Ethical Issues on Protection of Human Subjects in Biomedical Research Essay (Article)

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Since the invention of biomedical research, a multiplicity of ethical and value questions have arisen, with medical researchers often having the difficulty of locating the accurate balance of answers regarding various ethical compulsions and obligations in particular cases of human experimentation. The article ‘Human Subjects Protections in Biomedical Enhancement Research’ by Maxwell Mehlman and Jessica Berg offers useful insights on how human subjects should be protected ethically in research, especially when commercial benefits seems to take precedence over medical research (Mehlman & Berg, 2008, p. 546). The authors suggest two fundamental steps that can form the criteria for deciding “whether a medical experiment involving human subjects can be conducted in an ethical manner” (p. 546). First, the risks and potential benefits of any medical experiment must be evaluated and ascertained. Second, the issue of attaining the subject’s informed consent must be comprehensively dealt with especially when the research is carried out to improve human capabilities rather than for purposes of finding a cure to some sort of illness.

There are various underlying ethical issues pertaining medical experimentation in human subjects. First, ethical issues surrounding the protection of human subjects can be solved through assessing the risks and benefits of the medical experiment beforehand. In health-oriented research, the fundamental ethical concerns governing human subjects are contained in federal regulations. Investigators and government agencies must be overwhelmingly satisfied that such an experiment will maximize benefits while reducing risks, and that the hazards are within sensible limits in relation to projected benefits (Mehlman & Berg, 2008, p. 547). Investigators will only progress to request informed consent if all the above preconditions are satisfactorily met. The above criteria are also followed in enhancement research (p. 549). However, it may be prudent to employ Weijer and Miller’s strategy of evaluating risk and benefit if the medical research is expressly conducted to gain knowledge – that is, ensuring that the hazards are kept at a minimal, and are sensible in view of the significance of the knowledge to be achieved.

Second, the ethical principle of informed consent is used in the protection of human subjects. According to the article, the process is intended both to enhance individual wellbeing and to facilitate autonomy (Mehlman & Berg, 2008, p. 552). Through informed consent, potential subjects are offered the opportunity to evaluate personal issues along with underlying medical information to come up with unsurpassed choice on whether they are ready to take part in the research. This enhances the subject’s welfare. Autonomy is enhanced by the very fact that individuals are informed beforehand and given time to make rational judgments, thereby permitting them to implement control over their own lives.

Third, vulnerable populations must be protected by adding additional protections to curtail chances of being taken advantage of (Mehlman & Berg, 2008, p. 555). Cases are abound in Africa and other developing nations, whereby medical researchers have been accused of taking advantage of vulnerable populations occasioned by poverty to further their research agenda. According to the article, subjects must be deemed competent enough to make rational judgments on whether to participate in any particular study – medical or enhancement. If the participants are incapacitated, federal laws and regulations that allows for legally endorsed representatives of the subjects to consent on their behalf to participate in the research must be followed. All in all, issues of Risks-benefits analysis, informed consent, and protection of vulnerable populations are at the very core of human experimentation (Mehlman & Berg, 2008, p.555).

Reference List

Mehlman, M.J., & Berg, J.W. (2008). Human subjects protections in Biomedical Enhancement Research. Journal of Law, Medicine & Ethics, Vol. 36, Issue 3, pp. 546-549. Web.

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