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Sample Dissertation Paper on Ethics of Using Human Subjects in Clinical Trials
Since the Tuskegee Project involving the use of human subjects in clinical trials, there have been various concerns related to the ethics of working with human subjects in clinical trials. The ethical concerns revolve around respecting human dignity and engaging in acceptable treatment of human subjects and the reliability, validity, and credibility of research findings. Ethical considerations in research cannot be ignored. They are critical in studies involving human subjects due to the sanctity of human life and the need for respect to human rights across a broad spectrum. Adherence to ethical guidelines when working with human subjects in clinical trials is a critical determinant of reliability, integrity, and acceptability of findings drawn from such clinical research; thus, understanding the ethical expectations of working with human subjects is essential.
This study explores the ethical considerations of working with human subjects in clinical trials and the strategies for implementing them. The study's objective is to determine what ethical considerations are available for clinical trials involving human subjects and their effects on research outcomes. The research questions are:
· What are the key ethical considerations of working with human subjects in clinical trials?
· How do ethical considerations affect the reliability, integrity, and acceptability of research findings in clinical trials involving human subjects?
A literature review approach to research was used to answer the above questions. In the next section, a description of existing literature on the subject is presented. The subsequent section provides a discussion of the findings of the literature, while the last section is the conclusion, which gives a summary of the entire research paper and makes recommendations regarding the use of human subjects in clinical trials.
Clinical trials are often conducted to develop evidence of clinical practices that would be useful in the future. However, such trials cannot be complete without human subjects' involvement at one stage or the other. When working with human subjects, researchers must protect them to safeguard their lives. Various scholars have discussed the range of ethical considerations to be made when working with human subjects. For instance, Li et al. propose incorporating the basic ethical principles into clinical research as a strategy for streamlining the application of ethics in clinical research involving human subjects (231). Such principles may also be useful in preventing harm to the participants in clinical trials. Kapp describes the ethical principles, including the protection of human dignity (commonly referred to as autonomy), non-maleficence, beneficence, privacy, and trustworthiness (338). These values constitute the underlying principles that define ethical practice in clinical research and elsewhere and are also mentioned by Ahmad and Al-Sayed (2). Therefore, adopting such principles in clinical trials can be the starting point towards realizing research objectives effectively and presenting acceptable outcomes.
In spite of the clear directions on what constitutes ethical principles in clinical research, working with human subjects in clinical trials still comes with various challenges. According to Pisani et al., clinical researchers are often faced with various challenges in protecting human subjects, especially due to the use of technology (5). These challenges include the adequacy of participants' informed consent, strategies for responses to participants' safety concerns, security threats to sensitive data, and technological advancement that increase the risk of information exposure. These challenges make it difficult for researchers to deliver on their commitment to ethical conduct when working with human subjects in clinical trials. One of the common cases of non-adherence to ethical considerations in clinical research is the Tuskegee project conducted in West Africa, and the non-adherence can be attributed to failure to take the right decisions with respect to participants’ safety concerns at the right time (Paul and Brookes e17). Such issues may be difficult to project during the study design, and researchers have to be vigilant to ensure reliability, credibility, and acceptability of clinical research.
In any clinical trial, the acceptability of research findings is a key concern among researchers. Methodological ethical violations in research constitute one of the greatest threats to the acceptability of results. According to WHO, research conducted based on ethical violations is commonly construed to be acceptable (15). Practices such as the acquisition of participants' consent should be carried out through a clinical trial's entire lifetime to ensure that any safety concerns are identified and addressed acceptably for the participants to continue in the clinical trials (WHO 15). Failure to address safety concerns, violating participants' autonomy, and subjecting participants to risks beyond which they can tolerate therefore constitute violations of the informed consent requirement, hence an ethical violation in research. Such violations jeopardize the acceptability of research as well as the validity of findings since research findings cannot be considered reliable when collected from participants under duress.
Most studies on ethical considerations in research focus on research in the general context. Generalization of research ethics to clinical trials dealing with human subjects, however, seems to be inadequate in exploring the expanse of ethical action in clinical research. Practices such as obtaining informed consent, upholding participant autonomy, beneficence, non-maleficence, and maintaining participant privacy in research play an important role in the ethics of clinical trials. However, unlike conventional research in which these ethical principles are considered superficially and followed to the end after initial confirmation and documentation, adhering to the same principles during clinical trials requires consistent follow up with participants, continuously confirming their consent to continued participation in trials, and looking out for and addressing any safety concerns that may be raised. The mentioned aspects are necessary because the risks associated with clinical trials are expansive as the WHO mentions the risks of in-hospital infections and death as part of the potential risks in clinical research. Participants also need to be continuously assured of their role and progress in the trials throughout such studies.
Non-adherence to ethical considerations in clinical trials is associated with various negative outcomes. The most popular case of violation of ethical concerns in clinical trials was the Tuskegee project in West Africa, which resulted in the deaths of many participants. Such violations not only result in harm to participants but also have negative impacts on the reliability, credibility, and acceptability of research findings. Ethical violations in clinical trials result in compromised results since participants subjected to unethical conditions undergo duress and are unlikely to give credible results. Emphasis on adherence to ethical practices in clinical trials is thus paramount.
The study's objective was to determine the ethical considerations in clinical trials and the implications of non-adherence to ethical concerns in clinical trials on research validity, reliability, and acceptability of research. Ethical considerations in clinical trials include obtaining informed consent, practicing beneficence, non-maleficence, and upholding participant autonomy. In clinical trials, however, ethical considerations have to go beyond merely confirming the intention to adhere to these principles at the beginning of the trials to actually following up and confirming with participants at every stage of the trials due to the risks involved. Failure to adhere to such practices reduces the reliability of the information given by participants, thus limiting the acceptability and validity of research findings. While this study has been effective in achieving its objective, it has methodological and scope limitations. It is therefore suggested that future studies should focus on expanding the scope of the study and using more effective methods such as qualitative research approaches.
Ahmad, Wijdan and Moeen Al-Sayed. Human Subjects in Clinical Trials: Ethical Considerations and Concerns.” Journal of Translational Science, vol. 4, no. 6, 2018, pp. 1-5.
Kapp, Marshall. Ethical And Legal Issues in Research Involving Human Subjects: Do you want a Piece of Me? Journal of Clinical Pathology, vol. 59, 2006, pp. 335-339.
Li, Rebecca, Mary Wacholtz, Mark Barnes, Liam Boggs, Susan Callery-D’Amico, et al. “Incorporating Ethical Principles into Clinical Research Protocols: A Tool for Protocol Writers and Ethics Committees.” Journal of Medical Ethics, vol. 42, 2016, pp. 229-234.
Paul, Charlotte and Barbara Brookes. “The Rationalization of Unethical Research: Revisionist Accounts of the Tuskegee Syphilis Study and the New Zealand “Unfortunate Experiment”.” American Journal of Public Health, vol. 105, no. 10, 2015, pp. e12-e19.
Pisani, Anthony, Peter Wyman, David Mohr, Tatiana Perrino, et al. “Human Subjects Protection and Technology in Prevention Science: Selected Opportunities and Challenges.” Prevention Science, 2016, pp.1-14.
World Health Organization (WHO). Key Criteria for the Ethical Acceptability of COVID-19 Human Challenge Studies. World Health Organization, 6 May 2020. apps.who.int/iris/bitstream/handle/10665/331976/WHO-2019-nCoV-Ethics_criteria-2020.1-eng.pdf?ua=1. Accessed 08 August 2020.
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