compiled during the research 

misconduct proceeding pursuant to 

§§ 93.305 through 93.316, except to the 

extent the institution subsequently 

determines and documents that those 

records are not relevant to the 

proceeding or that the records duplicate 

other records that are being retained. 

These records include, but are not 

limited to: 

(1) The assessment report as required 

by § 93.306(d); 

(2) If an inquiry is conducted, the 

inquiry report and all records (other 

than drafts of the report) in support of 

that report, including, but not limited 

to, research records and the transcripts 

of any interviews conducted during the 

inquiry, information the respondent 

provided to the institution, and the 

documentation of any decision not to 

investigate as required by § 93.309(c); 

(3) If an investigation is conducted, 

the investigation report and all records 

(other than drafts of the report) in 


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support of that report, including, but not 

limited to, research records, the 

transcripts of each interview conducted 

pursuant to § 93.310(g), and information 

the respondent provided to the 

institution; 

(4) Decision(s) by the institutional 

deciding official, such as the written 

decision from the institutional deciding 

official with the final determination of 

research misconduct findings (whether 

the institution found research 

misconduct, and if so, who committed 

the misconduct) and implemented 

institutional actions; and 

(5) The complete record of any 

institutional appeal under § 93.314; 

(b) The documentation of the 

determination of irrelevant or duplicate 

records; and 

(c) A single index listing all 

documents in the institutional record. 

§ 93.224 Intentionally. 

To act intentionally means to act with 

the aim of carrying out the act. 

§ 93.225 Investigation. 

Investigation means the formal 

development of a factual record and the 

examination of that record that meets 

the criteria and follows the procedures 

of §§ 93.310 through 93.316 and leads to 

a decision not to make a finding of 

research misconduct or to a 

recommendation for a finding of 

research misconduct which may include 

a recommendation for other appropriate 

actions, including institutional and 

administrative actions. 

§ 93.226 Knowingly. 

To act knowingly means to act with 

the awareness of the act. 

§ 93.227 Notice. 

Notice means a written or electronic 

communication served in person or sent 

by mail or its equivalent to the last 

known street address, facsimile number, 

or email address of the addressee. 

§ 93.228 Office of Research Integrity or 

ORI. 

Office of Research Integrity or ORI 

means the office established by Public 

Health Service Act section 493 (42 

U.S.C. 289b) and to which the HHS 

Secretary has delegated responsibility 

for addressing research integrity and 

misconduct issues related to PHS 

supported activities. 

§ 93.229 Person. 

Person means any individual, 

corporation, partnership, institution, 

association, unit of government, or legal 

entity, however organized. 

§ 93.230 Plagiarism. 

Plagiarism means the appropriation of 

another person’s ideas, processes, 

results, or words, without giving 

appropriate credit. 

(a) Plagiarism includes the 

unattributed verbatim or nearly 

verbatim copying of sentences and 

paragraphs from another’s work, which 

materially mislead the reader regarding 

the contributions of the author. It does 

not include the limited use of identical 

or nearly-identical phrases which 

describe a commonly-used 

methodology. 

(b) Plagiarism does not include selfplagiarism 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. 

§ 93.231 Preponderance of the evidence. 

Preponderance of the evidence means 

proof by evidence that, compared with 

evidence opposing it, leads to the 

conclusion that the fact at issue is more 

likely true than not. 

§ 93.232 Public Health Service or PHS. 

Public Health Service or PHS consists 

of the following components within the 

HHS: the Office of the Assistant 

Secretary for Health, the Office of Global 

Affairs, the Administration for Strategic 

Preparedness and Response, the 

Advanced Research Projects Agency for 

Health, the Agency for Healthcare 

Research and Quality, the Agency for 

Toxic Substances and Disease Registry, 

the Centers for Disease Control and 

Prevention, the Food and Drug 

Administration, the Health Resources 

and Services Administration, the Indian 

Health Service, the National Institutes of 

Health, the Substance Abuse and Mental 

Health Services Administration, and 

any other components of HHS 

designated or established as 

components of the Public Health 

Service. 

§ 93.233 PHS support. 

PHS support means PHS funding, or 

applications or proposals therefor, for 

biomedical or behavioral research, 

biomedical or behavioral research 

training, or activities related to that 

research or training, that may be 

provided through funding for PHS 

intramural research; PHS grants, 

cooperative agreements, contracts; or 

subawards, contracts, or subcontracts 

under those PHS funding instruments; 

or salary or other payments under PHS 

grants, cooperative agreements, or 

contracts. 

§ 93.234 Recklessly. 

To act recklessly means to act without 

proper caution despite a known risk for 

harm. 

§ 93.235 Research. 

Research means a systematic 

experiment, study, evaluation, 

demonstration, or survey designed to 

develop or contribute to general 

knowledge (basic research) or specific 

knowledge (applied research) by 

establishing, discovering, developing, 

elucidating, or confirming information 

or underlying mechanisms related to 

biological causes, functions, or effects; 

diseases; treatments; or related matters 

to be studied. 

§ 93.236 Research integrity. 

Research integrity refers to the use of 

honest and verifiable methods in 

proposing, performing, and evaluating 

research; reporting research results and 

maintaining the research record with 

particular attention to adherence to 

rules, regulations, and guidelines; and 

following accepted practices of the 

relevant research community. 

§ 93.237 Research Integrity Officer or RIO. 

Research Integrity Officer or RIO 

refers to the institutional official 

responsible for administering the 

institution’s written policies and 

procedures for addressing allegations of 

research misconduct in compliance 

with this part. 

§ 93.238 Research misconduct. 

Research misconduct means 

fabrication, falsification, or plagiarism 

in proposing, performing, or reviewing 

research, or in reporting research 

results. Research misconduct does not 

include honest error or differences of 

opinion. 

§ 93.239 Research misconduct 

proceeding. 

Research misconduct proceeding 

means any actions related to alleged 

research misconduct taken under this 

part, including but not limited to, 

allegation assessments, inquiries, 

investigations, ORI oversight reviews, 

and appeals. 

§ 93.240 Research record. 

Research record means the record of 

data or results that embody the facts 

resulting from scientific inquiry. Data or 

results may be in physical or electronic 

form. Examples of items, materials, or 

information that may be considered part 

of the research record include, but are 

not limited to, research proposals, raw 

data, processed data, clinical research 

records, laboratory records, study 

records, laboratory notebooks, progress 


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reports, manuscripts, abstracts, theses, 

oral presentations, internet and online 

content, internal reports, and journal 

articles. 

§ 93.241 Respondent. 

Respondent means the individual 

against whom an allegation of research 

misconduct is directed or who is the 

subject of a research misconduct 

proceeding. 

§ 93.242 Retaliation. 

Retaliation means an adverse action 

taken against a complainant, witness, or 

committee member by an institution or 

one of its members in response to: 

(a) A good faith allegation of research 

misconduct; or 

(b) Good faith cooperation with a 

research misconduct proceeding. 

§ 93.243 Secretary or HHS. 

Secretary or HHS means the Secretary 

of HHS or any other official or employee 

of the HHS to whom the Secretary 

delegates authority. 

§ 93.244 Small institution. 

Small institution means an institution 

that receives PHS research funds but 

may be too small to conduct an inquiry 

or investigation into an allegation of 

research misconduct as required by this 

part without actual or apparent conflicts 

of interest. A small institution typically 

has a total of 10 or fewer institutional 

members. 

§ 93.245 Suspension and debarment. 

Suspension and debarment mean the 

actions that Federal agencies take to 

disqualify persons deemed not presently 

responsible from doing business with 

the government. 

(a) Suspension refers to the temporary 

disqualification of a person or entity for 

up to 18 months, typically during the 

pendency of an investigation and 

ensuing legal proceedings. 

(b) Debarment, meanwhile, refers to a 

final decision to disqualify a person or 

entity for a fixed period of time. Both 

suspension and debarment have 

government-wide effect: if an entity is 

suspended or debarred by one agency, it 

is prohibited from obtaining any Federal 

contracts or participating in 

nonprocurement transactions. 

(c) Policies and procedures governing 

suspension and debarment from 

procurement programs are set forth in 

the Federal Acquisition Regulation 

(FAR) at 48 CFR 9.406 and 9.407 (as 

further supplemented by HHS at 48 CFR 

309.4). 

(d) Policies and procedures governing 

suspension and debarment from 

nonprocurement programs are set forth 

in the Nonprocurement Common Rule 

(NCR) at 2 CFR part 180 (as further 

implemented by HHS at 2 CFR part 

376). 

(e) Actions undertaken under the FAR 

and NCR have reciprocal effect; 

exclusions issued under one system will 

result in ineligibility for all government 

procurement and nonprocurement 

programs. 

§ 93.246 Suspension and Debarment 

Official or SDO. 

Suspension and Debarment Official or 

SDO means the HHS official authorized 

to impose suspension and debarment. 

§ 93.247 This part. 

This part means 42 CFR part 93 in its 

entirety, unless otherwise explicitly 

noted. When referring to only a portion 

of 42 CFR part 93, that portion may be 

described as ‘‘subpart’’ (see § 93.25), or 

as ‘‘section’’ (text within a specific 

portion of the subpart). 

