Science Journal Retracts Stem-Cell Research Studies; Head Researcher Held Accountable

Tuesday, July 15, 2014
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The scientific journal, Nature, retracted two high-profile stem-cell research studies due to signs of inadequate data and plagiarism. According to Tech Times, researchers from the RIKEN Center for Development Biology in Kobe, Japan, published results on January 30, 2014, claiming that scientists of the institute had successfully reprogrammed mature cells into young stem-cells.

The stem-cells, a type of cell capable of differentiating into any human cell type, were allegedly created using an innovative, never-before-seen technique. The technique utilized elements of physics as opposed to the embryo-destructive genetic manipulations currently used.

To read the full article from Tech Times, click here.

The alleged results of this study gained a lot of attention in the regenerative medicine community. If the findings were true, this study would have been groundbreaking for the future of stem-cell research.

We have also written previous blogs discussing clinical research misconduct and fraud. To read another blog, click here.




The Alleged Breakthrough Stem-Cell Discoveries.

The study reported that after soaking the cells in an acid bath and then spinning them in a centrifuge, the results were younger, embryonic-like cells capable of manipulation. The study nicknamed these cells "Stimulus-Triggered Acquisition of Pluripotency," or STAP stem-cells. This specific strain of stem-cell would make it possible for replacement tissues to be created from a patient's own cells, thus preventing an attack on the immune system. Since the cells would be patient-specific, the need for immune-suppressing drugs could be eliminated. In addition, embryos would go unharmed and DNA manipulation would be unnecessary, two highly controversial factors in the stem-cell research debate.


The Questions Circling This Study.

The formal studies concluding such results were retracted due to figure errors, plagiarized descriptions and failed replications of the study. Within days of the studies' results being published, numerous scientists in the field of regenerative medicine came forward with questions of errors and plagiarism. The published study gained suspicion after numerous laboratories could not duplicate the claimed results.

The head researcher of the study agreed to a formal investigation by the RIKEN Institution. The investigation found discrepancies of data entry and oversight. This led to an author of the study being found guilty of misconduct, and the head researcher was accused of intentional misconduct.


What Constitutes Research Misconduct?

Medical and clinical researchers dedicate years and endless resources in the hope of contributing to the field of medicine. Unfortunately, it isn't uncommon for these researchers to find themselves defending their reputations and careers over accusations of research misconduct or fraud.

Researchers accused of such misconduct could potentially be the victim of a misinformed whistleblower, disgruntled former employees, the target of institutional politics, or the victim of an individual with ulterior motives. Regardless of the source, such accusations can be career threatening. Typically a researcher accused of misconduct or fraud will be accused of one of the following:

-    Manipulating or fabricating research data;
-    Failing to disclose a financial interest or not properly disclosing a conflict of interest;
-    Plagiarizing or using another's ideas without obtaining permission or giving due credit;
-    Failing to present data that contradicts one's own previous research;
-    Overlooking the use of flawed data or questionable interpretation of data;
-    Circumventing certain minor aspects of human-subject requirements;
-    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; and/or
-    Fabricating, falsifying or mishandling of data to gain some form of reward or benefit.



The Consequences of Research Misconduct.

Medical research misconduct and fraud are extremely grave accusations that could destroy your reputation and career. In the RIKEN stem-cell research misconduct case, the researchers' reprimand included retraction of their published findings, which is a detrimental blow to their reputations in the medical research community. Other consequences of similar cases could include job termination, loss of grants, exclusion from further research projects, placement on the debarred list (prohibiting future government funded research, employment or contracts) and even criminal prosecution.

The Office of Research Integrity (ORI) under the U.S. Department of Health and Human Services (HHS) maintains a publically accessible archive of case summaries in which administrative actions were imposed based on findings of research misconduct. This database can be accessed by clicking here.


Comments?


Have you ever been questioned for research misconduct or fraud? Do you believe such accusations can be career ending? Please leave any thoughtful comments below.


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


In order to combat such destructive accusations and avoid major punishments, it is critical to have a legal representative present on your behalf in an effective manner that does not compromise a legal defense. The Health Law Firm attorneys, through years of experience, have obtained the knowledge and skills necessary to navigate research misconduct cases. An accusation of research misconduct, even if later proven to be incorrect, may unfairly tarnish your professional reputation. Legal guidance and experienced insight are invaluable when it comes to protecting the time and efforts you have put forth in building a sustainable and impacting career.

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


Sources

Shah, Tina. "Nature journal retracts papers on 'breakthrough' stem cell discovery after discovering 'critical errors'." Tech Times. (July 6, 2014). From: http://www.techtimes.com/articles/9625/20140706/nature-journal-retracts-papers-on-breakthrough-stem-cell-discovery-after-discovering-critical-errors.htm

Kaplan, Karen. "Science journal retracts notable stem cell studies." Orlando Sentinel. (July 3, 2014). From: Orlando Sentinel Newspaper, News Section, Nation & World, Page A3.


About the Author: 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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7/15/2014

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