Term Paper on "Healthcare Research Ethics"

Term Paper 4 pages (1377 words) Sources: 3

[EXCERPT] . . . .

Healthcare Research Ethics

Briefly describe the case and the ethical issues at stake.

In March 2006, U.S.-based Parexel International initiated a research study in Britain intended to support the approval of TGN 1412, a new anti-Rheumatism drug. The research was conducted in a private London research facility pursuant to the approval by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). The drug had already been tested in animals, revealing no significant side effects (Kenter & Cohen, 2006). However, during phase I clinical trials, it was administered to six healthy research volunteers in whom it caused serious and potentially fatal multi-organ failure that required immediate emergency medical treatment and subsequent intensive care. While all of the subjects survived, one subject lost several fingers and toes to amputation as a result of the side effects of the drug (Kenter & Cohen, 2006).

According to post-trial analysis, the consent from presented to study participants failed to provide adequate information about the nature and extent of the potential side effects of the new drug (Kenter & Cohen, 2006). More specifically, data detailing possible differences between the potential effects of the drug on humans and animal research subjects was not disclosed t the MHRA prior to application for approval of the study (Kenter & Cohen, 2006).

Of the ethical principles you learned about this week, which do you think were breached by the researchers or organizations in this case? Why do you suppose this happened?

The two specific ethical violations represented by this study were (1) the failure of the research organization to provide all of the relevant data to the MHRA during the pre-approval phase, and (2) the inadequate information available to prospective study subjects in the consent forms used for the study. The reason for the first ethical violation likely was that the researching organization did not want to compromise or delay the approval of the study. Since the additional information was available but withheld from the approving entity at the time the study was being considered for approval, it was inexcusable. Likewise, the failure of the researcher to disclose the nature and full extent of all of the possible side effects to the prospective study participants undermined the ethical validity of the consent forms. In principle, consent forms cannot fulfill their intended purpose to the extent they fail to disclose relevant considerations and possible consequences to prospective study participants (Wolf, Walden, & Low, 2005). In this case, the impact of this ethical violation was compounded by the failure of the approving organization to adequately review the consent forms (Kenter & Cohen, 2006).

Suggest how the research might have been conducted to avoid or minimize the ethical problems. What benefits might have been lost as a result? Why is this a good trade-off?

In this example, the research could have been conducted in a much safer and ethically appropriate way. First, the research organization should have made all of the relevant data available to the approving organization for an objective determination of their potential significance. Second, the researchers should have made sure that the informed consent forms fully fulfilled their intended purpose by disclosing the full range, nature, and extent of the possible risks to prospective study participants. In this case, no benefits of the study would have been lost if it was approved. However, the tradeoff to the researcher would have been either the failure to obtain approval for the study or the failure to obtain enough study participants. Both of those scenarios would have been preferable and the human benefit of fulfilling the ethical obligations would have been preventing a dangerous study or, at least, permitting sufficient information to allow fully informed prospective study participants to make decisions in their best interests.

References

Kenter, M.J.H. And Cohen, A.F. "Establishing risk of human experimentation with drugs: lessons from TGN1412" Lancet, Vol. 386 (2006): 1387-91.

Olsen, D., Wang, H., and Pang, S. "Informed consent practices of Chinese nurse researchers." Nursing Ethics, Vol. 17, No. 2; (2010): 179 -- 187. Retrieved from:

http://ezp.waldenulibrary.org/login?url=http://search.ebscohost.com/login.aspx?di rect=true&db=rzh&AN=2010582175&site=ehost-live&scope=site.

Wolf, L. E, Walden, J.F., and Lo, B. "Human subject issues and IRB review in practice-based research."… READ MORE

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