Introduction
Conducting research that involves human subjects is highly beneficial for society, but without appropriate regulations, it may result in instances of mistreatment and abuse. All such research is presently governed by various legal and ethical principles to prevent such a situation. Ethics have several practical implications, such as obtaining informed consent, careful assessment of risk and benefits, and appropriate selection of the research subjects.
Informed Consent
The first of the applications of the research conduct principles is informed consent. It is based on the principle of respect for persons, which grants the research participants freedom of choice (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). The Belmont Report (1979) establishes three essential consent elements: “information, comprehension, and voluntariness” (Part C, para. 3). The information that should be disclosed varies, so researchers must adapt accordingly. For instance, Hadden et al. (2017) state that up to 18 elements should be disclosed on the form. The second aspect of consent, comprehension, is complicated for more technical studies. Nusbaum et al. (2017) find that obtaining informed consent is challenging due to the struggle to communicate the research details in an accessible way. Lastly, the researchers should ensure that the decision is “free of coercion and undue influence” (The Belmont Report, 1979, Part. C, para. 11). Consent may be especially challenging in emergency research, where new risks constantly emerge (Kaye, 2022). Kaye (2022) argues for “dynamic consent,” where participants continuously decide whether to re-affirm their participation (p. 8). Hence, the challenges of obtaining informed consent are diverse, and the researchers should constantly adapt.
Risk-Benefit Assessment
The second aspect required of the researchers is to systemically assess the full scope of risks and benefits the study may bring. It is based closely on beneficence, which dictates that persons’ decisions should be respected and their well-being protected (The Belmont Report, 1979). The assessment must provide a comprehensive basis for a balanced decision; in practice, however, ‘balanced’ is an abstract and relative term (The Belmont Report, 1979). Regardless, all researchers must follow the minimum requirements: no brutal or inhuman treatment risks reduced to those necessary, extra justification for high-risk situations, and appropriate justification for working with vulnerable populations (The Belmont Report, 1979). However, most of the reports presented for the ethical review relied on preclinical efficacy studies (PCESs), which seldom referenced any published reports (Wieschowski et al., 2018). Therefore, the early stages of research cause concerns about the effectiveness of risk-benefit assessments, which the investigators should consider.
Research Subjects Selection
Lastly, the selection of research subjects is likewise guided by ethical requirements. The principle of justice emphasizes the “fairness in distribution” of benefits from the research and inclusion appropriate for the given research task (The Belmont Report, 1979, Part. B, para. 11). Furthermore, vulnerable populations, for instance, economically disadvantaged or very ill, should be protected from maltreatment since they are often in a more dependent position (The Belmont Report, 1979). Bentley et al. (2017) underscore the importance of diversity and inclusion in genetic research, stating that it is presently focused primarily on the populations of European descent. As a result, individuals of African and Asian descent are underrepresented in genetic studies, limiting their potential to benefit from scientific advancements (Bentley et al., 2017). Bentley et al. (2017) advise that the researchers build capacity in non-Western nations and incentivize diversity in academia to improve the situation. Overall, researchers should select their subjects fairly, equitably, and culturally sensitive.
Conclusion
In conclusion, the researchers face numerous challenges in studies involving human subjects. Informed consent requires that a participant is not coerced, is aware, and understands all potential implications. The early stages of research require conducting a risk-benefit evaluation, which often relies on unpublished data. Moreover, communicating the risks and benefits to the participants may pose additional challenges if the study is complex. Lastly, the selection of subjects should be made with the consideration of diversity and inclusion principles and the sensitivity to the potential vulnerability of certain socio-economic groups.
References
Bentley, A. R., Callier, S., & Rotimi, C. N. (2017). Diversity and inclusion in genomic research: Why the uneven progress? Journal of Community Genetics, 8(4), 255–266. Web.
Hadden, K. B., Prince, L. Y., Moore, T. D., James, L. P., Holland, J. R., & Trudeau, C. R. (2017). Improving readability of informed consents for research at an academic medical institution. Journal of Clinical and Translational Science, 1(6), 361–365. Web.
Kaye, D. K. (2022). Navigating ethical challenges of conducting randomized clinical trials on COVID-19. Philosophy, Ethics, and Humanities in Medicine, 17(2), 1–11. Web.
Nusbaum, L., Douglas, B., Damus, K., Paasche-Orlow, M., & Estrella-Luna, N. (2017). Communicating risks and benefits in informed consent for research: A qualitative study. Global Qualitative Nursing Research, 4, 1–13. Web.
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Department of Health, Education, and Welfare. Web.
Wieschowski, S., Chin, W. W. L., Federico, C., Sievers, S., Kimmelman, J., & Strech, D. (2018). Preclinical efficacy studies in investigator brochures: Do they enable risk-benefit assessment? PLOS Biology, 16(4), 1–11. Web.
