The October issue of the journal Science features a series of short articles highlighting a database containing a list of more than 18,000 scientific papers and conference abstracts that have been retracted over the past several decades. An analysis of the database shows that nearly 60 percent of retraction notices mentioned fraud or other kinds of misconduct (the balance of which were retracted because of errors, problems with reproducibility and other issues). The Science article, as well as a link to the searchable database, can be accessed here. Not only does research misconduct have significant potential for reputational harm–potentially career ending for the investigator, with ripple effects for the institution–but as described below, when the associated research is federally funded, such misconduct could have significant legal (and liability) implications.
US health care organizations are used to warnings about the potential for exposure under the federal False Claims Act (FCA) resulting from improper claims submitted to federal payors such as Medicare and Medicaid. Less attention has been paid to the potential for FCA liability resulting from research non-compliance. Recipients of federal grant funding are subject to a variety of complex rules (e.g., the National Institute of Health (NIH) Grants Policy Statement), as well as the terms and conditions of the Notices of Award. Just as compliance with Medicare rules can lead to questions about potential FCA exposure for Medicare payments, compliance with federal grant funding rules can lead to the same questions for grant funds.
For example, grant recipients should consider the FCA implications of research misconduct. “Research misconduct” is defined by the Public Health Services’ (PHS’s) final rule, effective June 2005 (the Rule), as the “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.” 42 C.F.R. § 93.103. The Rule confers upon an organization an affirmative duty to protect PHS funds from misuse by ensuring the integrity of all PHS supported work, and primary responsibility for responding to and reporting allegations of research misconduct. 42 C.F.R. § 93.100(b). The Rule applies to grant funding from a variety of federal agencies, including the Food & Drug Administration, NIH, Centers for Medicare and Medicaid Services, and the Substance Abuse and Mental Health Services Administration, to name a few.
In addition to defining what constitutes research misconduct, the Rule establishes the responsibilities of regulated institutions to respond to allegations of research misconduct, and requires the development and implementation of policies and procedures for responding to, investigating and reporting allegations of research misconduct, as well as providing an “Assurance” that the entity is in compliance with the Rule. In order to substantiate a claim for research misconduct, the Rule requires that (a) there be a significant departure from accepted practices of the relevant research community; (b) the misconduct be committed intentionally, knowingly or recklessly; and (c) the allegation be proven by a preponderance of the evidence, which means that the totality of the evidence shows that it is more likely than not that research misconduct occurred.
The Department of Health and Human Services Office of Research Integrity (ORI) is charged with enforcing the Rule. The ORI may impose a range of sanctions for failure to comply with the requirements of the Rule, such as issuing a letter of reprimand, suspending or terminating a researcher’s federal grants, restricting a researcher’s activities on federally-funded research projects, up to and including debarring a researcher from participating in any federally-funded research. However, the more significant potential source of liability resulting from a research misconduct investigation is the FCA. If false or fabricated data is used to apply for or obtain grant funding, there may be a need to assess the potential for an FCA claim. Notably, whether a FCA claim can be sustained depends on a number of facts and circumstances, including whether the institution submitting the grant application had sufficient knowledge of the research misconduct that led to the claim for federal funding. In addition, under Universal Health Services v. U.S. ex rel Escobar, the false or fabricated data must be material to the receipt of the federal grant funds.
Institutional committees that are charged with conducting a research misconduct investigation under the Rule may be unaware of the potential for FCA liability and therefore may not realize the implications of decisions that are made along the way. For example, continued claims for reimbursement under a grant may be submitted to the grantor agency for additional payments, each of which could end up constituting an additional false claim if the misconduct is substantiated and material to payment (and potentially subject to treble damages and per claim civil monetary penalties). The committee may be well advised to engage counsel early so that parts of the research misconduct investigation can be conducted under privilege, and to weigh in on other critical decisions (e.g., continued receipt of grant funding, when to terminate the investigator involved in the allegation, etc.) – particularly where federal grant funds are involved and the potential for FCA liability exists.
In recent years, there has been an uptick in FCA suits brought against major academic research organizations related to false experimental data that was incorporated into grant requests and progress reports. Partly driven by activity that caught the attention of Sen. Charles Grassley, the US Department of Justice has become more aggressive in pursuing FCA cases against research institutions where researchers have been accused of misconduct. Private whistleblowers are also bringing suits, spurred by the treble damages offered under the FCA and the potential to receive of up to 30 percent of any amount recovered by the government.
An organization’s vulnerability to FCA claims related to federally funded research, as demonstrated by recent cases, may provide impetus for the implementation of more proactive review of its research program, including systematic scientific review of research results prior to their submission to grant sponsors and scientific publications.