Tag Archives: clinical trials

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.

KeyWords: research misconduct, attorney, research fraud defense, misconduct in science, clinical investigation fraud defense attorney, National Institutes for Health, NIH, fraud defense lawyer, medical investigation, clinical research fraud, clinical trials, grant fraud, institutional review board investigation, IRB, misconduct in science committee, MISC, defense counsel, data falsification, researcher’s attorney

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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Consequences of Clinical Research Fraud and Misconduct

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

Medical and clinical researchers, whether in an academic community or in a practice setting, spend years on clinical trials and investigations in hopes of contributing to their respective fields. Many of these researchers, however, find themselves defending their reputation after being accused of research fraud or research misconduct.


Why Researchers are Accused of Misconduct.

Although accusations of research fraud and misconduct 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.

Researchers Face Many Difference Accusations.

The most common accusations against researchers include: manipulating or concocting research data, failing to disclose financial interest or not properly disclosing conflict of interest, plagiarizing, failing to present data that contradicts one’s own previous research, overlooking the use of flawed data, and circumventing certain minor aspects of human-subject requirements. Researchers also face an enormous amount of pressure from funding sources. That influence on a researcher can lead to these accusations: changing the design, methodology or results of a study to meet a funding source’s expectations, ignoring details or cutting corners to meet a deadline, fabricating, falsifying or mishandling of data to gain some form of reward or benefit.

A Person and Professional Reputation can be Tarnished.

An accusation, even if later proven to be unfounded, may unfairly tarnish the personal and professional reputation of the researcher, cause the researcher to lose grants, bonuses and promotions, his or her employment may be terminated, or may even face criminal prosecution for fraud, theft or other applicable crimes.

To learn more on clinical research fraud and misconduct, click here.

Well-Known Cases of Research Fraud and Misconduct.

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

From 1992 to 2002 a former research professor in Vermont falsified and fabricated data in numerous federal grant applications and academic articles. He used two million dollars in government grants – taxpayer money – for studies to perpetrate his fraud. He pled guilty to falsifying 17 grant applications to the National Institutes of Health (NIH) and fabricating data in 10 of his papers. He was ordered to serve one year and a day in federal prison, permanently barred from ever receiving more federal research grants, and ordered to write letters of retraction and correction to a number of scientific journals.

A prominent Massachusetts anesthesiologist admitted to fabricating 21 medical studies that claimed to show benefits from painkillers like Vioxx and Celebrex, according to the hospital where he worked. This data used in the studies was published in several anesthesiology journals between 1996 and 2008. This doctor was sentenced to six months in prison, followed by three years of supervised release. He was ordered to pay a $5,000 fine, forfeit $50,000 to the government and make $360,000 in restitution to pharmaceutical companies. The plea deal effectively ended his career as a physician.

Visit the Office of Research Integrity (ORI) website to learn more on research fraud and misconduct.

Contact Health Law Attorneys Experienced in Clinical Research Fraud and Misconduct.

The Health Law Firm and its attorneys have experience in representing researchers, investigators, academicians and clinicians who are the subject of clinical research fraud and misconduct. The Health Law Firm and its attorneys also have experience in representing students, employees, researchers, investigators and “whistle blowers” who report such matters including those who become the victim or reprisals and retaliation by the person against whom the report is made.

Don’t wait. Obtain the advice and counsel of experienced attorneys who are familiar with such matters and can assist you before it is too late.

If you are facing research misconduct or research fraud accusations, please visit our website for more information at www.TheHealthLawFirm.com or call The Health Law Firm at (407) 331-6620 or (850) 439-1001.

Sources:

“Grantee Misconduct: Dr. Eric T. Poehlman.” National Institutes of Health. (March 7, 2012). From: http://www.nih.gov/news/granteemisconduct.htm

Arak, Joel. “Menopause Doc Fudged Data.” CBS Evening News. (February 11, 2009). From: http://www.cbsnews.com/2100-18563_162-703359.html

Interlandi, Jeneen. “An Unwelcome Discovery.” The New York Times. (October 22, 2006). From: http://www.nytimes.com/2006/10/22/magazine/22sciencefraud.html?pagewanted=all

Winstein, Keith and Armstrong, David. “Top Pain Scientist Fabricated Data in Studies, Hospital Says.” The Wall Street Journal. (March 11, 2009). From: http://online.wsj.com/article/SB123672510903888207.html

About the Authors: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.

Michael L. Smith, J.D., R.R.T.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.