76280 Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 93 

RIN 0937–AA12 

Public Health Service Policies on 

Research Misconduct 

AGENCY: U.S. Department of Health and 

Human Services (HHS). 

ACTION: Final rule. 

SUMMARY: This final rule revises the 

regulations governing Public Health 

Service Policies on Research 

Misconduct. The final rule reflects both 

substantive and non-substantive 

revisions in response to public 

comments and to improve clarity. The 

purpose of the final rule is to implement 

policy changes and respond to 

technological changes that occurred 

over the past several years applicable to 

research misconduct. 

DATES: Effective Date: This final rule is 

effective January 1, 2025. 

Applicability Date: All regulatory 

requirements are applicable beginning 

on or after January 1, 2026. 

ADDRESSES: Address any comments or 

questions regarding the final rule to 

Sheila R. Garrity, JD, MPH, MBA, 

Director, Office of Research Integrity 

(ORI), 1101 Wootton Parkway, Suite 

240, Rockville, MD 20852. Some 

commonly asked questions and answers 

will be posted on the ORI website prior 

to the effective date of the final rule. 

The URL for the ORI website is https:// 

ori.hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Justina Lawrence, (240) 453–8200. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Office of Research Integrity (ORI) 

within the Department of Health and 

Human Services (HHS) oversees and 

directs Public Health Service (PHS) 

research integrity activities on behalf of 

the HHS Secretary, with the exception 

of the regulatory research integrity 

activities of the Food and Drug 

Administration. 

ORI was established in 1993 by 

amendment to section 493 of the Public 

Health Service Act (42 U.S.C. 289b). The 

HHS Secretary has authority under 

section 493 to promulgate a regulation 

that provides an administrative process 

for entities that apply for or receive PHS 

funding for biomedical or behavioral 

research to respond to research 

misconduct allegations in connection 

with such research and to provide 

assurances to the Department that the 

entities have an administrative process 

in place to respond to research 

misconduct allegations, investigate 

research misconduct allegations, and 

comply with the Department’s 

regulation. Section 493 also authorizes 

the HHS Secretary to promulgate a 

regulation addressing ORI’s actions, 

including appropriate remedies, with 

respect to research misconduct. 

In 2005, HHS updated regulations 

implementing section 493 that predated 

ORI’s establishment. Specifically, HHS 

removed 42 Code of Federal Regulations 

(CFR) part 50, subpart A and added 42 

CFR part 93, Public Health Service 

Policies on Research Misconduct. Since 

2005, ORI and regulated entities 

experienced policy developments and 

technological changes applicable to 

research misconduct, such as the 2008 

NIH Public Access policy; the 2023 NIH 

Data Management and Sharing policy; 

the shift to saving data on the cloud; 

and the ability to use artificial 

intelligence to detect image falsification, 

among many other developments. 

Therefore, ORI decided to revise part 93. 

On October 6, 2023, ORI issued a 

Notice of Proposed Rulemaking (NPRM) 

that proposed revisions to 42 CFR part 

93 based on the experience ORI and 

institutions gained with the regulation 

since it was promulgated in 2005 (88 FR 

69583). In addition, the NPRM was 

issued in response to increasing public 

concerns about research integrity in 

science and institutional questions 

about research misconduct review 

proceedings. The NPRM proposed 

several changes to provide clarity, 

transparency, and a better streamlined 

process. 

The NPRM proposed changes to 

subpart A. These changes included 

requiring grant recipients to take 

responsibility for the research integrity 

assurances of their subrecipients; 

adding ORI oversight of and increasing 

reporting requirements for subsequent 

use exception determinations; reducing 

disclosure limitations; and expanding 

institutional reporting obligations. 

Proposed changes to subpart B in the 

NPRM included adding or revising 

definitions of commonly used terms 

such as institutional record, 

administrative record, honest error, 

intentionally, knowingly, recklessly, 

and accepted practices of the relevant 

research community. 

Proposed changes to subpart C in the 

NPRM included clarification for 

maintaining active institutional research 

integrity assurances and addressing 

apparent or actual conflicts of interest. 

The NPRM also proposed changes to the 

institutional research misconduct 

review process, including assessments, 

sequestration of research records, 

inquiries, investigations, and the 

maintenance of institutional records. 

Proposed changes to subpart D in the 

NPRM included clarification of 

institutional assembly of administrative 

records and potential ORI actions for 

institutional noncompliance. In 

addition, ORI proposed clarifying that 

the lack of an ORI finding of research 

misconduct does not overturn an 

institution’s determination of research 

misconduct. Other proposed changes to 

subpart D included when and how ORI 

may disclose information about a 

research misconduct proceeding. 

Proposed changes to subpart E in the 

NPRM included a streamlined process 

for contesting ORI findings of research 

misconduct and HHS administrative 

actions. The proposed appeals process 

included Administrative Law Judge 

(ALJ) review of an administrative 

record, rather than a de novo review of 

evidence presented at a hearing before 

an ALJ. 

The NPRM sought comments from 

individuals, institutional officials, 

organizations, institutions, research 

funding agencies, and other members of 

the public on the proposed revisions 

and how to improve the clarity of the 

existing regulation. 

II. Overview of Comments and 

Significant Changes in Final Rule 

ORI received 269 comments via 

Regulations.gov. ORI also received 

comments as part of its interagency 

review process. ORI received 199 

relevant comments representing the 

views of two main constituent groups: 

institutions and individuals. In several 

instances, duplicative comments were 

posted by the same institution or 

individual. ORI received 171 unique 

comments submitted by 123 institutions 

and 46 individuals. In two cases, an 

institution submitted two separate sets 

of comments; since the content of each 

submission was distinct, ORI counted 

each submission as a unique comment. 

In addition, some comments were 

endorsed by multiple individuals or 

institutions. For example, one 

institutional comment was explicitly 

supported by 70 separate commenters. 

Another institutional comment was 

explicitly supported by 83 separate 

commenters. Ten commenters 

supported an additional institutional 

statement, and three commenters 

supported other representative groups’ 

statements. 

Most comments addressed multiple 

sections of the proposed rule. Many 

commenters made general statements 

supporting the more efficient execution 

and oversight of research misconduct 

proceedings proposed in the NPRM; 


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however, most commenters 

recommended changes to enhance the 

clarity of the proposed regulation. These 

comments generally involved 

maintaining the balance between 

ensuring a complete review of 

misconduct allegations and protecting 

the rights of respondents and 

recognizing the potential for 

administrative burden and cost on 

institutions. 

Most commenters anticipated 

administrative burden resulting from 

various parts of the NPRM. These 

comments were divided among five 

topics: burden related to the assessment 

phase, burden related to determining 

honest error, burden related to 

transcribing interviews, burden related 

to reporting, and burdens placed on 

small institutions. Several commenters 

requested more time to implement the 

final rule, and the amount of time 

requested varied widely. A majority 

requested one year, while others 

requested different timelines. 

Many commenters recommended 

revisions to or removal of proposed 

definitions. Commenters also made 

general comments on the proposed rule, 

with most commenters recommending 

additions, revisions, or removal of 

various sections. 

Commenters expressed a variety of 

concerns about potential conflicts of 

interest but did not recommend the 

removal or revision of any particular 

section of the proposed regulation. 

Commenters also expressed concerns 

about harm to respondents’ reputation; 

these concerns included ORI’s access to 

assessment reports and potential 

breaches of confidentiality when 

sharing transcripts. Commenters also 

expressed concerns about the effects of 

the proposed regulation on 

whistleblowers. These concerns 

included fears of retaliation, negative 

effects on reporting misconduct, and 

breaches of confidentiality. 

The NPRM proposed several 

substantive changes in which 

commenters provided feedback that 

informed the drafting of the final rule. 

The following paragraphs provide an 

overview of the feedback received from 

commenters. More detailed descriptions 

of comments on specific sections of the 

proposed regulation are addressed 

below in section III. 

Subpart A Summary of Significant 

Public Comments and Changes 

Proposed § 93.102(a) would require 

primary PHS grant recipients to take 

responsibility for the compliance of 

their subrecipients. A number of 

commenters recommended removing 

the proposed requirement making each 

PHS funding recipient responsible for 

the compliance of their subrecipients, 

because institutional responsibility for 

regulatory compliance was not clarified. 

ORI did not intend to impose a new 

burden on prime funding recipients; in 

the final rule subrecipients are required 

to have their own assurances filed with 

ORI. Proposed § 93.105(b), which 

involved time limitations for research 

misconduct proceedings, required more 

reporting requirements and established 

that ORI makes the final determination 

of when a subsequent use exception can 

be applied. Commenters recommended 

revising this section to state that 

institutions should be afforded 

discretion in applying the subsequent 

use exceptions. ORI agreed institutions 

should be able to determine whether the 

subsequent use exception applies to a 

given situation. Proposed § 93.106 

would require increased institutional 

reporting obligations to ORI related to 

institutional confidentiality obligations. 

Commenters found the language of the 

proposed regulation in this section 

overcomplicated institutional 

confidentiality obligations, added 

problematic provisions, and contained 

information more appropriate for 

guidance. ORI recognized institutions’ 

concerns about implementing the 

confidentiality requirements in the 

proposed rule and changed the final 

rule to provide latitude for institutions 

to decide confidentiality requirements 

for themselves. A number of 

commenters disapproved omitting the 

2005 regulation’s Evidentiary Standards 

section from the NPRM, and asked ORI 

to maintain the burden of proof 

language from the 2005 regulation. ORI 

had proposed removing this section 

because evidentiary standards were 

discussed in several other parts of the 

NPRM; however, ORI concurred with 

commenters, restored and updated 

aspects of the Evidentiary Standards 

section, and revised the final rule to 

clarify specific situations in which an 

adverse inference can be made but did 

not address all situations in which an 

adverse inference can be made. Nothing 

in the final rule precludes an institution 

or HHS from drawing an adverse 

inference under a different set of facts 

if appropriate. 

Subpart B Summary of Significant 

Public Comments and Changes 

Proposed Secs. 93.205, 93.211, 

93.217, 93.236 and 93.245 set forth 

definitions for Appeal, Difference of 

Opinion, Honest Error, Research 

Integrity, Suspension and Debarment to 

provide definitions of commonly used 

terms. Several commenters 

recommended removing these 

definitions because they did not 

enhance the clarity of the regulation. 

ORI agreed and removed these 

definitions. Proposed Secs. 93.223, 

93.217, and 93.234, which set forth 

definitions for Institutional Record, 

Recklessly, and Small Institution, were 

also added to provide definitions for 

commonly used terms. Commenters 

recommended revisions to clarify these 

definitions. ORI concurred and revised 

these definitions, described in detail in 

the next section. 

Subpart C Summary of Significant 

Public Comments and Changes 

Proposed § 93.304 regarding 

institutional policies and procedures 

removed a provision that was in the 

2005 regulation requiring institutions to 

have policies and procedures in place to 

protect the rights of respondents. 

Commenters were concerned about 

protecting these rights and ORI restored 

the language from the 2005 regulation 

that institutions provide for all 

reasonable and practical efforts, if 

requested and as appropriate, to protect 

or restore the reputation of persons 

alleged to have engaged in research 

misconduct but against whom no 

finding of research misconduct is made. 

Proposed § 93.305 was meant to 

provide details on institutional 

responsibilities in the general conduct 

of misconduct proceedings. Some 

commenters appreciated the provision 

that permits an institution to add 

respondents to an ongoing misconduct 

case without conducting a separate 

inquiry for each new respondent. Other 

commenters were concerned that listing 

the types of researchers the institutions 

should consider as potential 

respondents created a confusing 

standard and could be detrimental to 

those individuals. ORI concurred and 

removed the list of potential corespondents as well as the parenthetical 

list of additional research records to 

examine, because these lists were 

intended to be exemplary rather than 

prescriptive. Some commenters found 

the section on pursuing leads overly 

prescriptive, while others found it 

overly broad. Many commenters were 

concerned that pursuing all leads during 

an inquiry would be burdensome and 

costly—as well as cause reputational 

harm to innocent researchers. ORI 

concurred and moved the requirement 

to pursue all leads to § 93.310(j), which 

details the investigation requirements. 

Commenters also objected to the 

proposed requirement to transcribe all 

interviews in § 93.305 of the NPRM, 

especially interviews conducted during 

the assessment or inquiry phase, 

because it could discourage reporting of 


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allegations and contribute to 

institutional burden. ORI concurred, 

revised the section, and moved it to 

§ 93.310(g), which details the 

investigation requirements. The revised 

section removes the requirement for 

transcribed interviews during the 

assessment and inquiry phases. Some 

commenters noted this section may not 

provide fair procedures to respondents. 

Other commenters recommended 

removing the section entirely, stating 

that institutions should be allowed to 

institute best practices without 

regulatory oversight. A few commenters 

favored retaining the section as 

proposed. ORI removed all portions of 

the proposed subsection that did not 

specify requirements—that is, sections 

on the institution’s choice to use a 

committee, consortium, or person to 

conduct, support, or participate in 

proceedings; what a consortium might 

be comprised of; and the institution’s 

choice to allow respondents/ 

complainants to object to committee or 

consortium member(s). The information 

was intended to be exemplary, not 

prescriptive. ORI intends to issue 

guidance on this topic. 

Proposed § 93.306, which describes 

the institutional assessment of research 

misconduct allegations, increased 

reporting requirements, and time 

limitations were added to ensure 

prompt institutional response in 

addressing allegations of misconduct. 

Commenters were concerned about the 

burden of increased pre-investigation 

reporting requirements. ORI concurred 

and revised this section to simplify the 

assessment phase and require 

institutions to document their 

assessment process rather than write a 

formal report. The final rule clarifies 

that, if an institution determines to close 

a research misconduct proceeding after 

the assessment, it must retain 

documentation of its rationale sufficient 

to permit a later review by ORI. 

Proposed § 93.307, which involves the 

institutional inquiry, increased 

reporting requirements, and time 

limitations were added to ensure 

prompt institutional response in 

addressing allegations of misconduct. 

The NPRM proposed to prohibit an 

institution from determining honest 

error during the inquiry stage. Some 

commenters requested clarification 

because the process for notifying 

additional respondents of an 

institutional inquiry appeared unclear. 

ORI concurred and revised this section 

to simplify the language. Commenters 

also recommended removing proposed 

§ 93.307(f)(2) because they conveyed the 

requirement that institutions determine 

honest error only at the investigation 

stage would unfairly burden both 

respondents and institutions. ORI 

agreed and removed § 93.307(f)(2). 

Several commenters recommended 

removing proposed § 93.307(h), which 

set a 60-day timeframe for completing 

an inquiry, stating that institutions 

should have more flexibility in the 

timeframe to thoroughly conduct an 

inquiry. ORI concurred and lengthened 

the inquiry timeline from 60 to 90 days. 

If the inquiry takes longer than 90 days 

to complete, the inquiry report must 

document the reasons for exceeding the 

90-day period. 

The institutional investigation phase 

described in proposed § 93.310 was 

meant to provide additional 

institutional responsibilities in the 

conduct of an institutional investigation 

of research misconduct, including 

additional reporting and proposed rules 

about sequestration of evidence, 

multiple respondents, and multiple 

institutions. A few commenters 

recommended removal of proposed 

§ 93.310(c)(2) because they conveyed 

their concern that the regulation 

infringes on the rights of respondents 

who are added to an ongoing 

investigation without an additional 

inquiry. ORI clarified § 93.310(c)(2) that 

when a new respondent is added to an 

ongoing proceeding, institutions may 

but are not required to conduct a 

separate inquiry for additional 

respondents, and additional 

respondents must be notified of 

allegation(s) and provided an 

opportunity to respond. 

Proposed § 93.313(k) and (l)(2) 

describing the institutional investigation 

report was meant to clarify the 

requirements for an investigation report. 

The section included lists of examples 

of sequestered materials. The section 

also included a prohibition against split 

decisions by an investigation 

committee. Commenters recommended 

removing proposed § 93.313(k), which 

included a requirement that institutions 

identify any research records and other 

evidence obtained and sequestered but 

not reviewed, because it was deemed 

resource-intensive and an unnecessary 

burden. ORI concurred and removed 

§ 93.313(k) as duplicative of 93.313(e). 

ORI notes that the inventory 

requirement described in 93.313(e) does 

not require identification of specific 

files or emails but allows for a broader 

summary of the types of files or emails 

sequestered. Commenters also 

recommended removing language in 

proposed § 93.313(l)(2) prohibiting 

investigation committees from making a 

split decision. ORI removed that 

prohibition and included language that 

the report must clearly state the 

investigation committee’s conclusions 

regarding whether research misconduct 

occurred. 

The institutional appeals process 

described in proposed § 93.314 would 

require that institutional appeals be 

completed within 120 days or apply for 

an extension. Commenters 

recommended deleting or significantly 

revising § 93.314, contending the 

institutional appeal was within the 

institution’s purview, not ORI’s. ORI 

concurred and removed most of the 

requirements in § 93.314 and added 

§ 93.315 to acknowledge institutional 

purview. ORI recognizes the potential 

inefficiency of starting oversight review 

while an institutional appeal is ongoing 

that could reverse or modify the 

institutional findings of research 

misconduct. The final rule clarifies that 

institutions should not transmit their 

institutional record until the conclusion 

of any institutional appeals. If an appeal 

is filed after the institution has 

transmitted the institutional record, the 

institution must promptly notify ORI so 

the agency can postpone oversight 

review until the institutional appeal is 

complete. 

Subpart D Summary of Significant 

Public Comments and Changes 

Proposed § 93.410(b) would allow ORI 

to publish notice of institutional 

research misconduct proceedings that 

did not result in ORI findings. Many 

commenters urged ORI to remove 

§ 93.410(b), which proposed that ORI 

may publish notice of institutional 

investigations and actions. Commenters 

cited regulatory overreach, breaches of 

confidentiality, and inconsistency with 

other agencies’ policies. ORI removed 

93.410(b) from the final rule, ensuring 

institutions have discretion in this area. 

Proposed § 93.411 would require HHS 

to provide notification and publish final 

HHS actions that result in a finding of 

research misconduct. One commenter 

objected to replacing ‘‘may’’ with 

‘‘shall,’’ regarding ORI’s publication of 

findings and settlements. ORI restored 

the 2005 regulatory language of ‘‘may’’ 

to retain flexibility. 

Subpart E Summary of Significant 

Public Comments and Changes 

Proposed § 93.512 provided for a 

simpler and more expedient appeals 

process, which would entail ALJ review 

of an administrative record to determine 

whether ORI’s findings and HHS’s 

proposed administrative actions (other 

than suspension or debarment) are 

reasonable and not based on a material 

error of law or fact. The proposed 

appeals process also provided for the 

possibility of a limited hearing if the 


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ALJ determines that there is a genuine 

dispute over material fact. One 

commenter, in response to the NPRM’s 

request for comments on the scope of 

and need for limited hearings, suggested 

the research misconduct process allows 

for sufficient procedures to make such 

limited hearings unnecessary. ORI 

agreed, removed proposed § 93.512 from 

the final rule, made clarifying edits 

throughout subpart E, including 

removing language concerning 

suspension and debarment and adding 

the qualifiers ‘‘proposed’’ or ‘‘HHS’’ 

before the phrase ‘‘administrative 

actions.’’ 

ORI made other changes in the final 

rule to generally provide clarity 

requested by the commenters. In 

addition to specific changes discussed 

below, ORI changed ‘‘will’’ to ‘‘may’’ in 

places throughout the final rule, as 

appropriate, to add flexibility. ORI made 

nonsubstantive edits throughout the 

final rule in accordance with the Plain 

Writing Act of 2010. ORI also merged or 

separated content within sections of the 

final rule to improve clarity and 

readability. ORI streamlined language to 

avoid repeatedly distinguishing research 

misconduct proceedings subject to part 

93 from suspension and debarment 

actions governed by regulations separate 

and distinct from part 93. These changes 

either were nonsubstantive or increased 

the flexibility accorded to regulated 

entities. 

