ORI indicates that its goal in revising the existing regulations (the 2005 Final Rule) is to avoid a complete rewrite while still making meaningful changes. The goal is to reduce the complexity and redundancy of existing procedures, fill gaps in definitions, and otherwise remedy problems with the 2005 Final Rule that have led to interpretation issues and inconsistencies over the years.

Helpfully, under the revised regulation, the structure of Part 93 will remain the same. Below, we offer a brief overview of some of the key changes ORI is proposing to make within each of the five subparts. Although many of these revisions will codify well-known best practices and ORI’s existing non-binding guidance, some of them may come as a surprise to the research community and counsel. As all of these draft provisions are subject to comment—and ORI has issued an earnest request for feedback and has committed to read and consider each comment received—the research community will not want to miss the opportunity to weigh in and help shape the future of these regulations.3

Subpart A – General

Under Subpart A, which provides information and procedural requirements governing research misconduct proceedings generally, ORI proposes a notable change to the 2005 Final Rule’s confidentiality provisions: providing explicit protection for witnesses and clarifying when and how disclosure of information regarding the proceedings may be made to those who “need to know.” The revision addresses different categories of potential disclosures. First, as a general matter, the NPRM proposes that the “[d]isclosure of ongoing research misconduct proceedings . . . is limited, to the extent possible, to those who need to know, consistent with a thorough, competent, objective, and fair research misconduct proceeding, or the purpose of this part as described in 93.101(f). In this context, ‘those who need to know’ may include public and private entities.” The “purpose” referenced is to “[p]rotect the health and safety of the public, promote the integrity of PHS supported research and the research process, and conserve public funds.” Commenters may want to ask ORI to provide more guidance in this area. Next, the proposed rule offers a few more specific instructions about who might “need to know” in various contexts. For example, with respect to concerns about the reliability of the research record, those who “need to know” might include “journals, editors, publishers, and public and private entities.” Further, other institutions (i.e., not the one conducting the proceedings) might “need to know” information about the matter if they might possess relevant records, currently employ the respondent, or fund ongoing research by the respondent. Relatedly, the NPRM indicates that, rather than proposing substantive language to govern the granting of anonymity to complainants or witnesses (deferring instead to applicable state or institutional policies), ORI plans to issue guidance on protecting anonymity in transcripts and other materials (it has expressly invited comment on this proposed approach).

With regard to evidentiary standards, the proposed rule retains the 2005 Final Rule’s requirement that allegations of research misconduct must be proven by a preponderance of the evidence. Interestingly, however, the NPRM removes the 2005 Final Rule’s discussion of burden of proof. Under the current rule, the destruction, absence of, or failure to provide records adequately documenting questioned research is considered evidence of research misconduct if an institution finds that the respondent intentionally, knowingly, or recklessly destroyed the records, failed to maintain them despite having the opportunity to do so, or maintained them but failed to produce them—and the respondent’s conduct reflects a significant departure from accepted practices in the research community. ORI is also proposing to remove provisions that require the respondent to prove, by a preponderance of the evidence, any affirmative defenses and mitigating factors raised. These aspects of the 2005 Final Rule have long created extra layers of complexity and uncertainty for institutions and respondents alike, and we expect their removal will be well received by many in the research community.

Another important area of clarification within Subpart A is ORI’s proposed revision to the “subsequent use” exception to the six-year limitations period that generally applies to research misconduct proceedings. ORI plans to explicitly define the circumstances where the exception is relevant, i.e., when the respondent “uses, republishes, or cites to the portion(s)” of the research record that is the subject of the allegations, whether in manuscripts, grant applications, progress reports submitted to PHS funding components, posters, presentations, or other research records. Perhaps most notably, if there are allegations that could fall under the exception, ORI proposes that before concluding the exception does not apply (and that the proceedings are therefore time-barred), institutions must notify ORI, which will have the final word on the matter. ORI seeks public input on how to further clarify the scope of the “subsequent use” exception.

