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Unethical Research

In: Business and Management

Submitted By bttct1987
Words 629
Pages 3
Business Research Ethics
Byron C. Nelson
March 2, 2013
RES 351
University of Phoenix
Prof. Lara Lucas

Unethical Research
Two employees of Lee Research of Lenexa Kansas were indited for falsifying research information. The research company was contracted by Schering/Plough, a subsidiary of Mereck & C, to conduct clinical trails of a new allergy medication. The trials were conducted from January 2010 to May 2010. Dr. Wayne Spencer, a licensened physician and the principle investigator of the study, along with Lisa Sharp, the director of clinical trials at Lee Research Institute were named in the inditement.Dr. Spencer and Sharp were each charged with one case of conspiracy, three counts of mail fraud, and one count of falsifying information required by the Food and Drig Administration (Pharmalot.com, 2011).
Dr. Spencer and Sharp were terminated by Lee Reasearch Institute following the inditements. Lee Research Institute immediately started an internal investigation of the alledged insedence in cooperation with the Food and Drug Administration and Schring/Plough (Kansas City Business Journal, 2011).
The indictment accuses the two former employees of providing false information of the patients participating in the study trials. The study was to be conducted using subjects 50 years old or greater who suffer from ragweed allergies. Employees of the contracted research organization were prohibited from participation in the case study. Dr. Spencer and Sharp are accused of falsifying the information of the participants. Eight individuals participated in the case study. The researchers stated all eight met the requirements of the study (Pharmalot.com, 2011).
Two of the participants were not over the required age of 50 and were employees of the contracted research organization. The indictment alleges that Dr. Spencer and Sharp reported to the Food and Drug Administration that all participants were over 50 years of age and provided false names and physical informaton of the two ineledgable participants. They had also arrainged for the two participants to have office visits while the Director was at lunch in order to conceal their participation. (Pharmalot.com, 2011).
“Throughout the investigation by Schering/Plough and the federal authorities, the company has been advised by the investigating officers that no wrongdoing of any sort has been found on the part of the company,” the statement reads. “In fact, the indictment itself alleges that the individuals involved took great pains to hide their actions from the company. The company continues to fully cooperate in ongoing investigations.” (Kansas City Business Journal, 2011)
Dr. Spencer and Sharp if convicted of the charges in the indictment could face up to five years in prison for the conspiracy charges and up to $250,000 in fines. For each mail fraud charge the individuals face up to 20 years in prison and $250,000 in fines. For providing false information to the Food and Drug Administration they each face three years in prison and fines up to $10,000 (Kansas City Business Journal, 2011).
Conclusion
The unethical research behavior that was involved was the falsifying of research information and the reoprting of that information to the Food and Drug Administration and to the contracting company. Had the findings from the research been utilized by the pharmacutical company as to potiental risks associated with the use of their products many people to have suffered from the misinformation. Potiental harm to Lee Research Institutes reputation could have effected its ability to continue to function as a contracted research organization in the pharmacutical industry. Ethical behavior on the part of the two individuals conducting the research would have avoided the situatuation.

References:

(2011, June). Retrieved March 2, 2013, from Pharmalot.com: http://pharmalot.com/2011/06/cro-employees-indited-for-falsifying-study-data/
(2011, June 2). Retrieved March 2, 2013 , from Kansas City Business Journal: http://bizjournal.com/kansascity

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