I. Introduction
Fraud in scientific and clinical research has become an issue of increasing public interest and scrutiny. Research fraud has been committed by high-profile scientists, has touched the most prestigious scientific journals and has extended to areas of great clinical importance. In one case involving multiple instances of research fraud, a professor at the University of Vermont College of Medicine was sentenced to a year in federal prison. During his sentencing, the presiding federal judge highlighted the significance of the misconduct in stark terms:
When you commit this kind of misconduct, you put at risk a community’s acceptance of all scientific and medical research. You put at risk fully the work of other scientists … When scientists use their skill, their intelligence, their sophistication, their position of trust to do something which puts people at risk, that is extraordinarily serious. 1Adam Silverman, Ex-professor gets jail time for faking data, The Burlington Free Press, June 29, 2006, at A1.
Given the importance of and public interest in research integrity issues, it is essential for researchers and research institutions—both academic and industry—to understand 42 C.F.R. Part 93 (“Part 93”), a complex federal regulatory framework that must be followed for investigating allegations of research misconduct related to research projects in which Public Health Service (“PHS”) funds have been requested or provided. 242 C.F.R. §93.102(a). The PHS consists of the following federal agencies: National Institutes of Health (“NIH”), Centers for Disease Control and Prevention, Food and Drug Administration, Substance Abuse and Mental Health Services Administration, Health Resources and Services Administration, Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry and Indian Health Service. 342 C.F.R. §93.220 (defining the PHS as “the unit within HHS” that includes these agencies). The sponsoring agency for the majority of PHS-funded research is the NIH, and therefore most Office of Research Integrity (“ORI”) cases are supported by NIH funding, to which Part 93 directly applies. 4See Office of Research Integrity (“ORI”), Handling Misconduct—Inquiry Issues, #19 (last updated April 19, 2011), available at https://ori.hhs.gov/ori-responses-issues. ORI, located within the U.S. Department of Health and Human Services (“HHS”), oversees and directs PHS research integrity activities, including oversight and compliance with Part 93. 5ORI, About ORI (last updated March 7, 2011), available at https://ori.hhs.gov/about-ori. It bears emphasis that Part 93 does not apply to, and ORI does not have jurisdiction to review, issues related to research for which PHS funds were not requested or provided. Even the existence of a federal assurance with ORI (see discussion at notes 11-13, infra, and accompanying text) does not give ORI authority over a non-PHS-funded matter—even if an institution uses its ORI-approved procedures to investigate issues relating to such research. See 42 C.F.R. §93.102; ORI, supra note 4, at #14. This article only addresses research for which Part 93 applies, and therefore we do not use the “PHS funding” qualifier throughout the article; instead, discussion of research misconduct hereinafter only refers to PHS-funded research that is subject to Part 93 oversight.
More specifically, Part 93 sets forth the processes and procedures by which allegations of research misconduct must be handled by “institutions”— the university or other research institution or entity that is the grantee for a particular qualifying research project—and by the federal government. 642 C.F.R. §93.201 (defining “allegation” as the “disclosure of possible research misconduct through any means of communication”); 42 C.F.R. §93.213 (defining “Institution” as “any individual or person that applies for or receives PHS support for any activity or program that involves the conduct of biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or training. This includes, but is not limited to, colleges and universities, PHS intramural biomedical or behavioral research laboratories, research and development centers, national user facilities, industrial laboratories or other research institutes, small research institutions, and independent researchers”). The regulations provide this framework based on a substantive definition of misconduct as well as a legal and evidentiary standard that must be met in order for there to be a finding of “misconduct” under Part 93. Research misconduct is defined as “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.” 742 C.F.R. §93.103. Each of the key components of this definition are defined further in §93.103: “Fabrication is making up data or results and recording or reporting them”; “Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record”; and “Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.” Id. To reach a finding of research misconduct, the investigating entity (the institution), or ORI in its oversight review, bears the burden of proving, by a preponderance of the evidence, that “(a) there be a significant departure from accepted practices of the relevant research community; and (b) the misconduct be committed intentionally, knowingly, or recklessly.” 842 C.F.R. §93.106. Academic institutions that receive PHS funding have adopted research misconduct policies and procedures compliant with Part 93 and most frequently apply those policies and procedures to all research conducted at the institution, regardless of source of funding. For that reason, understanding and clarifying Part 93 requirements is important for the vast majority of academic scientific research, whether or not funded by PHS agencies.
