It is unlikely that a court would find that current HHS regulations provide legal authority for PHS funding-agencies to address “serious noncompliance” with FCOI disclosure requirements as research misconduct. With one exception—the culpability standard for research misconduct—the administrative law governing bias and integrity in PHS-funded research does not support treating even the most serious cases of failure to disclose FCOI in itself as research misconduct in violation of PHS regulations. Indeed, there are at least four features of that law which would support a claim that an HHS action to treat FCOI nondisclosure as research misconduct was “arbitrary and capricious.” First, “serious noncompliance” with institutional FCOI disclosure requirements does not fall within the definition of “research misconduct” under 42 C.F.R. § 93.103. Second, one of the regulatory standards for a finding of research misconduct rests on a comparison with the “accepted practices” within the “relevant research community,” and there is currently no discernable consensus on FCOI disclosure requirements among major research institutions sufficient to establish clear parameters of “accepted practices.” Third, the intent behind the 2004– 2005 rulemaking process that revised research misconduct policies across agencies of the federal government, including NIH, was to create a uniform federal policy on research misconduct—a historical legacy that may throw up legal constraints to any agency’s unilateral effort to reshape the contours of administrative actions for research misconduct. Fourth, the regulatory structure within Title 42 of the C.F.R. that was created by the 2004–2005 rulemaking process supports the conclusion that HHS rulemakers saw FCOI nondisclosure as distinct from research misconduct.
Frisby, Tammy M.
"Regulatory Challenges for Treating Failure to Disclose FCOI as Research Misconduct in Public Health Research,"
Utah Law Review: Vol. 2020
, Article 5.
Available at: https://dc.law.utah.edu/ulr/vol2020/iss5/5