III. Section-by-Section Description of 

Changes in the Final Rule 

A. Application of Effective Date to 

Research Misconduct Proceedings, Final 

Rule § 93.75 

Commenters suggested delaying the 

effective date of the final rule, citing the 

time required for institutions to update 

their policies and procedures and train 

staff, with many commenters 

recommending an effective date 18 

months after the publication date. ORI 

retained the proposed effective date of 

January 1, 2025, but clarified that all 

regulatory requirements are applicable 

on or after January 1, 2026, in order to 

provide ample time for institutions to 

prepare for the final rule. ORI will not 

require institutions to implement and 

submit revised policies and procedures 

that comply with the final rule until the 

submission of their annual report 

covering 2025, which is due on or 

before April 30, 2026. ORI believes that 

this approach balances the need to 

promptly implement improvements 

made by the final rule with the time for 

institutions to update their policies and 

procedures. ORI added § 93.75 to clarify 

the applicability date, specifying that 

beginning on January 1, 2026, an 

institution must follow the final rule for 

allegations received by the institution 

on or after January 1, 2026. For 

allegations received by an institution 

before January 1, 2026, an institution 

must follow 42 CFR part 93 as 

published in the 2005 edition of the 

Code of Federal Regulations, unless the 

respondent and institution both elect in 

writing to follow the new final rule. 

B. Applicability, NPRM § 93.102(a) 

A number of commenters 

recommended removing the proposed 

requirement making each PHS funding 

recipient responsible for the compliance 

of their subrecipients, because 

institutional responsibility for 

regulatory compliance was not clarified. 

A few commenters recommended 

revision for the same reason, adding that 

subrecipients should have assurances 

on file with ORI to ensure compliance 

by all recipients of PHS funding. ORI 

removed the sentence, ‘‘Further, each 

recipient of such support is responsible 

for the compliance of their subrecipients 

with this part,’’ because ORI did not 

intend to impose a new burden on 

prime funding recipients; subrecipients 

are required to have their own 

assurances filed with ORI. 

C. Applicability, NPRM § 93.102(d) 

Revisions clarify that suspension and 

debarment at HHS are governed by 

regulations separate and distinct from 

part 93. As noted above, corresponding 

revisions throughout the final rule 

streamline language because there is no 

need to repeatedly distinguish research 

misconduct proceedings subject to this 

part from suspension and debarment 

actions subject to separate and distinct 

regulations. ORI also revised the 

language in this section to confirm that 

the Suspension and Debarment Official 

(SDO) and ORI may coordinate actions 

to the extent consistent with the SDO’s 

and ORI’s respective authorities. Such 

coordination includes jointly issuing 

notices or seeking settlements of actions 

and proceedings. 

D. Research Misconduct, NPRM Secs. 

93.103 

Commenters recommended deleting 

this section, because it duplicated 

information found elsewhere, 

specifically the definitions of 

fabrication, falsification, and plagiarism. 

ORI concurred and deleted this section 

in its entirety. 

E. Requirements for Findings of 

Research Misconduct, NPRM Secs. 

93.104(a), (b), and (c) 

Commenters expressed appreciation 

that the proposed regulation clarified 

the three requirements for findings of 

research misconduct and confirmed 

three elements must be met. ORI made 

one change for grammatical consistency 

across all subsections. 

F. Time Limitations, NPRM § 93.105(b) 

Commenters recommended revising 

this section to state that institutions 

should be allowed to determine their 

own timeframe for applying subsequent 

use exceptions. ORI agreed institutions 

should be able to determine whether the 

subsequent use exception applies to a 

given case. To have a consistent 

regulatory standard across all 

institutions, ORI retained the six-year 

limitation. Commenters also expressed 

concern about the potential cost and 

burdens of the proposed requirement 

that institutions inform ORI of the 

relevant facts before concluding the 

subsequent use exception does not 

apply. ORI concurred and revised the 

section to require institutions to 

document how they determined the 

exception did or did not apply and to 

retain that information in the 

institutional record. ORI may address 

the application of the subsequent use 

exception for institutional reporting 

requirements through future 

policymaking. 

G. Confidentiality, NPRM § 93.106 

In response to commenters 

mentioning circumstances in which 

institutions may have a legitimate need 

to inform persons outside the institution 

about a pending research misconduct 

proceeding, ORI clarified that 

institutions may alert journal editors 

and others who need to know of 

potentially inaccurate data in a timely 

manner, and the final rule specifies that 

institutions are not prohibited from 

managing published data or 

acknowledging that data may be 

unreliable. In addition, to prevent some 

institutions from keeping researchrelated information confidential longer 

than necessary, the final rule now 

clarifies the length of time an institution 

is bound by the confidentiality 

provision. Commenters also stated that 

the language proposed in this section 

overcomplicated institutional 

confidentiality obligations and 

contained information more appropriate 

for guidance. ORI recognized 

institutions’ concerns about overly 

prescriptive language and changed the 

final rule to provide greater latitude for 


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institutions to decide how to meet 

confidentiality requirements. ORI also 

removed the subsections that discussed 

what constitutes ‘‘those who need to 

know.’’ 

H. Appeal, NPRM § 93.204 

Commenters recommended deleting 

this definition because it was 

unnecessary. ORI concurred and 

removed this definition. 

I. Charge Letter, NPRM § 93.206 

ORI removed specific language 

addressing joint charge letters, because 

§ 93.102(d) of the final rule addresses 

situations in which ORI and the SDO 

may jointly issue notices. ORI also 

revised proposed § 93.206 to remove 

references to the SDO in the definition 

and avoid redundancy in subpart A. 

J. Difference of Opinion, NPRM § 93.211 

Several commenters recommended 

removing this definition because it did 

not enhance the clarity of the regulation. 

ORI agreed and removed this definition. 

K. Honest Error, NPRM § 93.217 

Several commenters requested 

revision of this definition of honest 

error. A minority of commenters asked 

ORI to add a reference to good faith and 

intent and to provide examples. Most 

commenters recommended removing 

the definition because they conveyed 

that it was unnecessary. ORI concurred 

and removed this definition. 

L. Institutional Record, NPRM § 93.223 

Commenters generally supported 

including this definition but expressed 

concerns about the institutional burden 

of sequestering irrelevant records and 

conveyed that the institutional 

investigation committee should have 

autonomy to decide which records to 

consider. While ORI understands 

sequestration imposes an institutional 

burden, ORI has found that records 

originally not considered by an 

institution may be relevant to the 

research misconduct proceeding. ORI 

balanced these concerns by revising the 

proposed definition of institutional 

record and retaining a maintenance 

requirement in § 93.318 for sequestered 

evidence that is not part of the 

institutional record. ORI revised the 

proposed definition to clarify that the 

institutional record comprises all 

records the institution compiled or 

generated during the research 

misconduct proceeding, except for the 

records the institution did not consider 

or rely on. The institutional record 

index does not need to include records 

the institution did not consider or rely 

on. ORI revised the proposed definition 

to include a requirement for a general 

description of records sequestered but 

not considered or relied on. 

Additionally, ORI revised wording to 

clarify that assessments are to be 

documented, but an assessment report is 

not required. ORI intends to issue 

guidance on this topic. 

M. Recklessly, NPRM § 93.234 

Many commenters proposed revisions 

to this definition. Some commenters 

requested clarification of and 

distinction between the definitions of 

‘‘knowingly’’ and ‘‘recklessly,’’ as well 

as a definition of ‘‘harm.’’ Several 

commenters requested guidance with 

examples to help institutions 

distinguish between ‘‘careless’’ and 

‘‘reckless’’ supervision. One commenter 

approved of the existing definition. ORI 

revised the definition in response to 

these comments to make it easier to 

apply in the research misconduct 

context. In particular, ORI revised the 

definition to make it specific to 

proposing, performing, or reviewing 

research, or reporting research results, 

rather than ‘‘acting’’ more generally, and 

specific to a risk of fabrication, 

falsification, or plagiarism. 

N. Investigation, NPRM § 93.225 

Commenters proposed revising this 

definition to provide further 

clarification. ORI agreed and revised the 

definition by removing unnecessary 

language for clarity. 

O. Research Integrity, NPRM § 93.236 

Many commenters recommended 

removing this definition because they 

found it narrow, unclear, and 

inconsistent with the National 

Academies of Sciences, Engineering, 

and Medicine (NASEM) definition. One 

commenter recommended retaining the 

proposed definition. ORI decided to 

remove this definition and may provide 

future guidance on this topic. 

P. Research Misconduct Proceedings, 

NPRM § 93.239 

Regarding the appeals process and 

involvement of an ALJ, ORI added 

clarifying language, ‘‘appeals under 

subpart E,’’ to avoid ambiguity and to 

distinguish this process from 

institutional appeals. 

Q. Research Record, NPRM § 93.240 

Commenters requested clarification of 

this definition. ORI added ‘‘records of’’ 

before ‘‘oral presentations’’ to exclude 

from the definition any records of 

completely internal presentations where 

problems were potentially identified 

and corrected before outside reporting. 

ORI also changed the phrase ‘‘internal 

reports’’ to ‘‘lab meeting reports’’ to 

clarify the meaning of this phrase, 

which may be part of the research 

record. Additionally, ORI removed 

‘‘internet’’ from ‘‘internet and online’’ 

content because of the repetitive 

meaning of the two words. ORI intends 

to issue guidance on this definition. 

R. Small Institution, NPRM § 93.244 

Several commenters recommended 

revisions to the definition because they 

conveyed that the criteria used to 

designate a small institution were overly 

restrictive. ORI agreed and removed the 

statement that a small institution 

typically has ‘‘a total of 10 or fewer 

institutional members’’ and may address 

this topic through future policymaking. 

S. Suspension and Debarment, NPRM 

§ 93.245 

ORI removed this proposed definition 

of ‘‘suspension and debarment’’ and 

merged significant aspects of the 

definition with ‘‘Suspension and 

Debarment Official or SDO’’ to reduce 

redundancy. 

T. Institutional Policies and Procedures, 

NPRM § 93.304 

One commenter commended ORI for 

requiring all institutions to file an 

assurance to apply for PHS support. 

Commenters expressed concern about 

omitting the 2005 regulation’s 

requirement to make all reasonable and 

practical efforts to restore the reputation 

of respondents not found to have 

committed research misconduct. 

Commenters requested restoring 

proposed § 93.304 to the 2005 wording. 

ORI concurred and restored the 2005 

wording regarding policies and 

procedures to protect the reputation of 

respondents when no finding has been 

made. 

U. General Conduct of Research 

Misconduct Proceedings—Sequestration 

of Research Records and Other 

Evidence, NPRM § 93.305(a) 

ORI noted the requirement to 

sequester all research records and other 

evidence was mentioned more than 

once in the NPRM. To reduce 

redundancy, this requirement is 

explained in full only once in the final 

rule, under General Conduct of Research 

Misconduct Proceedings. 

V. General Conduct of Research 

Misconduct Proceedings—Multiple 

Respondents, NPRM § 93.305(d) 

Some commenters appreciated the 

provision that permits an institution to 

add respondents to an ongoing research 

misconduct case without conducting a 

separate inquiry for each new 


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respondent. Others expressed the 

provision could set a precedent that 

infringes on respondents’ rights. To 

address this concern, the final rule 

specifies that each additional 

respondent must be provided notice of 

the allegations and an opportunity to 

respond, consistent with subpart C. 

Some commenters were also concerned 

that listing the types of researchers the 

institutions should consider as potential 

respondents created a confusing 

standard and could be detrimental to 

those individuals. ORI concurred and 

removed the list of potential corespondents as well as the parenthetical 

list of additional research records to 

examine, because these lists were 

intended to be exemplary rather than 

prescriptive. Some commenters 

suggested changing ‘‘must consider 

whether any additional researchers are 

responsible’’ to ‘‘may consider whether 

any additional researchers are 

responsible.’’ ORI revised this section to 

allow institutions the flexibility to use 

their own judgment. 

W. General Conduct of Research 

Misconduct Proceedings—Pursue Leads, 

NPRM § 93.305(f) 

Some commenters found this section 

overly prescriptive while others found it 

overly broad. Many commenters were 

concerned that pursuing all leads during 

an inquiry would be burdensome and 

costly—as well as cause reputational 

harm to innocent researchers. ORI 

concurred and moved the requirement 

to pursue all leads to § 93.310(j), which 

details the investigation requirements. 

ORI also removed the parenthetical list 

of additional research records to 

examine, because it was intended to be 

exemplary, not prescriptive. ORI 

intends to provide further guidance 

specifying recommended practices for 

pursuing leads. 

X. General Conduct of Research 

Misconduct Proceedings—Interviews, 

NPRM § 93.305(g) 

Commenters objected to the proposed 

requirement to transcribe all interviews, 

especially interviews conducted during 

the assessment or inquiry phase, 

because it could discourage reporting of 

allegations and contribute to 

institutional burden. Some commenters 

expressed that if transcriptions are 

mandatory, they should be required 

only during the investigation. ORI 

concurred, revised the proposed section, 

and moved it to § 93.310(g), which 

details the investigation requirements. 

The revised section removes the 

requirement for transcribed interviews 

during the assessment and inquiry 

phases. 

Y. Conduct of Research Misconduct 

Proceedings—Using a Committee, 

Consortium, or Other Person for 

Research Misconduct Proceedings, 

NPRM § 93.305(h) 

Some commenters noted a concern 

that this section may not provide fair 

procedures to respondents. Other 

commenters recommended removing 

the section entirely, stating that 

institutions should be allowed to 

institute best practices without 

regulatory oversight. A few commenters 

favored retaining the section as 

proposed. ORI removed all portions of 

the proposed subsection that did not 

specify requirements—that is, sections 

on the institution’s choice to use a 

committee, consortium, or person to 

conduct, support, or participate in 

proceedings; what a consortium might 

be comprised of; and the institution’s 

choice to allow respondents/ 

complainants to object to committee or 

consortium member(s). The information 

was intended to be exemplary, not 

prescriptive. 

Z. Institutional Assessment, NPRM 

§ 93.306 

A number of commenters were 

concerned about the burden of 

increased pre-investigation reporting 

requirements. ORI concurred and 

revised this section to simplify the 

assessment phase and require 

institutions to document their 

assessment process rather than write a 

formal report. Commenters also 

expressed concern about potential harm 

to respondents’ reputations if ORI is 

permitted to read an institution’s 

assessment documentation. In response 

to the concern about reputational harm, 

ORI notes that any assessment 

documentation obtained by ORI will be 

subject to the Privacy Act, 5 U.S.C. 

552a. Many commenters asked ORI to 

remove § 93.306(e), which proposed 

requiring institutions to complete the 

assessment within 30 days. Commenters 

expressed that this timeline was 

unrealistic, would be burdensome for 

institutions, and could undermine the 

rigor and utility of the sequestration 

process. One commenter was concerned 

about the impact of this assessment 

timeframe on respondents’ mental 

health. ORI concurred and removed the 

30-day assessment timeline 

requirement. 

AA. Institutional Inquiry, NPRM 

§ 93.307 

Some commenters requested 

clarification because the process for 

notifying additional respondents of an 

institutional inquiry appeared unclear. 

ORI concurred and revised this section 

to simplify the language. Commenters 

also recommended removing proposed 

§ 93.307(f)(2) because they conveyed 

that the requirement that institutions 

determine honest error only at the 

investigation stage would unfairly 

burden both respondents and 

institutions. ORI agreed and removed 

proposed § 93.307(f)(2). Several 

commenters recommended removing 

proposed § 93.307(h), which set a 60- 

day timeframe for completing an 

inquiry, stating that institutions should 

have more flexibility in the timeframe to 

thoroughly conduct an inquiry. ORI 

concurred and lengthened the inquiry 

timeline from 60 to 90 days. If the 

inquiry takes longer than 90 days to 

complete, the inquiry report must 

document the reasons for exceeding the 

90-day period. ORI also revised 

references to ‘‘research records’’ 

throughout the final rule to ensure 

consistency with § 93.307(d), which 

describes ‘‘research records and other 

evidence.’’ In addition, ORI removed 

proposed § 93.307(e)(5) in the final rule 

to eliminate redundancy, because 

§ 93.310(j) specifically addresses the 

institutional responsibility to pursue all 

leads. 

BB. Reporting to ORI on the Decision To 

Initiate an Investigation, NPRM § 93.309 

ORI removed the proposed 

requirement that the Institutional 

Deciding Official review the inquiry 

report and provide a written decision to 

proceed to an investigation, to eliminate 

potential administrative burden. 

CC. Institutional Investigation, NPRM 

§ 93.310 

A few commenters recommended 

removal of § 93.310(c)(2) because they 

expressed a concern that the regulation 

infringes on the rights of respondents 

who are added to an ongoing 

investigation without an additional 

inquiry. ORI clarified in § 93.310(c)(2) 

that when a new respondent is added to 

an ongoing proceeding, institutions may 

but are not required to conduct a 

separate inquiry for additional 

respondents, and additional 

respondents must be notified of 

allegation(s) and provided an 

opportunity to respond consistent with 

subpart C. In response to commenters 

requesting additional clarity for 

regulated entities, ORI moved proposed 

§ 93.310(h) regarding the institutional 

responsibility to pursue leads to 

§ 93.310(j) and streamlined the 

language, including clarifying the 

respondent notification requirement. 


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DD. Investigation Report, NPRM 

§ 93.313(k) 

Commenters requested clarity on how 

the investigation report should identify 

sequestered evidence. Commenters also 

recommended removing § 93.313(k), 

which included a requirement that 

institutions identify any research 

records and other evidence obtained 

and sequestered but not reviewed, 

because it was deemed resourceintensive and an unnecessary burden. 

ORI revised § 93.313 to replace 

proposed Secs. 93.313(e) and (k) with a 

single requirement in § 93.313(e) to 

include in the investigation report an 

inventory of sequestered research 

records and other evidence, except 

records the institution did not consider 

or rely on. ORI made a corresponding 

revision to § 93.220(c) of the final rule 

requiring that the institutional record 

include a general description of the 

records that were sequestered but not 

considered or relied on. ORI notes that 

the general description in § 93.220(c) 

does not require identification of 

specific files or emails but allows for a 

broader summary of the types of files or 

emails sequestered. 

EE. Investigation Report, NPRM 

§ 93.313(l)(2) 

Commenters recommended removing 

language in proposed § 93.313(l)(2) 

prohibiting investigation committees 

from making a split decision. ORI 

removed that prohibition and included 

language that the report must clearly 

state the investigation committee’s 

conclusions regarding whether research 

misconduct occurred for each separate 

allegation. 

FF. Institutional Appeals, NPRM 

§ 93.314 

Commenters recommended deleting 

or significantly revising proposed 

§ 93.314, which requires institutions to 

complete any institutional appeals 

within 120 days or seek an extension, 

contending the institutional appeal was 

within the institution’s purview, not 

ORI’s. ORI concurred and removed most 

of the requirements in § 93.314. ORI 

recognizes the potential inefficiency of 

starting oversight review while an 

institutional appeal is ongoing that 

could reverse or modify the institutional 

findings of research misconduct. The 

final rule clarifies that institutions 

should not transmit their institutional 

record until the conclusion of any 

institutional appeals. If an appeal is 

filed after the institution has transmitted 

the institutional record, the institution 

must promptly notify ORI so the agency 

can postpone oversight review until the 

institutional appeal is complete. 

GG. Decision by the Institutional 

Deciding Official, Final Rule § 93.314 

ORI added this section to clearly 

identify the responsibilities of the 

Institutional Deciding Official at the 

conclusion of an investigation and to 

respond to commenters generally 

requesting additional clarity. 

HH. Completing the Research 

Misconduct Process, NPRM § 93.316(a) 

ORI revised the requirement that 

institutions notify ORI in advance if an 

institution plans to close research 

misconduct proceedings to omit ‘‘or for 

any other reason’’ to eliminate 

unnecessary burden. 

II. Institutional Standards of Conduct, 

NPRM § 93.318 

This section was intended to indicate 

that ORI findings of research 

misconduct or HHS settlements of 

research misconduct proceedings, or the 

absence thereof, do not affect 

institutional findings or actions taken 

based on an institution’s standards of 

conduct. ORI combined (a) and (b) of 

this section and clarified language 

accordingly. 

JJ. Interaction With Other Entities and 

Interim Actions, NPRM § 93.401 

ORI added language to clarify the 

relationship between ORI and the HHS 

official authorized to impose suspension 

and debarment. 

KK. Final HHS Actions, NPRM § 93.406 

ORI removed unnecessary language 

regarding suspension and debarment. 

LL. HHS Administrative Actions, NPRM 

§ 93.407 

ORI revised this section to clarify that, 

for purposes of this regulation, HHS 

administrative actions do not include 

suspension and debarment. However, 

the HHS official authorized to impose 

suspension and debarment remains free 

to pursue those actions under applicable 

regulations, as stated in § 93.407(d). 

MM. Mitigating and Aggravating Factors 

in HHS Administrative Actions, NPRM 

§ 93.408 

ORI removed unnecessary language 

regarding suspension and debarment. 