Subpart C—Responsibilities of 

Institutions Compliance and 

Assurances 

§ 93.300 General responsibilities for 

compliance. 

Institutions must: 

(a) Have written policies and 

procedures for addressing allegations of 

research misconduct that meet the 

requirements of this part; 

(b) Respond to each allegation of 

research misconduct for which the 

institution is responsible under this part 

in a thorough, competent, objective, and 

fair manner, including precautions to 

ensure that individuals responsible for 

carrying out any part of the research 

misconduct proceeding do not have 

unresolved personal, professional, or 

financial conflicts of interest with the 

complainant, respondent, or witnesses; 

(c) Foster a research environment that 

promotes research integrity and the 

responsible conduct of research, 

discourages research misconduct, and 

deals promptly with allegations or 

evidence of possible research 

misconduct; 

(d) Take all reasonable and practical 

steps to protect the positions and 

reputations of good faith complainants, 

witnesses, and committee members and 

protect these individuals from 

retaliation by respondents and/or other 

institutional members; 

(e) Provide confidentiality to the 

extent required by § 93.106 to all 

respondents, complainants, and 

witnesses in a research misconduct 

proceeding, and to research subjects 

identifiable from research records or 

other evidence; 

(f) Take all reasonable and practical 

steps to ensure the cooperation of 

respondents and other institutional 

members with research misconduct 

proceedings, including, but not limited 

to, their providing information, research 

records, and other evidence; 

(g) Cooperate with HHS during any 

research misconduct proceeding or 

compliance review, including 

addressing deficiencies or additional 

allegations in the institutional record if 

directed by ORI; 

(h) Assist in administering and 

enforcing any HHS administrative 

actions imposed on its institutional 

members; and 

(i) Have an active research integrity 

assurance. 

§ 93.301 Research integrity assurances. 

(a) General policy. (1) An institution 

that applies for or receives PHS support 

for biomedical or behavioral research, 

biomedical or behavioral research 

training, or activities related to that 

research or research training, must 

provide HHS with an assurance of 

compliance with this part by 

establishing and then maintaining an 

active research integrity assurance. 

(2) PHS funding components may 

only authorize release of funds for 

extramural biomedical and behavioral 

research, biomedical and behavioral 

research training, or activities related to 

that research or research training, to 

institutions that have an active research 

integrity assurance on file with ORI. 

(b) Research integrity assurance. The 

Institutional Certifying Official must 

assure on behalf of the institution, 

initially and then annually thereafter, 

that the institution: 

(1) Has written policies and 

procedures for addressing allegations of 

research misconduct, in compliance 

with this part; 

(2) Complies with its policies and 

procedures for addressing allegations of 

research misconduct; and 

(3) Complies with all provisions of 

this part. 

§ 93.302 Maintaining active research 

integrity assurances. 

(a) Compliance with this part. ORI 

considers an institution in compliance 

with this part when it: 

(1) Has policies and procedures for 

addressing allegations of research 

misconduct according to this part, keeps 

them in compliance with this part, and 

upon request, provides them to ORI and 

other HHS personnel; 

(2) Complies with its policies and 

procedures for addressing allegations of 

research misconduct; 

(3) Complies with all provisions of 

this part; and 

(4) Takes all reasonable and practical 

specific steps to foster research integrity 


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consistent with § 93.300, including, but 

not limited to: 

(i) Informing the institution’s 

members about its policies and 

procedures for addressing allegations of 

research misconduct, and the 

institution’s commitment to compliance 

with the policies and procedures; and 

(ii) Making its policies and 

procedures for addressing allegations of 

research misconduct publicly available. 

(b) Annual report. An institution must 

file an annual report with ORI, which 

contains information specified by ORI, 

on the institution’s compliance with 

this part. The Institutional Certifying 

Official is responsible for certifying the 

content of this report and for ensuring 

the report is submitted as required. 

(c) Additional information. Along 

with its research integrity assurance or 

annual report, an institution must send 

ORI such other information as ORI may 

request on the institution’s research 

misconduct proceedings covered by this 

part and the institution’s compliance 

with the requirements of this part. 

§ 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 §§ 93.300(a), 

93.301, and 93.304, upon approval by 

ORI. 

(b) The Small Institution Statement 

does not relieve the institution from 

complying with any other provision of 

this part. 

(c) By submitting a Small Institution 

Statement, the institution agrees to 

report all allegations of research 

misconduct to ORI. ORI or another 

appropriate HHS office will work with 

the institution to develop and/or advise 

on a process for handling allegations of 

research misconduct consistent with 

this part. 

(d) If a small institution has or 

believes it has a conflict of interest 

during any phase of a research 

misconduct proceeding, the small 

institution should contact ORI for 

guidance. 

§ 93.304 Institutional policies and 

procedures. 

Institutions seeking an approved 

research integrity assurance must have 

written policies and procedures for 

addressing allegations of research 

misconduct. Such policies and 

procedures must: 

(a) Address and be consistent with all 

applicable requirements pertaining to 

institutional responsibilities included in 

this part; 

(b) Include and be consistent with 

applicable definitions in this part; and 

(c) Be made available to ORI in 

English. 

§ 93.305 General conduct of research 

misconduct proceedings. 

(a) Sequestration of research records 

and other evidence. An institution must 

promptly take all reasonable and 

practical steps to obtain all research 

records and other evidence, which may 

include copies of the data or other 

evidence so long as those copies are 

substantially equivalent in evidentiary 

value, needed to conduct the research 

misconduct proceeding; inventory the 

records and other evidence; and 

sequester them in a secure manner. 

Where the research records or other 

evidence are located on or encompass 

scientific instruments shared by 

multiple users, institutions may obtain 

copies of the data or other evidence 

from such instruments, so long as those 

copies are substantially equivalent to 

the evidentiary value of the instruments. 

Whenever possible, the institution must 

obtain the research records or other 

evidence: 

(1) Before or at the time the institution 

notifies the respondent of the 

allegation(s); and 

(2) Whenever additional items 

become known or relevant to the 

inquiry or investigation. 

(b) Access to research records. Where 

appropriate, an institution must give the 

respondent copies of, or reasonable 

supervised access to, the research 

records that are sequestered in 

accordance with § 93.305(a). 

(c) Maintenance of the institutional 

record. An institution, as the 

responsible legal entity for the PHS 

supported research, has a continuing 

obligation under this part to ensure that 

it maintains an adequate institutional 

record for a research misconduct 

proceeding. An institution must 

maintain the institutional record as 

required by § 93.317. 

(d) Multiple respondents. Institutions 

must consider whether any additional 

researchers are responsible for the 

alleged research misconduct. Notably, 

the principal investigator, other 

coauthors on the publication(s), coinvestigators on the funding proposal(s), 

collaborators, and laboratory members 

who were involved in conducting the 

experiments that generated the primary 

data or in generating the text and figures 

in the research records (e.g., published 

papers and funding proposals) must be 

considered as potential respondents 

during the assessment, inquiry, and/or 

subsequent investigation. If any 

additional respondent(s) are identified 

throughout the inquiry/investigation, 

they must be notified of the allegations, 

in accordance with §§ 93.307(c), 

93.308(a), and 93.310(c). 

(e) Multiple institutions. When 

multiple institutions are involved in the 

allegations, one institution must be 

designated as the lead institution if a 

joint research misconduct proceeding 

(inquiry and/or investigation) is 

conducted. In a joint research 

misconduct proceeding, the lead 

institution should obtain research 

records pertinent to the inquiry/ 

investigation and witness’ testimonies 

from the other relevant institutions. By 

mutual agreement, the joint research 

misconduct proceeding may include 

committee members from the 

institutions involved. The 

determination of whether further 

inquiry and/or investigation is 

warranted, whether research 

misconduct occurred, and which 

institutional actions are to be taken may 

be made by the institutions jointly or 

the responsibilities tasked to the lead 

institution. 

(f) Pursue leads. An institution must 

diligently pursue all significant issues 

and leads discovered in information 

obtained from evidence and/or 

testimony during the inquiry and/or 

investigation that are determined 

relevant to the inquiry and/or 

investigation, including any evidence of 

additional instances of possible research 

misconduct. The pursuit of any such 

issues and/or leads may extend to the 

examination of additional research 

records (e.g., published papers, grant 

applications) of the respondent(s) that 

contain similar data elements as that of 

the initial allegation(s). If additional 

allegations are raised during the inquiry 

or investigation, the respondent(s) must 

be notified in writing of the additional 

allegations raised against them. 

(g) Interviews. An institution must 

interview each respondent, 

complainant, and any other available 

person who has been reasonably 

identified as having information 

regarding any relevant aspects of the 

investigation, including witnesses 

identified by the respondent. 

Institutions may, but are not required to, 

conduct interviews during the 

assessment or inquiry. Interviews 

conducted during an assessment, 

inquiry, and/or investigation must be 

consistent with the requirements of this 

section. 

(1) Interviews must be transcribed. 

(2) Any exhibits shown to the 

interviewee during the interview must 

be numbered and referred to by that 

number in the interview. 

(3) The transcript of the interview 

must be made available to the relevant 

interviewee for correction. 


