On August 13, the United States Department of Agriculture (USDA) issued regulations on research misconduct in USDA-sponsored extramural research.1 With the final regulations, issued almost two years after the USDA proposed them,2 the USDA becomes the latest federal agency to adopt the federal-wide research misconduct policy announced a decade ago.3 The regulations are thus, not surprisingly, generally consistent with those adopted in recent years by other agencies, such as the U.S Public Health Service (PHS) and the National Science Foundation (NSF),4 with a few notable differences. Institutions that conduct or anticipate conducting USDA-sponsored research should ensure that institutional research misconduct policy is consistent with regulations and, should allegations of research misconduct arise under such research, that the regulations are followed. This alert highlights certain requirements of the USDA regulations, particularly differences between the USDA regulations and the PHS regulations with which institutions now have several years of experience. It presupposes familiarity with the basic framework for resolving research misconduct allegations under the PHS regulations.

Definition and standard of proof

The USDA regulations adopt the federal definition of "research misconduct" -- "[f]abrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Research misconduct does not include honest error or differences of opinion."5 A finding of research misconduct must be proven by a preponderance of the evidence, and the misconduct must represent a "significant departure from accepted practices of the relevant research community" and be "committed intentionally, knowingly, or recklessly."

When USDA learns of a research misconduct allegation, it will convene a Panel to examine institutional policies and procedures to gauge whether the institution is capable of resolving the allegation6 or whether an appropriate USDA agency, as determined by the Panel, will conduct the research misconduct proceedings. Institutions that receive or intend to receive USDA research funding thus may wish to review institutional policies to ensure compliance with the regulations and the ability to demonstrate competence to conduct their own reviews of research misconduct allegations.

Research misconduct proceedings

The regulations require that institutions conducting USDA-sponsored research have procedures to respond to research misconduct allegations, but the USDA regulations prescribe less detail than the PHS regulations. They do require that certain documents be maintained as part of the research record, including: (1) a statement of the allegations; (2) notification to the respondent; (3) a description of the inquiry and investigation process; (4) the inquiry and investigation reports; and (5) any recommended corrective action and the respondent's response to such recommendation.7 Records and other evidence necessary to assess the allegation must be obtained either before the institution notifies the respondent or immediately thereafter and must be retained securely for 3 years following final adjudication of the alleged research misconduct.8

With one exception, these requirements are generally no more demanding than PHS record keeping standards. The exception is a technical point: the USDA regulations, unlike the PHS rule, specifically require that an institution maintain a copy of the notification to the respondent.

Under the USDA regulations, institutions also must notify individuals engaged in USDA-funded research of the institution's research misconduct procedures.9

Protecting respondents and complainants

Consistent with the PHS regulations, the USDA regulations require institutions to have safeguards to protect the interests of respondents, including, among other things, giving the respondent notification of the allegations, access to evidence, and an opportunity to respond.10 Institutions are also required to protect good faith complainants from retaliation and maintain their anonymity if requested and if consistent with law or regulation.11

Reports to USDA

The USDA regulations require that institutions "promptly" notify the USDA Office of Inspector General and the USDA Research Integrity Officer (RIO) when an inquiry into an allegation of research misconduct involving USDA funds determines that an investigation is warranted.12 The final rule differs from the proposed rule, which would have required notification to USDA of all allegations of research misconduct involving USDA funds. Institutions engaged in USDA-funded research may wish to confirm that a suitable notification provision is included in institutional policy or standard procedures.

The USDA regulations also require the institution to provide the Agency RIO (ARIO) with certain information after completion of the investigation.13 The information USDA requires is consistent with the information that must be provided to the Office of Research Integrity under the PHS regulations.

Potential USDA action

The USDA retains the right to conduct its own inquiry, investigation, and adjudication after the institution has completed its proceedings. In addition, USDA agencies may seek to impose administrative sanctions as a result of a finding of research misconduct. Potential sanctions include debarment, recovery of funds, correction of the research record or any other appropriate remedy.14