Ethical Justification of Human Experimentation

Despite its many positive outcomes, research often presents significant challenges, and controversies become inevitable when ethical boundaries are tested. One such controversy is the idea of human experimentation. Thus, the question arises: for what purpose and under what conditions, if any, is experimentation on human subjects ethically permissible? To answer this question, it is necessary to understand concepts such as consent, equipoise, and the universal standard of care. 

Consent is an important topic in the discussion of human experimentation. It is a notion of free will, or autonomous decision-making, a vital component of the age-old ethical theory crafted by German philosopher Immanuel Kant: Kantian Ethics. Kantian ethics is rooted in four grounding principles: duty, universalizable maxim, treating others as ends-in-themselves, and rational autonomy. However, the most significant legacy of the four is arguably that of the emphasis on "autonomous will". As such, Kantian Ethics serves as the ethical rationale behind the objective of full transparency between the researcher and the subject so that the subject receives sufficient information to make an informed decision, free of any pressure, on participation. Full consent is often difficult to measure because of factors such as the fact that it's unknown how thoroughly the patient was informed of all risks associated with their study. In addition, simply acknowledging "consent" is not enough. It is the researcher's responsibility to objectively obtain consent, which could mean debriefing the subject about the associated risks and benefits or explicitly making it clear to the subject themselves that they are not aware of everything that could happen. In addition to this explicit transparency, eliminating outside incentives would further solidify that the consent is free from societal pressures and is solely a result of free will. For instance, offering money as an incentive to enlist in a clinical trial violates principles of autonomy and thus is coercive. It is not consent if subjects are motivated by factors such as socioeconomic gain.  

However consent is not always easy to determine accurately, some experts argue that experimentation on humans is not ethical at all. This belief stems from the notion that without knowledge and consent, human experimentation violates ethical principles such as the free-will principle of Kantian Ethics. According to those that subscribe to this belief, a possible solution would be to utilize alternative ways for research such as studying nonhuman animals, human cells, computer modeling, etc. However, humans are complex organisms; scientists and healthcare professionals have yet to truly and completely figure out how the human body works. Thus, trials that work on, for instance, computer models, may not translate back to humans. This makes these alternative solutions unreliable and poses a risk for using and practicing that research on humans. Thus, although the idea to use alternative study methods is valid, it is not a method upon which the scientific community can depend. Human experimentation is still necessary to yield a more accurate measurement and prediction of data. 

Universal standard of care and the practice of equipoise are also important concepts to consider when making a decision about this dilemma. Equipoise is "...the assumption that there is not one 'better' intervention present (for either the control or experimental group) during the design of a randomized controlled trial.” In other words, it exists when there is no positive rational basis for a choice between two options of care. The concept of equipoise is essential to maintaining ethics during an experiment. A universal standard of care essentially indicates that the standard of care in the country where the research is being conducted should match the standard of the sponsoring country. Without a universal standard of care and equipoise, a double standard in research and care emerges, creating an incentive to seek out subjects with the least access to healthcare. Targeting such vulnerable populations violates the Kantian Ethics principle of treating people as ends-in-themselves. This ethical principle denotes that it is important to treat others as though they have "absolute, infinite moral worth". Focusing on someone's socioeconomic status does not treat them in this manner and thus violates the principle. As a result, equipoise and a universal standard of care are crucial to the ethical justification of human experimentation. 

Human experimentation has been a controversial issue for a significant period. Understanding its ethical limitations are crucial to becoming more informed and aware of current situations. One such instance is the rise of the production and distribution of the COVID-19 vaccine. The approved vaccines have been through many levels of human trials to test the vaccine efficacy. Discourse about whether or not this is ethical or even necessary has been ongoing. Understanding the different factors, purposes, and conditions of the ethical justification of human experimentation can allow for discussions to consider the bigger picture and the different multifaceted perspectives before coming to a conclusion.


~Saathvika Diviti '25

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