Parrish Law Offices

After an institution finds a researcher guilty of research misconduct, the institution typically imposes sanctions that range from a letter of reprimand to termination. If the research was federally funded, the institution sends its report to the relevant federal agency, which may impose additional sanctions. The following examines some of the sanctions imposed by the Office of Research Integrity (ORI) and notes the following trends:

1. The requirement of certification of the authenticity of research and the imposition of supervision requirements are the most common sanctions;
2. The harshest sanction, debarment from receiving any federal funds, is most commonly applied against researchers who do not participate in the misconduct investigation; and
3. Recent sanctions are less severe compared with those meted out over the past two decades.

Each of these trends is discussed more fully below.

Certification and Supervision Restrictions

To avoid being debarred, most accused researchers (“Respondents”) enter into a Voluntary Settlement or Voluntary Exclusion Agreement with ORI that includes the acceptance of certain federal sanctions. The most common federal sanctions associated with a research misconduct finding are certification and supervision. A certification sanction requires the individual and/or institutional representative to certify the research is authentic. A supervision sanction requires the researcher to be supervised by another researcher within the institution. From 2010 to 2015, ORI imposed 62 sanctions on 61 Respondents. Forty-one of those sanctions were either certification or supervision restrictions or about two-thirds. However, in the previous five years (2005–2009), only 18 of the total 58 sanctions were categorized under either certification or supervision restrictions (i.e., approximately one-third).

Debarment and Respondents Who Avoid Settlements

Debarment is the harshest punishment that ORI can impose on an individual. The sanction of debarment is premised on a finding that a researcher is not presently fit to be a steward of federal funds. Debarment from receiving federal funds is government wide. Not only can the individual not receive research dollars, but he or she cannot receive student loans, federally-backed mortgages, or reimbursement for medical services provided to individuals covered by a governmental payer. ORI has imposed the debarment sanction for periods that range between two years and life.

Debarment is not imposed on individuals who enter a settlement agreement through which they agree not to seek federal funding. Debarment typically occurs when the researcher does not participate in the investigation—most commonly because he or she has left the country. An exception is the case of Paul Kornak who received a lifetime debarment. ORI indicated it was imposing such a harsh sanction “to protect the public interest overall. Given the scope of his criminal conviction, his longstanding pattern of criminal behavior, and his total disregard for the safety and well-being of human subjects, Mr. Kornak’s responsibility to engage in transactions with the federal government cannot be assured at any time in the future.” Since 2010, ORI has imposed debarment only eight times— all resulting from the Respondent’s failure to participate in the investigation. In the previous six years (2004–2009), 16 debarments were imposed.

As previously noted, the number of supervisions and certifications has increased, while the number of debarment sanctions has decreased by approximately half. Some of this trend may be a function of the fact that more Respondents are entering into settlements with ORI. Most agreements between ORI and the Respondent involve only the certification or supervision requirements.

Exclusions Versus Debarments

When a researcher does not enter an agreement with ORI, he or she is entitled to request a hearing. The time to prepare a case for hearing protracts the ORI review process, is a significant use of ORI’s legal resources, and generally is more expensive for the Respondent. Accordingly, it is likely that many of the ORI cases that have not been resolved over an extended period involve more serious proposed sanctions.

The duration of the exclusion period offered through a Voluntary Exclusion Agreement (VEA) is comparable with debarments imposed. If a Respondent is cooperative and enters into an agreement quickly and without questions, the duration of the exclusion is generally two or three years. If a Respondent initially contests the ORI findings but later enters a VEA, the exclusion period generally is longer. For example, Evan Dreyer originally contested the findings but later decided to enter into an exclusion agreement, presumably to be able to receive Medicare and Medicaid reimbursement for medical services he provided. He agreed to not seek federal research dollars for ten years to avoid being debarred from all federal funding for the same time period, if not longer. Although Dreyer ultimately accepted a 10-year period, the most common period of exclusion is three years (i.e., 84 of the 106, or approximately four-fifths of the exclusion settlements were sanctioned for duration of three years). Thus, it appears that accepting a VEA later increases the exclusion length.

Since 2010, ORI has offered, and Respondents have accepted, VEAs only 13 times. In the previous five years (2005– 2009), 24 VEAs were entered. Similar to the decrease in debarment sanctions in recent years, exclusion agreements have decreased by approximately half.

Conclusion

It appears more researchers are entering Voluntary Settlement Agreements with ORI, and the majority of those have simply a supervision or certification requirement. In the past five years, approximately two-thirds of the Respondents entered such agreements. Since 2010, only 21 researchers have been excluded or debarred from receiving federal funding