NN. Final HHS Action With No 

Settlement or Finding of Research 

Misconduct, NPRM § 93.410(a) 

ORI removed the phrase ‘‘as it deems 

necessary’’ in § 93.410(a) because it does 

not add further meaning to the section. 

OO. Final HHS Action With No 

Settlement or Finding of Research 

Misconduct, NPRM § 93.410(b) 

Many commenters urged ORI to 

remove § 93.410(b), which proposed 

that ORI publish notice of institutional 

investigations and actions. Commenters 

cited regulatory overreach, breaches of 

confidentiality, and inconsistency with 

other agencies’ policies. One commenter 

noted that ORI’s publication of 

institutional reports and findings would 

be inconsistent with the confidentiality 

provisions established in the clinical 

research context. A minority of 

commenters recommended revising the 

section to redact respondents’ 

identifying information to ensure 

confidentiality. A few commenters 

recommended retaining the section as 

proposed. ORI removed proposed 

§ 93.410(b) from the final rule, ensuring 

institutions have discretion in this area. 

PP. Final HHS Action With a Settlement 

or Finding of Misconduct, NPRM 

§ 93.411 

One commenter objected to replacing 

‘‘may’’ with ‘‘shall,’’ regarding ORI’s 

publication of findings and settlements. 

ORI restored the 2005 regulatory 

language of ‘‘may’’ to retain flexibility. 

QQ. HHS Compliance Actions, NPRM 

§ 93.413 

ORI revised this section to clarify the 

process for making a discretionary 

referral to the HHS official authorized to 

impose suspension and debarment 

under separate and distinct regulations. 

In addition, ORI changed the section’s 

name to ‘‘ORI compliance actions’’ for 

accuracy. 

RR. Notice, NPRM § 93.414 

One commenter objected to replacing 

‘‘may’’ with ‘‘shall’’ regarding ORI’s 

publication of findings and settlements. 

ORI restored the 2005 regulatory 

language of ‘‘may’’ to retain flexibility. 

Commenters were concerned this 

portion of the proposed regulation 

weakens respondents’ confidentiality 

protections and runs counter to the 

remedial purpose of regulations and 

HHS administrative actions. One 

commenter requested adding language 

to protect the institution’s 

confidentiality in subsection (b). 

Numerous commenters recommended 

requiring ORI to notify the relevant 

institution when it closes a case without 

a settlement or a finding of research 

misconduct. One commenter expressed 

that ORI should attempt to restore the 

reputation of respondents not found to 

have committed research misconduct; 

they also expressed that if a 

complainant is found to have conflicts 


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of interest with the respondent, ORI 

should consider taking action against 

the complainant. Another commenter 

was concerned about § 93.414(f), which 

provides that any publications or 

disclosures pursuant to this section are 

not considered appealable 

‘‘administrative actions.’’ ORI revised 

this section for clarity and removed 

proposed subsections 93.414(c)–(f) in 

response to the comments. 

SS. General Policy, NPRM § 93.500 

ORI revised this section to clarify that 

a respondent must exhaust 

administrative remedies under this part 

prior to seeking judicial review in 

Federal court. 

TT. Conferences, NPRM § 93.510 

ORI revised this section to restore in 

subsection 93.510(e) the phrase 

‘‘Whenever possible’’ from the 2005 

regulation to retain flexibility for the 

ALJ. 

UU. Hearing To Resolve Genuine 

Factual Dispute, NPRM § 93.511 

One commenter, in response to the 

NPRM’s request for comments on the 

scope of and need for limited hearings, 

suggested the research misconduct 

process allows for sufficient procedures 

to make such limited hearings 

unnecessary. ORI agreed, removed 

proposed § 93.511 from the final rule, 

and made corresponding edits 

throughout subpart E. 

VV. The Administrative Law Judge’s 

Ruling, NPRM § 93.512 

To promote consistency in agency 

decision making, ORI reinstated and 

updated from the 2005 regulation an 

opportunity for the Assistant Secretary 

for Health (ASH) to review the ALJ’s 

decision under subpart E. Although 

§ 93.511 in the final rule explicitly 

provides that the ASH may review the 

ALJ’s recommended decision before it 

becomes final, the ASH and the 

Secretary also have the ability to review 

ORI findings of research misconduct 

and/or proposed HHS administrative 

actions before a charge letter is issued 

under § 93.405 and to act as final 

decision maker before a charge letter is 

issued, if either of them so chooses. 

IV. Significant Comments Not Resulting 

in Changes 

A. Accepted Practices of the Relevant 

Research Community, NPRM § 93.200 

Commenters supported retaining this 

proposed definition but found it overly 

expansive. Commenters recommended 

revised language, including practices 

specific to PHS-funded research. ORI 

left this definition unchanged to 

acknowledge the expanding universe of 

research disciplines. 

B. Allegation, NPRM § 93.203 

Commenters supported revising this 

definition to clarify purposeful 

disclosure of possible research 

misconduct. After consideration, ORI 

left the definition as proposed, to avoid 

adding another element to the definition 

that may discourage reporting possible 

research misconduct. 

C. Assessment, NPRM § 93.205 

Many commenters recommended 

deleting this definition because they 

conveyed that it was unnecessary. Some 

commenters’ recommended revisions 

were related to concerns about the 

proposed description of the assessment 

phase in subpart C. A minority of 

commenters supported the inclusion of 

the definition but sought clarification 

for what constitutes readily available 

information. ORI made changes to 

subpart C and left the definition of 

‘‘assessment’’ as proposed because there 

was no consensus among the comments 

and because it was satisfied that the 

proposed definition served the purpose 

of explaining the term to those who may 

be unfamiliar with the term in the 

research misconduct context. ORI may 

address this topic through future 

policymaking. 

D. Complainant, NPRM § 93.207 

Commenters recommended revising 

this definition to add details about 

complainant anonymity. ORI agreed on 

the importance of anonymity and 

addressed confidentiality elsewhere in 

subpart A of the final rule. ORI left the 

definition of complainant unchanged. 

E. Contract, NPRM § 93.208 

One commenter proposed removing 

this definition because it is a commonly 

understood term. ORI opted to leave the 

definition as proposed, because it is 

helpful to those who are not familiar 

with contracts under the Federal 

Acquisition Regulation. 

F. Day, NPRM § 93.209 

Some commenters recommended 

removing or revising this definition to 

factor in academic calendars. Since 

academic calendars vary, ORI retained 

the definition in its proposed form. 

G. Departmental Appeals Board, NPRM 

§ 93.210 

One commenter recommended 

removing this definition because it is a 

commonly understood term. ORI 

retained the definition in its proposed 

form because it is helpful to those who 

are not familiar with that organization. 

H. Evidence, NPRM § 93.212 

A small number of commenters 

provided contradictory 

recommendations about removing or 

enhancing the definition. ORI retained 

the definition in its proposed form 

because there was no consensus among 

the comments and because it was 

satisfied that the proposed definition 

served the purpose of explaining the 

term to those who may be unfamiliar 

with the term in the research 

misconduct context. 

I. Falsification, NPRM § 93.214 

One commenter recommended 

revising this definition to include 

allegations of misconduct and intent. 

ORI retained the definition in its 

proposed form because it is consistent 

with the definition found in the 2000 

Office of Science and Technology 

Policy’s Federal Policy on Research 

Misconduct, 65 FR 76260 (Dec. 6, 2000). 

J. Good Faith, NPRM § 93.216 

Some commenters recommended 

revising this definition to express 

nuance without fundamentally altering 

its meaning. ORI retained the definition 

in its proposed form because 

commenters were not opposed to the 

meaning expressed in the definition. 

K. Institution, NPRM § 93.219 

One commenter recommended 

revising this definition to clarify that 

institutions are not persons. ORI 

retained the definition in its proposed 

form. While the definition refers to ‘‘any 

person,’’ the term ‘‘person’’ is defined in 

§ 93.226 of the final rule to include both 

individuals and other legal entities that 

are not individuals. 

L. Institutional Deciding Official, NPRM 

§ 93.221 

Commenters recommended revising 

this definition to permit the Research 

Integrity Officer, or RIO, to serve as the 

Institutional Deciding Official. ORI 

retained the definition in its proposed 

form, because requiring a different 

individual to serve in each role will 

better ensure a fair and unbiased 

outcome. 

M. Institutional Member, NPRM § 93.222 

Commenters recommended revising 

the definition to remove the inclusion of 

subcontractors and subrecipients. ORI 

retained the definition in its proposed 

form and clarified related wording 

under ‘‘Applicability’’ in subpart A, 

because an individual’s duty to protect 

PHS funds from misuse should not 

depend on the individual’s employment 

status with a specific institution. 


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N. Intentionally, NPRM § 93.224 

Commenters suggested revising this 

definition to provide further 

clarification. One commenter also 

suggested better harmonization with 

definitions used by other Federal 

agencies. ORI retained the definition in 

its proposed form to avoid including 

additional terms that could introduce 

ambiguity. ORI intends to explore 

opportunities to harmonize policy 

across Federal entities. 

O. Knowingly, NPRM § 93.226 

Many commenters generally 

supported retaining this proposed 

definition; however, several 

commenters requested clarification on 

distinctions among ‘‘knowingly,’’ 

‘‘recklessly,’’ and ‘‘intentionally.’’ ORI 

retained the definition in its proposed 

form to avoid including additional 

terms that could introduce ambiguity. 

P. Notice, NPRM § 93.227 

One commenter recommended 

removing this definition. Another 

commenter recommended revision to 

remove the word ‘‘serve.’’ ORI retained 

the definition because it describes an 

essential part of the process of notifying 

respondents. ORI retained the word 

‘‘serve’’ for clarity and notes that the 

definition does not require the use of a 

process server. 

Q. Office of Research Integrity or ORI, 

NPRM § 93.228 

One commenter recommended 

removing this definition because it is a 

commonly understood term. ORI 

retained the definition in its proposed 

form because it is helpful to the public. 

R. Plagiarism, NPRM § 93.230 

Commenters recommended revising 

this definition, particularly to clarify 

‘‘self-plagiarism.’’ ORI retained the 

definition in its proposed form. Because 

‘‘plagiarism’’ is defined as the 

appropriation of ‘‘another person’s’’ 

ideas, processes, results, or words, 

without giving appropriate credit, the 

exclusion of a ‘‘self-plagiarism’’ 

definition was intended to confirm that 

the appropriation must be of ‘‘another 

person’s’’ rather than one’s own ideas, 

processes, results, or words. Thus, ORI 

does not believe it necessary to further 

define ‘‘self-plagiarism’’ in its 

regulation, but ORI may address this 

topic through future policymaking. 

S. Preponderance of Evidence, NPRM 

§ 93.231 

One commenter supported the 

inclusion of the definition. Another 

commenter recommended revision to 

clarify the definition. ORI retained the 

definition because there was no 

consensus among the comments and 

because it was satisfied that the 

proposed definition served the purpose 

of explaining the term to those who may 

be unfamiliar with the term in the 

research misconduct context. 

T. Research Integrity Officer or RIO, 

NPRM § 93.237 

Several commenters provided 

feedback on this definition. Many 

commenters supported the inclusion of 

this definition. A minority of 

commenters recommended its removal 

because they conveyed that it was 

unnecessary or confusing. ORI retained 

the definition in its proposed form 

because it is helpful to the public and 

clarifies the specific responsibilities of 

this role. 

U. Research Misconduct, NPRM 

§ 93.238 

Commenters recommended revision 

of the definition to include questionable 

research practices. One commenter 

conveyed that the definition was 

unnecessary. One commenter requested 

retention of the proposed definition. 

ORI decided to retain this definition 

because it is consistent with the 

definition found in the 2000 Office of 

Science and Technology Policy’s 

Federal Policy on Research Misconduct, 

65 FR 76260 (Dec. 6, 2000). 

V. Retaliation, NPRM § 93.242 

Commenters recommended revision 

of this definition to make it more 

expansive. ORI retained the definition 

in its proposed form as a more limited 

definition is needed to accommodate 

HHS components that address 

retaliation in other contexts. 

W. General Responsibilities for 

Compliance, NPRM § 93.300(g) 

Commenters proposed removing the 

portion of § 93.300(g) that requires 

institutions to address deficiencies or 

additional allegations, noting that ORI 

already has a broad mandate to ensure 

compliance. One commenter asked ORI 

to add a requirement that institutions 

take precautions to ensure that 

complainants do not have unresolved 

conflicts of interest with the respondent. 

Some commenters recommended 

retaining the section as proposed. 

Commenters also requested more 

guidance on fostering an environment of 

research integrity and developing and 

evaluating effective training programs; 

one commenter offered suggestions 

about how to improve Responsible 

Conduct of Research training. ORI 

acknowledges the compliance process 

can be complex. ORI left this section 

unchanged because providing guidance 

rather than stipulating additional 

regulatory requirements reduces 

institutional burden. ORI intends to 

issue further guidance on these topics. 

X. Research Integrity Assurances, NPRM 

§ 93.301 

One commenter noted changing the 

title of this section from ‘‘Institutional 

Assurances’’ to ‘‘Research Integrity 

Assurances’’ was confusing and could 

be misread as materially altering the 

nature of institutional assurances. One 

commenter expressed it was 

inappropriate to require the person who 

coordinates an institution’s compliance 

assurances and Responsible Conduct of 

Research program to also be responsible 

for fostering an environment that 

supports research integrity, because that 

is a leadership-level responsibility. 

There was a request for more specific 

guidance on how institutions can foster 

research integrity, with examples 

focused not only on research but also 

the concept of ‘‘research integrity’’ more 

broadly. ORI acknowledges the 

compliance process can be complex. 

ORI left this section unchanged because 

providing guidance rather than 

stipulating additional regulatory 

requirements reduces institutional 

burden. ORI intends to issue further 

guidance on these topics. 

Y. Maintaining Active Research Integrity 

Assurances, NPRM § 93.302(a) 

One commenter requested greater 

clarity in proposed § 93.302(a)(4)(ii) on 

the scope of policies and procedures 

that institutions are required to make 

publicly available. ORI intends to issue 

guidance on this topic. 

Z. General Conduct of Research 

Misconduct Proceedings—Sequestration 

of Research Records and Other 

Evidence, NPRM § 93.305(a) 

Most commenters approved of 

proposed § 93.305(a) and expressed 

appreciation that institutions may 

sequester copies of records if they are 

substantially equivalent in evidentiary 

value. ORI retained the language as 

proposed. 

AA. General Conduct of Research 

Misconduct Proceedings—Multiple 

Institutions, NPRM § 93.305(e) 

Commenters appreciated ORI’s 

addition of this subsection because 

there has been an increase in complex 

cases involving more than one 

institution. However, they requested 

further guidance on how to handle such 

cases, including how to determine a 

lead institution. ORI intends to issue 

further guidance on this topic. 


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BB. General Conduct of Research 

Misconduct Proceedings—Interviews, 

NPRM § 93.305(g) 

Some commenters suggested revising 

NPRM section § 93.305(g)(5) to require 

institutions to redact all interview 

transcripts before forwarding them to 

the respondent, to protect interviewees’ 

identities. ORI left this section 

unchanged and moved it to § 93.310(g) 

because policies regarding interview 

transcriptions prior to the investigation 

phase should be left to the discretion of 

institutions. 

CC. Institutional Investigation, NPRM 

§ 93.310 

Commenters recommended revising 

§ 93.310(a) to extend the time to begin 

an investigation. ORI retained the 

proposed language because it is 

important to proceed promptly after an 

institution decides an investigation is 

warranted. 

DD. Investigation Time Limits, NPRM 

§ 93.311 

Several commenters approved of 

ORI’s increasing the investigation 

period from 120 to 180 days; however, 

a significant number of commenters 

expressed that 180 days is inadequate to 

conduct a thorough investigation. These 

commenters requested timeframes 

ranging up to a year or more. ORI 

retained the proposed 180-day timeline, 

because the timeframe balances the 

needs of institutions and the need of 

respondents to have investigations 

conclude within a reasonable amount of 

time, and institutions have the 

opportunity to request extensions. ORI 

will continue to work closely with 

institutions that request and 

substantiate the need for an extension. 

EE. Interaction With Other Entities and 

Interim Actions, NPRM § 93.401(b) 

Commenters recommended revising 

§ 93.401(b) to require ORI to notify the 

RIO or the Institutional Deciding 

Official if ORI makes a determination to 

refer a case to the Department of Justice 

or other Federal agencies while the 

institution’s research misconduct 

proceedings are pending. ORI retained 

the language of this section because 

such referrals are nonpublic. 

FF. ORI Allegation Assessments, NPRM 

§ 93.402 

One commenter was concerned about 

the removal of language that was in the 

2005 regulation specifying the 

requirements for ORI to conduct an 

assessment. ORI did not restore the 

language because it is redundant with 

§ 93.204 of the final rule. 

GG. Final HHS Action With No 

Settlement or Finding of Research 

Misconduct, NPRM § 93.410(b) 

One commenter stated that the 

institutional investigation report is part 

of a PHS-supported research process 

and should be made public; they 

suggested copies of or links to all 

institutional investigation reports 

should be posted on the ORI website. 

ORI retained the language as proposed 

because the institutional investigation 

report is not a public document and is 

protected by the Privacy Act, 5 U.S.C. 

552a. 

HH. Rights of the Parties, NPRM 

§ 93.505 

One commenter suggested that 

discovery and de novo review are not 

needed; all that should be required is 

consideration of all the evidence 

available to the ALJ, including the 

institutional record and additional 

testimony and other evidence provided 

during the appeal. ORI did not make 

further changes because ORI already 

proposed removing the discovery and 

de novo review provisions in the NPRM. 

V. Effective Date 

The final rule will become effective 

January 1, 2025, and all regulatory 

requirements will be applicable on 

January 1, 2026, which will apply 

prospectively. The effect of the 

prospective application to research 

misconduct proceedings will depend on 

when allegations are received by 

institutions. The final rule applies to 

research misconduct proceedings based 

on allegations received by institutions 

on or after January 1, 2026. For 

allegations received by an institution 

prior to January 1, 2026, an institution 

must follow 42 CFR part 93 as 

published in the 2005 edition of the 

Code of Federal Regulations, unless a 

respondent and institution agree in 

writing to apply the final rule to a 

particular research misconduct 

proceeding. Institutions must 

implement and submit revised policies 

and procedures that comply with the 

final rule along with their annual report 

covering 2025, which must be received 

by ORI on or before April 30, 2026. 

VI. Required Regulatory Analyses 

We examined the impacts of the final 

rule under Executive Order 12866, 

Executive Order 13563, Executive Order 

14094, the Regulatory Flexibility Act (5 

U.S.C. 601–612), the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4), and the Congressional Review 

Act (5 U.S.C. 801–808). 

Executive Orders 12866, 13563, and 

14094 direct us to assess all benefits, 

costs, and transfers of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). A 

‘‘significant regulatory action’’ under 

Executive Order 12866 Section 3(f)(1) 

(as amended by Executive Order 14094) 

includes a ‘‘regulatory action likely to 

result in a rule that may have an annual 

effect on the economy of $200 million 

or more (adjusted every 3 years by the 

Administrator of [the Office of 

Information and Regulatory Affairs 

(OIRA)] for changes in gross domestic 

product); or adversely affect in a 

material way the economy, a sector of 

the economy, productivity, competition, 

jobs, the environment, public health or 

safety, or State, local, territorial, or tribal 

governments or communities.’’ The 

analysis below concludes that this final 

rule is not a significant regulatory action 

under Executive Order 12866 Section 

3(f)(1). OIRA has determined that this 

final rule is a significant regulatory 

action, but that it does not meet the 

criteria set forth in 5 U.S.C. 804(2) 

under the Congressional Review Act. 

The Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would minimize any significant 

impact of a rule on small institutions. 

The analysis below concludes that the 

final rule will not have a significant 

economic impact on a substantial 

number of small institutions. 

The Unfunded Mandates Reform Act 

of 1995 (UMRA) generally requires that 

each agency conduct a cost-benefit 

analysis, identify and consider a 

reasonable number of regulatory 

alternatives, and select the least costly, 

most cost-effective, or least burdensome 

alternative that achieves the objectives 

of the rule before promulgating any 

proposed or final rule that includes a 

Federal mandate that may result in 

expenditures of more than $100 million 

(adjusted for inflation) in at least one 

year by State, local, and tribal 

governments, or by the private sector. 

