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Implications of Clinical Research Misconduct and Fraud Accusations

One of the most notorious recent cases of research misconduct involved a South Korean stem cell researcher who claimed to have cloned human embryonic stem cells. However, the researcher was accused of fabricating crucial data and charged with fraud and embezzlement. The fraud charges were eventually lifted, but not before the researcher’s reputation was destroyed.

Although accusations of research misconduct and fraud have been present for decades, the number of complaints is on the rise, according to the FDA. In many cases, the researcher accused of such misconduct may actually be the victim of one or more unscrupulous individuals who make the complaint for his or her own ulterior motives. Some researchers may be targeted by an academic institution or the government. Other cases may involve a “whistle blower” who may just have misunderstood the situation.

Generally, a researcher who is said to have committed research fraud or misconduct will be accused of one of the following:

  • Manipulating or concocting research data
  • Failing to disclose financial interest or not properly disclosing conflict of interest
  • Plagiarizing or using another’s ideas without obtaining permission or giving due credit
  • Failing to present data that contradict one’s own previous research
  • Overlooking the use of flawed data or questionable interpretation of data
  • Circumventing certain minor aspects of human-subject requirements (e.g. related to informed consent, confidentiality, etc.)
  • Changing the design, methodology or results of a study in response to pressure from a funding source
  • Ignoring details or cutting corners to meet a deadline
  • Fabricating, falsifying, or mishandling of data for gaining some form of reward or benefit

No matter the circumstances surrounding the case, medical research misconduct and fraud accusations are considered very serious and should not be taken lightly. To combat any of the resultant consequences, a working knowledge of how research misconduct and fraud procedures are handled is crucial. Although criminal charges may come out of such investigations, a knowledgeable, experienced attorney may be able to obtain a resolution without anyone even considering such action.

If you are facing research misconduct or research fruad accusations, please visit our website at www.TheHealthLawFirm.com for more information.

Guilty Plea to Research Misconduct Results in 4 1/2 Year Prison Sentence

By Michael L. Smith, R.R.T., J.D., Board Certified by The Florida Bar in Health Law and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

MS_smDong-Pyou Han, a former Iowa State University scientist was sentenced to four-and-a-half (4 ½)  years in prison on Wednesday July 1, 2015, for falsifying his research results concerning the effectiveness of an experimental HIV vaccine.  A plea agreement also required Han to pay $7.2 million in restitution to the National Institutes of Health (NIH), which funded the research.  Han was testing the experimental HIV vaccine on rabbits.  He spiked the rabbit blood with human antibodies to make it falsely appear the experimental vaccine caused the rabbits to develop antibodies to HIV.
Click here to the entire AP article.

What is Research Misconduct?

“Research misconduct” is intentional fabrication, falsification, or plagiarism during the course of clinical research. It is not honest differences of opinion or differences in the interpretation of data.  In Han’s case, the test results were fabricated in order to fraudulently secure millions of dollars in grants from the NIH.

Click here to read one of our blogs on the ABCs of IRBs.  For more resources, visit the Research Misconduct Website at National Institutes of Health.

Han’s Attorney Requests Probation, Not Prison.

According to an AP article, Han was represented by a federal public defender who asked the court to sentence Han to probation rather than prison.  The public defender argued that Han already lost his ability to work as a scientist and would most likely be deported to his native South Korea.  Instead, the judge in this case sentenced Han to four-and-a-half years (4 ½)  in prison.

Prison Sentences Unusual for Research Misconduct Cases.

Research misconduct investigations do not often result in prison sentences.  Most often, the sanction imposed on a scientist found to have committed research misconduct is a requirement to retract published articles, research or reports, and the loss of their research positions.  When NIH funding is involved, a prohibition on conducting any future NIH-funded research for a period of time is also often imposed.  A finding of research misconduct usually ends the research career of a scientist or physician.  However, when the fraud is blatant or when it involves a large amount of grant money, criminal prosecution may follow.

Contact Health Law Attorneys Experienced with Research Misconduct.

The attorneys of The Health Law Firm provide legal representation to doctors and other scientists involved in research in addition to representing healthcare providers in numerous other matters.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

Have you ever heard of research misconduct? Do you think the scientist received a fair punishment for his research misconduct? Please leave any thoughtful comments below.

Sources:

Pitt, David. “Ex-Iowa State Scientist Gets Prison for Faking HIV Research” Associated Press. (July 1, 2015). From:

http://abcnews.go.com/Technology/wireStory/iowa-state-scientist-prison-faking-aids-research-32161935

About the Authors: Michael L. Smith, R.R.T., J.D., is Board Certified by The Florida Bar in Health Law. He is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

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The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
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