Dissecting Clinical Research Misconduct and Fraud

Friday, March 30, 2012

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 the field of medicine. However, many of these researchers instead find themselves defending their reputation after being accused of research misconduct or research fraud.

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. Research misconduct and research fraud can have a major impact on a researcher, and it is very important to consult with an experienced health care attorney if you even suspect that you may be accused of misconduct or fraud. Obtaining an experienced attorney at the earliest stages of an investigation can help the researcher to avoid many pitfalls and mistakes that can harm or even give up defense opportunities the researcher may have. At the very least, legal guidance can assist in presenting the researcher's side of the case in an effective and organized manner that does not compromise a legal defense.
An accusation, even if later proven to be unfounded, may unfairly tarnish the personal and professional reputation of the researcher, cause him or her to lose grants, cause him or her to lose bonuses and promotions and may even lead to termination of his or her employment. There are many additional more serious and far-reaching consequences that may also result including:
  • Suspensions from employment.
  • Termination of employment
  • The requirement to retract a published article or chapter in a book, or certain potions of it
  • Loss of the authority of the researcher to participate in any other government contracting activities (often referred to as "debarment" or exclusion")
  • Reporting to the National Practitioner Data Bank (NPDB) for any individual who is a licensed health professional such as a medical doctor or registered nurse
  • Loss of any future grants by the individual
  • Publication on the research fraud website maintained by the National Institutes of Health (NIH) Office of Research Integrity (ORI)
  • Administrative discipline by the institution overseeing the investigation or research
  • Civil or administrative complaints being bought for the recovery of salaries, bonuses, expenses, fines or costs of investigation
  • Criminal prosecution for fraud, theft or other applicable crimes
To combat any of these consequences, a working knowledge of how research misconduct and fraud procedures are handled is crucial. An experienced attorney will be able to help you navigate your specific situation. 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 fraud accusations, please visit our website for more information at www.TheHealthLawFirm.com.


Response to: Dissecting Clinical Research Misconduct and Fraud
Wednesday, September 5, 2012
Mahesh says:

Not Guilty verdicts does NOT tell you soomene is good. The vast majority, as in just about every, criminal defendant did the act. The test is how his performance as a criminal lawyer reduced their punishment or argued a less offense. Anyone could have an impressive win record, just by taking on the easy cases or offenses that are more commonly easy to beat. You want the lawyer who will take on the hard ones and achieve the best outcome possible from those cases. The best sources of information are other attorneys. You won't find box scores, and they wouldn't mean anything if you did find them. Keep in mind the good ones are expensive. No problem, so long as you have several thousand to tens of thousands lying around.

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