Have you ever wondered what could happen if you’re accused of misconduct and face official proceedings? We are pleased to present a guest post from Callan Stein, a lawyer who represents U.S. researchers in misconduct cases, who describes some nuances many may not realize about these situations.
Most researchers know that being accused of research misconduct is a very serious matter. When research misconduct allegations are made, institutions embark upon lengthy, multi-staged inquiry and investigation processes as required by federal law. The federal government’s Office of Research Integrity (“ORI”) – part of the Department of Health and Human Services (HHS) – oversees those institutional findings and imposes potentially career-threatening punishments on those found guilty. While researchers generally understand the basics of how a research misconduct case unfolds, many are unaware of the nuances that bear greatly on the outcome. What follows are brief descriptions of eight such nuances of which every researcher should be aware.
- While “honest error” exempts researchers from misconduct, it is very hard to prove.
Section 93.103 of the federal regulations explicitly exempts “honest errors” from the definition of research misconduct because “honest errors” are, by their nature, not committed knowingly or recklessly. But while this exemption appears to be a refuge for researchers accused of research misconduct, in practice this is rarely the case because “honest error” is extremely difficult to prove.
As a preliminary matter, the “honest error” exemption is an affirmative defense, meaning the accused researcher bears the burden of proving it. ORI and HHS have also both consistently held that they do not need to disprove “honest error” to make research misconduct findings. Researchers claiming the exemption must do more than simply prove that their errors were unintentional. For example, one HHS administrative law judge required a researcher claiming that a transcription mistake was an “honest error” to prove that the error was not only unintentional, but also that his actions that led to the error were reasonable. Another HHS administrative law judge required a researcher claiming “honest error” to prove that he subjectively believed the error was true at the time of publication.
- Accepting responsibility for research misconduct is a mitigating factor, but such admissions will often hurt a court case.
When ORI is imposing punishment for research misconduct, the federal regulations require the punishment to be “commensurate with the seriousness of the misconduct.” To aid ORI in making that determination, Section 93.408 of the regulations suggests seven mitigating/aggravating factors ORI may consider. One such mitigating factor is whether the researcher has admitted his/her misconduct and thereby accepted responsibility for it.
On the basis of these regulations, an accused researcher could reasonably believe that his/her best course is to admit the allegations early. But while doing so may lessen the eventual sentence from the ORI, and earn kudos from colleagues who appreciate someone who takes responsibility for his/her actions, confessing to misconduct is, at best, a double-edged sword when it comes to research misconduct proceedings. First, an admission will not end the institutional process or keep the matter away from ORI. Although federal regulations permit institutions to close research misconduct cases early if the researcher makes a full confession, they also require institutions to notify ORI of the admission in advance of closing the case. Second, institutional regulations often contain shortcuts whereby an accused researcher waives certain rights by admitting misconduct. For example, upon an admission some regulations will permit the institution to bypass the inquiry process altogether and proceed directly to an investigation. This can significantly prejudice the accused researcher in two ways. First, it forces the researcher to defend against a research misconduct investigation that does not have as defined a scope as the inquiry process. Second, because the scope is not well defined, it is far easier for the committee conducting the investigation to expand the investigation to review other aspects of the research. Accordingly, the admission can ultimately result in more significant research misconduct findings and, therefore, harsher sanctions (even after mitigation is taken into account). In fact, admitting research misconduct recently became a lot riskier due to the heightened focus on the potential criminal implications of falsifying research data. This past July, a federal judge sentenced an Iowa-based researcher to 57 months in prison after he pled guilty to federal criminal charges stemming from his falsification and fabrication of research data to obtain NIH grants. Although this is an extreme case, it underscores the seriousness of research misconduct allegations and it is a graphic reminder that researchers should exercise extreme caution when even considering admitting misconduct to an institution.
- NIH funding is just one of many things that trigger ORI jurisdiction.
By federal statute, ORI’s research misconduct oversight authority is limited to projects for which federal assistance is provided or requested. The majority of such “federal assistance” comes in the form of grants from the Public Health Service’s granting agency, NIH. However, there are seven other PHS agencies, including the Centers for Disease Control and Prevention, the Food and Drug Administration, and the Agency for Healthcare Research and Quality. Assistance or requests for assistance from any of those agencies will likewise trigger ORI jurisdiction.
Initially, it is up to the institution to determine whether federal funding is involved. But ORI will also make its own jurisdictional determination, and in doing so it has routinely found that a mere request for federal assistance sufficiently triggers its oversight authority, irrespective of whether or not the request resulted in actual federal funding. ORI also does not interpret “funding” to be limited to the payment of salary, but can also include paying for any equipment or other laboratory resources.
- You can commit research misconduct by exaggerating or falsifying your own credentials.
Although the federal definition of research misconduct does not specifically address a researcher’s falsification or exaggeration of his/her own credentials when applying for PHS funds, ORI has – in certain circumstances – considered this research misconduct. ORI’s rationale is that reviewing an individual’s credentials during the grant application process is a critical aspect of determining whether that individual is capable of performing the proposed research.