There has been, unfortunately, a common misunderstanding by many institutions, and inaccurate but increasingly frequent assertions by those accused of research misconduct and their attorneys, that somehow ORI’s efforts to monitor whether an institution’s process has been carried out in compliance with Part 93, and ORI’s decision whether to pursue its own findings of misconduct on behalf of HHS, mean that the institutional findings and actions are only final upon ORI ratification. 9As discussed herein, although ORI typically does monitor whether an institution’s proceedings were carried out in basic compliance with Part 93, it is not possible to cure idiosyncratic procedural deficiencies that have already occurred during an investigation. However, ORI’s authority allows it to request additional clarification from institutions during ORI’s oversight review. See 42 C.F.R. §§93.400(b), 93.403(d)&(h), 93.317(c). See also Section III, infra. That particular misunderstanding often hobbles the implementation of the findings and determinations of research misconduct proceedings. This article seeks to explain the procedural framework that Part 93 requires and concludes that an institution’s procedurally compliant research misconduct process is final and not dependent on ORI’s final determination of whether to make its own findings of research misconduct. Understanding the legal and regulatory reasoning here is essential to an institution’s being able to reach final conclusions in these cases and to implement corrective actions, such as retractions, required retrainings in research integrity and other disciplinary actions, including termination of employment or tenure. We emphasize here that (i) the institution, and not ORI, has primary responsibility to conduct research misconduct investigations, and (ii) the institution’s, and deciding official’s, determinations at the end of such processes are final—that is, the finality is not determined by appellate or appellate-style review or ratification by ORI. So long as an institution has carried out its research misconduct proceedings in a procedurally sufficient manner, its own findings and actions are considered final regardless of whether ORI chooses to pursue research misconduct findings for HHS against a respondent.
II. A Covered Institution’s Obligations under Part 93
A. Generally: Sufficient Procedures
Part 93 imposes an obligation on institutions to respond to allegations of research misconduct in accordance with certain procedural standards. Although the obligation to “[h]ave written policies and procedures for addressing allegations” is a direct regulatory requirement under Part 93, 1042 C.F.R. §93.300(a). the regulations also mandate reinforcement of this obligation through a contract-like obligation, as an “institution with PHS supported biomedical or behavioral research … must provide PHS with an assurance of compliance with this part.” 1142 C.F.R. §93.301(a). This document must assure ORI that the institution has “written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct” and that it “[c]omplies with its own policies and procedures and the requirements of this part.” 1242 C.F.R. §93.301(b). Section 93.304 sets out a non-exhaustive list of processes that an institution must have to seek an approved assurance, including notice requirements—to both the individual about whom the allegation was made (the “respondent”) and to ORI—and protocols for handling the research record and evidence. 1342 C.F.R. §§93.304(a)-(m). Although Part 93 requires a certain level of procedural sufficiency, it does not go so far as to prescribe a precise substantive code of conduct—Part 93 directly states that an institution’s “internal standards of conduct” for research misconduct may be different than ORI’s standards. 1442 C.F.R. §93.319(a). Therefore, “an institution may find conduct to be actionable under its standards even if the action does not meet this part’s definition of research misconduct,” and, inversely, an ORI/HHS “finding or settlement does not affect institutional findings or administrative actions based on an institution’s internal standards of conduct.” 1542 C.F.R. §§93.319(a)-(b). Although an institution’s internal standards of conduct for research are not expressly required to be written under Part 93, Subpart C—Responsibilities of Institutions, we believe it is a best practice for such standards to be written and transparent so that the process is clearly understood by all parties—from researchers and administrators to ORI. One benefit of this approach from a regulatory perspective is that clear, written policies help ensure that ORI will understand such internal standards during any review of the institution’s research misconduct policies. See, e.g., 42 C.F.R. §93.412(b) (“ORI may decide that an institution is not compliant with this part if the institution shows a disregard for, or inability or unwillingness to implement and follow the requirements of this part and its assurance.”).
