Public Health Service Policies on Research Misconduct

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; 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 co-respondents as well as the parenthetical list of additional research records to examine, because these lists were intended to be exemplary rather than prescriptive. Some commenters found the section on pursuing leads overly prescriptive, while others found it overly broad. Many commenters were concerned that pursuing all leads during an inquiry would be burdensome and costly—as well as cause reputational harm to innocent researchers. ORI concurred and moved the requirement to pursue all leads to § 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 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 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 research-related information confidential longer than necessary, the final rule now clarifies the length of time an institution is bound by the confidentiality provision. Commenters also stated that the language proposed in this section overcomplicated institutional confidentiality obligations and contained information more appropriate for guidance. ORI recognized institutions' concerns about overly prescriptive language and changed the final rule to provide greater latitude for 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 respondent. Others expressed the provision could set a precedent that infringes on respondents' rights. To address this concern, the final rule specifies that each additional respondent must be provided notice of the allegations and an opportunity to respond, consistent with subpart C. Some commenters were also concerned that listing the types of researchers the institutions should consider as potential respondents created a confusing standard and could be detrimental to those individuals. ORI concurred and removed the list of potential co-respondents as well as the parenthetical list of additional research records to examine, because these lists were intended to be exemplary rather than prescriptive. Some commenters suggested changing “must consider whether any additional researchers are responsible” to “may consider whether any additional researchers are responsible.” ORI revised this section to allow institutions the flexibility to use their own judgment.

W. General Conduct of Research Misconduct Proceedings—Pursue Leads, NPRM § 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.

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 resource-intensive 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 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.

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.

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 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).”

For these tasks, we identified a pre-tax hourly wage for Education Administrators, Postsecondary. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for these individuals was $53.49 per hour. 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, with alternative estimates including between 17-26 hours, between 27-40 hours, or more than 40 hours. We appreciate these comments, and in response, we present an additional threshold analysis, following the same approach described above, but adopting several revised assumptions and updated data. This threshold analysis helps to determine whether it will result in a significant regulatory action per section 3(f)(1) of Executive Order 12866 and to determine whether any effects will exceed the UMRA threshold. For this analysis, we adopt a more recent estimate that 6,394 institutions holding research integrity assurances. Consistent with an upper-bound estimate from public comments, we adopt 40 hours as the average hours per covered entity. We updated the pre-tax hourly wage to $55.38 per hour, for a fully loaded hourly wage rate of $110.76. The modified assumptions indicate that, across all covered entities, 255,760 hours would be spent updating policies and procedures. Monetizing this impact using the fully loaded hourly wage rate, this would represent a cost in the first year of about $28.3 million. Thus, our modified threshold analysis indicates that the largest economic impact of the final rule would not exceed the monetary threshold for significant regulatory actions per section 3(f)(1) of Executive Order 12866 or the UMRA threshold. We emphasize that this estimate corresponds to an upper-bound estimate of the potential impacts based on public comments to the proposed rule.

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

Recurring Costs Attributable to the Final Rule

For institutions that address allegations of research misconduct, we identify additional recurring costs associated with the final rule's reporting, recordkeeping, and third-party disclosure requirements related to institutions responding to allegations of research misconduct. To quantify these impacts, we adopt an estimate of 230 cases per year, matching the most recent annual count of cases reported to HHS.

Consistent with our estimates in the Paperwork Reduction Act section of this Preamble, we believe that institutions will spend a total of 221,030 hours per year on these requirements, which is about 961 hours per case. To monetize these impacts, we adopt the fully loaded hourly value of time of $110.76 per hour for postsecondary education administrators. Across all 230 cases, we compute an annual cost associated with these regulatory requirements of $24,481,283 per year. The Paperwork Reduction Act section of this Preamble contains additional details on the annual burden estimates and total costs associated with each of these requirements.

Summary and Timing of Costs of the Final Rule

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