Subpart B – Definitions

ORI is proposing to revise Subpart B to provide a comprehensive list of 48 proposed definitions. Organizational changes will include relocating the definitions for key terms such as “research misconduct,” “fabrication,” “falsification,” and “plagiarism” (which are found in Subpart A under the 2005 Final Rule) to Subpart B with the rest of the definitions—a small but helpful update. Though the first three of these definitions remain unaltered under the NPRM, ORI proposes to refine the definition of “plagiarism.” Specifically, it has drafted a two-pronged definition to differentiate “unattributed text copied verbatim or nearly verbatim” from “the limited use of identical or nearly-identical phrases which describe a commonly-used methodology.” The former is problematic—the latter is not. The new definition also makes clear that self-plagiarism and authorship or credit disputes are not “research misconduct” and fall outside of ORI’s purview, resolving what has been an issue of occasional significance to institutions.

The proposed rule defines “honest error” to mean “a mistake made in good faith,” and “good faith” as applied specifically to respondents is defined as “acting with reasonable belief that respondent’s actions are consistent with accepted practices of the relevant research community.” These new definitions will be useful to have and seem broadly consistent with how institutions have historically interpreted “honest error.”

One new definition in Subpart B that should catch every institution’s eye is the introduction of what ORI calls the “Institutional Record,” which ORI describes as “robust and required.” Under the proposed rule, the Institutional Record must be submitted to ORI within the time period for completion of the investigation process (this is discussed further in the revisions to Subpart C). It will include the all institutional reports prepared at each stage of the proceedings and all records supporting the inquiry and investigation reports (including interview transcripts), decision(s) made by the institutional deciding official (which will be a defined term and must be distinct from the certifying official, which is also defined), the complete record of any institutional appeal, “any other records” the institution used for the proceeding, documentation related to any determination that records are irrelevant or duplicate and therefore not included in the record, and a single index listing all documents in the record. Though institutions have always been required to maintain these records and attach some of them to their reports to ORI (providing others only at ORI’s request), the proposed rule contemplates that institutions will now be required to produce all of this documentation as a matter of course. The Institutional Record will then become part of ORI’s Administrative Record—and ORI hopes this consolidated collection of documents will help facilitate its own review and the new streamlined appeals process under Subpart E.

Another significant (and welcome) change to the 2005 Final Rule is the addition of definitions for the critical terms “intentionally,” “knowingly,” and “recklessly.” The existing rule does not define the terms, and there has been relatively little to help guide institutions in deciphering and applying the nuances inherent in the different levels of intent. ORI notes it has received requests throughout the years to offer guidance, and it now proposes to define “intentionally” as acting with the aim of carrying out the act; “knowingly” as acting with awareness of the act; and “recklessly” as acting without proper caution despite a known risk for harm. As authority for the proposed definitions, ORI cites the HHS Departmental Appeals Board’s decisions in ORI v. Kreipke, No. CR5109 (May 18, 2018),4 and ORI v. Srivastava, No. CR5178 (Sept. 5, 2018).5 Commenters may wish to suggest revisions to bolster and clarify these definitions and/or to press ORI for further guidance and examples applying the proposed standards in the preamble to the final rule.

Finally, ORI proposes to define “accepted practices of the relevant research community,” a phrase that has long been open to interpretation (e.g., should the “relevant research community” be narrowly defined to include just the faculty at the specific institution conducting the proceeding, or should it encompass a broader community of researchers?). ORI wishes to define the term as “those practices established by 42 CFR part 93 and by PHS funding components, as well as commonly accepted professional codes or norms within the overarching community of researchers and institutions that apply for and receive PHS grants. These practices must be consistent with the definition of research integrity at § 93.236.”

Subpart C – Responsibilities of Institutions

Perhaps unsurprisingly, some of the most significant changes in the NPRM are found in the proposed revisions to Subpart C, which governs institutional responsibilities in conducting all aspects of research misconduct proceedings. Recognizing that institutions have sometimes conflated the different phases of a research misconduct proceeding, ORI is proposing several changes to guide institutions through the distinct phases of assessment, inquiry, and investigation and to seek to improve efficiency. There are some new requirements that are targeted at increasing transparency and fairness but may prove burdensome to institutions.

General Conduct of Research Misconduct Proceedings

The proposed rule includes several notable changes to Subpart C’s general requirements for institutions’ conduct of research misconduct proceedings. First, acknowledging that the way institutions and researchers access and store documents has changed drastically over the past two decades, ORI is proposing to modify its rules governing evidence collection and sequestration. Specifically, in the NPRM, ORI recognizes it will not always be possible to obtain “custody” of evidence and thus is moving away from that term. The proposed rule directs institutions to “obtain” the records and provides that copies (rather than original records) will be sufficient in all cases, as long as the copies are “substantially equivalent in evidentiary value.” Under the 2005 Final Rule, copies are only expressly discussed in the context of records or evidence encompassed in “scientific instruments shared by a number of users.”