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(4) The transcript(s) with any 

corrections and numbered exhibits must 

be included in the record of the 

investigation. 

(5) The respondent must not be 

present during the witnesses’ interviews 

but must be provided a transcribed copy 

of the interview. 

Using a committee, consortium, or 

other person for research misconduct 

proceedings. (1) An institution may use 

the services of a committee, consortium, 

or person that the institution reasonably 

determines to be qualified by practice 

and/or experience to conduct, support, 

or participate in the research 

misconduct proceedings. An institution 

may choose to use the same committee, 

consortium, or person for the 

assessment, inquiry, and/or 

investigation. 

(2) An institution must address any 

potential, perceived, or actual personal, 

professional, or financial conflicts of 

interest between members of the 

committee or consortium, or the 

qualified person and the complainant, 

respondent, or witnesses. 

(3) A consortium may be a group of 

institutions, professional organizations, 

mixed groups, or individuals that will 

conduct research misconduct 

proceedings for other institutions. 

(4) An institution must ensure that a 

committee, consortium, or person acting 

on its behalf conducts research 

misconduct proceedings in compliance 

with the requirements of this part. 

(5) An institution is not required to 

provide respondents or complainants 

the opportunity to object to the person 

or to one or more committee or 

consortium members chosen to conduct, 

support, or participate in the research 

misconduct proceedings. If an 

institution chooses to provide one 

respondent the opportunity to object in 

a proceeding, it must provide all 

respondents the opportunity to object in 

that proceeding. If an institution 

chooses to provide one complainant the 

opportunity to object in a proceeding, it 

must provide all complainants the 

opportunity to object in that proceeding. 

(i) Notifying ORI of special 

circumstances. At any time during a 

research misconduct proceeding, as 

defined in § 93.239, an institution must 

notify ORI immediately if it has reason 

to believe that any of the following 

conditions exist: 

(1) Health or safety of the public is at 

risk, including an immediate need to 

protect human or animal subjects. 

(2) HHS resources or interests are 

threatened. 

(3) Research activities should be 

suspended. 

(4) There is reasonable indication of 

possible violations of civil or criminal 

law. 

(5) Federal action is required to 

protect the interests of those involved in 

the research misconduct proceeding. 

(6) HHS may need to take appropriate 

steps to safeguard evidence and protect 

the rights of those involved. 

The Institutional Assessment 

§ 93.306 Institutional assessment. 

(a) Purpose. An assessment’s purpose 

is to decide if an allegation warrants an 

inquiry. 

(b) Conducting the institutional 

assessment. (1) Upon receiving an 

allegation of research misconduct, the 

RIO or another designated institutional 

official must promptly assess the 

allegation to determine whether the 

allegation: 

(i) Falls within the definition of 

research misconduct under this part, 

(ii) Is within the jurisdictional criteria 

of 42 CFR 93.102, and 

(iii) Is sufficiently credible and 

specific so that potential evidence of 

research misconduct may be identified. 

(2) In conducting the assessment, the 

RIO or another designated institutional 

official must review readily accessible 

information relevant to the allegation. 

The RIO or another designated 

institutional official does not need to 

interview the complainant, respondent, 

or other witnesses, or gather information 

beyond what may have been submitted 

with the allegation, except as necessary 

to determine whether the allegation is 

sufficiently credible and specific so that 

potential evidence of research 

misconduct may be identified. Should it 

be necessary to conduct interviews or 

gather information, such interviews 

must be conducted according to the 

requirements of § 93.305(g). 

Assessment results. (1) An inquiry 

must be conducted if the allegation 

meets the three assessment criteria at 

§ 93.306(b)(1). 

(2) If the RIO or another designated 

institutional official determines that 

requirements for an inquiry are met, 

they must: 

(i) Document the assessment, in the 

form of an assessment report (see 

§ 93.306(d)); and 

(ii) Promptly take all reasonable and 

practical steps to obtain all research 

records and other evidence that are 

needed, before or at the time the 

institution notifies the respondent of the 

allegation(s), consistent with § 93.305, 

and promptly initiate the inquiry. 

(2) If the RIO or another designated 

institutional official determines that 

requirements for an inquiry are not met, 

they must keep sufficiently detailed 

documentation of the assessment to 

permit a later review by ORI of the 

reasons why the institution decided not 

to conduct an inquiry. 

(d) Assessment report. (1) The RIO or 

another designated institutional official 

must document the process undertaken 

and the outcome of the assessment, 

including: 

(i) The allegation(s) assessed; 

(ii) The name(s), professional 

alias(es), and position(s) of the 

respondent(s); 

(iii) Any evidence reviewed; 

(iv) Whether the allegation falls 

within the definition of research 

misconduct under this part; 

(v) Whether the allegation is within 

the jurisdictional criteria of § 93.102; 

(vi) Whether the allegation is 

sufficiently credible and specific so that 

potential evidence of research 

misconduct may be identified; and 

(vii) Whether the institution will 

proceed to inquiry. If the assessment 

automatically moves to inquiry as 

required by § 93.306(e)(2), the 

assessment report must document this 

action. 

(2) The assessment report must be 

completed within 15 days of when the 

decision is made to move to inquiry 

under § 93.306(c) or the institution 

moves to inquiry under § 93.306(e)(2). 

(3) Institutions must keep these 

records in a secure manner for at least 

7 years after the assessment was 

conducted, and upon request, provide 

them to ORI. 

(e) Time for completion. (1) The 

institution must complete the 

assessment within 30 days of its 

initiation. 

(2) If the assessment will take longer 

than 30 days, the institution must 

initiate an inquiry consistent with 

§ 93.307. 

The Institutional Inquiry 

§ 93.307 Institutional inquiry. 

(a) Criteria warranting an inquiry. An 

inquiry is warranted if the allegation: 

(1) Was not assessed within the 30- 

day period for review provided in 

§ 93.306(e); or 

(2) Meets the following three criteria: 

(i) Falls within the definition of 

research misconduct under this part; 

(ii) Is within the jurisdictional criteria 

of § 93.102; and 

(iii) Is sufficiently credible and 

specific so that potential evidence of 

research misconduct may be identified. 

(b) Purpose. An inquiry’s purpose is 

to conduct an initial review of the 

evidence to decide if an allegation 

warrants an investigation. 


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(c) Notice to respondent. At the time 

of or before beginning an inquiry, an 

institution must make a good faith effort 

to notify in writing the presumed 

respondent, if any. If the inquiry 

subsequently identifies additional 

respondents, the institution must notify 

them. Only allegations specific to a 

particular respondent are to be included 

in the notification to that respondent. 

(d) Sequestration of the records. An 

institution must obtain all research 

records and other evidence needed to 

conduct the research misconduct 

proceeding, consistent with § 93.305(a). 

(e) Conducting the inquiry—(1) 

Multiple institutions. A joint research 

misconduct proceeding must be 

conducted consistent with § 93.305(e). 

(2) Person conducting the inquiry. 

Institutions may, but are not required to, 

convene committees of experts to 

conduct reviews at the inquiry stage to 

determine whether an investigation is 

warranted. The inquiry review may be 

done by a RIO or another designated 

institutional official in lieu of a 

committee, with the caveat that if 

needed, these individuals may utilize 

one or more subject matter experts to 

assist them in the inquiry review. 

(3) Review of evidence. The purpose 

of an inquiry is to conduct an initial 

review of the evidence to determine 

whether to conduct an investigation. 

Therefore, an inquiry does not require a 

full review of all the evidence related to 

the allegation. 

(4) Interviews. Institutions may, but 

are not required to, call witnesses or 

respondents for interviews that would 

provide additional information for the 

institution’s review. Any interviews 

conducted must follow the requirements 

of § 93.305(g). 

(5) Pursue leads. Institutions must 

diligently pursue all significant issues 

and leads, consistent with the 

requirements of § 93.305(f). 

(f) Inquiry results—(1) Criteria 

warranting an investigation. An 

investigation is warranted if: 

(i) There is a reasonable basis for 

concluding that the allegation falls 

within the definition of research 

misconduct under this part and involves 

PHS supported biomedical or behavioral 

research, biomedical or behavioral 

research training, or activities related to 

that research or research training, as 

provided in § 93.102; and 

(ii) Preliminary information-gathering 

and fact-finding from the inquiry 

indicates that the allegation may have 

substance. 

(2) Honest error and difference of 

opinion. (i) A conclusion of honest error 

or difference of opinion must not be 

made at the inquiry stage. 

(ii) An inquiry cannot determine that 

an allegation lacks sufficient substance 

based solely on a respondent’s 

unsubstantiated claim that the alleged 

research misconduct was a result of 

honest error or difference of opinion. 

(3) Findings of research misconduct. 

Findings of research misconduct, 

including the determination of whether 

the alleged misconduct is intentional, 

knowing, or reckless, cannot be made at 

the inquiry stage. 

(g) Inquiry report. (1) The institution 

must prepare a written report that meets 

the requirements of this section and 

§ 93.309. 

(2) If there is potential evidence of 

honest error or difference of opinion, 

the institution must note this in the 

inquiry report. 

(3) The institution must provide the 

respondent an opportunity to review 

and comment on the inquiry report and 

attach any comments received to the 

report. 