The regulations prescribe a two-part investigational process for addressing allegations of research misconduct. The first part is an investigational inquiry, which as a threshold matter is warranted if the allegation of research misconduct “[i]s sufficiently credible and specific so that potential evidence of research misconduct may be identified.” 1642 C.F.R. §§ 93.307(a)(3). The investigational inquiry is the institution’s preliminary information-gathering and fact-finding stage, or a process undertaken to “conduct an initial review of the evidence to determine whether … an investigation”—the second, more extensive part of the research misconduct process—is warranted. 1742 C.F.R. §93.307(c). If the inquiry results in a finding that an investigation is warranted, the institution must then undertake the investigation, or “the formal development of a factual record and the examination of that record leading to a decision not to make a finding of research misconduct or to a recommendation for a finding of research misconduct which may include a recommendation for other appropriate actions, including administrative actions.” 1842 C.F.R. §§93.215, 93.307(d). During an investigation, an institution must “[p]ursue diligently all significant issues and leads discovered that are determined relevant to the investigation … and continue the investigation to completion.” 1942 C.F.R. §93.310(h). The investigation must be memorialized in an “investigation report,” which must state whether research misconduct did or did not occur. 2042 C.F.R. §93.313. Finally, the regulations set forth that an institutional appeal is not required under Part 93. 2142 C.F.R. §93.314. However, §93.314 also states that if an institution’s procedures do provide for an appeal that could result in a reversal or modification of the findings of research misconduct, such an appeal must be completed within 120 days of its filing (although extensions may be granted by ORI).
B. Notification to/Cooperation With ORI
The “Responsibilities of Institutions” in Subpart C of Part 93 includes several requirements that notice be provided to ORI at certain stages in the research misconduct proceedings. The regulations set forth that if an institution closes a case “at the inquiry stage on the basis that an investigation is not warranted,” ORI need not be notified of the allegation of misconduct or the institution’s undertaking and conclusion. 2242 C.F.R. §93.316. However, if ORI receives an allegation directly from a complainant and then requests that the institution conduct the inquiry for such allegation, ORI will ask the institution to provide the outcome of the inquiry to ORI—even if the institution has decided that an investigation is not warranted. See ORI, Question and Answers - 42 CFR Part 93 (last updated April 25, 2011), available at http://ori.hhs.gov/qa-reg-6-05 (“When ORI has referred the allegation to the institution and has asked for an inquiry report or has otherwise learned of the allegation and requests further information, ORI must also be notified.”). However, if the inquiry results in a finding that the formal investigation is warranted, certain notification requirements follow. 23ORI also must be notified, even if there has been no “finding” that an investigation is warranted, if the institution has closed the case at or before the inquiry stage for reasons other than a “not warranted” finding, including, for example, when the respondent has admitted guilt or when the parties have settled. 42 C.F.R. §93.316(a). Further, there are special “certain circumstances” in which the institution must notify ORI immediately if it believes certain conditions exist, including health or safety risk to the public, HHS resources or interests being at risk or reasonable indication of possible violations of civil or criminal law. 42 C.F.R. §93.318. First, “[w]ithin 30 days of finding that an investigation is warranted, the institution must provide ORI with the written finding by the responsible institutional official and a copy of the inquiry report.” 2442 C.F.R. §93.308(a). Relatedly, the institution must notify ORI “of the decision to begin an investigation on or before the date the investigation begins.” 42 C.F.R. §93.310(b). If the institution does not complete the investigation within 120 days of beginning it, it must notify and ask ORI for an extension. 2542 C.F.R. §93.311(b). Once the report has been finalized, the institution must give ORI a copy of the report, explain whether the institution found research misconduct and describe any pending or completed administrative actions against the respondent. 2642 C.F.R. §93.315.
