Report on Research Compliance Volume 21, Number 3. February 22, 2024

Penn: ‘Underlying Distrust’ Implied

Penn believes the NPRM “would create a structure and exact costs that run counter to the fundamental purpose of identifying and addressing research misconduct as defined in the regulation and implies an underlying distrust of institutions’ commitment to research integrity,” according to the comment letter.

Penn listed seven “overarching” concerns about the NPRM in addition to calling out specific provisions. As drafted, the proposed rule:

• “is inconsistent with the statutory authority under which the regulation is promulgated in that the proposal increases and formalizes ORI’s presence and direction in every step of the process, including evaluations that occur prior to investigation;

• “is unnecessarily expansive in scope and prescriptive in process;

• “is not fully sensitive to protection of the rights and concerns of respondents and witnesses;

• “is incognizant of differences in needs, organization or practices across different institutions;

• “unnecessarily intrudes on institutional autonomy and primary responsibility for misconduct proceedings and as a result converts even early stages of academic review into a legalistic/prosecutorial setting;

• “discounts the custom, practice, benefits and efficiency of traditional scientific discourse in evaluating and correcting human errors in the scientific record; and

• “generates substantial, additional institutional burden without advancing the purposes of identifying and addressing instances of research misconduct more effectively than can be achieved under the current regulatory framework.”

‘Tremendous Opportunity’ Squandered?

Nearly half of the 199 comments posted online on the regulations.gov website refer to the COGR and/or ARIO letter, indicating some consensus about what organizations generally don’t like about the proposed rule. Ninety-four comments mention COGR, while 84 cite ARIO. Seventy-four comments reference both.

Like others, COGR didn’t have much positive to say about the NPRM.

“ORI had a tremendous opportunity to take the lessons learned from agency and institutional experience under the 2005 Regulations and make substantive improvements to the Proposed Regulations that would benefit ORI, institutions, and participants in research misconduct proceedings,” the letter states. “Unfortunately, rather than engaging in an iterative process to learn what changes would be most beneficial to improving these regulations, ORI issued a brief [request for information] and then proposed modifications that did little to help institutions and participants to streamline processes and rapidly conclude matters.”^[2]

If adopted as written, the proposed rule would “add significant new reporting and administrative requirements with attendant costs; reduce institutional discretion in the conduct of proceedings; restrict mechanisms to terminate a matter prior to investigation; and increase ORI oversight and management of all phases of the review process,” COGR said.

COGR’s 19-page comment letter organizes its “major areas of concern” under the following headings: “inappropriate limitations on institutional authority during pre-investigative review process,” “transition from peer-driven to prosecution focused review process,” “increased complexity and confusion” and “inadequate confidentiality protections.”

ARIO also expressed a preference for keeping the current regulation in favor of the NPRM.

“Although it is clear that the current NPRM was intended to facilitate the short-term management and oversight of research misconduct proceedings, it is also clear that if these and other issues outlined [in its comment letter] below are not corrected, the long-range secondary effects of the NPRM will harm the ability of RIOs and faculty to engage constructively with other researchers and thus to support the integrity of ongoing research,” ARIO said. “Under the circumstances, it is the view of ARIO that the status quo of 42 CFR [p]art 93 is preferable to the current NPRM as written or any final rule that does not adequately address the significant concerns outlined below. We look forward to working with ORI to revise the NPRM in a manner that would better serve the long-term goals of the [Public Health Service] ORI, academic research institutions, and research integrity as a whole.”^[3]

Expansion of ‘Respondents’ Questioned

ARIO said the following provisions “added as attempts at supporting more efficient execution and oversight of research misconduct proceedings would nonetheless have unintended consequences that pose serious risks:

• “to respondents’ rights and due process [§ 93.305(g); § 93.306(d)(iii); § 93.306(d)(vii)(2); § 93.306(e)(2); § 93.313(l)(2)];

• “to the ability of institutions to conduct adequate sequestration prior to or concomitant with respondent notification [§ 93.306(d)(vii)(2); § 93.306(e)(2)];

• “to the purpose of the inquiry as a mechanism to protect respondent reputation [§ 93.307(h)(2)];

• “to the integrity of ongoing research as a process that welcomes, analyzes, and corrects honest error every day [§ 93.306(d)(iii); § 93.306(d)(vii)(2); § 93.306(e)(2); § 93.307(f)(2)];

• “to the academic freedom that enables researchers to correct their own research record when warranted [§ 93.106(d)];

• “and to the likelihood that vulnerable complainants will come forward with their concerns [§ 93.305(g); § 93.306].”

The need for more time to implement changes is frequently mentioned by commenters. Although COGR requested a year, ARIO and Penn advocated for “at least 18 months” from issuance of a final rule. “Currently, [ORI’s] timeline anticipates providing institutions no more than six to nine months implementation time, with publication of the final rule in the summer of 2024, and an effective date of January 1, 2025,” Penn noted.

ARIO objected to a new “requirement that every co-author, co-investigator on funding proposals, collaborator, and lab member must be considered as a potential respondent [as] inconsistent with due process rights for fair procedures and is unfairly detrimental to those individuals.”

“Considering and then designating respondents throughout the course of research misconduct proceedings should be based on the specific information available to the institution and should not be a process that requires ruling out every individual with a professional nexus to the research about which allegations have been raised,” ARIO’s comment letter said. “We suggest ORI remove this language, or at a minimum, change the text from ‘must be considered as potential respondents’ to ‘may be considered as potential respondents.’”

Deadlines for Assessment, Inquiry Opposed

Multiple comments also drew attention to new deadlines included in the NPRM, beginning with the assessment phase.

