Ethics of Obtaining Data for Clinical Research

Introduction

The research of scientific papers conducted on the topic of ethical issues is of value. This is since obtaining this information can help prevent ethical problems in the future when working with patients. Particular attention should be paid to the problems of ethics in the treatment and research on patients with hepatitis and syphilis. The reason is the scrupulous nature of these diseases, thereby the examination of literary sources becomes of particular importance. To acquire the necessary data, this academic work will analyze the articles of Krugman, Edwards, Beecher, and the National Commission document. This procedure plays an important role in obtaining data for further research.

Rationale for the Studies

The first aspect that will be investigated in this paper is the researchers’ rationale for implementing and carrying out Willowbrook hepatitis research and the Tuskegee syphilis studies. This is since Willowbrook State School is one of the main initiators of conducting experiments related to the study of hepatitis. However, a study by Krugman (1986) notes the questionability of the ethical aspect of the examination data, which may cause concern. Therefore, it is necessary to consider the reasons that were identified for creating the scientific work. One of the first justifications that was identified is equating hepatitis with an epidemiological disease. It was noted that the “patient population increased from 3,000 in 1953, 4,000 in 1955, and eventually exceeded 6,000” (Krugman, 1986, p. 158). Thus, the ever-increasing number of patients in Willowbrook forced the institution to take action to investigate the causes of such a situation.

The second article, which reasons and justifications for conducting an experiment on syphilis patients require special attention, is the Tuskegee Syphilis Study written by Edwards in 1973. This work was engaged in the analysis of scientific paper on patients with untreated venereal disease among the black population in Alabama (Nix, 2017). The rationale for this examination was to obtain information about the nature of the disease, comparing the course of the disease depending on the presence or absence of treatment (Edwards, 1973). Moreover, it was intended to provide valuable data for creating programs to limit the occurrence of syphilis among black population of low-income.

Ethical Problems Inherent in the Research Protocols

Consideration of the ethics of conducting research is one of the decisive issues when it comes to the degree of trust. Compliance with ethical principles determines the entire course of academic work and helps to achieve the most successful results (Zhang, 2017). Willowbrook hepatitis experiments became the basis for a debate on the proposed topic since some aspects of the experiment may be interpreted as unethical. However, the author emphasizes that during conducting of the process involving children, the consent of their parents and guardians was collected, and the principles of the correct attitude to the subjects and the conditions of the study established in the organization were observed. Despite this, actions to violate the safety of the health of the subjects at their risk of hepatitis infection became morally wrong concerning minors. Thus, ethical violations occurred because children did not receive any benefit from the results of the study but, on the contrary, were exposed to danger.

The second scientific experiment of the Tuskegee syphilis study can be criticized when considering problems in the research protocol. The most critical issue, which represents a crucial violation for a medical institution and a threat to the health of the subjects, is the absence of a fully formed protocol for the experiment. Moreover, the lack of informed consent on the part of the participants is superimposed on this fact, which is a grave mistake and a problem on the part of the researchers (Edwards, 1973). This is because the participants of the scientific work carried out are exposed to the possibility of infection with the disease in question.

Biomedical Ethical Principles

The next important step in this research work is the discussion of biomedical ethical principles that must be observed in healthcare. The basis of this analysis is the study of the Belmont Report, which provides a justification for their use in practice. First of all, it is necessary to gain an understanding of what the basic biomedical principles are. These aspects of the study include the principles of respect for persons, beneficence, and justice (National Commission for the Protection of Human Subjects, 1979; Siddiqui & Sharp, 2021). Further, the research work will consider these main features in more detail.

Such a principle as respect for a person implies treating the patient as an autonomous individual who can make decisions. It is worth noting that biomedical ethical principles are closely interrelated with generally accepted ethics (Artal & Rubenfeld, 2017). In cases where patients may be deprived of such an opportunity, they are entitled to be protected by a healthcare institution. In other words, in practice, this aspect is expressed in providing people with full awareness of their treatment and the necessary procedures and conditions for conducting a study so that they independently decide to agree to it or not.

The second biomedical principle is to provide not only freedom of choice but also the implementation of actions to preserve the well-being of patients. The report highlights such rules as “do no harm and maximize possible benefits” (National Commission for the Protection of Human Subjects, 1979, p. 5). In practice, it is expressed in the compilation of such a scientific experiment that will bring only positive results for participants, such as finding ways to treat hepatitis or syphilis.

The last principle that requires special attention is the provision of justice. This aspect consists of the fair provision of medical care to all patients. Refusal to provide health care services is possible only if rational reasoning is provided (Beecher, 1966). When applying this biomedical ethical principle in practice, an example from the election of experimental participants can be considered. Therefore, it is essential to take into account the choice of objects depending on the frequency of selection or easy accessibility (National Commission for the Protection of Human Subjects, 1979, p. 5). Consequently, all members of the studied groups should be selected based on the topic derived from the scientific work. In relation to medical practice, justice is considered as granting equal rights when providing the opportunity to receive treatment and medicines.

Conclusion

In conclusion, this work investigated the importance of ethical principles in the example of two scientific papers that conducted experiments on analyzing diseases such as syphilis and hepatitis. The main problems were the lack of informed consent, not ensuring the usefulness of the results for the subjects, and the lack of a research protocol. Moreover, biomedical ethical principles were analyzed, the consideration of which is of critical importance. All these issues make it necessary to spread awareness about the importance of observing the rules of ethics in scientific research.

References

Artal, R., & Rubenfeld, S. (2017). Ethical issues in research. Best Practice & Research Clinical Obstetrics & Gynaecology, 43, 107-114. Web.

Beecher, H. K. (1966). Ethics and clinical research. Biomedical Ethics and the Law.

Edwards, C.C. (1973). Final report of the Tuskegee syphilis study ad hoc advisory panel. Public Health Service.

Krugman, S. (1986). The Willowbrook hepatitis studies revisited: ethical aspects. Reviews of Infectious Diseases, 8(1), 157-162. Web.

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.

Nix, E. (2017). Tuskegee experiment: The infamous syphilis study. History. Web.

Siddiqui, W., & Sharp, R. R. (2021). Beyond the Belmont Report. The American Journal of Bioethics, 21(10), 1-4. Web.

Zhang, J. J. (2017). Research ethics and ethical research: some observations from the Global South. Journal of Geography in Higher Education, 41(1), 147-154. Web.

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StudyCorgi. 2023. "Ethics of Obtaining Data for Clinical Research." May 14, 2023. https://studycorgi.com/ethics-of-obtaining-data-for-clinical-research/.

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