ORI may also “respond directly to any allegation of research misconduct,” whether that is “before, during, or after an institution’s response to the matter.” 2742 C.F.R. §93.400. As explained in greater detail below, ORI’s response does not serve as an appeal of the institution’s process or actions; instead, any possible ORI findings and administrative actions taken are independent from the institutional decisions. Nonetheless, institutions must cooperate with ORI during its review of an allegation, including by “providing all research records and evidence under the institution’s control, custody, or possession and access to all persons within its authority necessary to develop a complete record of relevant evidence.” 2842 C.F.R. §93.304(m).
III. Independence of Institution’s and ORI’s Processes
Subparts D (“Responsibilities of [ORI/HHS]”) and E (“Opportunity to Contest ORI Findings of Research Misconduct and HHS Administrative Actions”) to Part 93 set forth the framework for federal agency review of research misconduct allegations. In this section, we explain how this framework relates to, but is independent from, the institutional proceedings set forth in Subpart C (“Responsibilities of Institutions”).
A. Plain Text of Part 93
Subpart D, entitled “Responsibilities of [ORI/HHS],” sets forth the procedural framework for ORI’s review. A key theme of this subpart is the discretionary nature of ORI’s investigational authority. When ORI becomes aware of an allegation of research misconduct, “it may conduct an initial assessment or refer the matter to the relevant institution for an assessment, inquiry, or other appropriate actions.” 2942 C.F.R. §93.402(a) (emphasis added). ORI has commented that it will rarely conduct the “initial assessment” of a misconduct allegation, as that task is typically handled by the institution. 30ORI, supra note 22 (“There will rarely be a need for HHS, rather than an institution, to conduct an inquiry or investigation, but if it is necessary, the OIG would carry out that responsibility. Sections 93.400, 93.404, 93.500, and 93.523.”). Similarly, “ORI may conduct reviews of research misconduct proceedings,” 3142 C.F.R. §93.403 (emphasis added). and in its review of institutional proceedings, the list of activities that ORI is authorized to undertake is also preceded by “may”:
In conducting its review, ORI may:
- (a) determine whether there is HHS jurisdiction under this part;
- (b) consider any reports, institutional findings, research records and evidence;
- (c) determine if the institution conducted the proceedings in a timely and fair manner in accordance with this part with sufficient thoroughness, objectivity and competence to support the conclusions;
- (d) obtain additional information or materials from the institution, the respondent, complainants or other persons or sources;
- (e) conduct additional analyses and develop evidence;
- (f) decide whether research misconduct occurred, and if so who committed it;
- (g) make appropriate research misconduct findings and propose HHS administrative actions; and
- (h) take any other actions necessary to complete the HHS’ review. 32Id. (emphasis added).
While ORI may review an institution’s findings, procedures and evidence under this list of activities, Part 93 does not provide any mechanism by which ORI may overturn findings or actions taken by an institution at the conclusion of the institution’s own research misconduct proceedings. Part 93 also does not require ORI to do anything in regard to final institutional findings—ORI indeed may receive and review final reports from institutions, and then decline to pursue the matter further for HHS.
What is often misunderstood by institutions, or misconstrued by respondents or their counsel, is that ORI’s decision to pursue or not pursue research misconduct findings—and in particular, when ORI declines to pursue findings—does not serve as a ratification or rebuke of findings made or actions taken by the institution. ORI may decline to pursue findings of misconduct based on a variety of pragmatic and policy-based factors, and the level of culpability or malfeasance associated with a particular instance of misconduct. Because the purpose of HHS administrative action is remedial, the appropriate ORI action on behalf of HHS takes into consideration the seriousness of the misconduct and the need to (1) protect the health and safety of the public, (2) promote the integrity of PHS-funded research and (3) conserve public funds. 3342 C.F.R. §93.408. In addition, as we understand it, informal considerations can even include evidentiary weaknesses in the case or factors related to the significance of the underlying events from the perspective of the federal government, such as the seniority of the respondent, the sufficiency of the institution’s corrective actions, the scientific importance of the research at issue and whether the respondent has accepted responsibility for the misconduct. Therefore, it is incorrect to assert that ORI’s decision not to pursue findings of research misconduct serves as an exoneration of the respondent. 34As but one implication of this clarification, ORI’s declination to pursue findings should not serve as a sufficient basis to compel an institution to engage in its obligation to take “[a]ll 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 findings of research misconduct is made.” 42 C.F.R. §93.304(l).
