Introduction to a summary of the article
The article discusses the violation of ethical principles, particularly the lack of honesty or transparency when informing group subjects or participants of safety concerns, particularly the abrupt decision to end a clinical trial performed by Pfizer. The article highlights the story of a patient who was disorganized with breast cancer, and her care nurse informed her of the new medication being developed and that if it succeeded, it would save her life (Gubar, 2020). It tells of the gross violation and misconduct she went through as a participant in this clinical trial.
Relevance code of ethics
There are various codes of ethics in government clinical trials, specifically when humans are involved as test subjects (Dankar et al., 2019). In this case, the patient was the test subject. In a particular case, the particular code of conduct in violation was informed consent. As seen in the article, the patient needed to be made aware and had no prior knowledge of why the study in trial one was closed indefinitely, and no result or findings were presented to her. As a subject in the clinical trial, she had the right to be informed of the findings and the reasons for the closure of the research in phase I of the trial. Informed consent is the central code and the guiding principle when humans are the subject of research (Research Ethics & Compliance. (n.d.). Various elements of informed consent must be availed to the participants, and the participant or the subject in this matter must be made aware of the purpose of the research, benefits, and risk, and her consent in the form of a signature confirming he or she is aware of the risks and benefits involved in participating to that research. This code of conduct was violated, and the research failed to adhere to ethical principles concerning research using humans as their test subjects.
Reasons for violation
The article has provided several reasons which resulted in gross violation of the code of ethics. One of the primary reasons was the rush to conclude within the project timeline. This project had its timeline, and the stakeholders wanted the project to meet its deadline; therefore, the research was outside the time limit since the findings or objectives of the research were behind and needed to be met (Gubar, 2020). These reasons resulted in an abrupt decision to close the trial without bearing in mind the health risk of the participants involved in the test. The second reason was financial incentives. Conducting clinical trials is very expensive and can consume significant resources that may become unviable to the company or stakeholders. However, in this case, the article showcases a probability of conflict of interest between the involved parties, particularly the participants and the scientist in charge of the research. This is because the researchers emphasized achieving their test subjects (participants) rather than the health and well-being of their participants.
Ways the violation could have been avoided
The matter at hand was based on principles of the code of ethics. Moral obligations to do what is tight no matter the cost. By being honest and transparent when informing the participants about the clinical trial. They would have done so by following the guidelines regarding the principle of informed consent the violation could have been avoided. In addition, those involved in the research would have been honest and transparent about the trials in their first and second phase.
Personal reflection
If I had been conducting the research, I could have adhered to the principles of informed consent. In addition, I could have made the decision based on the best interest of the participants. The best interest, in this case, would have been their safety concerns and health well-being. Moreover, I would have ensured the trial process was a collective responsibility where they would be involved in making critical decisions concerning their health and well-being.
References
Dankar, F. K., Gergely, M., & Dankar, S. K. (2019). Informed consent in biomedical research. Computational and structural biotechnology journal, 17, 463-474.
Gubar, S. (2020, October 29). The Stressful Conclusion of a Clinical Trial. The New York Times. https://www.nytimes.com/2020/10/29/well/live/clinical-trial-cancer-drug-pfizer.html
Informed Consent Guidelines & Templates | Research Ethics & Compliance. (n.d.). Research-Compliance.umich.edu. https://research-compliance.umich.edu/informed-consent-guidelines#:~:text=Informed%20consent%20is%20the%20process
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