By Michael L. Smith, R.R.T.. J.D.
Big healthcare fraud cases involving billions of dollars are becoming more common. Those cases usually involve submitting claims for healthcare services that were medically unnecessary, or never provided at all. A lesser known type of healthcare fraud involves fraudulent research known as research misconduct.
Dong-Pyou Han, PhD, a former researcher at Iowa State University, was indicted by federal prosecutors based upon his research misconduct. The indictment alleges that Han falsified scientific data to make it appear the experimental vaccine he was developing was working to neutralize or control the HIV virus in rabbits. Han faces a possible sentence of 5 years in prison and a $250,000 fine for each of the four counts in the indictment.
The filing of criminal charges for research misconduct is rare. Han's falsified results were used to support grants of $19 million from the NIH since 2008. His falsified data was presented at seven national and international symposia as well as numerous laboratory meetings. In Han's case, the criminal charges were probably filed because the fraud was continued for several years and resulted in the payment of millions of dollars on federal funds. His institution lost an additional $1.4 million grant after the research misconduct was identified.
A research misconduct proceeding is usually initiated by the institution where the researcher is conducing research. Once the institution determines research misconduct exists, the institution reports that finding to Department of Health and Human Services (HHS) Office of Research Integrity (ORI), which is the federal agency with oversight of federally funded research.
The ORI conducts its own investigation and may impose administrative sanctions against the researcher including debarment from participating in federally funded research. The ORI does not have the authority to initiate criminal charges. The ORI refers the results of its investigation to the federal agency that funded the research, usually the NIH. Eventually, the case may be referred to the U.S. Attorney for criminal prosecution. By the time a research misconduct case reaches the U.S. Attorney, it has been investigated multiple times by the institution and the ORI.
Every institution engaged in research is required to conduct research misconduct proceedings in compliance with the federal regulations. The federal regulations define research misconduct as fabrication, 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 under the federal regulations. A finding of research misconduct requires: (1) there be a significant departure from accepted practices of the relevant research community; (2) the misconduct be committed intentionally, knowingly or recklessly; and (3) the allegation be proven by a preponderance of the evidence. A finding of research misconduct may also be based upon the destruction, absence of, or a researcher's failure to provide research records adequately documenting the questioned research under the regulation.
A research misconduct proceeding is more complicated than the regulations make it appear because there are a limited number of individuals who have the scientific background and experience to examine the allegations and the research. The individuals who have that background and experience may also have conflicts of interest that preclude them from participating in the proceeding. The federal regulations require the institution to ensure that the individuals responsible for carrying out any part of the research misconduct proceeding do not have unresolved personal, professional or financial conflicts of interest with the complainant, researcher or witnesses involved in the proceeding.
The regulations are straightforward, but a research misconduct proceeding can be extremely complex due to the nature of the research data involved. Individuals accused of research misconduct need to retain experienced counsel to represent them in that proceeding immediately, and definitely before they attempt to respond to their institution's inquiry. Individuals involved in research are passionate about that research, but they are usually not equipped to objectively respond to the concerns raised by their institutions. Additionally, research misconduct proceeding under the policies of most institutions must be conducted in a very short time period of 120 days. A researcher may only have a matter of days to respond to an inquiry by the institution, and most researchers do not have the ability to adequately respond on their own under such limited time restrains.
Most research misconduct proceedings do not involve conduct as blatant as Han's. However, research misconduct is still healthcare fraud that will receive increased regulatory scrutiny in the future.
Michael L. Smith is board certified in health law by The Florida Bar and practices at The Health Law Firm in Altamonte Springs, Fla. This article is for general information only and is not a substitute for formal legal advice.