The letter, jointly authored by the Council on Governmental Relations (COGR), the Association of American Medical Colleges (AAMC), and the Association of Research Integrity Officers (ARIO), addresses concerns about the National Institutes of Health (NIH) Guide Notice NOT-OD-19-020, which requires recipient institutions to report suspected research misconduct. The authors underscore the importance of scientific integrity and acknowledge the harm caused by misconduct but argue that mandating reporting based on mere suspicion, rather than substantiated findings, threatens the reputations and due process rights of researchers. They note that the current Public Health Service (PHS) Regulations emphasize presumption of innocence and confidentiality, and do not require routine reporting to NIH prior to an investigative finding, instead relying on the Office of Research Integrity (ORI) to act as an intermediary when necessary.
The organizations express concerns about vague definitions of “suspicion” and “learning” of misconduct, as well as a lack of clarity regarding how NIH will use reported information. They argue that reporting requirements based on suspicion could lead to legal challenges, increased administrative burdens, and potential harm to innocent parties associated with research projects. Instead, the letter recommends aligning the NIH reporting requirements with established PHS Regulations, which mandate reporting only under specific circumstances involving threats to safety, federal interests, or legal violations, typically via ORI. This approach, they contend, would uphold due process, reduce duplicative efforts, and ensure that reporting is reserved for situations that truly warrant direct NIH involvement. The associations ultimately urge the NIH to reconsider the current Guide Notice’s standards in favor of a more precise and fair framework.