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The ethical issue of conducting medical research and testing new treatments has been a hot topic for many decades. Despite the need for such processes, various aspects present controversial arguments about testing methods. People who are wholly or relatively unable to protect their interests fall into vulnerable categories. Often, vulnerable populations, such as African Americans, low-income citizens, or prisoners, are subjected to experimental treatments and technologies. These people are at increased risk because of harmful historical stereotypes, complex forms of consent, and treatment without consent or knowledge of the experiment.
Historical Context
It is important to understand that historical hindsight has found considerable evidence of abuse of vulnerable populations for the sake of experimentation. The first factor contributing to the proliferation of experimental medical research on vulnerable people is its historical perception, especially of African Americans. This issue has been present in medical practice since the 15th century, according to Washington, who states that the painting depicts “the transplantation of a black leg onto a white body” (2008, p. 354). The emphasis on color depicts the importance of one person over another and the concealment of information about whether another person is dead or alive. The idea of the possible sacrifice of one person to save a white person’s life remains important throughout the continued development of experimental research. In addition, in history, the notion that African Americans were “cheaper” participants in experiments created a general belief that they were easier to recruit to research.
Modern clinical research should be more adequate for all people and respect the rights of each participant equally in all countries. However, stereotypical methods continue to evolve; Kelly argues that “developing countries with a wide range of vulnerable populations. are often economically profitable places” to conduct scientific experiments and human trials (2013, p. 1). Thus, regardless of society’s outdated perceptions, the high involvement of black people in clinical trials is proof that it remains relevant in today’s developed world. Washington and Kelly’s arguments are valid in that in every time period, vulnerable groups have been involved in dangerous experiments that scientists have not concealed.
Consent and understanding of the experiment
Understanding the historical context reveals not only a lack of consent but also a lack of awareness among vulnerable groups about life-threatening experiments being conducted. This issue is discussed by Kelly, who states that “in India in 2003, eight subjects died while testing the anti-clotting drug streptokinase” without knowledge of the experiment or their participation (2013, p. 2). Similarly, Washington (2008) highlights the evidence of non-consensual testing in Zinsser’s memoir, which explains that a person can be falsely arrested and forced to consent to various medical experiments under threat of prison. Participants in such an experiment could be anyone who does not fall into the category of more vulnerable citizens. Yet anyone who does not fall into the category of more vulnerable citizens can become a participant in such an experiment. In so doing, their evidence underscores the urgency of the problem of racism and social insecurity of the most vulnerable groups.
Research suggests that the choice of medical treatment varies according to racial characteristics and social status. For example, the development of a blood substitute was developed and widely used after approval only in South Africa and for testing on black patients in emergency departments, resulting in an experiment involving “21,000 patients without asking their permission” (Washington, 2008, p. 353). Another group of people are prisoners who have been involuntarily involved in various tests throughout the 20th century. Nevertheless, there is no evidence of a process of legalization of experimental medical procedures that were performed on patients. So, the issue of consent still exists, especially among people of color and in developing countries, and earlier in history, the same pattern could be seen among prisoners.
Complicated Consent Form
Consent is the form that must be filled out and signed that the testers were given the legitimate right to use groups of people for experiments. In addition, most consent sheets present a set of procedures that contain complicated wording that can be confusing, as well as additions that carry persuasive functions. Understanding the purpose of the study, the role of the participants in the study, and how the study will be used can create some difficulties. As a result, obtaining informed consent can be challenging, and extra attention needs to be given to developing the right communication tactics. The problem is that a person who agrees to participate in a clinical experiment has a vague understanding of the process and is strongly influenced by the consent form presented by the company.
For example, Washington, in analyzing Quinn’s case, states, “Other elements of the AbioCor consent form can be read as encouraging the hopes that Quinn held” (2008, p. 350). In addition, various theoretical analyses have proven that consent forms use many complex terms and professional jargon to shift the focus on benefits and downplay potential risks.
Moreover, the creation of consent forms is highly dependent on the overall healthcare environment. For example, although ethics boards are able to review and identify unethical behavior occurring in medical trials around the world, accountability is difficult because “many research projects involve pharmaceutical research corporations working together to conduct research” (Kelly, 2013, p. 4). This connection makes it difficult to identify the perpetrator for prosecution.
Potential Solutions
Changing benefit-risk ratios and increasing real and expected risk with decreasing benefits to vulnerable populations would keep the latter out of the trial groups or discontinue future participation until the problem is thoroughly addressed. The priority of healthcare leaders should be to protect their rights, well-being, and safety with an assessment of the vulnerability, confidentiality, and safety of vulnerable individuals and additional measures taken. The understanding and assessment of threats to these populations globally in relation to the level of societal acceptance and risk quantification is currently lacking uniformity and fairness due to various factors, “making it difficult to establish protections in biomedical research that benefit the medical society” (Kelly, 2013, p. 3). In addition, there is a need to consider the accessibility of new medical technologies and treatments to the classes used to test new techniques. Appropriate programs need to be established to enable more people, especially in developing countries, to use medical procedures after clinical trials or research (Washington, 2008). Furthermore, prisoners must be treated with respect as normal test subjects because their situation limits their freedom to consent or refuse.
At the same time, all information about foreseeable possible harm must be included in consent documents in a clear and understandable manner. Researchers need specific advice from the authorities about the practical problems encountered in conducting different kinds of research. The current situation requires competent, knowledgeable, and sensitive researchers to guide conscientious groups in treating vulnerable groups with care, patience, respect, and fairness while allowing free will and avoiding seduction, encouragement, insensitivity, or discrimination. Whether privately or publicly funded, clinical research must reflect the long-term interests of society within the parameters of the procedure and the guidelines. Improved attitudes and approaches to such sensitive research could come from increased awareness among scientists, especially the media and the public. Medical research is evolving and becoming increasingly complex, hindering the creation of complete, reliable monitoring systems by obscuring the differences between potential risks and benefits.
References
Kelly, S. (2013) Testing drugs on the developing world. The Atlantic. Web.
Washington, H. A. (2008). The machine age. Medical apartheid: The dark history of medical experimentation on black Americans from colonial times to the present. (pp. 347-358). Anchor.
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