Section 93.404, “Findings of research misconduct and proposed administrative actions,” confirms this understanding of ORI’s authority. This section states that ORI, after completing its review of a case, either “closes the case without a finding of research misconduct,” or “[m]akes findings of research misconduct and proposes and obtains HHS approval of administrative actions based on the record … or [r]ecommends that HHS seek to settle the case.” 3542 C.F.R. §93.404. Neither avenue gives ORI the authority to “reverse” or “remand,” or otherwise challenge, the institution’s own and independent conclusion. 36Id.; 42 C.F.R. §93.319 (“An HHS finding or settlement does not affect institutional findings or administrative actions based on an institution’s internal standards of conduct”). See also, 42 C.F.R. §93.406 (“Unless the respondent contests the charge letter … the ORI finding of research misconduct is the final HHS action on the research misconduct issues and the HHS administrative actions become final and will be implemented”) (emphasis added). The use of “final HHS action,” as opposed to “final action,” is another example of the independence of the institution’s process.
We note that, in practice, many institutional proceedings are not carried out in a vacuum in which there is no contact with ORI. Instead, ongoing proceedings at all stages often involve communication with ORI, whereby ORI is able to provide assistance to institutions through its Rapid Response for Technical Assistance (RRTA) program to facilitate investigations and assist institutions to conduct them efficiently and with appropriate documentation. 37See ORI, Rapid Response for Technical Assistance (last updated Jan. 27, 2016), available at http://ori.hhs.gov/rapid-response-technical-assistance. ORI is able to provide feedback on how the institution can ensure proper sequestration of evidence, develop a suitable factual record and generally manage a procedurally sufficient inquiry and investigation. ORI encourages institutional research integrity officers to reach out to ORI with questions, and through this process and additional ORI outreach efforts many such officers are comfortable using the agency as a resource throughout the investigation process. By the same token, ORI is not equipped to participate in the sequestration of original scientific materials or engage in other efforts designed to obtain additional facts independently, and therefore it relies on institutions to provide ORI with the factual record needed to conduct a satisfactory review of an institutional proceeding, including by requesting that the institution provide additional factual information or provide additional commentary on its institutional findings where appropriate. 38Part 93 requires such cooperation on factual matters, stating that an institution’s policies and procedures must include “[f]ull and continuing cooperation with ORI during its oversight review … includ[ing] providing all research records and evidence under the institution’s control, custody, or possession and access to all persons within its authority necessary to develop a complete record of relevant evidence.” 42 C.F.R. §93.304(m). However, these mechanisms for communication and collaboration between the institution and ORI do not change the fact that, as codified under Part 93, the final actions ORI may take following its review of an institution’s research misconduct proceeding are to conclude that it will not make a finding of misconduct, or to conclude that there was misconduct and propose additional actions against the respondent as a result of such misconduct.
ORI may nevertheless decide to take compliance actions against an institution, based on the institution’s failure to adhere to the requirements of Part 93 in its research misconduct process. If an institution “fails to comply with its assurance and the requirements of [Part 93],” HHS may “take corrective actions” or “[a]ny other action appropriate to the circumstances.” 3942 C.F.R. §93.413(c). This provision provides ORI with a mechanism to address ongoing deficiencies with respect to the institutional requirements in Part 93 (as described in Section II, supra); however, this is not a mechanism geared toward allowing ORI to second-guess an institution’s decision-making in any particular investigation, and we are not aware of any efforts by ORI to use this catch-all authority to overturn factual findings in an institutional proceeding. Another possibility is that, if an institution has conducted an investigation and has concluded that no misconduct occurred, ORI can nevertheless conclude, under Section 93.404, that misconduct had in fact occurred, and then impose its own administrative actions on that basis. Nonetheless, neither option allows ORI to reverse or remand an institution’s procedurally sufficient findings, and, as mentioned above, Part 93 states that an ORI/HHS “finding or settlement does not affect institutional findings or administrative actions based on an institution’s internal standards of conduct.” 4042 C.F.R. §93.319(b).