Each agency must also seek input from 

State, local, and tribal governments. The 

current threshold after adjustment for 

inflation using the Implicit Price 

Deflator for the Gross Domestic Product 

is $183 million, reported in 2023 

dollars. Per the analysis below, this final 

rule will not result in an unfunded 

mandate in any year that meets or 

exceeds this amount. 

Baseline and Summary of Impacts 

Under the current regulatory 

requirements, all recipients of PHS 


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76290 Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Rules and Regulations 

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. Accessed March 29, 

2024. 

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. Accessed March 29, 2024. 

3For example, see ‘‘Comment from COGR, HHS– 

OASH–2023–0014, HHS–OASH–2023–0014–0001, 

2023–21746.’’ https://www.regulations.gov/ 

comment/HHS-OASH-2023-0014-0074. Accessed 

March 29, 2024. 

4U.S. Bureau of Labor Statistics. Occupational 

Employment and Wages, May 2022. 11–9033 

Education Administrators, Postsecondary. Mean 

hourly wage. https://www.bls.gov/oes/current/ 

oes119033.htm. Accessed March 29, 2024. 

support for biomedical or behavioral 

research, biomedical or behavioral 

research training, or activities related to 

that research or research training must 

comply with certain reporting and 

record keeping requirements. However, 

since many of these impacts have not 

been comprehensively quantified and 

monetized in a previously published 

regulatory impact analysis, when 

considering the potential impacts of this 

final rule, we adopt an analytic baseline 

that excludes many ongoing activities 

associated with the existing 

requirements. For example, absent any 

further regulatory action, we anticipate 

that covered entities would continue to 

incur costs (inclusive of the opportunity 

costs of staff time and other resources) 

associated with filing an annual 

statement of assurance (research 

integrity assurance) and an annual 

report on allegations received; costs 

associated with submitting reports and 

evidence to support their results and 

conclusions of inquiries or 

investigations of research misconduct; 

and costs associated with obtaining all 

research records and other evidence 

when there is an allegation of research 

misconduct and engaging persons to 

handle the process for addressing the 

allegations of research misconduct. 

We anticipate that the final rule will 

likely reduce the burden of compliance 

by institutions through reduced 

confusion and uncertainty. Thus, the 

benefits of this final rule stem from 

reduced confusion for research 

institutions to understand the 

requirements that apply to them. This 

final rule will reduce the potential for 

lengthy back-and-forth discussions 

between ORI and institutions to ensure 

that institutions conduct complete and 

fair investigations of allegations of 

research misconduct. It will also 

streamline the process for respondents 

to appeal ORI findings of research 

misconduct and proposed HHS 

administrative actions. We anticipate 

that these revisions will reduce the 

burden across the affected research 

community. This final rule will also 

help foster an environment of 

responsible conduct of research. 

We anticipate that this final rule will 

likely result in one-time costs associated 

with covered institutions updating their 

policies and procedures for responding 

to allegations of research misconduct. 

For institutions that undertake 

proceedings to address allegations of 

research misconduct, we identify and 

monetize additional recurring costs 

associated with documenting aspects of 

those proceedings. We quantify and 

monetize these costs in the next section. 

One-Time Costs Associated With 

Updating Policies and Procedures 

In support of the NPRM, we 

performed an initial threshold analysis 

to assess the approximate magnitude of 

the impacts of the proposed rule to 

determine whether it would result in a 

significant regulatory action per section 

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

identified the potential costs associated 

with covered institutions updating their 

policies and procedures for responding 

to allegations of research misconduct as 

the largest impact under the proposed 

rule. To quantify this impact, we 

adopted a count of 5,910 institutions 

holding research integrity assurances 

that would update their policies and 

procedures. For the purposes of the 

initial threshold analysis, we adopted 

16 hours as an estimate for the average 

time across all covered entities for these 

tasks. Across all covered entities, this 

was 94,560 total hours spent updating 

policies and procedures. 

To monetize the change in time use 

associated with these activities, we 

adopted an hourly value of time based 

on the cost of labor, including wages 

and benefits, and also indirect costs, 

which ‘‘reflect resources necessary for 

the administrative oversight of 

employees and generally include time 

spent on administrative personnel 

issues (e.g., human resources activities 

such as hiring, performance reviews, 

personnel transfers, affirmative action 

programs), writing administrative 

guidance documents, office expenses 

(e.g., space rental, utilities, equipment 

costs), and outreach and general training 

(e.g., employee development).’’ 1

For these tasks, we identified a pretax hourly wage for Education 

Administrators, Postsecondary. 

According to the U.S. Bureau of Labor 

Statistics, the mean hourly wage for 

these individuals was $53.49 per hour.2

We assumed that benefits plus indirect 

costs equal approximately 100 percent 

of pre-tax wages, and adjusted this 

hourly rate by multiplying by two, for 

a fully loaded hourly wage rate of 

$106.98. We multiplied this fully loaded 

hourly wage rate by the 94,560 total 

hours across covered entities spent 

updating policies and procedures and 

estimated a total cost in the first year of 

about $10.1 million. 

We received public comments 

suggesting it will take institutions more 

than 16 hours to update their policies 

and procedures,3 with alternative 

estimates including between 17–26 

hours, between 27–40 hours, or more 

than 40 hours. We appreciate these 

comments, and in response, we present 

an additional threshold analysis, 

following the same approach described 

above, but adopting several revised 

assumptions and updated data. This 

threshold analysis helps to determine 

whether it will result in a significant 

regulatory action per section 3(f)(1) of 

Executive Order 12866 and to determine 

whether any effects will exceed the 

UMRA threshold. For this analysis, we 

adopt a more recent estimate that 6,394 

institutions holding research integrity 

assurances. Consistent with an upperbound estimate from public comments, 

we adopt 40 hours as the average hours 

per covered entity. We updated the pretax hourly wage to $55.38 per hour,4 for 

a fully loaded hourly wage rate of 

$110.76. The modified assumptions 

indicate that, across all covered entities, 

255,760 hours would be spent updating 

policies and procedures. Monetizing 

this impact using the fully loaded 

hourly wage rate, this would represent 

a cost in the first year of about $28.3 

million. Thus, our modified threshold 

analysis indicates that the largest 

economic impact of the final rule would 

not exceed the monetary threshold for 

significant regulatory actions per section 

3(f)(1) of Executive Order 12866 or the 

UMRA threshold. We emphasize that 

this estimate corresponds to an upperbound estimate of the potential impacts 

based on public comments to the 

proposed rule. 

As discussed in greater detail in the 

Preamble, this final rule includes 

several revisions that generally reduce 

the burden on the institutions covered, 

compared to the proposed rule. To 

estimate the costs associated with 

covered institutions updating their 

policies and procedures, we adopt 16 

hours as an estimate for the average time 

per covered entity and apply the 

updated fully loaded hourly wage 


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Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Rules and Regulations 76291 

estimate ($110.76) and covered entity 

count (6,394 institutions). Combining 

these assumptions results in an estimate 

of the total cost associated with 

updating policies and procedures in the 

first year of about $11.3 million. 

Recurring Costs Attributable to the Final 

Rule 

For institutions that address 

allegations of research misconduct, we 

identify additional recurring costs 

associated with the final rule’s 

reporting, recordkeeping, and thirdparty disclosure requirements related to 

institutions responding to allegations of 

research misconduct. To quantify these 

impacts, we adopt an estimate of 230 

cases per year, matching the most recent 

annual count of cases reported to HHS. 

Consistent with our estimates in the 

Paperwork Reduction Act section of this 

Preamble, we believe that institutions 

will spend a total of 221,030 hours per 

year on these requirements, which is 

about 961 hours per case. To monetize 

these impacts, we adopt the fully loaded 

hourly value of time of $110.76 per hour 

for postsecondary education 

administrators. Across all 230 cases, we 

compute an annual cost associated with 

these regulatory requirements of 

$24,481,283 per year. The Paperwork 

Reduction Act section of this Preamble 

contains additional details on the 

annual burden estimates and total costs 

associated with each of these 

requirements. 

Summary and Timing of Costs of the 

Final Rule 

Across all covered institutions, we 

anticipate that the final rule will result 

in about $11.3 million in one-time costs 

associated with institutions updating 

policies and procedures. We account for 

timing of these impacts by assuming 

they will occur in 2025. We also 

identify incremental costs of about 

$24.5 million associated with the final 

rule’s reporting, recordkeeping, and 

third-party disclosure requirements 

related to institutions responding to 

allegations of research misconduct. 

Consistent with the implementation 

schedule of the final rule, we account 

for timing of these recurring impacts by 

assuming they will occur in 2026 and in 

subsequent years. Over a 5-year time 

horizon, we report a present value of 

total costs attributable to the final rule 

of about $102.5 million, or annualized 

costs of about $21.7 million, both 

calculated using a constant 2% real 

discount rate. 

TABLE 1—COSTS OF THE FINAL RULE

[Constant 2023 dollars, 2% discount rate] 

Year Cost 

2025 .................................. $11,331,191 

2026 .................................. 24,481,283 

2027 .................................. 24,481,283 

2028 .................................. 24,481,283 

2029 .................................. 24,481,283 

Present Value ............ 102,499,288 

Annualized ................. 21,746,084 

Regulatory Flexibility Act 

The Regulatory Flexibility Act (5 

U.S.C. 601–612) requires agencies to 

prepare a regulatory flexibility analysis 

describing the impact of the final rule 

on small entities (‘‘institutions’’ for 

purposes of the final rule) unless they 

certify that a final rule will not, if 

promulgated, have a significant 

economic impact on a substantial 

number of small institutions. HHS 

generally considers a rule to have a 

significant impact on a substantial 

number of small institutions if it has at 

least a 3% impact on revenue on at least 

5% of small institutions. We considered 

whether the final rule would result in 

effects that exceed these thresholds. 

This analysis below concludes, and the 

Secretary certifies that this final rule 

will not have a significant impact on a 

substantial number of small institutions, 

as defined by the Regulatory Flexibility 

Act, based on the following facts. 

As of March 1, 2024, approximately 

22 percent (1,412) of 6,394 institutions 

holding research integrity assurances 

are small institutions. The primary 

impact of the final rule on covered 

institutions results from the reporting 

and record keeping provisions, which 

are analyzed in detail under the heading 

‘‘The Paperwork Reduction Act.’’ 

Potentially significant annual burdens 

apply only if an institution learns of 

possible research misconduct and 

begins an inquiry, investigation, or both. 

Institutions covered by 42 CFR part 93 

reported having conducted a total of 124 

inquiries and 121 investigations during 

the 2023 reporting period. In total, one 

inquiry and three investigations were 

conducted by small institutions. Small 

institutions may be able to avoid 

developing and filing the full policies 

and procedures for addressing 

allegations of research misconduct 

required by § 93.304 by filing a Small 

Institution Statement. Under the 2005 

regulation, this is called a Small 

Organization Statement. ORI or another 

appropriate HHS office will work with 

small institutions to develop and/or 

advise on a process for handling 

allegations of research misconduct 

consistent with 42 CFR part 93. The 

burden of filing the Small Institution 

Statement is 0.5 hour. Thus, the burden 

of developing and filing the full policies 

and procedures for addressing 

allegations of research misconduct 

required by § 93.304 will not fall on a 

substantial number of small entities. 

A small entity that files the Small 

Institution Statement must still report 

allegations of research misconduct to 

ORI and comply with all provisions of 

the final rule except as described in 

§ 93.303. The most significant burden 

that could fall on an entity filing a Small 

Institution Statement is in addressing 

allegations of research misconduct, 

which would include obtaining all 

research records and other evidence 

when there is an allegation of research 

misconduct, engaging persons to handle 

the process for addressing the 

allegations of research misconduct, and 

submitting reports and evidence to 

support the small institution’s results 

and conclusions of inquiries or 

investigations of research misconduct. 

The average burden per response is 

estimated at 40 hours. Based on reports 

of research misconduct over the past 

five years, fewer than five small 

institutions will have to incur that 

burden in any year. Based on this 

analysis, HHS concludes that the 

regulations set forth in the final rule 

will not impose a significant burden on 

a substantial number of small 

institutions. 

Paperwork Reduction Act 

Sections 104, 301–303, 305–313, and 

315–318 of this final rule contain 

information collection requirements that 

are subject to review and approval by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act (PRA) of 1995 (44 U.S.C. 3501– 

3521). These provisions involve the 

following institutional activities in 

addressing allegations of misconduct 

involving PHS-funded research: 

Title: The title of the section of the 

Public Health Service Policies on 

Research Misconduct involving 

institutional activities. 

Description: The relevant passage(s) of 

the section describing the institutional 

information collection requirements. 

Description of Respondents: The 

‘‘respondents’’ for the collection of 

information described in this regulation 

are institutions that apply for or receive 

PHS support through grants, contracts, 

or cooperative agreements for any 

project or program that involves the 

conduct of biomedical or behavioral 

research, biomedical or behavioral 

research training, or activities related to 


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76292 Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Rules and Regulations 

that research or training (see definition 

of ‘‘Institution’’ at § 93.216). 

Subpart A—General 

Section 93.104 

(ii) For research misconduct that 

appears subject to the subsequent use 

exception, institutions must document 

their determination that the subsequent 

use exception does not apply. Such 

documentation must be retained in 

accordance with § 93.318. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—40 hours. 

Total Annual Burden—9,200 hours. 

Subpart C—Responsibilities of 

Institutions 

Compliance and Assurances 

Section 93.305 

(b) Access to research records. Where 

appropriate, an institution must give the 

respondent copies of, or reasonable 

supervised access to, the research 

records that are sequestered in 

accordance with paragraph (a) of this 

section. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—25 hours. 

Total Annual Burden—5,750 hours. 

(c) Maintenance of sequestered 

research records and other evidence. An 

institution must maintain the 

sequestered research records and other 

evidence as required by § 93.318. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—80 hours. 

Total Annual Burden—18,400 hours. 

(g) Notifying ORI of special 

circumstances. At any time during a 

research misconduct proceeding, as 

defined in § 93.235, an institution must 

notify ORI immediately if it has reason 

to believe that any of the following 

conditions exist: 

(1) Health or safety of the public is at 

risk, including an immediate need to 

protect human or animal subjects. 

(2) HHS resources or interests are 

threatened. 

(3) Research activities should be 

suspended. 

(4) There is reasonable indication of 

possible violations of civil or criminal 

law. 

(5) Federal action is required to 

protect the interests of those involved in 

the research misconduct proceeding. 

(6) HHS may need to take appropriate 

steps to safeguard evidence and protect 

the rights of those involved. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—1 hour. 

Total Annual Burden—230 hours. 

The Institutional Assessment 

Section 93.306 

(c) Assessment results. 

(2) If the RIO or another designated 

institutional official determines that 

requirements for an inquiry are met, 

they must: (i) document the assessment; 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—80 hours. 

Total Annual Burden—18,400 hours. 

(ii) promptly sequester all research 

records and other evidence, consistent 

with § 93.305(a), and promptly initiate 

the inquiry. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—160 hours. 

Total Annual Burden—36,800 hours. 

(3) If the RIO or another designated 

institutional official determines that 

requirements for an inquiry are not met, 

they must keep sufficiently detailed 

documentation of the assessment to 

permit a later review by ORI of the 

reasons why the institution did not 

conduct an inquiry. Such 

documentation must be retained in 

accordance with § 93.318. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—10 hours. 

Total Annual Burden—2,300 hours. 

The Institutional Inquiry 

Section 93.307 

(d) Sequestration of records. An 

institution must obtain all research 

records and other evidence needed to 

conduct the research misconduct 

proceeding, consistent with § 93.305(a). 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—80 hours. 

Total Annual Burden—18,400 hours. 

Section 93.308 

(a) Notice to respondent. The 

institution must notify the respondent 

whether the inquiry found that an 

investigation is warranted. The notice 

must include a copy of the inquiry 

report and include a copy of or refer to 

this part and the institution’s policies 

and procedures adopted under its 

research integrity assurance. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—2 hours. 

Total Annual Burden—460 hours. 

Section 93.309 

(a) Within 30 days of determining that 

an investigation is warranted, the 

institution must provide ORI with a 

copy of the inquiry report, which 

includes the following information: 

(1) The names, professional aliases, 

and positions of the respondent and 

complainant; 

(2) A description of the allegation(s) 

of research misconduct; 

(3) The PHS support, including, for 

example, grant numbers, grant 

applications, contracts, and publications 

listing PHS support; 

(4) The composition of the inquiry 

committee, if used, including name(s), 

position(s), and subject matter expertise; 

(5) Inventory of sequestered research 

records and other evidence and 

description of how sequestration was 

conducted; 

(6) Transcripts of any transcribed 

interviews; 

(7) Timeline and procedural history; 

(8) Any scientific or forensic analyses 

conducted; 

(9) The basis for recommending that 

the allegation(s) warrant an 

investigation; 

(10) The basis on which any 

allegation(s) do not merit an 

investigation; 

(11) Any comments on the inquiry 

report by the respondent or the 

complainant; and 

(12) Any institutional actions 

implemented, including 

communications with journals or 

funding agencies. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—4 hours. 

Total Annual Burden—920 hours. 

(b) Institutions must keep detailed 

documentation of inquiries to permit a 

later assessment by ORI of the reasons 

why the institution decided not to 

investigate. Such documentation must 

be retained in accordance with § 93.318. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 


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Annual Average Burden per 

Response—0 hours. Burden accounted 

for in § 93.316(a)(2). 

Total Annual Burden—0 hours. 

(c) In accordance with § 93.305(g), 

institutions must notify ORI of any 

special circumstances that may exist. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—2 hours. 

Total Annual Burden—460 hours. 

The Institutional Investigation 

Section 93.310 

Institutions conducting research 

misconduct investigations must: (b) 

Notify ORI of the decision to begin an 

investigation on or before the date the 

investigation begins and provide an 

inquiry report that meets the 

requirements of § 93.307 and § 93.309. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—0 hours. Burden accounted 

for in § 93.309(a). 

Total Annual Burden—0 hours. 

(d) Notice to the respondent. Notify 

the respondent in writing of the 

allegation(s) within a reasonable amount 

of time after determining that an 

investigation is warranted, but before 

the investigation begins. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—0 hours. Burden accounted 

for in § 93.308(a). 

Total Annual Burden—0 hours. 

(g) Interviews. During the 

investigation, an institution must 

interview each respondent, 

complainant, and any other available 

person who has been reasonably 

identified as having information 

regarding any relevant aspects of the 

investigation, including witnesses 

identified by the respondent. (1) 

Interviews during the investigation must 

be recorded and transcribed. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—300 hours. 

Total Annual Burden—69,000 hours. 

(3) The transcript of the interview 

must be made available to the relevant 

interviewee for correction. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—4 hours. 

Total Annual Burden—920 hours. 

(5) The respondent must be provided 

a transcript of the interview. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—4 hours. 

Total Annual Burden—920 hours. 

(j) Pursue leads. If additional 

allegations are raised, the respondent(s) 

must be notified in writing of the 

additional allegations raised against 

them. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—2 hours. 

Total Annual Burden—460 hours. 

Section 93.310 

(b) Extension of time limit. If unable 

to complete the investigation in 180 

days, the institution must ask ORI for an 

extension in writing that includes the 

circumstances or issues warranting 

additional time. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—1 hour. 

Total Annual Burden—230 hours. 

(c) Progress reports. If ORI grants an 

extension, it may direct the institution 

to file periodic progress reports. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—1 hour. 

Total Annual Burden—230 hours. 

Section 93.312 

(a) The institution must give the 

respondent a copy of the draft 

investigation report and, concurrently, a 

copy of, or supervised access to, the 

research records and other evidence that 

the investigation committee considered 

or relied on. The respondent must 

submit any comments on the draft 

report to the institution within 30 days 

of receiving the draft investigation 

report. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—2 hours. 

Total Annual Burden—460 hours. 

Section 93.313 

A final investigation report for each 

respondent must be in writing and 

include: 

(a) Description of the nature of the 

allegation(s) of research misconduct, 

including any additional allegation(s) 

addressed during the research 

misconduct proceeding. 

(b) Description and documentation of 

the PHS support, including, for 

example, any grant numbers, grant 

applications, contracts, and publications 

listing PHS support. 

(c) Description of the specific 

allegation(s) of research misconduct for 

consideration in the investigation of the 

respondent. 

(d) Composition of investigation 

committee, including name(s), 

position(s), and subject matter expertise. 

(e) Inventory of sequestered research 

records and other evidence, except 

records the institution did not consider 

or rely on; and a description of how any 

sequestration was conducted during the 

investigation. This inventory must 

include manuscripts and funding 

proposals that were considered or relied 

on during the investigation. 