In one case, ORI found that a researcher who held a Ph.D. committed research misconduct by falsely claiming that she was also an M.D. in three PHS grant applications. In another case, ORI found that an individual committed research misconduct by falsely claiming to have attended M.I.T. and earning an M.S. in organic chemistry. Neither researcher was accused of falsifying or fabricating any research data, but in both cases ORI imposed a three-year debarment.
- You can commit research misconduct without ever publishing a single word.
When most researchers think of research misconduct, they think of someone who has published false or fabricated results in a scientific journal. But traditional publication is not a prerequisite for research misconduct.
For instance, when a researcher falsifies or fabricates data in a grant application or progress report to PHS or NIH, even if that document is never published, ORI still considers it “reporting research results” within the federal definition of research misconduct. Indeed, the ORI Case Summaries page is littered with research misconduct findings based on false data in grant applications and progress reports. In addition, ORI has likewise made research misconduct findings when false or fabricated data were included in: (1) manuscripts given to a mentor or lab chief; (2) PHS applications for the continuation of already-approved projects; (3) abstracts, posters, oral presentations, and preliminary reports presented at scientific meetings/conferences; (4) central databases (e.g., for multi-center clinical trials); and, (5) patent applications.
- Federal regulations make research misconduct proceedings confidential, but only to a point.
Section 93.108 of the federal regulations appears to require that research misconduct proceedings be kept confidential by expressly limiting the disclosure of the identities of respondents and complainants to “those who need to know.” Section 93.300 of the regulations then appears to heighten that requirement by stating that PHS expressly holds institutions responsible for ensuring that confidentiality.
However, almost as casually as PHS bestows this confidentiality, it begins to chip away at it with exceptions that all but swallow the rule. First, institutions must still disclose respondents’ and complainants’ identities to ORI. Second, anyone contesting a research misconduct finding by ORI will necessarily have to forgo this confidentiality because HHS administrative proceedings must be public. Third, and most importantly, the federal regulations’ confidentiality provisions are expressly limited to “research misconduct proceedings.” Therefore, if by committing research misconduct a researcher also violated an institutional policy or procedure (which is likely), there is nothing constraining the institution from disclosing confidential information related to its own internal corrective action.
- Researchers should not wait for a hearing before HHS to defend themselves, because HHS hearings are virtually never granted.
Research misconduct proceedings are often lengthy, and can last for months — or even years. For this reason, accused researchers are often understandably hesitant to invest the resources necessary to defend themselves at the institutional stages, and instead rely on their perceived right to a hearing before HHS to appeal a finding of research misconduct. This is a critical mistake. Although Subpart E of the federal regulations purports to provide researchers the “opportunity to contest findings of research misconduct and administrative actions,” in practice this “opportunity” is almost entirely illusory.
Prior to 2005, a panel of scientists adjudicated research misconduct cases before ORI, including granting and denying hearing requests. But in 2005, PHS amended its regulations to impart those decisions to an HHS administrative law judge; since then not a single judge has granted a hearing request in a research misconduct case. (One researcher obtained a hearing but only after he filed a federal lawsuit against HHS to overturn the judge’s initial denial of his hearing request.) See Bois v. U.S. Department of Health and Human Services, et al.
- A debarment does far more than just prevent you from applying for federal grants.
Section 93.205 of the federal regulations defines a debarment as a “Government wide exclusion….from eligibility for Federal grants.” Debarred individuals are forbidden from participating in any “covered transaction” with the Federal government, which is defined very broadly — participating in both procurement and nonprocurement transactions such as grants, cooperative agreements, contacts, subcontracts, scholarships, fellowships, loans, and any other form of Federal funding.
From the face of these regulations it is clear that debarred individuals cannot apply for or receive any salary or other financial assistance from the federal government. But because the regulations are written so broadly the federal government has interpreted them to also prohibit debarred individuals from receiving nonfinancial assistance. This means that, in addition to being forbidden from applying for their own grants, debarred individuals also cannot use equipment, laboratory space, laboratory personnel, or any other resources that the federal government paid for, in whole or in part. Put another way, according to the federal government’s interpretation, if you are debarred and your laboratory uses a microscope that was even partially paid for with federal funds, then you cannot conduct research there.
In conclusion, readers should note that these descriptions do not comprehensively address each topic. Researchers accused of misconduct are strongly encouraged to retain legal counsel early in the process, and devise a specifically-tailored defense strategy that incorporates these and other considerations.
Callan Stein is a litigation associate at Donoghue Barrett & Singal, P.C. in Boston, Massachusetts. He has represented researchers all over the United States in research misconduct proceedings at the institutional and ORI levels. In addition to research misconduct cases, Stein’s practice primarily focuses on white-collar criminal defense, and civil and whistleblower litigation.
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