Conflict of Interest in Clinical Research

Conflict of interest does not merely involve monetary gains or interests.  It may also be manifested in different forms such as personal belief, lack of transparencies, favoritism or special (arranged) care that is not part of the clinical trial protocol (Hamrell, & Dombey, 2012).  Therefore, conflict of interest may skew the fair process of impartial or unbiased decisions in clinical research (Nabel, 2006). Nevertheless, potential conflict of interests may not automatically forbid anyone from conducting a clinical research or trial. However, the conflicts must be a “disclosed event” to the appropriate institutional review board (IRB) and responsible parties (Hamrell, & Dombey, 2012).  For this reason, principal investigators are obligated to disclose some personal information to the sponsor(s) and the IRB before any clinical trial involving human subject begins.

The process involved in minimizing conflict of interest in clinical research demands higher integrity in scientific research.  To this effect, many  scholars have gone further to suggest a disclosure of family ties or prohibition of the principal investigator’s participation in a clinical trial if his or her immediate family members have any form of financial investments or interests in the trial in question (Lo, Wolf, & Berkeley, 2000). Perhaps, based on the inherent possibility of bias opinion associated with conflict of interest, it is reasonable to have disclosure-transparency, as a part of clinical study’s ethical standards.

In most clinical studies, violation of ethical code of conducts stemmed from the lack of biased-free environments, and conflict of interests.  Hence, consistency with experimental protocol is very important to avoid nexus bias in data collection and analysis unless when subject’s life is at immediate danger. Therefore, in order to protect human subject fairly in a clinical trial, and post-approval integrity, safety and efficacy of the medicinal product in question, principal investigators must maintain bias-free principles in conducting clinical research.

References

Hamrell, M., & Dombey, S. (2012). Scientific Integrity. Walden DVD. Retrieve from http://sylvan.live.ecollege.com/ec/crs/default.learn?CourseID=6493792&Survey=1&47=10828390&ClientNodeID=984640&coursenav=1&bhcp=1.

Henney, J. E. (2000). Human subject protection and financial conflicts of interest [Speech]. U.S. Food and Drug Administration. Presented at the National Institutes of Health, Bethesda, MD. Retrieved from http://www.fda.gov/NewsEvents/Speeches/ucm054199.htm.

Lo, B., Wolf, L. E., & Berkeley, A. (2000). Conflict-of-interest policies for investigators in clinical trials. The New England Journal of Medicine, 343(22), 1616–1620. Retrieved  from http://ezp.waldenulibrary.org/login?url=http://proquest.umi.com.ezp.           waldenulibrary.org/pqdweb?did=64762462&sid=1&Fmt=4&clientId=70192&RQT=309&VName=PQD.

Nabel, E. G. (2006). Editorials: Conflict of interest—or conflict of priorities? The New England   Journal of Medicine, 355(22), 2365–2367. Retrieved from http://ezp.waldenulibrary.org/login? url=http://proquest.umi.com.ezp.waldenulibrary.org/pqdweb?did= 1173810731&sid=2&Fmt =4&clientId=70192&RQT=309&VName=PQD.

ORI. (2012). Handling Misconduct. Retrieve from http://ori.hhs.gov/handling-misconduct.

Rhoades, L. (2004). New Institutional Research Misconduct Activity. ORI. Retrieve from

http://ori.hhs.gov/handling-misconduct.