(h) Time for completion. (1) The 

institution must complete the inquiry 

within 60 days of its initiation unless 

circumstances clearly warrant a longer 

period. 

(2) If the inquiry will take longer than 

60 days, the institution must notify ORI 

and request an extension. As part of the 

request, the institution must describe 

the particular circumstances or issues 

that would warrant additional time to 

complete the inquiry. 

(3) If the inquiry takes longer than 60 

days to complete, the inquiry report 

must document the reasons for 

exceeding the 60-day period. 

§ 93.308 Notice of the results of the 

inquiry. 

(a) Notice to respondent. The 

institution must notify the respondent 

whether the inquiry found that an 

investigation is warranted. The notice 

must include a copy of the inquiry 

report and include a copy of or refer to 

this part and the institution’s policies 

and procedures adopted under its 

research integrity assurance. 

(b) Notice to complainants. The 

institution is not required to notify the 

complainant(s) whether the inquiry 

found that an investigation is warranted. 

The institution may, but is not required 

to, provide relevant portions of the 

report to the complainant(s) for 

comment. If an institution provides 

notice to one complainant in a case, it 

must provide notice, to the extent 

possible, to all complainants in the case. 

§ 93.309 Reporting to ORI on the decision 

to initiate an investigation. 

(a) Within 30 days of deciding that an 

investigation is warranted, the 

institution must provide ORI with the 

written decision by the institutional 

deciding official and a copy of the 

inquiry report which includes the 

following information: 

(1) The names, professional aliases, 

and positions of the respondent and 

complainant; 

(2) A description of the allegation(s) 

of research misconduct; 

(3) The PHS support, including, for 

example, grant numbers, grant 

applications, contracts, and publications 

listing PHS support; 

(4) The composition of the inquiry 

committee, including name(s), 

position(s), and subject matter expertise; 

(5) Inventory of sequestered research 

records and other evidence and 

description of how sequestration was 

conducted; 

(6) Transcripts of interviews, if 

conducted; 

(7) Timeline and procedural history; 

(8) Any scientific or forensic analyses 

conducted; 

(9) The basis for recommending that 

the allegation(s) warrant an 

investigation; 

(10) The basis on which any 

allegation(s) do not merit further 

investigation; 

(11) Any comments on the inquiry 

report by the respondent or the 

complainant; 

(12) Any institutional actions 

implemented, including 

communications with journals or 

funding agencies; and 

(13) Written decision from the 

institutional deciding official that an 

investigation is warranted. 

(b) The institution must provide the 

following information to ORI whenever 

requested: 

(1) The institutional policies and 

procedures under which the inquiry 

was conducted; 

(2) The research records and other 

evidence reviewed, transcripts of any 

interviews, and copies of all relevant 

documents; and 

(3) The charges for the investigation to 

consider. 

(c) Institutions must keep sufficiently 

detailed documentation of inquiries to 

permit a later assessment by ORI of the 

reasons why the institution decided not 

to conduct an investigation. Consistent 

with § 93.317, institutions must keep 

these records in a secure manner for at 

least 7 years after the termination of the 

inquiry, and upon request, provide them 

to ORI. 

(d) In accordance with § 93.305(i), 

institutions must notify ORI and other 

PHS agencies, as relevant, of any special 

circumstances that may exist. 


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The Institutional Investigation 

§ 93.310 Institutional investigation. 

Institutions conducting research 

misconduct investigations must: 

(a) Time. Begin the investigation 

within 30 days after deciding that an 

investigation is warranted. 

(b) Notice to ORI. Notify ORI of the 

decision to begin an investigation on or 

before the date the investigation begins 

and provide an inquiry report that meets 

the requirements of §§ 93.307 and 

93.309. 

(c) Notice to the respondent. Notify 

the respondent in writing of the 

allegation(s) within a reasonable amount 

of time after determining that an 

investigation is warranted, but before 

the investigation begins. 

(1) The institution must give the 

respondent written notice of any 

allegation(s) of research misconduct not 

addressed during the inquiry or in the 

initial notice of investigation within a 

reasonable amount of time of deciding 

to pursue such allegation(s). 

(2) If the institution identifies 

additional respondents during the 

investigation that were not identified 

during the inquiry, the institution is not 

required to conduct a separate inquiry. 

If any additional respondent(s) are 

identified during the investigation, the 

institution must notify them of the 

allegation(s). 

(3) While an investigation into 

multiple respondents can convene with 

the same investigation committee 

members, separate investigation reports 

and research misconduct 

determinations are required for each 

respondent. 

(d) Sequestration of the records. An 

institution must obtain all research 

records and other evidence needed to 

conduct the research misconduct 

proceeding, consistent with § 93.305(a). 

(e) Documentation. Use diligent 

efforts to ensure that the investigation is 

thorough and sufficiently documented 

and includes examination of all research 

records and other evidence relevant to 

reaching a decision on the merits of the 

allegation(s). 

(f) Ensuring a fair investigation. Take 

reasonable steps to ensure an impartial 

and unbiased investigation to the 

maximum extent practicable, including 

participation of persons with 

appropriate scientific expertise who do 

not have unresolved personal, 

professional, or financial conflicts of 

interest relevant to the investigation. An 

institution may use the same committee 

members from the inquiry in their 

subsequent investigation. 

(g) Interviews. Conduct interviews, 

consistent with § 93.305(g). 

(h) Pursue leads. Pursue diligently all 

significant issues and leads, consistent 

with the requirements of § 93.305(f), and 

continue the investigation to 

completion. Once a proceeding reaches 

the investigation stage, the institution 

may choose to add to or expand the 

ongoing investigation by including any 

allegation(s) pertaining to the same 

respondent or research records in 

question (e.g., manuscripts or funding 

proposals) that come to the institution’s 

attention during the investigation, rather 

than opening an inquiry to review those 

allegation(s). 

(i) Multiple respondents. Consider, 

consistent with § 93.305(d), the prospect 

of additional researchers being 

responsible for the alleged research 

misconduct. 

(j) Multiple institutions. A joint 

research misconduct proceeding must 

be conducted consistent with 

§ 93.305(e). 

§ 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 § 93.312, and 

sending the final institutional record 

including the final report to ORI under 

§ 93.315. 

(b) Extension of time limit. If unable 

to complete the investigation in 180 

days, the institution must ask ORI for an 

extension in writing that includes the 

circumstances or issues warranting 

additional time. 

(c) Progress reports. If ORI grants an 

extension, it may direct the institution 

to file periodic progress reports. 

(d) Investigation report. If the 

investigation takes longer than 180 days 

to complete, the investigation report 

must include the reasons for exceeding 

the 180-day period. 

§ 93.312 Opportunity to comment on the 

draft investigation report. 

(a) The institution must give the 

respondent a copy of the draft 

investigation report and, concurrently, a 

copy of, or supervised access to, the 

records on which the report is based. 

The respondent must submit any 

comments on the draft report to the 

institution within 30 days of the date on 

which the respondent received the draft 

investigation report. 

(b) The institution is not required to 

provide the complainant(s) a copy of the 

draft investigation report or relevant 

portions of that report. Should the 

institution choose to do so, all 

complainants must be treated in the 

same way—absent extenuating 

circumstances. The complainant must 

submit any comments on the draft 

report to the institution within 30 days 

of the date on which the complainant 

received the draft investigation report or 

relevant portions of it. 

§ 93.313 Investigation report. 

A final investigation report for each 

respondent must be in writing and 

include: 

(a) Describe the nature of the 

allegation(s) of research misconduct, 

including any additional allegation(s) 

addressed during the research 

misconduct proceeding. 

(b) Describe and document the PHS 

support, including, for example, any 

grant numbers, grant applications, 

contracts, and publications listing PHS 

support. 

(c) Describe the specific allegation(s) 

of research misconduct for 

consideration in the investigation for 

each respondent. 

(d) Composition of investigation 

committee, including name(s), 

position(s), and subject matter expertise. 

(e) Inventory of sequestered research 

records/other evidence and how 

sequestration was conducted during the 

investigation, if applicable. 

(f) Listing of all manuscripts, funding 

proposals, and research records that 

were examined during the investigation. 

(g) Transcripts of all interviews 

conducted, as described in § 93.305(g). 

(h) Identification of the specific 

published papers, manuscripts 

submitted but not accepted for 

publication (including online 

publication), PHS grant/contract 

applications, progress reports, 

presentations, posters, or other research 

records that allegedly contained the 

falsified, fabricated, or plagiarized 

material. 

(i) Any scientific or forensic analyses 

conducted. 

(j) If not already provided to ORI with 

the inquiry report, include the 

institutional policies and procedures 

under which the investigation was 

conducted. 

(k) Identify and summarize the 

research records and other evidence 

reviewed and identify any evidence 

obtained and sequestered but not 

reviewed. 

(l) For each separate allegation of 

research misconduct identified during 

the investigation, provide a finding as to 

whether research misconduct did or did 

not occur, and if so: 

(1) Identify the individual(s) 

responsible for the misconduct; 


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(2) Indicate whether the research 

misconduct was falsification, 

fabrication, and/or plagiarism; and if the 

requirements for a finding of research 

misconduct, as described in § 93.104, 

have been met. Voting or split decisions 

by the investigation committee members 

are not permitted in the final 

recommendation in the investigation 

report. 