(f) Transcripts of all interviews 

conducted, as described in § 93.310(g). 

(g) Identification of the specific 

published papers, manuscripts 

submitted but not accepted for 

publication (including online 

publication), PHS funding applications, 

progress reports, presentations, posters, 

or other research records that allegedly 

contained the falsified, fabricated, or 

plagiarized material. 

(h) Any scientific or forensic analyses 

conducted. 

(i) If not already provided to ORI, the 

institutional policies and procedures 

under which the investigation was 

conducted. 

(j) Any comments made by the 

respondent and complainant on the 

draft investigation report and the 

investigation committee’s consideration 

of those comments. 

(k) A statement for each separate 

allegation of whether the investigation 

committee recommends a finding of 

research misconduct. 

(1) If the investigation committee 

recommends a finding of research 

misconduct for an allegation, the 

investigation report must, for that 

allegation: 

(i) Identify the individual(s) who 

committed the research misconduct. 

(ii) Indicate whether the research 

misconduct was falsification, 

fabrication, and/or plagiarism. 

(iii) Indicate whether the research 

misconduct was committed 

intentionally, knowingly, or recklessly. 

(iv) State whether the other 

requirements for a finding of research 

misconduct, as described in § 93.103, 

have been met. 

(v) Summarize the facts and the 

analysis which support the conclusion 


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and consider the merits of any 

explanation by the respondent. 

(vi) Identify the specific PHS support. 

(vii) Identify whether any 

publications need correction or 

retraction. 

(2) If the investigation committee does 

not recommend a finding of research 

misconduct for an allegation, the 

investigation report must provide a 

detailed rationale. 

(l) List of any current support or 

known applications or proposals for 

support that the respondent has pending 

with PHS and non-PHS Federal 

agencies. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—160 hours. 

Total Annual Burden—36,800 hours. 

Section 93.315 

(a) If a respondent appeals an 

institution’s finding(s) of research 

misconduct or institutional actions, the 

institution must promptly notify ORI. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—1 hour. 

Total Annual Burden—230 hours. 

(b) If the institution has not 

transmitted its institutional record to 

ORI in accordance with § 93.316 prior to 

the appeal, the institution must wait 

until the appeal is concluded to 

transmit its institutional record. The 

institution must ensure that the 

complete record of the appeal is 

included in the institutional record 

consistent with § 93.220(a)(5). 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—0 hours. Burden accounted 

for in § 93.316(a). 

Total Annual Burden—0 hours. 

(c) If the institution has transmitted 

its institutional record to ORI in 

accordance with § 93.316 prior to the 

appeal, the institution must provide ORI 

a complete record of the appeal once the 

appeal is concluded. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—2 hours. 

Total Annual Burden—460 hours. 

Section 93.316 

After the Institutional Deciding 

Official has made a final determination 

of research misconduct findings in 

accordance with § 93.314, the 

institution must transmit the 

institutional record to ORI. The 

institutional record must be consistent 

with § 93.220 and logically organized. 

Per § 93.220: The institutional record 

comprises: 

(a) The records that the institution 

compiled or generated during the 

research misconduct proceeding, except 

records the institution did not consider 

or rely on. These records include, but 

are not limited to: 

(1) Documentation of the assessment 

as required by § 93.306(c). 

(2) If an inquiry is conducted, the 

inquiry report and all records (other 

than drafts of the report) considered or 

relied on during the inquiry, including, 

but not limited to, research records and 

the transcripts of any transcribed 

interviews conducted during the 

inquiry, information the respondent 

provided to the institution, and the 

documentation of any decision not to 

investigate as required by § 93.309(c). 

(3) If an investigation is conducted, 

the investigation report and all records 

(other than drafts of the report) 

considered or relied on during the 

investigation, including, but not limited 

to, research records, the transcripts of 

each interview conducted pursuant to 

§ 93.310(g), and information the 

respondent provided to the institution. 

(4) Decision(s) by the Institutional 

Deciding Official, such as the written 

decision from the Institutional Deciding 

Official under § 93.314. 

(5) The complete record of any 

institutional appeal consistent with 

§ 93.315. 

(b) A single index listing all the 

research records and evidence that the 

institution compiled during the research 

misconduct proceeding, except records 

the institution did not consider or rely 

on. 

(c) A general description of the 

records that were sequestered but not 

considered or relied on. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—4 hours. 

Total Annual Burden—920 hours. 

Section 93.317 

(a) Institutions must notify ORI in 

advance if the institution plans to close 

a research misconduct proceeding at the 

assessment, inquiry, investigation, or 

appeal stage on the basis that the 

respondent has admitted to committing 

research misconduct or a settlement 

with the respondent has been reached. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—1 hour. 

Total Annual Burden—230 hours. 

(b) The [respondent’s written] 

admission statement must meet all 

elements required for a research 

misconduct finding under § 93.103 and 

must be provided to ORI before the 

institution closes its research 

misconduct proceeding. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—10 hours. 

Total Annual Burden—2,300 hours. 

(b—continued): The institution must 

also provide a statement to ORI 

describing how it determined that the 

scope of the misconduct was fully 

addressed by the admission and 

confirmed the respondent’s culpability. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—10 hours. 

Total Annual Burden—2,300 hours. 

Section 93.318 

(a) Maintenance of institutional 

record and all sequestered evidence. An 

institution must maintain the 

institutional record and all sequestered 

evidence including physical objects 

(regardless of whether the evidence is 

part of the institutional record) in a 

secure manner for seven years after 

completion of the proceeding or the 

completion of any HHS proceeding 

involving the research misconduct 

allegation under subparts D and E of 

this part, whichever is later, unless 

custody has been transferred to HHS 

under paragraph (b) of this section or 

ORI advises otherwise in writing. 

Number of Respondents—230. 

Number of Responses per 

Respondent—1. 

Annual Average Burden per 

Response—8 hours. 

Total Annual Burden—1,840 hours. 


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ESTIMATED ANNUALIZED BURDEN HOUR TABLE (9/3/2024) 

Forms 

(If necessary) Type of respondent Number of respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

Hours 

§ 93.104 .......................................... Institutions ...................................... 230 1 40 9,200 

§ 93.305.b ....................................... Institutions ...................................... 230 1 25 5,750 

§ 93.305.c ........................................ Institutions ...................................... 230 1 80 18,400 

§ 93.325 .......................................... Institutions ...................................... 230 1 1 230 

§ 93.306.c.2.i ................................... Institutions ...................................... 230 1 80 18,400 

§ 93.306.c.2.ii .................................. Institutions ...................................... 230 1 160 36,800 

§ 93.306.c.2.iii ................................. Institutions ...................................... 230 1 10 2,300 

§ 93.307 .......................................... Institutions ...................................... 230 1 80 18,400 

§ 93.308 .......................................... Institutions ...................................... 230 1 2 460 

Sec 93.309.a ................................... Institutions ...................................... 230 1 4 920 

Sec 93.309.c ................................... Institutions ...................................... 230 1 2 460 

§ 93.310.g.1 .................................... Institutions ...................................... 230 1 300 69,000 

§ 93.310.g.3 .................................... Institutions ...................................... 230 1 4 920 

§ 93.310.g.5 .................................... Institutions ...................................... 230 1 4 920 

§ 93.310.j ......................................... Institutions ...................................... 230 1 2 460 

§ 93.310.b ....................................... Institutions ...................................... 230 1 1 230 

§ 93.310.c ........................................ Institutions ...................................... 230 1 1 230 

§ 93.312 .......................................... Institutions ...................................... 230 1 2 460 

§ 93.313 .......................................... Institutions ...................................... 230 1 160 36,800 

§ 93.315.a ....................................... Institutions ...................................... 230 1 1 230 

§ 93.315.c ........................................ Institutions ...................................... 230 1 2 460 

Total ......................................... ......................................................... ........................ ........................ ........................ 221,030 

Estimated annualized cost to respondents 

(9/3/2024) Forms 

(If necessary) 

Type of 

respondent 

Total burden 

hours 

Hourly wage 

rate 

Total respondent 

cost 

§ 93.104 ....................................................... Institutions ................................................... 9,200 $111 $1,018,992 

§ 93.305.b .................................................... Institutions ................................................... 5,750 111 636,870 

§ 93.305.c ..................................................... Institutions ................................................... 18,400 111 2,037,984 

§ 93.325 ....................................................... Institutions ................................................... 230 111 25,475 

§ 93.306.c.2.i ................................................ Institutions ................................................... 18,400 111 2,037,984 

§ 93.306.c.2.ii ............................................... Institutions ................................................... 36,800 111 4,075,968 

§ 93.306.c.2.iii .............................................. Institutions ................................................... 2,300 111 254,748 

§ 93.307 ....................................................... Institutions ................................................... 18,400 111 2,037,984 

§ 93.308 ....................................................... Institutions ................................................... 460 111 50,950 

Sec 93.309.a ................................................ Institutions ................................................... 920 111 101,899 

Sec 93.309.c ................................................ Institutions ................................................... 460 111 50,950 

§ 93.310.g.1 ................................................. Institutions ................................................... 69,000 111 7,642,440 

§ 93.310.g.3 ................................................. Institutions ................................................... 920 111 101,899 

§ 93.310.g.5 ................................................. Institutions ................................................... 920 111 101,899 

§ 93.310.j ...................................................... Institutions ................................................... 460 111 50,950 

§ 93.310.b .................................................... Institutions ................................................... 230 111 25,475 

§ 93.310.c ..................................................... Institutions ................................................... 230 111 25,475 

§ 93.312 ....................................................... Institutions ................................................... 460 111 50,950 

§ 93.313 ....................................................... Institutions ................................................... 36,800 111 4,075,968 

§ 93.315.a .................................................... Institutions ................................................... 230 111 25,475 

§ 93.315.c ..................................................... Institutions ................................................... 460 111 50,950 

Total ...................................................... ...................................................................... ........................ ........................ 24,481,283 

Following publication of the final 

rule, ORI will publish 60-day and 30- 

day notices in the Federal Register 

seeking public comment on these 

information collection requirements and 

associated burden estimates, and ORI 

will submit an Information Collection 

Request (ICR) to OMB seeking approval 

for these requirements under existing 

OMB Control Number 0937–0198, 

which currently covers the assurance 

and annual reporting requirements of 42 

CFR part 93 (the Institutional Assurance 

and Annual Report on Possible Research 

Misconduct, PHS–6349, and the 

Assurance of Compliance by Sub-Award 

Recipients, PHS–6315). Before the 

applicability date of this final rule, ORI 

anticipates publishing a notice in the 

Federal Register announcing OMB’s 

decision to approve, modify, or 

disapprove this ICR. This final rule does 

not make any substantive revisions to 

the Assurance or Annual Report that 

would require clearance under the PRA, 

but ORI anticipates making minor 

updates to these forms as part of the 

upcoming revision to 0937–0198. 

An Agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. 

List of Subjects in 42 CFR Part 93 

Government contracts, Grant 

programs, Reporting and recordkeeping 

requirements, Research, Science and 

technology. 

■ For reasons discussed in the 

preamble, HHS is revising 42 CFR part 

93 to read as follows: 


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76296 Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Rules and Regulations 

PART 93—PUBLIC HEALTH SERVICE 

POLICIES ON RESEARCH 

MISCONDUCT 

Sec. 

93.25 Organization of this part. 

93.50 Special terms. 

93.75 Application of effective date to 

research misconduct proceedings. 

Subpart A—General 

93.100 General policy. 

93.101 Purpose. 

93.102 Applicability. 

93.103 Requirements for findings of 

research misconduct. 

93.104 Time limitations. 

93.105 Evidentiary standards. 

93.106 Confidentiality. 

93.107 Coordination with other agencies. 

Subpart B—Definitions 

93.200 Accepted practices of the relevant 

research community. 

93.201 Administrative action. 

93.202 Administrative record. 

93.203 Allegation. 

93.204 Assessment. 

93.205 Charge letter. 

93.206 Complainant. 

93.207 Contract. 

93.208 Day. 

93.209 Departmental Appeals Board or 

DAB. 

93.210 Evidence. 

93.211 Fabrication. 

93.212 Falsification. 

93.213 Funding Component. 

93.214 Good Faith. 

93.215 Inquiry. 

93.216 Institution. 

93.217 Institutional Certifying Official. 

93.218 Institutional Deciding Official. 

93.219 Institutional member. 

93.220 Institutional record. 

93.221 Intentionally. 

93.222 Investigation. 

93.223 Knowingly. 

93.224 Notice. 

93.225 Office of Research Integrity or ORI. 

93.226 Person. 

93.227 Plagiarism. 

93.228 Preponderance of the evidence. 

93.229 Public Health Service or PHS. 

93.230 PHS support. 

93.231 Recklessly. 

93.232 Research. 

93.233 Research Integrity Officer or RIO. 

93.234 Research misconduct. 

93.235 Research misconduct proceeding. 

93.236 Research record. 

93.237 Respondent. 

93.238 Retaliation. 

93.239 Secretary or HHS. 

93.240 Small institution. 

93.241 Suspension and Debarment Official 

or SDO. 

Subpart C—Responsibilities of Institutions 

Compliance and Assurances 

93.300 General responsibilities for 

compliance. 

93.301 Research integrity assurances. 

93.302 Maintaining active research integrity 

assurances. 

93.303 Research integrity assurances for 

small institutions. 

93.304 Institutional policies and 

procedures. 

93.305 General conduct of research 

misconduct proceedings. 

The Institutional Assessment 

93.306 Institutional assessment. 

The Institutional Inquiry 

93.307 Institutional inquiry. 

93.308 Notice of the results of the inquiry. 

93.309 Reporting to ORI on the decision to 

initiate an investigation. 

The Institutional Investigation 

93.310 Institutional investigation. 

93.311 Investigation time limits. 

93.312 Opportunity to comment on the 

draft investigation report. 

93.313 Investigation report. 

93.314 Decision by the Institutional 

Deciding Official. 

93.315 Institutional appeals. 

93.316 Transmittal of the institutional 

record to ORI. 

93.317 Completing the research misconduct 

process. 

Other Institutional Responsibilities 

93.318 Retention and custody of the 

institutional record and all sequestered 

evidence. 

93.319 Institutional standards of conduct. 

Subpart D—Responsibilities of the U.S. 

Department of Health and Human Services 

General Information 

93.400 General statement of ORI authority. 

93.401 Interaction with other entities and 

interim actions. 

Research Misconduct Issues 

93.402 ORI allegation assessments. 

93.403 ORI review of research misconduct 

proceedings. 

93.404 Findings of research misconduct 

and proposed HHS administrative 

actions. 

93.405 Notifying the respondent of findings 

of research misconduct and proposed 

HHS administrative actions. 

93.406 Final HHS actions. 

93.407 HHS administrative actions. 

93.408 Mitigating and aggravating factors in 

HHS administrative actions. 

93.409 Settlement of research misconduct 

proceedings. 

93.410 Final HHS action with no settlement 

or finding of research misconduct. 

93.411 Final HHS action with a settlement 

or finding of misconduct. 

Institutional Compliance Issues 

93.412 Making decisions on institutional 

noncompliance. 

93.413 ORI compliance actions. 

Disclosure of Information 

93.414 Notice. 

Subpart E—Opportunity to Contest ORI 

Findings of Research Misconduct and 

Proposed HHS Administrative Actions 

General Information 

93.500 General policy. 

Process for Contesting Research Misconduct 

Findings and/or Proposed HHS 

Administrative Actions 

93.501 Notice of appeal. 

93.502 Appointment of the Administrative 

Law Judge. 

93.503 Filing of the administrative record. 

93.504 Standard of review. 

93.505 Rights of the parties. 

93.506 Authority of the Administrative Law 

Judge. 

93.507 Ex parte communications. 

93.508 Filing, format, and service. 

93.509 Filing motions. 

93.510 Conferences. 

93.511 The Administrative Law Judge’s 

ruling. 

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

§ 93.25 Organization of this part. 

This part is subdivided into five 

subparts. Each subpart contains 

information related to a broad topic or 

specific audience with special 

responsibilities as shown in the 

following table. 

TABLE 1 TO § 93.25 

In subpart 

. . . 

You will find sections related to 

. . . 

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

part. 

B .............. Definitions used in this part. 

C .............. Responsibilities of institutions 

with PHS support. 

D .............. Responsibilities of the U.S. Department of Health and 

Human Services and the Office of Research Integrity. 

E .............. Information on how to contest 

ORI research misconduct findings and proposed HHS administrative actions. 

§ 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. 

§ 93.75 Application of effective date to 

research misconduct proceedings. 

(a) An institution must follow this 

part for allegations received by the 

institution on or after January 1, 2026, 

except for the policies and procedures 

required under §§ 93.300(a) and 

93.302(b), which must be implemented 

and submitted by due date of the annual 

report covering the 2025 reporting year, 

as specified by ORI. 

(b) For allegations received by an 

institution before January 1, 2026, 

unless the institution and the 

respondent both elect in writing to 

follow this part, an institution must 

follow this part as published in the 2005 

edition of the Code of Federal 

Regulations. 


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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 to 

perform inquiries or investigations at 

any time. Institutions and institutional 

members have an affirmative duty to 

protect PHS funds from misuse by 

ensuring the integrity of all PHSsupported 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 institutions to 

participate in PHS-supported research; 

(f) Protect the health and safety of the 

public, promote the integrity of PHSsupported research and the research 

process, and conserve public funds. 

§ 93.102 Applicability. 

(a) Every extramural or intramural 

institution that applies for or receives 

PHS support for biomedical or 

behavioral research, biomedical or 

behavioral research training, or 

activities related to that research or 

research training must comply with this 

part. 

(b) This part applies to allegations of 

research misconduct involving: 

(1) Applications or proposals for PHS 

support for biomedical or behavioral 

extramural or intramural research, 

biomedical or behavioral research 

training, or activities related to that 

research or research training; 

(2) PHS-supported biomedical or 

behavioral extramural or intramural 

research; 

(3) PHS-supported biomedical or 

behavioral extramural or intramural 

research training programs; 

(4) PHS-supported extramural or 

intramural activities that are related to 

biomedical or behavioral research or 

research training, such as, but not 

limited to, the operation of tissue and 

data banks or the dissemination of 

research information; 

(5) Research records produced during 

PHS-supported research, research 

training, or activities related to that 

research or research training; and 

(6) Research proposed, performed, 

reviewed, or reported, as well as any 

research record generated from that 

research, regardless of whether an 

application or proposal for PHS funds 

resulted in an awarded grant, contract, 

cooperative agreement, subaward, or 

other form of PHS support. 

(c) This part does not supersede or 

establish an alternative to any 

applicable statutes, regulations, policies, 

or procedures for handling fiscal 

improprieties, the ethical treatment of 

human or animal subjects, criminal 

matters, personnel actions against 

Federal employees, or addressing 

whistleblowers and/or retaliation. 

(d) This part does not supersede or 

establish an alternative to the HHS 

suspension and debarment regulations 

set forth at 2 CFR part 180, as 

implemented by HHS at 2 CFR part 376; 

and 48 CFR part 9, subpart 9.4, as 

supplemented by HHS at 48 CFR part 

309, subpart 309.4. The Suspension and 

Debarment Official SDO and ORI may 

coordinate actions to the extent 

consistent with the SDO’s and ORI’s 

respective authorities. Such 

coordination includes jointly issuing 

notices or seeking settlements of actions 

and proceedings. 

(e) This part does not prohibit or 

otherwise limit how institutions handle 

allegations of misconduct that do not 

fall within this part’s definition of 

research misconduct or that do not 

involve PHS support. 

§ 93.103 Requirements for findings of 

research misconduct. 

A finding of research misconduct 

made under this part requires that: 

(a) There be a significant departure 

from accepted practices of the relevant 

research community; and 

(b) The misconduct be committed 

intentionally, knowingly, or recklessly; 

and 

(c) The allegation be proven by a 

preponderance of the evidence. 

§ 93.104 Time limitations. 

(a) Six-year limitation. This part 

applies only to research misconduct 

occurring within six years of the date 

HHS or an institution receives an 

allegation of research misconduct. 

(b) Exceptions to the six-year 

limitation. Paragraph (a) of this section 

does not apply in the following 

instances: 

(1) Subsequent use exception. The 

respondent continues or renews any 

incident of alleged research misconduct 

that occurred before the six-year 

limitation through the use of, 

republication of, or citation to the 

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

processed data, journal articles, funding 

proposals, data repositories) alleged to 

have been fabricated, falsified, or 

plagiarized, for the potential benefit of 

the respondent. 