Subpart E, titled “Opportunity to Contest ORI Findings of Research Misconduct and HHS Administrative Actions,” provides further clarity that the federal administrative role does not include appellate review of an institution’s proceedings and conclusions. This subpart allows a respondent to contest the findings or actions taken through ORI’s research misconduct proceedings but does not apply to the institution’s proceedings. Section 93.500 provides that “[t]his subpart provides a respondent an opportunity to contest ORI findings of research misconduct and HHS administrative actions” and that “[a] respondent has an opportunity to contest ORI research misconduct findings and HHS administrative actions under this part … by requesting an administrative hearing.” 4142 C.F.R. §93.500(a)-(b) (emphasis added); see also
42 C.F.R. §93.501(a) (“A respondent may contest ORI findings of research misconduct and HHS administrative actions, including any debarment or suspension action, by requesting a hearing within 30 days of receipt of the charge letter or other written notice provided under §93.405”). The parties to such a hearing, which occurs before an administrative law judge, are “the respondent and ORI”—again, not the institution. 42§93.505. Thus, Part 93 sets forth a procedural scheme for administrative review of actions taken against a respondent, but the respondent’s rights only apply to ORI’s research misconduct proceedings and not to the institutional research misconduct proceedings that typically precede ORI proceedings.
C. The “Federal Research Misconduct Policy”
Federal Register commentary reinforces the conclusion that federal agency oversight of an institution’s research misconduct process is independent from the institution’s own process. HHS has explained that the purpose of Part 93 “is to implement legislative and policy changes applicable to research misconduct that occurred over the last several years, including the common Federal policies and procedures on research misconduct issued by the Office of Science and Technology Policy on December 6, 2000.” 4370 Fed. Reg. 28,370 (May 17, 2005). The “common Federal polic[y]” that is referred to and implicitly endorsed in this commentary is the “Federal Research Misconduct Policy,” which sets forth generally applicable principles relating to research misconduct issues. 4465 Fed. Reg. 76,262 (Dec. 2, 2000). That policy plainly describes an oversight framework whereby the “primary responsibility” for investigating misconduct lies with the institution and any federal administrative review is simply an “additional” layer of oversight:
Federal agencies have ultimate oversight authority for federally funded research, but research institutions bear primary responsibility for prevention and detection of research misconduct and for the inquiry, investigation and adjudication of research misconduct alleged to have occurred in association with their own institution.
…
After reviewing the record of the investigation, the institution’s recommendations to the institution’s adjudicating official and any corrective actions taken by the research institution, the agency will take additional oversight or investigative steps if necessary. Upon completion of its review, the agency will take appropriate administrative action in accordance with applicable laws, regulations or policies. 4565 Fed. Reg. at 76,263 (emphasis added).
This commentary leaves no doubt that the lack of any provision in Part 93 addressing a mandated administrative appeal of the institution’s misconduct findings and actions is no federal agency drafting error. Instead, it strongly suggests that ORI’s review of an institution’s research misconduct proceedings is an avenue by which the agency may gather facts and maintain a dialogue with the institution in order to develop ORI’s own findings and conclusions about allegations of research misconduct—findings that are designed to account for the federal government’s interests in such research.
IV. Conclusion
42 C.F.R. Part 93 puts in place a process for carrying out research misconduct proceedings in which the research institution bears primary responsibility. Research institutions must comply with the procedural framework that Part 93 requires, but assuming compliance with this framework, institutional findings and actions taken at the conclusion of a research misconduct proceeding will not be subject to refutation, cancellation or reversal by the federal agency tasked with overseeing compliance with research misconduct—apart from ORI’s authority to determine independently that research misconduct had occurred even though the institution had concluded that there had been no misconduct. To alleviate any confusion within an institution’s research community, institutional policies should make clear the primacy and finality of the institutional process. Institutions should also pay careful attention to ensure that their research misconduct procedures—as memorialized in clear, transparent documents—comply with Part 93 and that they adhere to such procedures in practice. If an institution adopts and uses procedures consistent with Part 93, the deciding official’s findings, conclusions and remediation determinations at the end of the institutional misconduct process may be considered final and fully implemented.