(3) Summarize the facts and the 

analysis which support the conclusion 

and consider the merits of any 

explanation by the respondent; 

(4) Identify the specific PHS support; 

(5) Identify whether any publications 

need correction or retraction; and 

(6) List any current support or known 

applications or proposals for support 

that the respondent has pending with 

PHS and non-PHS Federal agencies. 

Include and consider any comments 

made by the respondent and 

complainant on the draft investigation 

report. 

(n) The basis on which allegation(s) 

did not result in a research misconduct 

determination. 

(o) Any institutional actions 

recommended or implemented 

including communications with 

journals or funding agencies. 

§ 93.314 Institutional appeals. 

(a) While not required by this part, if 

the institution’s policies and procedures 

provide for an appeal by the respondent 

that could result in a reversal or 

modification of the findings of research 

misconduct in the investigation report, 

the institution must notify ORI of and 

complete any such appeal within 120 

days of its initiation. Appeals of 

institutional personnel actions or other 

actions that would not result in a 

reversal or modification of the findings 

of research misconduct are excluded 

from the 120-day limit. 

(b) If unable to complete any appeals 

within 120 days, the institution must 

ask ORI for an extension in writing that 

includes the circumstances or issues 

warranting additional time. 

(c) ORI may grant requests for 

extension for good cause. If ORI grants 

an extension, it may direct the 

institution to file periodic progress 

reports. 

§ 93.315 Transmittal of the institutional 

record to ORI. 

The institution must transmit to ORI 

the institutional record. The 

institutional record must be consistent 

with § 93.223 and logically organized. 

§ 93.316 Completing the research 

misconduct process. 

(a) ORI expects institutions to carry 

inquiries and investigations through to 

completion and to pursue diligently all 

significant issues and credible 

allegations of research misconduct. 

Institutions must notify ORI in advance 

if the institution plans to close a 

research misconduct proceeding at the 

assessment, inquiry, investigation, or 

appeal stage on the basis that the 

respondent has admitted to committing 

research misconduct, a settlement with 

the respondent has been reached, or for 

any other reason. 

(b) A respondent’s admission of 

research misconduct must be made in 

writing and signed by the respondent. 

An admission must specify the 

falsification, fabrication, and/or 

plagiarism that occurred and which 

research records were affected. The 

admission statement must meet all the 

elements required for a research 

misconduct finding under § 93.104 and 

must be provided to ORI before the 

institution closes its research 

misconduct proceeding. The institution 

must also provide a statement to ORI 

describing how it determined that the 

scope of the misconduct was fully 

addressed by the admission and 

confirmed the respondent’s culpability. 

(c) After consulting with the 

institution on its basis for closing a case 

under paragraph (a) of this section, ORI 

may conduct an oversight review of the 

institution’s handling of the case and 

take appropriate action including: 

(1) Approving or conditionally 

approving closure of the case; 

(2) Directing the institution to 

complete its process; 

(3) Directing the institution to address 

deficiencies in the institutional record; 

(4) Referring the matter for further 

investigation by HHS; or, 

(5) Taking a compliance action. 

Other Institutional Responsibilities 

§ 93.317 Retention and custody of the 

institutional record. 

(a) Maintenance of institutional 

record. Unless custody has been 

transferred to HHS under paragraph (b) 

of this section, or ORI has advised the 

institution in writing that it no longer 

needs to retain the institutional record, 

an institution must maintain the 

institutional record in a secure manner 

for 7 years after completion of the 

proceeding or the completion of any 

PHS proceeding involving the research 

misconduct allegation under subparts D 

and E of this part, whichever is later. 

(b) Provision for HHS custody. On 

request, institutions must transfer 

custody of or provide copies to HHS of 

the institutional record or any 

component of the institutional record 

and any sequestered physical objects, 

such as a computer hard drive, for ORI 

to conduct its oversight review, to 

develop the administrative record, or to 

present the administrative record in any 

proceeding under subparts D and E of 

this part. 

§ 93.318 Institutional standards of 

conduct. 

(a) Institutions may have standards of 

conduct different from the standards for 

research misconduct under this part. 

Therefore, an institution may find 

conduct to be actionable under its 

standards even if the conduct does not 

meet this part’s definition of research 

misconduct. 

(b) An HHS or ORI finding or 

settlement on research misconduct 

findings does not affect institutional 

findings or actions taken based on an 

institution’s standards of conduct. 

Subpart D—Responsibilities of the U.S. 

Department of Health and Human 

Services 

General Information 

§ 93.400 General statement of ORI 

authority. 

(a) ORI review. ORI may respond 

directly to any allegation of research 

misconduct at any time before, during, 

or after an institution’s response to the 

matter. The ORI response may include, 

but is not limited to: 

(1) Conducting allegation 

assessments; 

(2) Determining independently if 

jurisdiction exists under this part; 

(3) Forwarding allegations of research 

misconduct to the appropriate 

institution or HHS component for 

inquiry or investigation; 

(4) Requesting clarification or 

additional information, documentation, 

research records, or other evidence as 

necessary from an institution or its 

members or other persons or sources to 

carry out ORI’s review; 

(5) Notifying or requesting assistance 

and information from PHS funding 

components or other affected Federal 

and state offices and agencies or 

institutions; 

(6) Reviewing the institutional record 

and directing the institution to address 

deficiencies or additional allegations in 

the institutional record; 

(7) Making a finding of research 

misconduct; and 

(8) Proposing or taking administrative 

actions. 

(b) ORI assistance to institutions. ORI 

will: 

(1) Provide information, technical 

assistance, and procedural advice to 

institutional officials as needed 

regarding an institution’s research 


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misconduct proceedings and the 

sufficiency of the institutional record. 

(2) Issue guidance and provide 

information to support institutional 

implementation of and/or compliance 

with the requirements of this part. 

(c) Review of institutional research 

integrity assurances. ORI will review 

institutional research integrity 

assurances and policies and procedures 

for compliance with this part. 

(d) Institutional compliance. ORI may 

make findings and impose HHS 

compliance actions related to an 

institution’s compliance with this part 

and with its policies and procedures, 

including an institution’s participation 

in research misconduct proceedings. 

§ 93.401 Interaction with other entities and 

interim actions. 

(a) ORI may notify and consult with 

other entities including government 

funding agencies, institutions, private 

organizations, journals, publishers, and 

editors at any time if those entities have 

a need to know about or have 

information relevant to a research 

misconduct proceeding. 

(b) If ORI believes that a criminal or 

civil fraud violation may have occurred, 

it shall promptly refer the matter to the 

Department of Justice (DOJ), the HHS 

Inspector General (OIG), or other 

appropriate investigative body. ORI may 

provide expertise and assistance to the 

DOJ, OIG, PHS offices, other Federal 

offices, and state or local offices 

involved in investigating or otherwise 

pursuing research misconduct 

allegations or related matters. 

(c) ORI may notify affected PHS 

offices and funding components at any 

time to enable them to take appropriate 

interim actions. 

(d) The information provided will not 

be disclosed as part of the peer review 

and advisory committee review 

processes but may be used by the 

Secretary in making decisions about the 

award or continuation of funding. 

Research Misconduct Issues 

§ 93.402 ORI allegation assessments. 

(a) When ORI receives an allegation, 

it may conduct an assessment or refer 

the matter to the relevant institution for 

an assessment, inquiry, or other 

appropriate actions. 

(b) If ORI decides that an inquiry is 

warranted, it forwards the matter to the 

appropriate institution or HHS 

component. 

(c) If ORI decides that an inquiry is 

not warranted it will close the case and 

forward the allegation in accordance 

with paragraph (d) of this section. 

(d) ORI may forward allegations that 

do not fall within the jurisdiction of this 

part to the appropriate HHS component, 

Federal or state agency, institution, 

organization, journal, or other 

appropriate entity. 

§ 93.403 ORI review of research 

misconduct proceedings. 

(a) In conducting its review of 

research misconduct proceedings, ORI 

will: 

(1) Determine whether PHS has 

jurisdiction under this part; 

(2) Consider the institutional record 

and decide whether the institutional 

record is sufficient, provide instructions 

to the institution(s) if ORI determines 

that revisions are needed or additional 

allegations of research misconduct 

should be addressed, and require 

institutions to provide the respondent 

with an opportunity to respond to 

information or allegations added to the 

institutional record; 

(3) Determine if the institution 

conducted the proceedings in a timely 

and fair manner in accordance with this 

part with sufficient thoroughness, 

objectivity, and competence to support 

the conclusions; and 

(4) After reviewing in accordance 

with paragraphs (a)(1) through (3) of this 

section, decide whether to close the case 

without further action or proceed with 

the case. 

