Traditionally, the Department of Health and Human Services’ Public Health Service (“PHS”) has narrowly defined research misconduct as conduct that calls into question the integrity of a body of scientific work. This includes fabrication, falsification, and plagiarism in proposing, performing, or reviewing research, or in reporting research results. See 42 CFR 93.103.

Fabrication is making up data or results and recording and/or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results, such that he research does not accurately reflect the research record compiled. Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. Honest error or a difference of opinion is not research misconduct. See 42 CFR 93.103(d).

While most institutions have incorporated this tripartite definition into their own internal research misconduct policy, public and private institutions may broaden PHS’s standard definition. Before responding to an allegation of research misconduct, you should review the relevant policies that may govern the allegations.

Not exclusively. While institutional recipients of federal funds play a central role in detecting and evaluating allegations of research misconduct, institutions are not the only bodies charged with policing scientific researchers. To be sure, institutions bear a heavy burden. To receive federal funds, institutions must adopt written policies and procedures conforming to the Office of Research Integrity (“ORI”) regulations and take “all reasonable and practical specific steps to foster research integrity,” including educating research members of their individual reporting obligations. See 42 CFR 93.301 & 93.302. Institutional compliance must be reported annually to ORI in writing. See 42 CFR 93.302.

However, despite the heavy burdens imposed on grantee institutions by ORI historically, research misconduct allegations have originated with individual scientists, whether colleagues, competitors, or sometimes even collaborators of the accused researcher – not the institution’s dedicated research integrity branch. Other times, third-party “watchdog” organizations committed to scouring the internet looking for potential research misconduct report concerns directly to the journal publishing the relevant data or, often on an anonymous basis, to the institution. Yet another path is for the funding agencies themselves to internally investigate potential fraud, often reported by a whistleblower, through their respective inspector-generals (note ORI delegates this responsibility to the Department of Justice or the HHS inspector-general).

Regardless of who first reports concerns – whether a watchdog, disgruntled colleague, institution or law enforcement – the accuser is under no obligation to vet allegations with the accused before making a report to the institution’s research integrity officer or directly to a publication. This process ensures that an accused researcher typically does not learn of the allegations until the initial step of the institutional process, the “Inquiry,” is in full swing. See 42 CFR 93.307(b)

There are two oversight bodies: the institution where the federally-funded research has taken place; and, the Office of Research Integrity (“ORI”). At the institutional level, research misconduct proceedings are usually conducted by the Research Integrity Officer (“RIO”) and/or the Vice Provost for Research, often in conjunction with members of the institution’s legal team. The RIO is responsible for ensuring the internal review, inquiry, and/or investigation adheres to the institutional procedure. If necessary, this includes notifying the ORI that an inquiry has proceeded to an investigation. Upon accepting a complaint, the ORI may direct the institution to continue investigation or may conduct its own investigation. Depending on the fact-finding conducted by ORI, ORI may impose discipline or offer a settlement agreement addressing the conduct of a respondent.

Institutions receiving federal funding are on the hook for promptly and adequately investigating sexual harassment allegations. A term or condition of all National Health Institute (“NIH”) and National Science Foundation (“NSF”) grant awards, is that the recipient institution foster a work environment conducive to high quality research and urge institutions to report people to the appropriate authorities. Moreover, institutions must assure their compliance with civil rights protections prior to receiving federal funds.

What this means is that institutions not only have to address allegations internally, and quickly, but they must also keep the funding agency apprised of that investigation. While NIH and NSF differ slightly in when and what information must be reported to the agency, grantee institutions generally must notify the funding agency of any change in key personnel (Principal Investigator or “PI” or co-PI’s) employment status, such as administrative or disciplinary action, including a decision to limit access to the institution’s facilities or resources or modifying employment in response to allegations of sexual harassment.