(i) When the respondent uses, 

republishes, or cites to the portion(s) of 

the research record that is alleged to 

have been fabricated, falsified, or 

plagiarized, in submitted or published 

manuscripts, submitted PHS grant 

applications, progress reports submitted 

to PHS funding components, posters, 

presentations, or other research records 

within six years of when the allegations 

were received by HHS or an institution, 

this exception applies. 

(ii) For research misconduct that 

appears subject to the subsequent use 

exception, institutions must document 

their determination that the subsequent 

use exception does not apply. Such 

documentation must be retained in 

accordance with § 93.318. 

(2) Exception for the health or safety 

of the public. If ORI or the institution, 

following consultation with ORI, 

determines that the alleged research 

misconduct, if it occurred, would 

possibly have a substantial adverse 

effect on the health or safety of the 

public, this exception applies. 

§ 93.105 Evidentiary standards. 

(a) Standard of proof. An institutional 

or HHS finding of research misconduct 

must be proved by a preponderance of 

the evidence. 

(b) Burden of proof. (1) The institution 

or HHS has the burden of proof for 

making a finding of research 

misconduct. A respondent’s destruction 

of research records documenting the 

questioned research is evidence of 

research misconduct where the 

institution or HHS establishes by a 


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76298 Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Rules and Regulations 

preponderance of the evidence that the 

respondent intentionally or knowingly 

destroyed records after being informed 

of the research misconduct allegations. 

A respondent’s failure to provide 

research records documenting the 

questioned research is evidence of 

research misconduct where the 

respondent claims to possess the 

records but refuses to provide them 

upon request. 

(2) The respondent has the burden of 

going forward with and proving, by a 

preponderance of the evidence, all 

affirmative defenses raised. In 

determining whether HHS or the 

institution has carried the burden of 

proof imposed by this part, the finder of 

fact shall give due consideration to 

admissible, credible evidence of honest 

error or difference of opinion presented 

by the respondent. 

(3) The respondent has the burden of 

going forward with and proving, by a 

preponderance of the evidence, any 

mitigating factors relevant to a decision 

to impose administrative actions after a 

research misconduct proceeding. 

§ 93.106 Confidentiality. 

(a) Disclosure of the identity of 

respondents, complainants, and 

witnesses while conducting the research 

misconduct proceedings is limited, to 

the extent possible, to those who need 

to know, as determined by the 

institution, consistent with a thorough, 

competent, objective, and fair research 

misconduct proceeding, and as allowed 

by law. Those who need to know may 

include institutional review boards, 

journals, editors, publishers, co-authors, 

and collaborating institutions. This 

limitation on disclosure of the identity 

of respondents, complainants, and 

witnesses no longer applies once an 

institution has made a final 

determination of research misconduct 

findings. The institution, however, must 

disclose the identity of respondents, 

complainants, or other relevant persons 

to ORI pursuant to an ORI review of 

research misconduct proceedings under 

this part. 

(b) Except as may otherwise be 

prescribed by applicable law, 

confidentiality must be maintained for 

any records or evidence from which 

research subjects might be identified. 

Disclosure is limited to those who need 

to know to carry out a research 

misconduct proceeding. 

(c) This section does not prohibit 

institutions from managing published 

data or acknowledging that data may be 

unreliable. 

§ 93.107 Coordination with other agencies. 

(a) When more than one agency of the 

Federal Government has jurisdiction 

over a research misconduct allegation, 

HHS will cooperate with the other 

agencies in designating a lead agency to 

coordinate the response of the agencies 

to the allegation. Where HHS is not the 

lead agency, it may, in consultation 

with the lead agency, take appropriate 

action. 

(b) In research misconduct 

proceedings involving more than one 

agency, HHS may refer to the other 

agency’s (or agencies’) evidence or 

reports if HHS determines that the 

evidence or reports will assist in 

resolving HHS issues. In appropriate 

cases, HHS may seek to resolve 

allegations jointly with the other agency 

or agencies. 

Subpart B—Definitions 

§ 93.200 Accepted practices of the 

relevant research community. 

Accepted practices of the relevant 

research community means those 

practices established by 42 CFR part 93 

and by PHS funding components, as 

well as commonly accepted professional 

codes or norms within the overarching 

community of researchers and 

institutions that apply for and receive 

PHS awards. 

§ 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 

transcript of any virtual or in-person 

meetings under § 93.403(b) between the 

respondent and ORI, and 

correspondence between the respondent 

and ORI; any additional information 

provided to ORI while the case is 

pending before ORI; and any analysis or 

additional information generated or 

obtained by ORI. Any analysis or 

additional information generated or 

obtained by ORI will also be made 

available to the respondent. 

§ 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 Assessment. 

Assessment means a consideration of 

whether an allegation of research 

misconduct appears to fall within the 

definition of research misconduct; 

appears to involve PHS-supported 

biomedical or behavioral research, 

biomedical or behavioral research 

training, or activities related to that 

research or research training; and is 

sufficiently credible and specific so that 

potential evidence of research 

misconduct may be identified. The 

assessment only involves the review of 

readily accessible information relevant 

to the allegation. 

§ 93.205 Charge letter. 

Charge letter means the written 

notice, as well as any amendments to 

the notice, sent to the respondent stating 

the findings of research misconduct and 

any proposed HHS administrative 

actions. 

§ 93.206 Complainant. 

Complainant means an individual 

who in good faith makes an allegation 

of research misconduct. 

§ 93.207 Contract. 

Contract means an acquisition 

instrument awarded under the Federal 

Acquisition Regulation (FAR), 48 CFR 

chapter 1. 

§ 93.208 Day. 

Day means calendar day unless 

otherwise specified. If a deadline falls 

on a Saturday, Sunday, or Federal 

holiday, the deadline will be extended 

to the next day that is not a Saturday, 

Sunday, or Federal holiday. 

§ 93.209 Departmental Appeals Board or 

DAB. 

Departmental Appeals Board or DAB 

means the organization, within the HHS 

Office of the Secretary, established to 

conduct hearings and provide impartial 

review of disputed decisions made by 

HHS operating components. 

§ 93.210 Evidence. 

Evidence means anything offered or 

obtained during a research misconduct 

proceeding that tends to prove or 

disprove the existence of an alleged fact. 

Evidence includes documents, whether 

in hard copy or electronic form, 

information, tangible items, and 

testimony. 

§ 93.211 Fabrication. 

Fabrication means making up data or 

results and recording or reporting them. 


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§ 93.212 Falsification. 

Falsification means manipulating 

research materials, equipment, or 

processes, or changing or omitting data 

or results such that the research is not 

accurately represented in the research 

record. 

§ 93.213 Funding component. 

Funding component means any 

organizational unit of the PHS 

authorized to award grants, contracts, or 

cooperative agreements for any activity 

covered by this part involving research 

or research training; funding 

components may be agencies, bureaus, 

centers, institutes, divisions, offices, or 

other awarding units within the PHS. 

§ 93.214 Good faith. 

(a) Good faith as applied to a 

complainant or witness means having a 

reasonable belief in the truth of one’s 

allegation or testimony, based on the 

information known to the complainant 

or witness at the time. An allegation or 

cooperation with a research misconduct 

proceeding is not in good faith if made 

with knowledge of or reckless disregard 

for information that would negate the 

allegation or testimony. 

(b) Good faith as applied to an 

institutional or committee member 

means cooperating with the research 

misconduct proceeding by impartially 

carrying out the duties assigned for the 

purpose of helping an institution meet 

its responsibilities under this part. An 

institutional or committee member does 

not act in good faith if their acts or 

omissions during the research 

misconduct proceedings are dishonest 

or influenced by personal, professional, 

or financial conflicts of interest with 

those involved in the research 

misconduct proceeding. 

§ 93.215 Inquiry. 

Inquiry means preliminary 

information-gathering and preliminary 

fact-finding that meets the criteria and 

follows the procedures of § 93.307 

through § 93.309. 

§ 93.216 Institution. 

Institution means any person that 

applies for or receives PHS support for 

any activity or program that involves the 

conduct of biomedical or behavioral 

research, biomedical or behavioral 

research training, or activities related to 

that research or training. This includes, 

but is not limited to, colleges and 

universities, PHS intramural biomedical 

or behavioral research laboratories, 

research and development centers, 

national user facilities, industrial 

laboratories or other research institutes, 

research institutions, and independent 

researchers. 

§ 93.217 Institutional Certifying Official. 

Institutional Certifying Official means 

the institutional official responsible for 

assuring on behalf of an institution that 

the institution has written policies and 

procedures for addressing allegations of 

research misconduct, in compliance 

with this part; and complies with its 

own policies and procedures and the 

requirements of this part. The 

Institutional Certifying Official is 

responsible for certifying the content of 

the institution’s annual report, which 

contains information specified by ORI 

on the institution’s compliance with 

this part, and ensuring the report is 

submitted to ORI, as required. 

§ 93.218 Institutional Deciding Official. 

Institutional Deciding Official means 

the institutional official who makes 

final determinations on allegations of 

research misconduct and any 

institutional actions. The same 

individual cannot serve as the 

Institutional Deciding Official and the 

Research Integrity Officer. 

§ 93.219 Institutional member. 

Institutional member or members 

means an individual (or individuals) 

who is employed by, is an agent of, or 

is affiliated by contract or agreement 

with an institution. Institutional 

members may include, but are not 

limited to, officials, tenured and 

untenured faculty, teaching and support 

staff, researchers, research coordinators, 

technicians, postdoctoral and other 

fellows, students, volunteers, subject 

matter experts, consultants, or attorneys, 

or employees or agents of contractors, 

subcontractors, or sub-awardees. 

§ 93.220 Institutional record. 

The institutional record comprises: 

(a) The records that the institution 

compiled or generated during the 

research misconduct proceeding, except 

records the institution did not consider 

or rely on. These records include, but 

are not limited to: 

(1) Documentation of the assessment 

as required by § 93.306(c). 

(2) If an inquiry is conducted, the 

inquiry report and all records (other 

than drafts of the report) considered or 

relied on during the inquiry, including, 

but not limited to, research records and 

the transcripts of any transcribed 

interviews conducted during the 

inquiry, information the respondent 

provided to the institution, and the 

documentation of any decision not to 

investigate as required by § 93.309(c). 

(3) If an investigation is conducted, 

the investigation report and all records 

(other than drafts of the report) 

considered or relied on during the 

investigation, including, but not limited 

to, research records, the transcripts of 

each interview conducted pursuant to 

§ 93.310(g), and information the 

respondent provided to the institution. 

(4) Decision(s) by the Institutional 

Deciding Official, such as the written 

decision from the Institutional Deciding 

Official under § 93.314. 

(5) The complete record of any 

institutional appeal consistent with 

§ 93.315. 

(b) A single index listing all the 

research records and evidence that the 

institution compiled during the research 

misconduct proceeding, except records 

the institution did not consider or rely 

on. 

(c) A general description of the 

records that were sequestered but not 

considered or relied on. 

§ 93.221 Intentionally. 

To act intentionally means to act with 

the aim of carrying out the act. 

§ 93.222 Investigation. 

Investigation means the formal 

development of a factual record and the 

examination of that record that meets 

the criteria and follows the procedures 

of §§ 93.310 through 93.317. 

§ 93.223 Knowingly. 

To act knowingly means to act with 

awareness of the act. 

§ 93.224 Notice. 

Notice means a written or electronic 

communication served in person or sent 

by mail or its equivalent to the last 

known street address, facsimile number, 

or email address of the addressee. 

§ 93.225 Office of Research Integrity or 

ORI. 

Office of Research Integrity or ORI 

means the office established by Public 

Health Service Act section 493 (42 

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

Secretary has delegated responsibility 

for addressing research integrity and 

misconduct issues related to PHSsupported activities. 

§ 93.226 Person. 

Person means any individual, 

corporation, partnership, institution, 

association, unit of government, or other 

legal entity, however organized. 

§ 93.227 Plagiarism. 

Plagiarism means the appropriation of 

another person’s ideas, processes, 

results, or words, without giving 

appropriate credit. 

(a) Plagiarism includes the 

unattributed verbatim or nearly 

verbatim copying of sentences and 

paragraphs from another’s work that 


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materially misleads the reader regarding 

the contributions of the author. It does 

not include the limited use of identical 

or nearly identical phrases that describe 

a commonly used methodology. 

(b) Plagiarism does not include 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. 

§ 93.228 Preponderance of the evidence. 

Preponderance of the evidence means 

proof by evidence that, compared with 

evidence opposing it, leads to the 

conclusion that the fact at issue is more 

likely true than not. 

§ 93.229 Public Health Service or PHS. 

Public Health Service or PHS consists 

of the following components within 

HHS: the Office of the Assistant 

Secretary for Health, the Office of Global 

Affairs, the Administration for Strategic 

Preparedness and Response, the 

Advanced Research Projects Agency for 

Health, the Agency for Healthcare 

Research and Quality, the Agency for 

Toxic Substances and Disease Registry, 

the Centers for Disease Control and 

Prevention, the Food and Drug 

Administration, the Health Resources 

and Services Administration, the Indian 

Health Service, the National Institutes of 

Health, the Substance Abuse and Mental 

Health Services Administration, and 

any other components of HHS 

designated or established as 

components of the Public Health 

Service. 

§ 93.230 PHS support. 

PHS support means PHS funding, or 

applications or proposals for PHS 

funding, for biomedical or behavioral 

research, biomedical or behavioral 

research training, or activities related to 

that research or training, that may be 

provided through: funding for PHS 

intramural research; PHS grants, 

cooperative agreements, or contracts; 

subawards, contracts, or subcontracts 

under those PHS funding instruments; 

or salary or other payments under PHS 

grants, cooperative agreements, or 

contracts. 

§ 93.231 Recklessly. 

To act recklessly means to propose, 

perform, or review research, or report 

research results, with indifference to a 

known risk of fabrication, falsification, 

or plagiarism. 

§ 93.232 Research. 

Research means a systematic 

experiment, study, evaluation, 

demonstration, or survey designed to 

develop or contribute to general 

knowledge (basic research) or specific 

knowledge (applied research) by 

establishing, discovering, developing, 

elucidating, or confirming information 

or underlying mechanisms related to 

biological causes, functions, or effects; 

diseases; treatments; or related matters 

to be studied. 

§ 93.233 Research Integrity Officer or RIO. 

Research Integrity Officer or RIO 

refers to the institutional official 

responsible for administering the 

institution’s written policies and 

procedures for addressing allegations of 

research misconduct in compliance 

with this part. 

§ 93.234 Research misconduct. 

Research misconduct means 

fabrication, falsification, or plagiarism 

in proposing, performing, or reviewing 

research, or in reporting research 

results. Research misconduct does not 

include honest error or differences of 

opinion. 

§ 93.235 Research misconduct 

proceeding. 

Research misconduct proceeding 

means any actions related to alleged 

research misconduct taken under this 

part, including allegation assessments, 

inquiries, investigations, ORI oversight 

reviews, and appeals under subpart E of 

this part. 

§ 93.236 Research record. 

Research record means the record of 

data or results that embody the facts 

resulting from scientific inquiry. Data or 

results may be in physical or electronic 

form. Examples of items, materials, or 

information that may be considered part 

of the research record include, but are 

not limited to, research proposals, raw 

data, processed data, clinical research 

records, laboratory records, study 

records, laboratory notebooks, progress 

reports, manuscripts, abstracts, theses, 

records of oral presentations, online 

content, lab meeting reports, and journal 

articles. 

§ 93.237 Respondent. 

Respondent means the individual 

against whom an allegation of research 

misconduct is directed or who is the 

subject of a research misconduct 

proceeding. 

§ 93.238 Retaliation. 

Retaliation means an adverse action 

taken against a complainant, witness, or 

committee member by an institution or 

one of its members in response to: 

(a) A good faith allegation of research 

misconduct; or 

(b) Good faith cooperation with a 

research misconduct proceeding. 

§ 93.239 Secretary or HHS. 

Secretary or HHS means the Secretary 

of HHS or any other official or employee 

of HHS to whom the Secretary delegates 

authority. 

§ 93.240 Small institution. 

Small institution means an institution 

that may be too small to conduct an 

inquiry or investigation into an 

allegation of research misconduct as 

required by this part without actual or 

apparent conflicts of interest. 

§ 93.241 Suspension and Debarment 

Official or SDO. 

Suspension and Debarment Official 

(SDO) means the HHS official 

authorized to impose suspension and 

debarment, which are the actions that 

Federal agencies take to disqualify 

persons deemed not presently 

responsible from doing business with 

the Federal Government. 

Subpart C—Responsibilities of 

Institutions 

Compliance and Assurances 

§ 93.300 General responsibilities for 

compliance. 

Institutions must: 

(a) Have written policies and 

procedures for addressing allegations of 

research misconduct that meet the 

requirements of this part; 

(b) Respond to each allegation of 

research misconduct for which the 

institution is responsible under this part 

in a thorough, competent, objective, and 

fair manner, including taking 

precautions to ensure that individuals 

responsible for carrying out any part of 

the research misconduct proceeding do 

not have unresolved personal, 

professional, or financial conflicts of 

interest with the complainant, 

respondent, or witnesses; 

(c) Foster a research environment that 

promotes research integrity and the 

responsible conduct of research, 

discourages research misconduct, and 

deals promptly with allegations or 

evidence of possible research 

misconduct; 

(d) Take all reasonable and practical 

steps to protect the positions and 

reputations of good faith complainants, 

witnesses, and committee members and 

to protect these individuals from 

retaliation by respondents and/or other 

institutional members; 

(e) Provide confidentiality consistent 

with § 93.106 to all respondents, 

complainants, and witnesses in a 

research misconduct proceeding, and to 


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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 with an active research 

integrity assurance on file with ORI. 

(b) Research integrity assurance. The 

Institutional Certifying Official must 

assure on behalf of the institution, 

initially and then annually thereafter, 

that the institution: 

(1) Has written policies and 

procedures for addressing allegations of 

research misconduct, in compliance 

with this part. 

(2) Complies with its policies and 

procedures for addressing allegations of 

research misconduct. 

(3) Complies with all provisions of 

this part. 

§ 93.302 Maintaining active research 

integrity assurances. 

(a) Compliance with this part. ORI 

considers an institution in compliance 

with this part when it: 

(1) Has policies and procedures for 

addressing allegations of research 

misconduct according to this part, keeps 

those policies in compliance with this 

part, and upon request, provides them 

to ORI and other HHS components. 

(2) Complies with its policies and 

procedures for addressing allegations of 

research misconduct. 

(3) Complies with all provisions of 

this part. 

(4) Takes all reasonable and practical 

specific steps to foster research integrity 

consistent with § 93.300, including but 

not limited to: 

(i) Informing the institution’s 

members about its policies and 

procedures for addressing allegations of 

research misconduct, and the 

institution’s commitment to compliance 

with the policies and procedures; and 

(ii) Making its policies and 

procedures for addressing allegations of 

research misconduct publicly available. 

(b) Annual report. An institution must 

file an annual report with ORI, which 

contains information specified by ORI, 

on the institution’s compliance with 

this part. The Institutional Certifying 

Official is responsible for certifying the 

content of this report and for ensuring 

the report is submitted as required. 

(c) Additional information. Along 

with its annual report, an institution 

must send ORI such other information 

as ORI may request on the institution’s 

research misconduct proceedings 

covered by this part and the institution’s 

compliance with the requirements of 

this part. 

§ 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 may 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) Provide for all reasonable and 

practical efforts, if requested and as 

appropriate, to protect or restore the 

reputation of persons alleged to have 

engaged in research misconduct but 

against whom no finding of research 

misconduct is made. 

§ 93.305 General conduct of research 

misconduct proceedings. 

(a) Sequestration of research records 

and other evidence. An institution must 

promptly take all reasonable and 

practical steps to obtain all research 

records and other evidence, which may 

include copies of the data or other 

evidence so long as those copies are 

substantially equivalent in evidentiary 

value, needed to conduct the research 

misconduct proceeding; inventory the 

research records and other evidence; 

and sequester them in a secure manner. 

Where the research records or other 

evidence are located on or encompass 

scientific instruments shared by 

multiple users, institutions may obtain 

copies of the data or other evidence 

from such instruments, so long as those 

copies are substantially equivalent in 

evidentiary value to the instruments. 

Whenever possible, the institution must 

obtain the research records or other 

evidence: 

(1) Before or at the time the institution 

notifies the respondent of the 

allegation(s); and 

(2) Whenever additional items 

become known or relevant to the 

inquiry or investigation. 

