The regulations do little to clarify these questions, and in fact the current PHS rules add complexity by prescribing a differently worded standard for finding a conflict of interest: whether “a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting” of the research. Most researchers would likely contend that their interests do not affect their research in any way. Also unclear is what probability the word “could” implies in this context: More likely than not? A theoretical possibility? A one percent chance? The appearance of an effect? Nor is it clear how an institution would gauge those odds in particular cases. Nor again is it clear what the regulations mean by “directly and significantly.” The ambiguity in this standard may lead to over-reporting of “conflicts of interest.” For example, institutions may tend to report to PHS situations in which investigators have SFIs related to PHS-funded research even if the institution did not believe that the SFI “could directly and significantly affect the design, conduct, or reporting” of the research. The PHS NPRM proposes a new regulatory standard for investigator disclosure of interests to the institution, but the proposed change does not resolve the most difficult issues of interpretation. Investigators would be required to disclose each SFI “that reasonably appears to be related to the Investigator’s institutional responsibilities.” The NPRM does not explain, however, what “related” means in this context. Further, the proposed rule would require the institution to determine whether an SFI “[a]ppears to be affected by the PHS- funded research; or is in an entity whose financial interest appears to be affected by the research.” And “[a] financial conflict of interest exists when the institution, through its designated officials, reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.” Thus, it appears that many of the interpretative questions that arise under the current PHS regulations would remain unresolved under the proposed rule.

## B. What conditions and restrictions suffice to manage a conflict?

The PHS regulations require that an identified conflict of interest must be “managed, reduced or eliminated.” 34/ The PHS NPRM if adopted would require institutions to implement a plan to manage identified conflicts of interest and to inform NIH of the management plan’s “key elements.” The proposed rule identifies examples of “conditions or restrictions that might be imposed to manage a financial conflict of interest.” However, neither current regulations nor the proposed rule prescribe elements of a plan that NIH would deem necessary or sufficient to manage a conflict of interest. If the proposed rule is adopted, guidance may emerge as NIH reviews and provides feedback to institutions on management plan elements identified in institutional reports. In the meantime, institutions may wish to consult nongovernmental sources for guidance on management plans and use their own judgment. 35/

The National Association Of College and University Attorneys

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