Institutions should also be aware that their response might be subject to scrutiny as well. Sexual harassment allegations against an awardee may also be brought to the funding agency directly, rather than to the grantee institution. In that case, the funding agency will alert the institution and take all appropriate actions – including requiring the institution to implement a change in personnel, if key people are found guilty of sexual harassment of if the institution is found not in compliance with applicable laws and regulations.

There are several government agencies tasked with detecting and rooting out fraud in federally-funded research. Generally, the Department of Health and Human Services (HHS) is responsible for ensuring the proper use of Public Health Services (PHS) funds. Institutions who learn of allegations of research misconduct have certain legal obligations to report and coordinate with the Office of Research Integrity (“ORI”), the designated federal body within HHS primarily responsible for investigating allegations of research misconduct involving PHS-sponsored federal funds and imposing punishments.

The Office of the Inspector General within HHS (HHS-OIG) also plays a role in detecting and deterring fraud and abuse in federally-sponsored research programs. The HHS-OIG may receive referrals from ORI and other agencies to investigate concerns for misuse of federal funding arising out of fraudulent research and alleged non-compliance. By the same token, concerns of gross misuse of federal funds and potential False Claims Act violations may be referred for civil or criminal investigation by the Department of Justice (“DOJ”).

An institution must alert ORI any time it conducts an “Institutional Investigation” (often the second phase launched after an institutional inquiry yields sufficient evidence of potential research misconduct) and must likewise provide ORI with a copy of its written findings, including the name and position of the respondent, its “Inquiry Report.” ORI may request additional information after receiving the initial notice. 42 CFR § 93.309 (a)(b).

ORI’s authority to investigate allegations of research misconduct and make findings is virtually unfettered. Once ORI learns of allegations (usually by virtue of the institution’s “Investigation Report”) it can, among other things: defer to the institutional fact-finding process; consider or ignore any evidence it wants; obtain additional evidence or information; conduct independent analyses; develop new theories; and, make its own findings.

It depends. An allegation of research misconduct typically raises concern that the data reported was intentionally or deliberately manipulated or otherwise knowingly reported as inaccurate. Where the data collected using Public Health Service, NIH or other federal funds, the alleged failure to accurately report data may violate agreed-to terms and conditions under which grantee institutions and named PD/PIs certify that the data presented is accurate. Both the individual scientist who reports the data and the grantee institution holding the funding should be weary that holding out fabricated/falsified data that is represented to the funding agencies as valid and authentic can give rise to both civil and criminal liability under the federal False Claims Act. While the DOJ has not historically investigated research grantees for potential FCA liability in this scenario, over the past two years federal law enforcement agencies have made it a priority to closely scrutinize the use of federal funds by academic medical centers and universities, including the potential failure to investigate and report research misconduct and other noncompliance with research grant terms.

Under PHS’s regulations, institutions receiving federal funding must meet certain legal requirements to implement policies aimed at fostering responsible research practicing and address potential misconduct. Institutions may impose upon its researchers different or greater requirements in addition to those required under PHS regulations. Thus, it is possible that an institution may find certain conduct actionable under its own policies, even while it does not rise to the level of research misconduct under PHS standards. Even a finding by ORI that certain conduct would not be actionable under PHS regulations will not affect the institution’s internal investigatory efforts, nor any finding or any administrative actions that it imposes.

More and more it is the case that institutions receive complaints of unethical or questionable practices that, while unadvisable, do not rise to the level of research misconduct. Institutions, often faced with vigorous opposition from the accused researcher, should freely acknowledge those circumstances. While continuation of the research misconduct proceedings, or a referral to ORI, may not be warranted in these circumstances, an institution’s hands are not tied. Institutions may explore other avenues of redress, such as legal actions for claims such as breach of contract, copyright infringement, and intentional interference claims. Institutions may also avail itself of any and all disciplinary actions already written in its policies. These policies and procedures may go above and beyond the requirements set by ORI and address the “grey areas” of research, such as alleged self-plagiarism, sabotage, sloppy lab practices, and other deceptive or unethical behaviors in the lab.