(b) Access to research records. Where 

appropriate, an institution must give the 

respondent copies of, or reasonable 

supervised access to, the research 

records that are sequestered in 

accordance with paragraph (a) of this 

section. 

(c) Maintenance of sequestered 

research records and other evidence. An 

institution must maintain the 

sequestered research records and other 

evidence as required by § 93.318. 

(d) Multiple respondents. If an 

institution identifies additional 

respondents during an inquiry or 

investigation, the institution is not 

required to conduct a separate inquiry 

for each new respondent. However, each 

additional respondent must be provided 

notice of and an opportunity to respond 

to the allegations, consistent with this 

subpart. 

(e) Multiple institutions. When 

allegations involve research conducted 

at multiple institutions, one institution 

must be designated as the lead 


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institution if a joint research 

misconduct proceeding is conducted. In 

a joint research misconduct proceeding, 

the lead institution should obtain 

research records and other evidence 

pertinent to the proceeding, including 

witness testimony, from the other 

relevant institutions. By mutual 

agreement, the joint research 

misconduct proceeding may include 

committee members from the 

institutions involved. The 

determination of whether further 

inquiry and/or investigation is 

warranted, whether research 

misconduct occurred, and the 

institutional actions to be taken may be 

made by the institutions jointly or 

tasked to the lead institution. 

(f) Using a committee, consortium, or 

other person for research misconduct 

proceedings. (1) An institution must 

address any potential, perceived, or 

actual personal, professional, or 

financial conflicts of interest between 

members of the committee or 

consortium, or other person, and the 

complainant, respondent, or witnesses. 

(2) An institution must ensure that a 

committee, consortium, or person acting 

on its behalf conducts research 

misconduct proceedings in compliance 

with the requirements of this part. 

(g) Notifying ORI of special 

circumstances. At any time during a 

research misconduct proceeding, as 

defined in § 93.235, an institution must 

notify ORI immediately if it has reason 

to believe that any of the following 

conditions exist: 

(1) Health or safety of the public is at 

risk, including an immediate need to 

protect human or animal subjects. 

(2) HHS resources or interests are 

threatened. 

(3) Research activities should be 

suspended. 

(4) There is reasonable indication of 

possible violations of civil or criminal 

law. 

(5) Federal action is required to 

protect the interests of those involved in 

the research misconduct proceeding. 

(6) HHS may need to take appropriate 

steps to safeguard evidence and protect 

the rights of those involved. 

The Institutional Assessment 

§ 93.306 Institutional assessment. 

(a) Purpose. An assessment’s purpose 

is to determine whether an allegation 

warrants an inquiry. 

(b) Conducting the institutional 

assessment. Upon receiving an 

allegation of research misconduct, the 

RIO or another designated institutional 

official must promptly assess the 

allegation to determine whether the 

allegation: 

(1) Falls within the definition of 

research misconduct under this part; 

(2) Is within the applicability criteria 

of § 93.102; and 

(3) Is sufficiently credible and specific 

so that potential evidence of research 

misconduct may be identified. 

(c) Assessment results. (1) An inquiry 

must be conducted if the allegation 

meets the three assessment criteria in 

paragraph (b) of this section. 

(2) If the RIO or another designated 

institutional official determines that 

requirements for an inquiry are met, 

they must: 

(i) Document the assessment; and 

(ii) Promptly sequester all research 

records and other evidence, consistent 

with § 93.305(a), and promptly initiate 

the inquiry. 

(3) If the RIO or another designated 

institutional official determines that 

requirements for an inquiry are not met, 

they must keep sufficiently detailed 

documentation of the assessment to 

permit a later review by ORI of the 

reasons why the institution did not 

conduct an inquiry. Such 

documentation must be retained in 

accordance with § 93.318. 

The Institutional Inquiry 

§ 93.307 Institutional inquiry. 

(a) Criteria warranting an inquiry. An 

inquiry is warranted if the allegation 

meets the following three criteria: 

(1) Falls within the definition of 

research misconduct under this part; 

(2) Is within the applicability criteria 

of § 93.102; and 

(3) Is sufficiently credible and specific 

so that potential evidence of research 

misconduct may be identified. 

(b) Purpose. An inquiry’s purpose is 

to conduct an initial review of the 

evidence to determine whether an 

allegation warrants an investigation. An 

inquiry does not require a full review of 

the evidence related to the allegation. 

(c) Notice to the respondent. At the 

time of or before beginning an inquiry, 

an institution must make a good faith 

effort to notify in writing the presumed 

respondent, if any. If the inquiry 

subsequently identifies additional 

respondents, the institution must notify 

them. Only allegations specific to a 

particular respondent are to be included 

in the notification to that respondent. If 

additional allegations are raised, the 

respondent(s) must be notified in 

writing of the additional allegations 

raised against them. 

(d) Sequestration of records. An 

institution must obtain all research 

records and other evidence needed to 

conduct the research misconduct 

proceeding, consistent with § 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 convene committees of 

experts to conduct reviews at the 

inquiry stage to determine whether an 

investigation is warranted. The inquiry 

review may be done by a RIO or another 

designated institutional official in lieu 

of a committee, with the caveat that if 

needed, these individuals may utilize 

one or more subject matter experts to 

assist them in the inquiry. 

(3) Interviews. Institutions may 

interview witnesses or respondents that 

would provide additional information 

for the institution’s review. 

(f) Inquiry results—(1) Criteria 

warranting an investigation. An 

investigation is warranted if: 

(i) There is a reasonable basis for 

concluding that the allegation falls 

within the definition of research 

misconduct under this part and involves 

PHS-supported biomedical or 

behavioral research, biomedical or 

behavioral research training, or 

activities related to that research or 

research training, as provided in 

§ 93.102; and 

(ii) Preliminary information-gathering 

and fact-finding from the inquiry 

indicates that the allegation may have 

substance. 

(2) Findings of research misconduct. 

Findings of research misconduct, 

including the determination of whether 

the alleged misconduct is intentional, 

knowing, or reckless, cannot be made at 

the inquiry stage. 

(g) Inquiry report. (1) The institution 

must prepare a written report that meets 

the requirements of this section and 

§ 93.309. 

(2) If there is potential evidence of 

honest error or difference of opinion, 

the institution must note this in the 

inquiry report. 

(3) The institution must provide the 

respondent an opportunity to review 

and comment on the inquiry report and 

attach any comments received to the 

report. 

(h) Time for completion. (1) The 

institution must complete the inquiry 

within 90 days of its initiation unless 

circumstances warrant a longer period. 

(2) If the inquiry takes longer than 90 

days to complete, the inquiry report 

must document the reasons for 

exceeding the 90-day period. 

§ 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 


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investigation is warranted. The notice 

must include a copy of the inquiry 

report and include a copy of or refer to 

this part and the institution’s policies 

and procedures adopted under its 

research integrity assurance. 

(b) Notice to complainant. The 

institution is not required to notify a 

complainant whether the inquiry found 

that an investigation is warranted. The 

institution may, but is not required to, 

provide relevant portions of the report 

to a complainant for comment. If an 

institution provides notice to one 

complainant in a case, it must provide 

notice, to the extent possible, to all 

complainants in the case. 

§ 93.309 Reporting to ORI on the decision 

to initiate an investigation. 

(a) Within 30 days of determining that 

an investigation is warranted, the 

institution must provide ORI with a 

copy of the inquiry report, which 

includes the following information: 

(1) The names, professional aliases, 

and positions of the respondent and 

complainant; 

(2) A description of the allegation(s) 

of research misconduct; 

(3) The PHS support, including, for 

example, grant numbers, grant 

applications, contracts, and publications 

listing PHS support; 

(4) The composition of the inquiry 

committee, if used, including name(s), 

position(s), and subject matter expertise; 

(5) Inventory of sequestered research 

records and other evidence and 

description of how sequestration was 

conducted; 

(6) Transcripts of any transcribed 

interviews; 

(7) Timeline and procedural history; 

(8) Any scientific or forensic analyses 

conducted; 

(9) The basis for recommending that 

the allegation(s) warrant an 

investigation; 

(10) The basis on which any 

allegation(s) do not merit an 

investigation; 

(11) Any comments on the inquiry 

report by the respondent or the 

complainant; and 

(12) Any institutional actions 

implemented, including 

communications with journals or 

funding agencies. 

(b) The institution must provide the 

following information to ORI whenever 

requested: 

(1) The institutional policies and 

procedures under which the inquiry 

was conducted; and 

(2) The research records and other 

evidence reviewed, and copies of all 

relevant documents. 

(c) Institutions must keep detailed 

documentation of inquiries to permit a 

later assessment by ORI of the reasons 

why the institution decided not to 

investigate. Such documentation must 

be retained in accordance with § 93.318. 

(d) In accordance with § 93.305(g), 

institutions must notify ORI of any 

special circumstances that may exist. 

The Institutional Investigation 

§ 93.310 Institutional investigation. 

Institutions conducting research 

misconduct investigations must: 

(a) Time. Begin the investigation 

within 30 days after deciding an 

investigation is warranted. 

(b) Notice to ORI. Notify ORI of the 

decision to begin an investigation on or 

before the date the investigation begins 

and provide an inquiry report that meets 

the requirements of §§ 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, the institution may but is 

not required to conduct a separate 

inquiry for each new respondent. If any 

additional respondent(s) are identified 

during the investigation, the institution 

must notify them of the allegation(s) and 

provide them an opportunity to respond 

consistent with this subpart. 

(3) While an investigation into 

multiple respondents can convene with 

the same investigation committee 

members, separate investigation reports 

and research misconduct 

determinations are required for each 

respondent. 

(d) Sequestration of records. Obtain 

all research records and other evidence 

needed to conduct the investigation, 

consistent with § 93.305(a). 

(e) Documentation. Use diligent 

efforts to ensure that the investigation is 

thorough and sufficiently documented 

and includes examination of all research 

records and other evidence relevant to 

reaching a decision on the merits of the 

allegation(s). 

(f) Ensuring a fair investigation. Take 

reasonable steps to ensure an impartial 

and unbiased investigation to the 

maximum extent practicable, including 

participation of persons with 

appropriate scientific expertise who do 

not have unresolved personal, 

professional, or financial conflicts of 

interest relevant to the investigation. An 

institution may use the same committee 

members from the inquiry in their 

subsequent investigation. 

(g) Interviews. During the 

investigation, an institution must 

interview each respondent, 

complainant, and any other available 

person who has been reasonably 

identified as having information 

regarding any relevant aspects of the 

investigation, including witnesses 

identified by the respondent. 

(1) Interviews during the investigation 

must be recorded and transcribed. 

(2) Any exhibits shown to the 

interviewee during the interview must 

be numbered and referred to by that 

number in the interview. 

(3) The transcript of the interview 

must be made available to the relevant 

interviewee for correction. 

(4) The transcript(s) with any 

corrections and numbered exhibits must 

be included in the institutional record 

of the investigation. 

(5) The respondent must not be 

present during the witnesses’ interviews 

but must be provided a transcript of the 

interview. 

(h) Multiple respondents. Consider, 

consistent with § 93.305(d), the prospect 

of additional researchers being 

responsible for the alleged research 

misconduct. 

(i) Multiple institutions. A research 

misconduct proceeding involving 

multiple institutions must be conducted 

consistent with § 93.305(e). 

(j) Pursue leads. Pursue diligently all 

significant issues and leads discovered 

that are determined relevant to the 

investigation, including any evidence of 

additional instances of possible research 

misconduct, and continue the 

investigation to completion. If 

additional allegations are raised, the 

respondent(s) must be notified in 

writing of the additional allegations 

raised against them. 

§ 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 

transmitting the institutional record 

including the final investigation report 

and decision by the Institutional 

Deciding Official to ORI in accordance 

with § 93.316. 


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(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 

research records and other evidence that 

the investigation committee considered 

or relied on. The respondent must 

submit any comments on the draft 

report to the institution within 30 days 

of receiving the draft investigation 

report. 

(b) The institution may provide the 

complainant a copy of the draft 

investigation report or relevant portions 

of that report. The comments of the 

complainant, if any, must be submitted 

within 30 days of the date on which the 

complainant received the draft 

investigation report or relevant portions 

of it. 

§ 93.313 Investigation report. 

A final investigation report for each 

respondent must be in writing and 

include: 

(a) Description of the nature of the 

allegation(s) of research misconduct, 

including any additional allegation(s) 

addressed during the research 

misconduct proceeding. 

(b) Description and documentation of 

the PHS support, including, for 

example, any grant numbers, grant 

applications, contracts, and publications 

listing PHS support. 

(c) Description of the specific 

allegation(s) of research misconduct for 

consideration in the investigation of the 

respondent. 

(d) Composition of investigation 

committee, including name(s), 

position(s), and subject matter expertise. 

(e) Inventory of sequestered research 

records and other evidence, except 

records the institution did not consider 

or rely on; and a description of how any 

sequestration was conducted during the 

investigation. This inventory must 

include manuscripts and funding 

proposals that were considered or relied 

on during the investigation. 

(f) Transcripts of all interviews 

conducted, as described in § 93.310(g). 

(g) Identification of the specific 

published papers, manuscripts 

submitted but not accepted for 

publication (including online 

publication), PHS funding applications, 

progress reports, presentations, posters, 

or other research records that allegedly 

contained the falsified, fabricated, or 

plagiarized material. 

(h) Any scientific or forensic analyses 

conducted. 

(i) If not already provided to ORI, the 

institutional policies and procedures 

under which the investigation was 

conducted. 

(j) Any comments made by the 

respondent and complainant on the 

draft investigation report and the 

investigation committee’s consideration 

of those comments. 

(k) A statement for each separate 

allegation of whether the investigation 

committee recommends a finding of 

research misconduct. 

(1) If the investigation committee 

recommends a finding of research 

misconduct for an allegation, the 

investigation report must, for that 

allegation: 

(i) Identify the individual(s) who 

committed the research misconduct. 

(ii) Indicate whether the research 

misconduct was falsification, 

fabrication, and/or plagiarism. 

(iii) Indicate whether the research 

misconduct was committed 

intentionally, knowingly, or recklessly. 

(iv) State whether the other 

requirements for a finding of research 

misconduct, as described in § 93.103, 

have been met. 

(v) Summarize the facts and the 

analysis which support the conclusion 

and consider the merits of any 

explanation by the respondent. 

(vi) Identify the specific PHS support. 

(vii) Identify whether any 

publications need correction or 

retraction. 

(2) If the investigation committee does 

not recommend a finding of research 

misconduct for an allegation, the 

investigation report must provide a 

detailed rationale. 

(3) List of any current support or 

known applications or proposals for 

support that the respondent has pending 

with PHS and non-PHS Federal 

agencies. 

§ 93.314 Decision by the Institutional 

Deciding Official. 

The Institutional Deciding Official is 

responsible for making a final 

determination of research misconduct 

findings. This determination must be 

provided in a written decision that 

includes: 

(a) Whether the institution found 

research misconduct and, if so, who 

committed the misconduct; and 

(b) A description of relevant 

institutional actions taken or to be 

taken. 

§ 93.315 Institutional appeals. 

(a) If a respondent appeals an 

institution’s finding(s) of research 

misconduct or institutional actions, the 

institution must promptly notify ORI. 

(b) If the institution has not 

transmitted its institutional record to 

ORI in accordance with § 93.316 prior to 

the appeal, the institution must wait 

until the appeal is concluded to 

transmit its institutional record. The 

institution must ensure that the 

complete record of the appeal is 

included in the institutional record 

consistent with § 93.220(a)(5). 

(c) If the institution has transmitted 

its institutional record to ORI in 

accordance with § 93.316 prior to the 

appeal, the institution must provide ORI 

a complete record of the appeal once the 

appeal is concluded. 

§ 93.316 Transmittal of the institutional 

record to ORI. 

After the Institutional Deciding 

Official has made a final determination 

of research misconduct findings in 

accordance with § 93.314, the 

institution must transmit the 

institutional record to ORI. The 

institutional record must be consistent 

with § 93.220 and logically organized. 

§ 93.317 Completing the research 

misconduct process. 

(a) ORI expects institutions to carry 

inquiries and investigations through to 

completion and to pursue diligently all 

significant issues and credible 

allegations of research misconduct. 

Institutions must notify ORI in advance 

if the institution plans to close a 

research misconduct proceeding at the 

assessment, inquiry, investigation, or 

appeal stage on the basis that the 

respondent has admitted to committing 

research misconduct or a settlement 

with the respondent has been reached. 

(b) A respondent’s admission of 

research misconduct must be made in 

writing and signed by the respondent. 

An admission must specify the 

falsification, fabrication, and/or 

plagiarism that occurred and which 

research records were affected. The 

admission statement must meet all 

elements required for a research 

misconduct finding under § 93.103 and 

must be provided to ORI before the 

institution closes its research 

misconduct proceeding. The institution 

must also provide a statement to ORI 


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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 

§ 93.318 Retention and custody of the 

institutional record and all sequestered 

evidence. 

(a) Maintenance of institutional 

record and all sequestered evidence. An 

institution must maintain the 

institutional record and all sequestered 

evidence including physical objects 

(regardless of whether the evidence is 

part of the institutional record) in a 

secure manner for seven years after 

completion of the proceeding or the 

completion of any HHS proceeding 

involving the research misconduct 

allegation under subparts D and E of 

this part, whichever is later, unless 

custody has been transferred to HHS 

under paragraph (b) of this section or 

ORI advises otherwise in writing. 

(b) Provision for HHS custody. On 

request, institutions must transfer 

custody, or provide copies, to HHS of 

the institutional record or any 

component of the institutional record 

and any sequestered evidence 

(regardless of whether the evidence is 

included in the institutional record) for 

ORI to conduct its oversight review, 

develop the administrative record, or 

present the administrative record in any 

proceeding under subparts D and E of 

this part. 

§ 93.319 Institutional standards of 

conduct. 

Institutions may have standards of 

conduct different from the standards for 

research misconduct under this part. 

ORI findings of research misconduct or 

HHS settlements of research misconduct 

proceedings, or the absence thereof, do 

not affect institutional findings or 

actions taken based on an institution’s 

standards of conduct. 

Subpart D—Responsibilities of the U.S. 

Department of Health and Human 

Services 

General Information 

§ 93.400 General statement of ORI 

authority. 

(a) ORI review. ORI may respond 

directly to any allegation of research 

misconduct at any time before, during, 

or after an institution’s response to the 

matter. The ORI response may include 

but is not limited to: 

(1) Conducting allegation 

assessments; 

(2) Determining independently 

whether jurisdiction exists under this 

part; 

(3) Forwarding allegations of research 

misconduct to the appropriate 

institution or HHS component for 

inquiry or investigation; 

(4) Requesting clarification or 

additional information, documentation, 

research records, or other evidence as 

necessary from an institution or its 

members or other persons or sources to 

carry out ORI’s review; 

(5) Notifying or requesting assistance 

and information from PHS funding 

components, other affected Federal and 

state offices and agencies, or 

institutions; 

(6) Reviewing the institutional record 

and directing the institution to address 

deficiencies or additional allegations in 

the institutional record; 

(7) Making a finding of research 

misconduct; and 

(8) Taking actions as necessary to 

protect the health and safety of the 

public, to promote the integrity of PHSsupported biomedical or behavioral 

research, biomedical or behavioral 

research training, or activities related to 

that research or research training, or to 

conserve public funds. 

(b) ORI assistance to institutions. ORI 

may: 

(1) Provide information, technical 

assistance, and procedural advice to 

institutional officials as needed 

regarding an institution’s research 

misconduct proceedings and the 

sufficiency of the institutional record; 

and 

(2) Issue guidance and provide 

information to support institutional 

implementation of and/or compliance 

with the requirements of this part. 

(c) Review of institutional research 

integrity assurances. ORI will review 

institutional research integrity 

assurances and policies and procedures 

for compliance with this part. 

(d) Institutional compliance. ORI may 

make findings and impose ORI 

compliance actions related to an 

institution’s compliance with this part 

and with its policies and procedures, 

including an institution’s participation 

in research misconduct proceedings. 

§ 93.401 Interaction with other entities and 

interim actions. 

(a) ORI may notify and consult with 

other entities, including government 

funding agencies, institutions, journals, 

publishers, and editors, at any time if 

those entities have a need to know about 

or have information relevant to a 

research misconduct proceeding. 

(b) If ORI believes that a criminal or 

civil fraud violation may have occurred, 

it shall promptly refer the matter to the 

Department of Justice (DOJ), the HHS 

Office of Inspector General (OIG), or 

other appropriate investigative body. 

