The HHS Office of Research Integrity (ORI) gets an “A” for effort on its new proposed regulation revising research misconduct rules, but maybe a “D” overall. Most of the nearly 200 comments on the proposed rule posted online take aim at specific provisions—such as new deadlines—and accuse ORI of rushing implementation, requesting instead a year or longer to implement any final rule. The University of Pennsylvania gave it an “F”—actually suggesting ORI start over and work directly with regulated institutions to craft a new notice of proposed rulemaking (NPRM).
“The scope and impact of the proposed changes, in our view, warrant withdrawal of the proposed rule and the initiation of a collaborative process between ORI and representatives of affected institutions to develop an improved regulation that better serves our common goal of addressing allegations of research misconduct in a fair, efficient and consistent manner and allocates responsibility and authority appropriately,” wrote Dawn A. Bonnell, Penn senior vice provost for research and professor of engineering and applied science.[1]
Penn’s 11-page comment letter to ORI Director Shelia Garrity also references those submitted by the Council on Governmental Relations (COGR) and the Association of Research Integrity Officers (ARIO). Both are critical of the proposed rule, but neither went as far as Penn in suggesting it be rescinded.
Bonnell acknowledged the “extensive efforts that ORI devoted to the NPRM” and the agency’s goal of updating “the regulation to keep pace with changes that have occurred in the research environment, and to resolve interpretive questions that have arisen under the existing regulation by clarifying processes and definitions.”
But, she added, “It is also apparent that many of the changes are designed to facilitate ORI’s access to and ease of use in reviewing institutional materials in conducting its oversight reviews. We can appreciate ORI’s desire to implement some of these goals to facilitate its own internal process, but we are concerned that the current proposal—weighted in many cases to suit ORI’s administrative preferences—does not sufficiently recognize or account for the institutional research environment or the concerns that institutions need to consider and address.”
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:
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“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;
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“is unnecessarily expansive in scope and prescriptive in process;
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“is not fully sensitive to protection of the rights and concerns of respondents and witnesses;
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“is incognizant of differences in needs, organization or practices across different institutions;
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“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;
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“discounts the custom, practice, benefits and efficiency of traditional scientific discourse in evaluating and correcting human errors in the scientific record; and
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“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.”