(b) If ORI decides to proceed with the 

case, ORI will: 

(1) Obtain additional information or 

materials from the institution, the 

respondent, complainants, or other 

sources, as needed; 

(2) Conduct additional analyses, as 

needed; 

(3) Provide the respondent the 

opportunity to access the institutional 

record, any additional information 

provided to ORI while the case is 

pending before ORI, and any analysis or 

additional information generated or 

obtained by ORI; 

(4) Provide the respondent the 

opportunity to submit information to 

ORI; 

(5) Allow the respondent and the 

respondent’s attorney, if represented, to 

meet virtually or in person with ORI to 

discuss the information that the 

respondent has provided to ORI and 

have ORI’s meetings with the 

respondent transcribed, with a copy of 

the transcript provided to the 

respondent for review and suggested 

correction; 

(6) Close the administrative record 

following paragraphs (b)(3) through (5) 

of this section; 

(7) Provide the respondent the 

opportunity to access the complete 

administrative record; and 

(8) Take any other actions necessary 

to complete ORI’s review. 

§ 93.404 Findings of research misconduct 

and proposed administrative actions. 

(a) After completing its review of the 

administrative record, ORI can: 

(1) Close the case without a separate 

ORI finding of research misconduct; 

(2) Make findings of research 

misconduct and propose and take 

administrative actions based on the 

administrative record; or 

(3) Seek to settle the case. 

(b) The lack of an ORI finding of 

research misconduct does not overturn 

an institution’s determination that the 

conduct constituted professional or 

research misconduct warranting 

remediation under the institution’s 

policy. 

§ 93.405 Notifying the respondent of 

findings of research misconduct and HHS 

administrative actions. 

(a) When ORI makes a finding of 

research misconduct or seeks to impose 

HHS administrative actions, other than 

suspension or debarment, it notifies the 

respondent in a charge letter. The 

charge letter includes the ORI findings 

of research misconduct, including the 

basis for such findings in the 

administrative record, and any proposed 

administrative actions. The charge letter 

also advises the respondent how they 

can access the administrative record and 

of the opportunity to contest the 

findings and administrative actions 

under subpart E of this part. In cases 

involving a suspension or debarment 

action, the HHS SDO issues a notice of 

suspension or proposed debarment to 

the respondent as part of the charge 

letter. The notice of suspension or 

proposed debarment issued by the HHS 

SDO will include instructions on how 

the respondent can contest the 

suspension and/or proposed debarment. 

(b) ORI sends the charge letter by 

certified mail, private delivery service, 

or electronic mail to the last known 

address of the respondent or the last 

known principal place of business of the 

respondent’s attorney, if represented. 

§ 93.406 Final HHS actions. 

(a) Unless the respondent contests the 

findings and/or the administrative 

actions, other than suspension and/or 

proposed debarment, contained in the 

charge letter within the 30-day period 

prescribed in § 93.501, the ORI finding 

of and HHS administrative actions, 

other than suspension and/or proposed 

debarment, proposed for research 

misconduct issues are final. 

(b) Unless the respondent contests a 

suspension and/or proposed debarment 

within the 30-day period prescribed in 

the NCR or FAR, respectively, the SDO 

may close the record and issue a final 


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debarment decision in the matter. 

Respondents may request 

reconsideration of a final debarment 

decision with the SDO. 

§ 93.407 HHS administrative actions. 

(a) Based on the administrative 

record, HHS may impose administrative 

actions that include but are not limited 

to: 

(1) Clarification, correction, or 

retraction of the research record. 

(2) Letters of reprimand. 

(3) Imposition of special certification 

or research integrity assurance 

requirements to ensure compliance with 

applicable regulations or terms of PHS 

grants, contracts, or cooperative 

agreements. 

(4) Suspension or termination of a 

PHS grant, contract, or cooperative 

agreement. 

(5) Restriction on specific activities or 

expenditures under an active PHS grant, 

contract, or cooperative agreement. 

(6) Special review of all requests for 

PHS funding. 

(7) Imposition of supervision 

requirements on a PHS grant, contract, 

or cooperative agreement. 

(8) Certification of attribution or 

authenticity in all requests for support 

and reports to the PHS. 

(9) Prohibition on participating in any 

advisory capacity to the PHS. 

(10) Adverse personnel action if the 

respondent is a Federal employee, in 

compliance with relevant Federal 

personnel policies and laws. 

(11) Suspension or debarment 

administrative actions under the 

Nonprocurement Common Rule (NCR) 

at 2 CFR part 180 for nonprocurement 

transactions (as further implemented by 

HHS at 2 CFR part 376) or under the 

Federal Acquisition Regulation (FAR) at 

48 CFR 9.406 and 9.407 for procurement 

transactions (as further supplemented 

by HHS at 48 CFR 309.4). Such 

administrative actions have reciprocal 

effect; exclusions issued under one 

system will result in ineligibility for all 

government procurement and 

nonprocurement programs. 

(b) In connection with findings of 

research misconduct, HHS also may 

seek to recover PHS funds spent in 

support of the activities that involved 

research misconduct. 

(c) Any authorized HHS component 

may impose, administer, or enforce 

administrative actions separately or in 

coordination with other HHS 

components, including, but not limited 

to ORI, OIG, the PHS funding 

component, and the SDO. 

§ 93.408 Mitigating and aggravating 

factors in HHS administrative actions. 

The purpose of HHS administrative 

actions is remedial. The appropriate 

administrative action is commensurate 

with the seriousness of the misconduct 

and the need to protect the health and 

safety of the public, promote the 

integrity of the PHS supported research 

and research process, and conserve 

public funds. ORI considers the 

following aggravating and mitigating 

factors in determining appropriate HHS 

administrative actions and their terms. 

Distinct from ORI’s process, the SDO 

considers the aggravating and mitigating 

factors listed in the NCR or FAR, 

whichever is appropriate to the funding 

mechanism, when considering 

suspension and debarment actions. The 

existence or nonexistence of any factor 

is not determinative. 

(a) Knowing, intentional, or reckless. 

Were the respondent’s actions knowing 

or intentional or were the actions 

reckless? 

(b) Pattern. Was the research 

misconduct an isolated event or part of 

a continuing or prior pattern of 

dishonest conduct? 

(c) Impact. Did the misconduct have 

significant impact on the proposed or 

reported research record, research 

subjects, other researchers, institutions, 

or the public health or welfare? 

(d) Acceptance of responsibility. Has 

the respondent accepted responsibility 

for the misconduct by: 

(1) Admitting the conduct; 

(2) Cooperating with the research 

misconduct proceedings; 

(3) Demonstrating remorse and 

awareness of the significance and 

seriousness of the research misconduct; 

and 

(4) Taking steps to correct or prevent 

the recurrence of the research 

misconduct? 

(e) Failure to accept responsibility. 

Does the respondent blame others rather 

than accepting responsibility for the 

actions? 

(f) Retaliation. Did the respondent 

retaliate against complainants, 

witnesses, committee members, or other 

individuals? 

(g) Continued risk to PHS funding. 

Does the respondent demonstrate 

responsible stewardship of research 

resources? 

(h) Other factors. Are other factors 

relevant to the circumstances of a 

particular case? 

§ 93.409 Settlement of research 

misconduct proceedings. 

(a) HHS may settle a research 

misconduct proceeding at any time it 

concludes that settlement is in the best 

interests of the Federal Government and 

the public health or welfare. 

(b) A settlement agreement precludes 

the respondent from contesting any ORI 

findings of research misconduct, HHS 

administrative actions (other than a 

suspension or debarment decision), or 

ORI’s jurisdiction in handling the 

research misconduct proceeding. 

(c) Settlement agreements are publicly 

available, regardless of whether ORI 

made a finding of research misconduct. 

§ 93.410 Final HHS action with no 

settlement or finding of research 

misconduct. 

When the final HHS action does not 

result in a settlement or finding of 

research misconduct, ORI may: 

(a) Provide written notice to the 

respondent, the relevant institution, the 

complainant, and HHS officials, as it 

deems necessary. 

(b) To the extent permitted by the 

Privacy Act, 5 U.S.C. 552a, and ORI’s 

system of records notice for research 

misconduct proceedings, publish notice 

of institutional research misconduct 

findings and implemented institutional 

actions related to the falsified, 

fabricated, or plagiarized material in the 

research record, but not the names or 

other identifying information of the 

respondent(s), if doing so is within the 

best interests of HHS to protect the 

health and safety of the public, to 

promote the integrity of the PHS 

supported research and research 

process, or to conserve public funds. 

§ 93.411 Final HHS action with a 

settlement or finding of misconduct. 

When a final HHS action results in a 

settlement or research misconduct 

finding, ORI: 

(a) Shall provide final notification of 

any research misconduct findings and 

HHS administrative actions to the 

respondent, the relevant institution, and 

HHS officials, including the SDO. The 

SDO shall provide a separate notice of 

final HHS action on any suspension or 

debarment actions. 

(b) May provide final notification of 

any research misconduct findings and 

HHS administrative actions to the 

complainant(s). 

(c) Shall send a notice to the relevant 

journal, publisher, data repository, or 

other similar entity identifying 

publications or research records which 

require correction or retraction. 

(d) Shall publish notice of the 

research misconduct findings. 

(e) Shall notify the respondent’s 

current employer, if the employer is an 

institution subject to this part. 


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Institutional Compliance Issues 

§ 93.412 Making decisions on institutional 

noncompliance. 