(c) ORI may provide expertise and 

assistance to the DOJ, OIG, PHS offices, 

other Federal offices, and state or local 

offices involved in investigating or 

otherwise pursuing research misconduct 

allegations or related matters. 

(d) ORI may notify affected PHS 

offices and funding components at any 

time to enable them to take appropriate 

interim actions. 

(e) The information provided will not 

be disclosed as part of the peer review 

and advisory committee review 

processes but may be used by the 

Secretary in making decisions about the 

award or continuation of funding. 

(f) ORI may refer a research 

misconduct matter to the SDO at any 

time for consideration under the HHS 

suspension and debarment regulations. 

ORI may provide technical assistance 

and share other information that the 

SDO needs to know to consider the 

referred matter. 

Research Misconduct Issues 

§ 93.402 ORI allegation assessments. 

(a) When ORI receives an allegation, 

it may conduct an assessment or refer 

the matter to the relevant institution for 

an assessment, inquiry, or other 

appropriate actions. 

(b) If ORI conducts an assessment and 

determines an inquiry is warranted, it 

forwards the matter to the appropriate 

institution or HHS component. 

(c) If ORI conducts an assessment and 

determines an inquiry is not warranted, 

it will close the case and forward the 

allegation in accordance with paragraph 

(d) in this section. 

(d) ORI may refer allegations that do 

not fall within the jurisdiction of this 

part to the appropriate HHS component, 

Federal or state agency, institution, 

organization, journal, or other 

appropriate entity. 


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§ 93.403 ORI review of research 

misconduct proceedings. 

(a) In conducting its review of 

research misconduct proceedings, ORI 

will: 

(1) Determine whether this part 

applies; 

(2) Consider the institutional record 

and determine whether the institutional 

record is sufficient, provide instructions 

to the institution(s) if ORI determines 

that revisions are needed or additional 

allegations of research misconduct 

should be addressed, and require 

institutions to provide the respondent 

with an opportunity to respond to 

information or allegations added to the 

institutional record; 

(3) Determine whether the institution 

conducted the proceedings in a timely 

and fair manner in accordance with this 

part with sufficient thoroughness, 

objectivity, and competence to support 

the conclusions; and 

(4) After reviewing in accordance 

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

section, determine whether to close the 

case without further action or proceed 

with the case. 

(b) If ORI determines to proceed with 

the case, ORI will: 

(1) Obtain additional information or 

materials from the institution, the 

respondent, complainants, or other 

sources, as needed; 

(2) Conduct additional analyses, as 

needed; 

(3) Provide the respondent the 

opportunity to access the institutional 

record, any additional information 

provided to ORI while the case is 

pending before ORI, and any analysis or 

additional information generated or 

obtained by ORI; 

(4) Provide the respondent the 

opportunity to submit information to 

ORI; 

(5) Allow the respondent and the 

respondent’s attorney, if represented, to 

meet virtually or in person with ORI to 

discuss the information that the 

respondent has provided to ORI; 

(6) Have ORI’s virtual or in-person 

meeting(s) with the respondent 

transcribed and provide a copy of the 

transcript to the respondent for review 

and suggested correction; 

(7) Close the administrative record 

following paragraphs (b)(3) through (6) 

of this section; 

(8) Provide the respondent the 

opportunity to access the complete 

administrative record; and 

(9) Take any other actions necessary 

to complete ORI’s review of the research 

misconduct proceedings. 

§ 93.404 Findings of research misconduct 

and proposed HHS administrative actions. 

(a) After completing its review of the 

administrative record, ORI may: 

(1) Close the case without a separate 

ORI finding of research misconduct; 

(2) Make findings of research 

misconduct and propose and take HHS 

administrative actions based on the 

administrative record; or 

(3) Seek to settle the case. 

(b) The lack of an ORI finding of 

research misconduct does not overturn 

an institution’s determination that the 

conduct constituted professional or 

research misconduct warranting 

remediation under the institution’s 

policy. 

§ 93.405 Notifying the respondent of 

findings of research misconduct and 

proposed HHS administrative actions. 

(a) When ORI makes a finding of 

research misconduct or proposes HHS 

administrative actions, it notifies the 

respondent in a charge letter. The 

charge letter: 

(1) Includes ORI’s findings of research 

misconduct, including the basis for such 

findings in the administrative record, 

and any proposed HHS administrative 

actions; 

(2) Advises the respondent how to 

access the administrative record; and 

(3) Informs the respondent of the 

opportunity to contest the findings and 

proposed HHS administrative actions 

under subpart E of this part. 

(b) ORI sends the charge letter by 

certified mail, private delivery service, 

or electronic mail or other electronic 

means to the last known address of the 

respondent or the last known principal 

place of business of the respondent’s 

attorney, if represented. 

§ 93.406 Final HHS actions. 

Unless the respondent contests the 

findings and/or the proposed HHS 

administrative actions contained in the 

charge letter within the 30-day period 

prescribed in § 93.501(a), the ORI 

findings and HHS administrative 

actions are final. 

§ 93.407 HHS administrative actions. 

(a) Based on the administrative 

record, HHS may impose administrative 

actions that include but are not limited 

to: 

(1) Clarification, correction, or 

retraction of the research record. 

(2) Letter(s) of reprimand. 

(3) Imposition of special certification 

or research integrity assurance 

requirements to ensure compliance with 

applicable regulations or terms of HHS 

grants, contracts, or cooperative 

agreements. 

(4) Suspension of award activities 

under, or termination of, a PHS grant, 

contract, or cooperative agreement. 

(5) Restriction on specific activities or 

expenditures under an active PHS grant, 

contract, or cooperative agreement. 

(6) Special review of all the 

respondent’s requests for PHS funding. 

(7) Imposition of supervision 

requirements on a PHS grant, contract, 

or cooperative agreement. 

(8) Certification of attribution or 

authenticity in all requests for support 

and reports to PHS. 

(9) Prohibition of the respondent in 

participating in any advisory capacity 

with the PHS. 

(10) Recommending that the relevant 

agency take adverse personnel action(s), 

if the respondent is a Federal employee, 

in compliance with relevant Federal 

personnel policies and laws. 

(b) In connection with research 

misconduct findings, HHS also may 

seek to recover PHS funds spent 

supporting activities involving research 

misconduct. 

(c) Any authorized HHS component 

may impose, administer, or enforce 

administrative actions separately or in 

coordination with other HHS 

components, including, but not limited 

to ORI, OIG, and the PHS funding 

component. 

(d) HHS administrative actions under 

this part do not include suspension or 

debarment. Regardless of whether HHS 

administrative actions are imposed 

under this part, HHS may pursue 

suspension and debarment under the 

HHS suspension and debarment 

regulations. 

§ 93.408 Mitigating and aggravating 

factors in HHS administrative actions. 

The purpose of HHS administrative 

actions is remedial. The appropriate 

administrative action is commensurate 

with the seriousness of the misconduct 

and the need to protect the health and 

safety of the public, promote the 

integrity of the PHS-supported research 

and research process, and conserve 

public funds. ORI considers the 

following aggravating and mitigating 

factors in determining appropriate HHS 

administrative actions and their terms. 

The existence or nonexistence of any 

factor is not determinative. 

(a) Knowing, intentional, or reckless. 

Were the respondent’s actions knowing 

or intentional or were the actions 

reckless? 

(b) Pattern. Was the research 

misconduct an isolated event or part of 

a continuing or prior pattern of 

dishonest conduct? 

(c) Impact. Did the misconduct have 

significant impact on the proposed or 


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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 

determines that settlement is in the best 

interests of the Federal Government and 

the public health or welfare. 

(b) Settlement agreements are publicly 

available, regardless of whether ORI 

made a finding of research misconduct. 

(c) A settlement agreement precludes 

the respondent from contesting any ORI 

findings of research misconduct, HHS 

administrative actions, or ORI’s 

jurisdiction in handling the research 

misconduct proceeding. 

§ 93.410 Final HHS action with no 

settlement or finding of research 

misconduct. 

When the final HHS action does not 

result in a settlement or finding of 

research misconduct, ORI may provide 

written notice to the respondent, the 

relevant institution, the complainant, 

and HHS officials. 

§ 93.411 Final HHS action with a 

settlement or finding of research 

misconduct. 

When a final HHS action results in a 

settlement or research misconduct 

finding(s), ORI may: 

(a) Provide final notification of any 

research misconduct findings and HHS 

administrative actions to the 

respondent, the relevant institution, and 

appropriate HHS officials. 

(b) Provide final notification of any 

research misconduct findings and HHS 

administrative actions to the 

complainant(s). 

(c) Send a notice to the relevant 

journal, publisher, data repository, or 

other similar entity identifying 

publications or research records that 

require correction or retraction. 

(d) Publish notice of the research 

misconduct findings. 

(e) Notify the respondent’s current 

employer if the employer is an 

institution subject to this part. 

Institutional Compliance Issues 

§ 93.412 Making decisions on institutional 

noncompliance. 

ORI may determine an institution is 

not compliant with this part if the 

institution does not implement and 

follow the requirements of this part and 

its own research integrity assurance. In 

making this decision, ORI may consider, 

but is not limited to the following 

factors: 

(a) Failure to establish and comply 

with policies and procedures under this 

part; 

(b) Failure to respond appropriately 

when allegations of research 

misconduct arise; 

(c) Failure to report to ORI all 

investigations and findings of research 

misconduct under this part; 

(d) Failure to cooperate with ORI’s 

review of research misconduct 

proceedings; or 

(e) Other actions or omissions that 

have a material, adverse effect on 

reporting and responding to allegations 

of research misconduct. 

§ 93.413 ORI compliance actions. 

(a) If ORI determines an institution is 

not compliant with this part, it may take 

a compliance action against the 

institution. 

(b) If ORI determines an institution is 

not compliant with this part, ORI may 

take any or all of the following 

compliance actions: 

(1) Require the institution to accept 

and/or implement technical assistance 

provided by ORI. 

(2) Issue a letter of reprimand. 

(3) Require the institution to take 

corrective actions. 

(4) Place the institution on special 

review status. For a designated period, 

ORI will closely monitor the 

institution’s activities for compliance 

with this part. Monitoring may consist 

of, but is not limited to, compliance 

reviews and/or audits. 

(5) Direct that research misconduct 

proceedings be handled by HHS. 

(6) Any other action appropriate to 

the circumstances. 

(c) If an institution fails to comply 

with the requirements of this part, ORI 

may refer the institution to the SDO for 

consideration under the HHS 

suspension and debarment regulations. 

(d) If the institution’s actions 

constitute a substantial or recurrent 

failure to comply with this part, ORI 

may revoke the institution’s research 

integrity assurance under § 93.301 or 

§ 93.303. 

(e) ORI may make public any findings 

of institutional noncompliance and ORI 

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 may disclose or publish a 

notice regarding settlements, ORI 

findings of research misconduct, and 

HHS administrative actions, and release 

or withhold information as permitted by 

the Privacy Act and the Freedom of 

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

Subpart E—Opportunity To Contest 

ORI Findings of Research Misconduct 

and Proposed HHS Administrative 

Actions 

General Information 

§ 93.500 General policy. 

(a) This subpart provides a 

respondent an opportunity to contest 

ORI findings of research misconduct 

and/or proposed HHS administrative 

actions included in a charge letter. 

(b) A respondent may contest ORI’s 

research misconduct findings and 

proposed HHS administrative actions by 

filing a notice of appeal with an 

Administrative Law Judge (ALJ) at the 

DAB. 

(c) Based on the administrative 

record, the ALJ shall rule on whether 

ORI’s research misconduct findings and 

any proposed HHS administrative 

actions are reasonable and not based on 

a material error of law or fact. The ALJ’s 

ruling constitutes a recommended 

decision to the Assistant Secretary for 

Health (ASH) in accordance with 

§ 93.511(b). 

(d) A respondent must exhaust all 

available administrative remedies under 

this subpart before seeking judicial 

review of ORI’s findings and/or HHS 

administrative actions. The contested 

findings and/or administrative actions 

shall be inoperative while the 


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respondent is pursuing administrative 

remedies under this subpart. 

Process for Contesting Research 

Misconduct Findings and/or Proposed 

HHS Administrative Actions 

§ 93.501 Notice of appeal. 

(a) Time to file. A respondent may 

contest ORI’s findings of research 

misconduct and/or proposed HHS 

administrative actions by filing a notice 

of appeal within 30 days of receipt of 

the charge letter provided under 

§ 93.405. 

(b) Form of a notice of appeal. The 

respondent’s notice of appeal must be: 

(1) In writing; 

(2) Signed by the respondent or by the 

respondent’s attorney; and 

(3) Submitted to the DAB Chair 

through the DAB electronic filing 

system, with a copy sent to ORI by 

certified mail, electronic mail, or other 

equivalent (i.e., with a verified method 

of delivery). 

(c) Contents of a notice of appeal. The 

notice of appeal must: 

(1) Admit or deny each ORI finding of 

research misconduct and each factual 

assertion made in support of each 

finding; 

(2) Accept or challenge each proposed 

HHS administrative action; 

(3) Provide detailed, substantive 

reasons for each denial or challenge 

with references to the administrative 

record; 

(4) Identify any legal issues or 

defenses that the respondent intends to 

raise during the proceeding, with 

references to the administrative record; 

and 

(5) Identify any mitigating factors in 

the administrative record. 

§ 93.502 Appointment of the 

Administrative Law Judge. 

(a) Within 30 days of receiving a 

notice of appeal, the DAB Chair, in 

consultation with the Chief ALJ, must 

designate an ALJ to determine whether 

the notice of appeal is timely filed and 

within the ALJ’s jurisdiction under this 

subpart. If the appeal is determined to 

be timely and within the ALJ’s 

jurisdiction, the ALJ shall decide the 

reasonableness of the ORI research 

misconduct findings and proposed HHS 

administrative actions in accordance 

with this subpart. The ALJ shall dismiss 

an appeal if it is untimely or not within 

the ALJ’s jurisdiction under this 

subpart. 

(b) No ALJ may serve in any 

proceeding under this subpart if they 

have any actual or apparent conflict of 

interest, bias, or prejudice that might 

reasonably impair their objectivity in 

the proceeding. 

(c) Any party to the proceeding may 

request the ALJ to withdraw from the 

proceeding because of an actual or 

apparent conflict of interest, bias, or 

prejudice under paragraph (b) of this 

section. The motion to disqualify must 

be timely and state with particularity 

the grounds for disqualification. The 

ALJ may rule upon the motion or certify 

it to the Chief ALJ for decision. If the 

ALJ rules upon the motion, either party 

may appeal the decision to the Chief 

ALJ. 

(d) An ALJ must withdraw from any 

proceeding for any reason found by the 

ALJ or Chief ALJ to be disqualifying. 

§ 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 the appeal. 

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

the administrative record. 

(c) The parties have no right to 

supplement the administrative record. 

§ 93.504 Standard of review. 

(a) The ALJ shall review the 

administrative record to determine 

whether the ORI research misconduct 

findings and proposed HHS 

administrative actions reflected in the 

charge letter are reasonable and not 

based on a material error of law or fact. 

(b) The ALJ may permit the parties to 

file briefs making legal and factual 

arguments based on the administrative 

record. 

§ 93.505 Rights of the parties. 

(a) The parties to the appeal are the 

respondent and ORI. The investigating 

institution is not a party to the case 

unless it is a respondent. 

(b) Except as otherwise limited by this 

subpart, the parties may: 

(1) Be accompanied, represented, and 

advised by an attorney; 

(2) Participate in any case-related 

conference held by the ALJ; and 

(3) File motions or briefs in writing 

before the ALJ. 

(c) The parties have no right to 

discovery before the ALJ. 

§ 93.506 Authority of the Administrative 

Law Judge. 

(a) The ALJ assigned to the case must 

conduct a fair and impartial proceeding, 

avoid unnecessary delay, maintain 

order, and assure that a complete and 

accurate record of the proceeding is 

properly made. The ALJ is bound by, 

and may not refuse to follow or find 

invalid, all Federal statutes and 

regulations, Secretarial delegations of 

authority, and applicable HHS policies, 

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

section. 

(b) Subject to review as provided 

elsewhere in this subpart, the ALJ may: 

(1) Hold conferences with the parties 

to identify or simplify the issues, or to 

consider other matters that may aid in 

the prompt disposition of the 

proceeding; 

(2) Rule on motions and other 

procedural matters; 

(3) Except for the respondent’s notice 

of appeal, modify the time for the filing 

of any document required or authorized 

under the rules in this subpart; 

(4) Upon motion of a party, decide 

cases, in whole or in part, by summary 

judgment where there is no disputed 

issue of material fact; 

(5) Regulate the course of the appeal 

and the conduct of representatives and 

parties; and 

(6) Take action against any party for 

failing to follow an order or procedure 

or for disruptive conduct. 

(c) The ALJ does not have the 

authority to: 

(1) Enter an order in the nature of a 

directed verdict; 

(2) Compel settlement negotiations; 

(3) Enjoin any act of the Secretary; 

(4) Review suspension or proposed 

debarment; 

(5) Find invalid or refuse to follow 

Federal statutes or regulations, 

Secretarial delegations of authority, or 

HHS policies; 

(6) Authorize the parties to engage in 

discovery; and 

(7) Modify the time for filing the 

respondent’s notice of appeal. 

(d) The Federal Rules of Evidence and 

the Federal Rules of Civil Procedure do 

not govern the proceedings under this 

subpart. 

§ 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 

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 


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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. 

(c) Within 10 days after being served 

with a motion, or other time as set by 

the ALJ, a party may file a response to 

the motion. The moving party may not 

file a reply to the response unless 

allowed by the ALJ. 

(d) The ALJ may not grant a motion 

before the time for filing a response has 

expired, except with the parties’ 

consent. However, the ALJ may overrule 

or deny any motion without awaiting a 

response. 

(e) The ALJ must make a reasonable 

effort to dispose of all motions 

promptly. 

§ 93.510 Conferences. 

(a) The ALJ must schedule an initial 

conference with the parties within 30 

days of the DAB Chair’s assignment of 

the case. 

(b) The ALJ may use the initial 

conference to discuss: 

(1) Identification and simplification of 

the issues, specification of genuine 

disputes of fact and their materiality to 

the ORI findings of research 

misconduct, and any proposed HHS 

administrative actions; 

(2) Identification of material legal 

issues and any need for briefing; 

(3) Scheduling dates for the filing of 

briefs based on the administrative 

record; and 

(4) Other matters that may encourage 

the fair, just, and prompt disposition of 

the proceedings. 

(c) The ALJ may schedule additional 

conferences as appropriate, upon 

reasonable notice to or request of the 

parties. 

(d) All conferences will be recorded 

with copies provided to the parties 

upon request. 

(e) Whenever possible, the ALJ shall 

memorialize in writing any oral rulings 

within 10 days after a conference is 

held. 

§ 93.511 The Administrative Law Judge’s 

ruling. 

(a) Based on the administrative 

record, the ALJ shall issue a ruling in 

writing within 60 days after the last 

submission by the parties in the case, 

setting forth whether ORI’s research 

misconduct findings and proposed HHS 

administrative actions reflected in the 

charge letter are reasonable and not 

based on a material error of law or fact. 

If the ALJ is unable to meet the 60-day 

deadline, the ALJ must set a new 

deadline and promptly notify the 

parties. The ALJ shall serve a copy of 

the ruling upon the parties and the 

ASH. 

(b) The ruling of the ALJ constitutes 

a recommended decision to the ASH. 

The ASH may review the ALJ’s 

recommended decision and adopt, 

modify, or reject it (in whole or in part) 

as needed to ensure that the decision is 

reasonable and not based on a material 

error of law or fact. Within 30 days after 

service of the ALJ’s recommended 

decision, the ASH shall notify the 

parties of the ASH’s intent to review or 

not to review the ALJ’s recommended 

decision. If the ASH does not provide 

notice of intent within the 30-day 

period or notifies the parties that the 

ASH does not intend to review the ALJ’s 

recommended decision, the ALJ’s 

recommended decision shall become 

final. An ALJ’s recommended decision 

that becomes final in that manner or the 

ASH’s decision after review constitutes 

the final HHS action on both ORI’s 

findings of research misconduct and any 

HHS administrative actions. 

Dated: September 9, 2024. 

Xavier Becerra, 

Secretary. 

[FR Doc. 2024–20814 Filed 9–12–24; 8:45 am] 

BILLING CODE 4150–31–P 


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