Introduction
Research on humans is integral for progress in different disciplines, including medicine, psychology, and sociology. However, such studies should take into account the ethical dimensions for conducting an experiment. In addition, proper procedures should be followed to ensure that the outcome is justifiable and upholds the dignity of participants (Prostran, 2018). Regrettably, most of the studies which were done before the formation of the institutional review boards (IRBs) used small samples of vulnerable populations without adhering to any moral codes. As a result, there were instances of abuses, scandals, and tragedies, some of which were legally resolved in courts (Prostran, 2018). The objective of this paper is to summarize and discuss the ethical issues in “Moore v. Regents of the University of California.”
Summary of the Case
The case of Moore v. Regents of the University of California (S006987) mainly concerns the commercial use of human tissue without consent. The plaintiff, John Moore, was under treatment for hairy-cell leukemia when the physicians, comprising of five defendants, at UCLA Medical Center realized that they could have monetary benefit from Moore’s blood and other tissues. By failing to disclose the extent to which the body fluids of the patient were being used, the doctors did not provide proper informed consent.
The plaintiff alleged that he had property interests for the tissue and spleen that the defendants had used in their commercial medical research. The judges opined that physicians failed in their responsibility to protect the patient due their personal interest, which negatively affected the doctors’ judgment. The court of Appeal ruled that property rights existed, but this was overruled by the Supreme Court (Spector-Bagdady et al., 2018). However, it held that physicians have a fiduciary duty to tell a patient of any personal interest in the treatment.
Vulnerability of the Patient
There are many studies conducted which involve vulnerable populations whose integrity cannot be fully protected. As stated by Prostran (2018), such people have limited capacity to give consent due to absence of power or choice. When conducting studies on such populations, it is important to ensure the efficacy of the research as well as the safety of the persons involved. Moore was a vulnerable person because he had a chronic health condition and needed treatment from the experts. Given that he was not vastly informed on the nature of his sickness, he had to agree with whatever the physicians said would promote his health.
Resulting Legislation
Although there were no law adjustments, the Moore v. Regents of University of California battle has contributed to creation of awareness on patient’s rights in clinical studies. In his book, Next, Michael Chrichton extrapolates the possible legal implication following the experience of Moore (as cited in Zielinski, 2017). There has also been publication of a book and production of a film, both titled The immortal life of Henrietta lacks, which focuses on studies with patients diagnosed with cancer (Zielinski, 2017). In addition, Guerrini et al. (2019) has published a scholarly article stating that since the clinical researchers and the authors demand for patents and copyrights, the patients whose tissues and other bios are used should also be compensated. Such studies help to prevent possible violation of patients’ rights to an informed consent.
Violation of Human Rights and Societal Benefit of the Case
Gross violation of human rights is evident in the case but there are equally various benefits which the medics and other members of the society can gain. As stated by Simpson and Innes (2020), “in soliciting the patient’s consent, a physician has a fiduciary duty to disclose all information material to [that] patient’s [informed] decision” (p. 6). Therefore, the physicians failed to observe this right by taking samples of the patient’s blood and tissues without disclosing its use for commercial research.
The principle to do no harm to the patient was also violated because the defendants took more samples than was required for the patient. In addition, since the doctor treating Moore also had some commercial interest in the study, his judgment in treating the patient was negatively affected. However, the fact that the issue was solved in the supreme court helped to create awareness for people following the case. Most citizens now know their rights and can ask the medics to explain the intention of any bio procedure.
Current Requirements for Human Research
The researcher has a duty to disclose their profession, qualification, and objective of the study to the respondents. The objective is to ensure that rogue people are not involved in investigations which can potentially harm the participants (Simpson & Innes, 2020). It is also necessary for informed consent to be provided at every stage of the research. Notably, some patients may belong to a vulnerable population due to power restrictions, such as minors or choice limitations; for instance, the mentally ill. In such cases, the parents or guardians can provide the signature if they verify that the study is relevant. Researchers must always ensure that no harm is incurred by the participant and that the results from the study will benefit the population.
Conclusion
Research studies done on humans are necessary and may increase in the future due to the need to expand knowledge. However, it is important that the interest of the participants is always safeguarded to prevent the unethical practice. Moore was not provided with informed consent despite his tissues being used for a commercial research. He also had to endure the pain of having more of his blood and other bios taken as a sample under the pretense that it was for his treatment. The case was painful but has helped to spread awareness on the rights of participants. Future reforms should consider ownership interest for the donors and property rights.
References
Guerrini, C. J., Lewellyn, M., Majumder, M. A., Trejo, M., Canfield, I., & McGuire, A. L. (2019). Donors, authors, and owners: How is genomic citizen science addressing interests in research outputs? BMC Medical Ethics, 20(84). Web.
Prostran, M. (Ed.). (2018). Clinical trials in vulnerable populations. Books on Demand.
Simpson, J. K., & Innes, S. (2020). Informed consent, duty of disclosure and chiropractic: Where are we? Chiropractic & Manual Therapies, 28(60). Web.
Spector-Bagdady, K., De Vries, R., G., Gornick, M. G., Shuman, A. G., Kardia, S., & Platt, J. (2018). Encouraging participation and transparency in biobank research. Health Affairs, 37(8), 1313-1320. Web.
Zielinski, S. (2017). “Fair” use of our cells. Smithsonian Magazine. Web.