ORI would allow just 30 days for what is now an informal process that has no deadline. “Under the proposed rule, if the assessment takes longer than 30 days to complete, the institution would be required to initiate an inquiry in lieu of completing the assessment,” according to the comment letter from Ropes & Gray LLP and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard, which called the deadline “excessively rigid.”^[4]

This comment was also signed by representatives from Cornell University, Washington University in St. Louis, Tulane University, Children’s National Hospital, Public Responsibility in Medicine and Research and the Association for the Accreditation of Human Research Protection Programs.

The authors contended that such a deadline “would lead to rushed assessments that are much more prone to errors in judgment, mistakes in assessing facts, and other undesirable outcomes. Additionally, it would undoubtedly result in procedural unfairness for individuals against whom non-meritorious allegations have been raised, when allegations proceed to inquiry but substantively were suitable for dismissal at the assessment stage. The inquiry process is often a very stressful experience for respondents, and it would be unfortunate to have individuals named as respondents and subject to an inquiry simply because an institution is unable to finish an assessment within 30 days.” A 90-day deadline might be an option, the commenters wrote.

The Ropes & Gray group also opposes a provision that would require institutions to seek permission from ORI to extend an inquiry past 60 days; currently, institutions “simply document the reasons for exceeding the 60-day period in the inquiry report,” which ORI should not change.

Penn went further in its comment letter: it proposed that, if ORI wants to require a deadline for inquiries, it should be 120 days.

The Ropes & Gray commenters also urged “reconsideration of the provision in the NPRM providing that transcripts of all interviews must be provided to the respondent,” saying “such a practice raises confidentiality concerns and may cause individuals either to refuse to interview with committees or limit their responses for fear of retaliation by a respondent.”

COGR called attention to changes to the timeframe for completion of misconduct investigations. “We appreciate the fact that the Proposed Regulations extend the investigation period from 120 to 180 days, but experience under the 2005 Regulations has shown that many investigations require a year or more to complete, and ORI routinely grants extensions in such cases,” COGR said.

“ORI should extend the deadline for completion of the investigation to 365 days. The investigation process is complicated and requires coordination of the complainant, respondent, and scientific experts who serve on the investigation committee or advise the process, as well as the conduct of detailed document review, formal, transcribed interviews, examination and analysis of all evidence, and the drafting of a carefully documented report,” according to COGR’s comment letter.

Attorneys: Less Disclosure, More Settlements

As could be expected, most of the comments come from institutions. However, noteworthy among noninstitutions is a comment submitted by attorney Paul Thaler and his law firm, Cohen, Seglias, Pallas, Greenhall, and Furman P.C., which “represents scientists at every stage of the research misconduct process—from the institutional process to ORI’s oversight review, and before other funding organizations and academic journals.”^[5]

The firm also wasn’t overly thrilled with the proposed rule, critiquing some of the same provisions but with a few of its own. Like others, Thaler and his colleagues objected to a proposed change that would allow ORI to “publish notice of institutional research misconduct proceedings, even without a finding by HHS,” writing that this would “inherently and improperly damage the reputations of respondents and represents a seismic change in the protections historically afforded to accused scientists.”

While addressing provisions in the NPRM, they said could “significantly and unjustifiably harm scientists,” the attorneys suggested ORI consider adopting processes akin to those of the National Science Foundation, which publishes no identifying information about its misconduct findings.

“While we recognize that ORI has traditionally taken the position that it must nevertheless publish all findings and settlements, we urge ORI to keep the permissive language of the regulation and to embrace the possibility of instances where findings or settlements need not be published,” they wrote. “We firmly believe that settlements, in particular, would be more common and useful to the process if there were the possibility of reaching agreements that do not become public in appropriate circumstances. Allowing ORI to offer a settlement to a respondent without publication, may result in respondents being more willing to accept terms that involve more oversight for longer periods, or to settle earlier in the process, thereby further conserving time, effort, and funds from all involved in the process.”

‘Under-Appreciation’ of Culture Cited

Additionally, Thaler and his colleagues “agree that introducing a definition for ‘accepted practices of the relevant research community’ is a positive change,” but said, “further clarity should be introduced by establishing what constitutes ‘commonly accepted professional codes or norms,’ and indicating that it is the institutional (or HHS, as applicable) burden to demonstrate a significant departure from these accepted practices.”

They added that the NPRM should “require scientists from the respondent’s discipline to participate on any Inquiry or Investigation Committee. The requirement to demonstrate a significant departure from accepted practices should be appropriately analyzed, and not simply treated as a box-checking exercise and conflated with the alleged research misconduct itself. We believe there has been (and continues to be) an under-appreciation for the significance of culture in reviewing and analyzing research misconduct allegations.”

The attorneys said, “foreign-born or foreign-trained scientists, especially those who are non-native English speakers, may be operating under a different set of norms, by virtue of different training or due to difficulties with the English language. This important element should be considered in analysis not only of accepted practices, but also the level of intent to engage in research misconduct that these scientists may or may not have possessed.”

The attorneys said they appreciated the definition of plagiarism in the NPRM.

“The updated definition of ‘plagiarism’ provides useful guidance. By including in the new definition of this term more specific details on what is and is not considered plagiarism (i.e., the fact that self-plagiarism, authorship disputes, and credit disputes are excluded from the definition of research misconduct), the updated regulation codifies existing ORI guidance in a way that ensures that complainants, institutions, and others cannot disregard the distinction between these practices and improper plagiarism rising to level of research misconduct,” the firm wrote. “Although this guidance has been in effect for years, the distinction is too often lost on those both making plagiarism allegations and those evaluating the allegations.”