Ethics of Trials in Healthy Volunteers

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Authors : Orgah Adikwu Emmanuel


Ethics of clinical research have raised many issues of debate. This, according to Friedman et al., (2010) range from the expected professional obligations of physician, whether clinical research is a worthy cause especially when clinical equipoise is in doubt and what research may imply for patients and societal good. Other such related issues of debate include: which should be an appropriate study design, who should serve as the control group, should placebo be allowed, how well informed is informed consent, equitable conduct of trials among disadvantaged/underprivileged societies, the poor, avoidance of exploitation, how conflict of interest could mar research objectives, protection of subjects confidentiality, right of access to data, control of specimens, and publication ethics.

These general issues of ethical debate are largely based on studies involving subjects who are ill and less on those concerning healthy volunteers. This is perhaps because the concept of medical research ethics is focused on safeguarding the physician-patient relationship which inadvertently comes into question when seeking scientific knowledge for health improvement, (Miller and Rosenstein, 2003). It may be perceived also that the history of ethics emanated from the reckless behaviour of some physicians while dealing with their patients. It is therefore perceived that research involving healthy volunteers is less likely to evoke ethical concern since they are not ill, are not imposed with a condition capable of compromising their autonomy and decision-making capacity, and there is no reason for morbidity in their ability to give informed consent. Yet, research involving volunteers have features that can diminish prospective participants’ ability to exercise free and informed choice and the level of uncertainty characterizing this form of inquiry makes subjects vulnerable to harm.

It is expected that healthy volunteers do not experience “therapeutic misconception” hence should not be confused about the differences between being a research subject and being treated for a health condition, (Appelbaum et al., 1987). They are expectedly not under the control of the study physician hence should not feel pressure to participate in research. This notwithstanding, healthy volunteers possess characteristics that could make them subjects of ethical abuse even though perceived as non-vulnerable. The area of ethical concerns arises mostly from the monetary payment to volunteers for inconvenience and lost time (undue Inducement), risk assessment and inappropriate informed consent procedure.


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