APS Comments on Proposed Research Misconduct Policies

December 5, 2023

Sheila Garrity, JD, MPH, MBA
Office of Research Integrity
1101 Wootton Parkway, Suite 240
Rockville, MD 20852

Re: RIN 0937-AA12

Dear Ms. Garrity:

Thank you for the opportunity to provide input on the Notice of Proposed Rulemaking for Public Health Service Policies on Research Misconduct. The American Physiological Society (APS) is a global, multidisciplinary community of more than 10,000 biomedical scientists and educators. Many APS members work and train in academic labs around the country and rely on Public Health Service funding to support their research and to educate the next generation of scientists. APS supports the Office of Research Integrity’s efforts to update 42 CFR Part 93 to clarify definitions and requirements. Below we offer comments on a subset of the polices and proposed updates.

In the proposed updates to subpart C, it states that “ORI plans to issue guidance indicating that an interview conducted at the inquiry phase can be carried forward into investigation and need not be repeated unless it might reveal further information.” Providing guidance to support this practice will be helpful to institutions as they evaluate research misconduct, significantly reducing the level of administrative burden and the amount of time and effort for all involved. APS also supports the language in section 93.310(h) that allows investigators to pursue additional allegations that may come to light during an investigation, instead of initiating new inquiries.

There is a need for additional clarity in the definition of who “needs to know” as described in section 93.106 on confidentiality. APS recommends that the final rule clarify whether all co-authors on a journal article containing alleged or confirmed research misconduct can or should be notified, and at what stage of the research misconduct proceedings. Section 93.305(d) on multiple respondents only requires notification of co-authors if they are identified as additional respondents. Additional information is needed to understand under what circumstances must co-authors be notified, and whether and when it is permissible for complainants, respondents and/or institutional officials to notify co-authors of alleged or confirmed misconduct in cases where the co-authors are not identified as respondents or witnesses.

Section 93.106 also describes circumstances under which other institutions may be made aware of research misconduct proceedings. For situations where a respondent is employed at an institution other than the one conducting the research misconduct proceedings, it should be made clear that the employing institution should only be informed if the respondent is found to have committed research misconduct through a completed investigation. Sharing information at the assessment, inquiry or incomplete investigation stage is not appropriate unless the employing institution possesses records relevant to the proceedings. Sharing information on research misconduct proceedings before the results of the investigation are complete risks damaging the reputations of respondents who may in the end be found to have not committed research misconduct.

APS is concerned about the time limits for assessments of allegations as specified in section 93.306(e)(2). Because assessments may involve gathering information to determine whether an allegation meets the criteria to proceed to an inquiry, this process may take longer than 30 days to complete. Requiring institutions to complete all assessments within 30 days or move automatically to the inquiry phase would likely result in many more inquiries being initiated. This would represent a significant burden not only for institutions, but also for those who conduct the inquiries. The people conducting the inquiries are often researchers themselves, and to ask them to complete this work within 60 days would likely require them to slow or pause their own research in order to meet this requirement.

Allowing up to 180 days for full investigations of research misconduct (section 93.311) will help institutions and investigators conduct thorough and fair investigations while still conveying outcomes in a timely manner. However, research misconduct proceedings may involve reviewing large amounts of material and data, as well as interviewing multiple witnesses. APS urges flexibility in the timelines for conducting all stages of research misconduct proceedings. Because investigation outcomes have very high stakes for everyone involved, a thorough and fair process must be prioritized.

Thank you for this opportunity to provide input on behalf of the American Physiological Society.

Sincerely,
Dennis Brown, Ph.D., FAPS
Chief Science Officer

Physiology is a broad area of scientific inquiry that focuses on how molecules, cells, tissues and organs function in health and disease. The American Physiological Society connects a global, multidisciplinary community of more than 10,000 biomedical scientists and educators as part of its mission to advance scientific discovery, understand life and improve health. The Society drives collaboration and spotlights scientific discoveries through its 16 scholarly journals and programming that support researchers and educators in their work.