Second, the NPRM adds a requirement for institutions to maintain the above-described, newly introduced Institutional Record. Third, the proposed rule imposes an affirmative obligation on institutions to consider whether additional researchers (other than the respondent) are responsible for the alleged misconduct. The revision specifically identifies the principal investigator, co-authors on affected publications, co-investigators on funding proposals, collaborators, and lab members involved in the experiments as individuals who “must” be considered as potential respondents. Fourth, the proposed rule includes a provision providing guidance on how to handle a situation where multiple institutions are involved in the allegations. This circumstance arises fairly frequently, and the new direction on this topic (including how a joint proceeding is to be conducted) should prove useful to institutions.

Fifth, ORI proposes to add a few procedural requirements governing interviews, including that the respondent is prohibited from attending witness interviews but must be provided with transcripts. Sixth, the NPRM includes an express statement that it is permissible for the same person, committee, or consortium to conduct all three phases of the proceedings (assessment, inquiry, and investigation). Seventh, ORI addresses potential conflict of interest situations by proposing to clarify that institutions are not required to allow respondents or complainants the opportunity to object to the person(s) conducting the proceedings. But if the institution does afford such opportunity, it must do so fairly, i.e., by providing all respondents and complaints in the proceeding an equal opportunity to object.

Preliminary Assessment

One of the most substantial revisions to Subpart C is the addition of a section addressing the preliminary assessment process. This has always been the first step in research misconduct proceedings, but the 2005 Final Rule did not prescribe the manner in which the assessment was to be conducted or how long it should take. The NPRM changes all that, offering a level of detail commensurate with that provided for the other phases of the proceedings (i.e., inquiry and investigation). A few institutions may not welcome ORI’s increased direction and oversight over the assessment process, but we expect most will appreciate the new guidance in this area (particularly since the proposed standards are fairly straightforward).

At section 93.306, ORI proposes to make clear that although the institution must review “readily accessible” information in deciding whether an inquiry is warranted, it need not conduct interviews or gather information “beyond what may have been submitted with the allegation”—unless doing so is necessary to determine whether the allegation meets the criteria for an inquiry.

The NPRM requires an institution to prepare an assessment report within 15 days of making its determination. This report—which will be included in the “Institutional Record”—must include a description of the allegation, the name and position of the respondent, any evidence reviewed, whether the allegation is encompassed within the definition of research misconduct, the jurisdictional criteria, and the criteria for proceeding to an inquiry, and whether the institution will proceed to an inquiry. Consistent with ORI’s prior (informal) guidance that assessments should be “brief,” ORI is imposing a 30-day deadline to complete the assessment process. If the institution does not meet that deadline, it must initiate an inquiry.

Inquiry

With respect to the inquiry phase, the NPRM clarifies that during this early stage of the proceedings, institutions are not required to convene expert committees—the inquiry may be conducted by just one person (e.g., the RIO or another designated official), who may rely on other experts to assist with the review as needed. Likewise, ORI notes in the revised regulation that institutions need not interview witnesses or respondents as part of the inquiry. These are very helpful clarifications that may enable some institutions to simplify and expedite the inquiry process.

Institutions will be interested in the proposed rule’s emphasis on what conclusions an institution may not reach during an inquiry: it cannot make a conclusion about honest error or difference of opinion (though potential evidence of such must be noted in the injury report); it cannot conclude that an allegation lacks substance “based solely on a respondent’s unsubstantiated claim that the alleged research misconduct was a result of honest error or difference of opinion”; and it cannot make determinations of research misconduct, including whether the alleged misconduct was intentional, knowing, or reckless. These important limitations should help guide institutions in distinguishing between the inquiry and investigation.

The proposed rule also modifies the 2005 Final Rule’s inquiry report requirements. For example, if an institution forms an inquiry committee, it will need to disclose the committee’s composition, including names, positions, and subject matter expertise. Institutions will be obligated to describe how they conducted the sequestration process, and they also will be required to include with the report any interview transcripts and scientific or forensic analyses conducted. And in a new development, ORI proposes to require institutions to notify ORI and request an extension in the event an inquiry will stretch beyond 60 days. Currently, institutions are merely required to note the reason(s) for the delay in their records.