ORI may decide that an institution is 

not compliant with this part if the 

institution does not implement and 

follow the requirements of this part and 

its own research integrity assurance. In 

making this decision, ORI may consider, 

but is not limited to the following 

factors: 

(a) Failure to establish and comply 

with policies and procedures under this 

part; 

(b) Failure to respond appropriately 

when allegations of research 

misconduct arise; 

(c) Failure to report to ORI all 

investigations and findings of research 

misconduct under this part; 

(d) Failure to cooperate with ORI’s 

review of research misconduct 

proceedings; or 

(e) Other actions or omissions that 

have a material, adverse effect on 

reporting and responding to allegations 

of research misconduct. 

§ 93.413 HHS compliance actions. 

(a) An institution’s failure to comply 

with the requirements of this part may 

result in enforcement action against the 

institution. 

(b) If an institution fails to comply 

with the requirements of this part, HHS 

may take some or all of the following 

compliance actions: 

(1) Require the institution to accept 

and/or implement technical assistance 

provided by HHS. 

(2) Issue a letter of reprimand. 

(3) Require the institution to take 

corrective actions. 

(4) Place the institution on special 

review status. For a designated period, 

ORI will closely monitor the 

institution’s activities for compliance 

with this part. Monitoring may consist 

of, but is not limited to, compliance 

reviews and/or audits. 

(5) Direct that research misconduct 

proceedings be handled by HHS. 

(6) Recommend that HHS debar or 

suspend the institution. 

(7) Any other action appropriate to 

the circumstances. 

(c) If the institution’s actions 

constitute a substantial or recurrent 

failure to comply with this part, ORI 

may revoke the institution’s research 

integrity assurance under § 93.301 or 

§ 93.303. 

(d) ORI may make public any findings 

of institutional noncompliance and HHS 

compliance actions. 

Disclosure of Information 

§ 93.414 Notice. 

(a) ORI may disclose information to 

other persons for the purpose of 

providing or obtaining information 

about research misconduct as permitted 

under the Privacy Act, 5 U.S.C. 552a 

and ORI’s system of records notice for 

research misconduct proceedings. 

(b) ORI shall disclose or publish a 

notice regarding settlements and HHS 

administrative actions, and release or 

withhold information as permitted by 

the Privacy Act and the Freedom of 

Information Act, 5 U.S.C. 552. 

(c) ORI shall disclose or publish final 

findings of research misconduct when 

they become final. 

(1) HHS may publish the respondent’s 

name, professional alias, respondent’s 

current and/or former position, a 

detailed summary of the findings, and 

corrective actions imposed, in any 

venue it deems appropriate. 

(2) Such venues include, but are not 

limited to, Federal Government 

exclusionary lists (if relevant), the 

Federal Register, ORI’s website, other 

HHS publications, professional journals 

and other publications, and media 

outlets. 

(d) To the extent allowed by law, ORI 

will not release information that would 

reveal a confidential source. 

(e) When ORI closes a case without a 

settlement or a finding of research 

misconduct, disclosure may be made to 

the respondent, relevant institution, and 

complainant(s). Prior to making any 

disclosure, ORI will first consider the 

privacy interests of respondent(s), 

complainant(s), witnesses, research 

subjects or others who may be identified 

in the disclosure and determine whether 

limited disclosures or confidentiality 

agreements are needed to protect those 

interests. 

(f) Any publications or disclosures 

pursuant to this section are not 

considered appealable ‘‘administrative 

actions’’ under this part. 

Subpart E—Opportunity To Contest 

ORI Findings of Research Misconduct 

and HHS Administrative Actions 

General Information 

§ 93.500 General policy. 

(a) This subpart provides a 

respondent an opportunity to contest 

ORI findings of research misconduct 

and/or HHS administrative actions, 

other than suspension or proposed 

debarment, included in a charge letter. 

To contest a suspension or proposed 

debarment included in a charge letter, 

the respondent must provide the SDO 

directly with information and argument 

in opposition to the suspension or 

proposed debarment in accordance with 

2 CFR part 180 (or successor regulation) 

or with 48 CFR 9.406 and 9.407, as 

governed by the mechanism of PHS 

funding involved. A respondent may 

contest ORI findings and/or HHS 

administrative actions other than 

suspension and proposed debarment 

under this subpart; contest only the 

suspension or proposed debarment 

action under 2 CFR part 180 or 48 CFR 

9.406 and 9.407; or both. 

(b) A respondent may contest ORI 

research misconduct findings and HHS 

administrative actions, other than 

suspension and proposed debarment, by 

filing a notice of appeal with an 

Administrative Law Judge (ALJ) at the 

DAB. 

(c) Based on the administrative 

record, the ALJ shall rule on the 

reasonableness of the ORI research 

misconduct findings and the HHS 

administrative actions other than 

suspension or debarment. 

(d) The ALJ’s ruling made under 

§ 93.512 is the final HHS action with 

respect to the research misconduct 

findings and administrative actions, 

other than suspension or proposed 

debarment. Where a respondent contests 

a suspension or proposed debarment, 

the ALJ shall provide a copy of the 

ruling to the SDO to be included in the 

official record under 2 CFR part 180 or 

48 CFR 9.406 and 9.407; the SDO 

decides the debarment action under the 

appropriate regulation. 

Process for Contesting Research 

Misconduct Findings and/or 

Administrative Actions 

§ 93.501 Notice of appeal. 

(a) Time to file. A respondent may 

contest ORI findings of research 

misconduct and/or HHS administrative 

actions other than suspension and 

proposed debarment by filing a notice of 

appeal within 30 days of receipt of the 

charge letter provided under § 93.405. 

(b) Form of a notice of appeal. The 

respondent’s notice of appeal must be: 

(1) In writing; 

(2) Signed by the respondent or by the 

respondent’s attorney; and 

(3) Submitted to the DAB Chair 

through the DAB electronic filing 

system with a copy sent by certified 

mail, electronic mail, or other 

equivalent (i.e., with a verified method 

of delivery), to ORI. If the respondent is 

also contesting suspension or proposed 

debarment under 2 CFR part 180, the 

respondent must send a courtesy copy 

of the notice of appeal to the SDO. 

(c) Contents of a notice of appeal. The 

notice of appeal must: 


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(1) Admit or deny each finding of 

research misconduct and each factual 

assertion made in support of each 

finding; 

(2) Accept or challenge each proposed 

administrative action; 

(3) Provide detailed, substantive 

reasons for each denial or challenge 

with references to the administrative 

record; 

(4) Identify any legal issues or 

defenses that the respondent intends to 

raise during the proceeding with 

references to the administrative record; 

(5) Identify any mitigating factors in 

the administrative record; and 

(6) State whether a suspension or 

proposed debarment is also being 

contested under 2 CFR part 180 or 48 

CFR 9.406 and 9.407. 

§ 93.502 Appointment of the 

Administrative Law Judge. 

(a) Within 30 days of receiving a 

notice of appeal, the DAB Chair, in 

consultation with the Chief ALJ, must 

designate an ALJ to determine whether 

the notice of appeal is timely filed and 

within the ALJ’s jurisdiction under this 

subpart. If the appeal is determined to 

be timely and within the ALJ’s 

jurisdiction, the ALJ shall decide the 

reasonableness of the ORI research 

misconduct findings and administrative 

actions in accordance with this subpart. 

The ALJ shall dismiss an appeal if it is 

untimely or not within the ALJ’s 

jurisdiction under this subpart. 

(b) No ALJ may serve in any 

proceeding under this subpart if they 

have any actual or apparent conflict of 

interest, bias, or prejudice that might 

reasonably impair their objectivity in 

the proceeding. 

(c) Any party to the proceeding may 

request the ALJ to withdraw from the 

proceeding because of an actual or 

apparent conflict of interest, bias, or 

prejudice under paragraph (b) of this 

section. The motion to disqualify must 

be timely and state with particularity 

the grounds for disqualification. The 

ALJ may rule upon the motion or certify 

it to the Chief ALJ for decision. If the 

ALJ rules upon the motion, either party 

may appeal the decision to the Chief 

ALJ. 

(d) An ALJ must withdraw from any 

proceeding for any reason found by the 

ALJ or Chief ALJ to be disqualifying. 

§ 93.503 Filing of the administrative 

record. 

(a) For appeals that are not dismissed 

under § 93.502(a), ORI will file the 

administrative record for this appeal. 

(b) The ALJ’s review will be based on 

the administrative record. 

(c) The parties have no right to 

supplement the administrative record. 

§ 93.504 Standard of review. 

(a) The ALJ shall review the 

administrative record to determine 

whether ORI’s findings and HHS’s 

proposed administrative actions, other 

than suspension and debarment, 

reflected in the charge letter are 

reasonable and not based on a material 

error of law or fact. 

(b) The ALJ may permit the parties to 

file briefs making legal and factual 

arguments based on the administrative 

record. 

(c) If the ALJ determines that there is 

a genuine dispute over facts material to 

the ORI findings of research misconduct 

or HHS administrative actions other 

than suspension and debarment, the ALJ 

may hold a limited hearing to resolve 

that genuine factual dispute. 

§ 93.505 Rights of the parties. 

(a) The parties to the appeal are the 

respondent and ORI. The investigating 

institution is not a party to the case 

unless it is a respondent. 

(b) Except as otherwise limited by this 

subpart, the parties may: 

(1) Be accompanied, represented, and 

advised by an attorney; 

(2) Participate in any case-related 

conference held by the ALJ; 

(3) File motions or briefs in writing 

before the ALJ; 

(4) Present evidence relevant to the 

factual issues at a hearing, if applicable; 

and 

(5) Present and cross-examine 

witnesses at a hearing, if applicable. 

(c) The parties have no right to 

discovery before the ALJ. 

§ 93.506 Authority of the Administrative 

Law Judge. 

(a) The ALJ assigned to the case must 

conduct a fair and impartial proceeding, 

avoid unnecessary delay, maintain 

order, and assure that a complete and 

accurate record of the proceeding is 

properly made. The ALJ is bound by, 

and may not refuse to follow or find 

invalid, all Federal statutes and 

regulations, Secretarial delegations of 

authority, and applicable HHS policies, 

as provided in paragraph (c)(5) of this 

section. 

(b) Subject to review as provided 

elsewhere in this subpart, the ALJ may: 

(1) Review the administrative record 

and issue a ruling without convening a 

hearing; 

(2) Hold conferences with the parties 

to identify or simplify the issues, or to 

consider other matters that may aid in 

the prompt disposition of the 

proceeding; 

(3) Rule on motions and other 

procedural matters; 

(4) Except for the respondent’s notice 

of appeal, modify the time for the filing 

of any document required or authorized 

under the rules in this subpart. 

(5) Upon motion of a party, decide 

cases, in whole or in part, by summary 

judgment where there is no disputed 

issue of material fact; 

(6) Regulate the course of the appeal 

and the conduct of representatives, 

parties, and witnesses; 

(7) Take action against any party for 

failing to follow an order or procedure 

or for disruptive conduct; 

(8) Set and change the date, time, 

schedule, and place of the hearing, if 

applicable, upon reasonable notice to 

the parties; 

(9) Continue or recess the hearing, if 

applicable, in whole or in part for a 

reasonable period of time; 

(10) Administer oaths and 

affirmations at the hearing, if applicable; 

(11) Require each party before the 

hearing, if applicable, to provide the 

other party and the ALJ with copies of 

any exhibits that the party intends to 

introduce into evidence; and 

(12) Examine witnesses and receive 

evidence presented at the hearing, if 

applicable. 

(c) The ALJ does not have the 

authority to: 

(1) Enter an order in the nature of a 

directed verdict; 

(2) Compel settlement negotiations; 

(3) Enjoin any act of the Secretary; 

(4) Review suspension or proposed 

debarment; 

(5) Find invalid or refuse to follow 

Federal statutes or regulations, 

Secretarial delegations of authority, or 

HHS policies; 

(6) Authorize the parties to engage in 

discovery; and 

(7) Modify the time for filing the 

respondent’s notice of appeal. 

(d) The Federal Rules of Evidence and 

the Federal Rules of Civil Procedure do 

not govern the proceedings under this 

subpart. 

§ 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. 

§ 93.508 Filing, format, and service. 

(a) Filing. (1) Unless the ALJ provides 

otherwise, all submissions required or 


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authorized to be filed in the proceeding 

must be filed with the ALJ. 

(2) Submissions are considered filed 

when they are filed with the DAB 

according to the DAB’s filing guidance. 

(b) Format. (1) The ALJ may designate 

the format for copies of 

nondocumentary materials such as 

videotapes, computer disks, or physical 

evidence. This provision does not apply 

to the charge letter or other written 

notice provided under § 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. 

§ 93.509 Filing motions. 

(a) Parties must file all motions and 

requests for an order or ruling with the 

ALJ, serve them on the other party, state 

the nature of the relief requested, 

provide the legal authority relied upon, 

and state the facts alleged in support of 

the motion or request. 

(b) All motions must be in writing 

except for those made during a 

prehearing conference or at a hearing. 

(c) Within 10 days after being served 

with a motion, or other time as set by 

the ALJ, a party may file a response to 

the motion. The moving party may not 

file a reply to the response unless 

allowed by the ALJ. 

(d) The ALJ may not grant a motion 

before the time for filing a response has 

expired, except with the parties’ consent 

or after a hearing on the motion. 

However, the ALJ may overrule or deny 

any motion without awaiting a 

response. 

(e) The ALJ must make a reasonable 

effort to dispose of all motions 

promptly, and, whenever possible, 

dispose of all outstanding motions 

before the hearing. 

§ 93.510 Conferences. 

(a) The ALJ must schedule an initial 

conference with the parties within 30 

days of the DAB Chair’s assignment of 

the case. 

(b) The ALJ may use the initial 

conference to discuss: 

(1) Identification and simplification of 

the issues, specification of genuine 

disputes of fact and their materiality to 

the ORI findings of research misconduct 

and any administrative actions; 

(2) Identification of material legal 

issues and any need for briefing; 

(3) Scheduling dates for the filing of 

briefs based on the administrative 

record or the hearing, if applicable; and 

(4) Other matters that may encourage 

the fair, just, and prompt disposition of 

the proceedings. 

(c) The ALJ may schedule additional 

conferences as appropriate, upon 

reasonable notice to or request of the 

parties. 

(d) All conferences will be recorded 

with copies provided to the parties 

upon request. 

(e) The ALJ shall memorialize in 

writing any oral rulings within 10 days 

after a conference is held. 

(f) By 15 days before the scheduled 

hearing date, if applicable, the ALJ must 

hold a prehearing conference to resolve 

to the maximum extent possible all 

outstanding issues about evidence, 

witnesses, motions and all other matters 

that may encourage the fair, just, and 

prompt resolution of genuine factual 

disputes. 

§ 93.511 Hearing to resolve genuine 

factual dispute. 

(a) The ALJ may hold a virtual or inperson hearing that is limited to 

resolving a genuine factual dispute. 

(b) The ALJ shall permit the parties to 

call witnesses and to question 

witnesses. The ALJ may also question 

witnesses. 

(c) The parties are not required to 

submit prehearing briefs. 

(d) The parties are not required to give 

opening or closing statements at the 

hearing. 

(e) The hearing will be transcribed, 

and the parties will have an opportunity 

to review the transcript and submit 

proposed corrections to the ALJ. 

(f) Following receipt of the transcript 

and proposed corrections to the 

transcript, the ALJ may permit the 

parties to file briefs with suggested 

factual findings based on the transcript. 

(g) The ALJ will issue findings of fact 

to the parties that resolves the genuine 

factual dispute. 

§ 93.512 The Administrative Law Judge’s 

ruling. 

(a) Based on the administrative record 

and any findings of fact as a result of a 

hearing, if applicable, the ALJ shall 

issue a ruling in writing setting forth 

whether ORI’s findings and HHS’s 

proposed administrative actions, other 

than suspension and debarment, 

reflected in the charge letter are 

reasonable and not based on a material 

error of law or fact within 60 days after 

the last submission by the parties in the 

case. If unable to meet the 60-day 

deadline, the ALJ must set a new 

deadline and promptly notify the parties 

and the SDO if a suspension or 

proposed debarment is contested. The 

ALJ shall serve a copy of the ruling 

upon the parties. If a suspension or 

proposed debarment is contested, the 

ALJ shall provide a copy of the ruling 

to the SDO to be included in the official 

record under 2 CFR part 180. 

(b) The ruling of the ALJ constitutes 

the final HHS action on the findings of 

research misconduct and administrative 

actions other than suspension or 

debarment. The decision of the SDO 

constitutes the final HHS action 

regarding suspension or debarment 

under 2 CFR part 180. 

Dated: September 27, 2023. 

Xavier Becerra, 

Secretary. 

[FR Doc. 2023–21746 Filed 10–5–23; 8:45 am] 

BILLING CODE 4150–31–P 

CORPORATION FOR NATIONAL AND 

COMMUNITY SERVICE 

45 CFR Parts 2520, 2521 and 2522 

RIN 3045–AA84 

AmeriCorps State and National 

Updates 

AGENCY: Corporation for National and 

Community Service. 

ACTION: Proposed rule with request for 

comments. 

SUMMARY: The Corporation for National 

and Community Service (operating as 

AmeriCorps) proposes to revise its 

regulations governing the AmeriCorps 

State and National program. This 

proposed rule would make four 

substantive changes to the regulations 

governing the AmeriCorps State and 

National program to provide 

programmatic and grantmaking 

flexibilities. Specifically, this proposed 

rule would: limit AmeriCorps State and 

National grantees’ required share of 

program costs (known as ‘‘match’’ or 

‘‘cost share’’) to a scale that starts at 24 

percent for the first three-year grant 

cycle and increases more incrementally 

with each successive three-year grant 

cycle, until it reaches 50 percent in the 

sixth three-year grant cycle (that is, the 

sixteenth year of the grant) and beyond; 

simplify the criteria that allow 

AmeriCorps to waive match for 

AmeriCorps State and National grantees; 

allow AmeriCorps to grant waivers of 

education hour limitations under 

certain circumstances to permit 

AmeriCorps State and National 

AmeriCorps members to spend an 


lotter on DSK11XQN23PROD with PROPOSALS1