Investigation

With respect to the investigation phase, institutions will be relieved to see the very significant clarification that if additional respondents or allegations are identified during the investigation, the institution does not have to start from scratch with a separate inquiry—it can bring them into the existing investigation. (Separate reports and determinations will, of course, continue to be required for each respondent.) The proposed rule also states that, when determining whether the requirements for a finding of research misconduct have been met, “[v]oting or split decisions by the investigation committee members are not permitted in the final recommendation in the investigation report.”

ORI is proposing changes to the required content of investigation reports; these additions generally track the inquiry report revisions described above. And, perhaps due to its years of experience with institutions requesting extensions for completion of the investigation process, ORI proposes to extend the time limit for completing an investigation from 120 to 180 days. Note, however, that under the NPRM, institutions will need to compile and finalize the new “robust” Institutional Record within that expanded time frame.

One point on which commenters may wish to seek clarity is ORI’s proposed revision to section 93.316, Completing the Research Misconduct Process. Under the 2005 Final Rule, institutions are required to notify ORI in advance if they intended to close a case on the basis of an admission, settlement, or for any other reason. This advance-notice requirement expressly excludes situations where the institution elects to close the case at the inquiry stage because it finds an investigation is not warranted, or at the investigation stage based on a finding of no research misconduct. Under the NPRM, however, institutions will be required to provide advance notice to ORI in the event they plan to close a case at any stage “for any other reason”—without caveat or limitation.

Subpart D – Responsibilities of HHS

Under Subpart D, which describes HHS’s and ORI’s responsibilities, ORI proposes to—

1. make clear that even if ORI does not find that research misconduct occurred, that does not overturn an institution’s determination that the conduct was professional or research misconduct in accordance with the institution’s policy;
2. clarify the actions ORI may take for institutional noncompliance, including placing institutions in a temporary “special review status” that will entail close ORI supervision;
3. afford greater procedural protections to respondents during ORI’s review of institutional proceedings by providing them with access to the Institutional and Administrative Records and any additional documentation (including that reflecting ORI’s analysis) and allowing them to meet with ORI in person or virtually to discuss any additional information the respondent submits; and
4. describe the circumstances when ORI may disclose information about a research misconduct proceeding (ORI proposes to publish notice of institutional research misconduct findings and implemented institutional actions).

Subpart E – Opportunity to Contest ORI Findings of Research Misconduct and HHS Administrative Actions

Under Subpart E, which covers respondents’ rights to contest ORI’s research misconduct findings and/or HHS administrative actions, ORI aims to create a “simpler and more expedient” appeals process. Under the 2005 Final Rule, an Administrative Law Judge (ALJ) conducts a de novo review and a hearing at which the respondent, ORI, and witnesses provide evidence and testimony.

ORI proposes to streamline that process by presenting its Administrative Record (including the Institutional Record) for the ALJ’s review, allowing for the possibility of a hearing if there is a genuine dispute over material fact. The ALJ’s task would be 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.” There would be no further administrative appeals.

Authored by Joel Buckman, William Ferreira, Madelyn Wessel, and Christine Reynolds.

References

1 88 Fed. Reg. 69583 (Oct. 6, 2023), https://www.govinfo.gov/content/pkg/FR-2023-10-06/pdf/2023-21746.pdf.

2 ORI intends that for any research misconduct allegation received by HHS or an institution before the revised regulation’s effective date, the proceeding will fall under the prior regulations (the 2005 Final Rule)—but ORI is inviting comment on “aspects to consider” if it were to entertain individual requests to apply the revised regulation to a particular ongoing proceeding.

3 U.S. Dep’t of Health & Human Servs., HHS Releases Notice of Proposed Rulemaking to Update 2005 Public Health Service Policies on Research Misconduct, Oct. 5, 2023, https://www.hhs.gov/about/news/2023/10/05/hhs-releases-notice-proposed-rulemaking-update-2005-public-health-service-policies-research-misconduct.html (“‘The NPRM is an opportunity for ORI and PHS-funded institutions to establish a mutual understanding about how we will work together to protect the integrity of research . . . . [t]his is why it is absolutely critical for the research community to provide comments. The public needs to know that every comment will be read and considered as we work on the final rule or develop further guidance in the future’” (quoting Sheila Garrity, ORI Director)).

4 This decision is available at https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2018/alj-cr5109/index.html.

5 This decision is available at https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2018/alj-cr5178/index.html.