Essay Example on Ethical Issues in Clinical Trials: Informed Consent and Beyond

I am working at Contract Research Organization and belong to Project Management Division. I am a Project Manager who is handling some clinical trials. Working in Japan but closely working with the US/Asia Pacific team. There was an ethical issue in the organization whereby some rules were not followed by the people who were in charge. Participants of any clinical trials around the globe must be educated about informed consent before the process begins. The primary goal of this essay is to discuss the failure to give informed consent to participants of a clinical trial to find a pneumonia vaccine and explain what should have been done to avoid such errors in the future.

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According to the clinical trials and policies, Catania et al (2019) explain that participants undergoing any research must be informed about the risks and benefits involved. The National Research Act Belmont Report of 1979 contains all the ethical principles that must be followed when using human subjects for clinical trials since people need to be protected from harm (Catania et al., 2019). The process requires a verbal discussion with the parties, and afterward, a written document is signed by the people involved and present. In some cases, human subjects used for clinical trials often fall sick or maybe too sedated in such a way that they need medical assistance (Catania et al., 2019). In such cases, the short form of the informed consent document can be used on the patient. However, in cases where the human subjects unable to comprehend the information contained in the ICD, legal representation is allowed.

In this case, the company was under investigation since some records of several human subjects were missing from the company's database. The participants who had not signed the informed consent document were interviewed and asked to explain the process they were taken through before being enrolled for the trial to find a pneumonia vaccine.

One of the most significant issues that were addressed during that time was that human subjects were lacking informed consent documents (ICD). Some participants were also not aware of what medical risks they were exposed to or the benefits they would get after that. According to the ethical principles, human subjects have a right to know the injuries they are likely to get and the treatment options they have a right to be given. Moreover, it could be established whether the participants were enrolled willingly, or they were forced or tricked into being part of the clinical trial for a pneumonia vaccine.

The validity of informed consent is often unclear, and there is a certain level that is questionable since there should be sufficient information t make the process valid. One of the ways in which informed consent becomes valid is when the participation by the human subjects is voluntary when the risk-benefit ratio is included, and the inclusion of the purpose of the research study and the procedures involved are included. In research, the essential thing is not to focus on the benefits the human subjects will get at the end of the procedure.

Another issue regarding informed consent after some participants from the company were interviewed is that there were issues of paternalism. The participants were not aware of the various levels of protection that were included in the guidelines regarding their autonomous choices. Due to the insufficient information that was given, some human subjects were misinformed and ended up taking higher risks for more significant benefits.

As a project manager, I would have devised a way of ensuring that everyone had an informed consent document and that all benefits and risks were sufficiently explained and understood. Moreover, those who did not understand the guidelines contained in the informed consent document would have been advised to get legal representation. However, the most significant change would be thorough training.

The first step would be gathering the participants and giving them exclusive training so that they become aware of all they need to know and the procedures they will undergo. An open forum would be advantageous since it would enable the participants to ask questions regarding their risks and benefits during the trial and other legal matters that may emerge during the process (Dickert et al., 2017). The participants would be educated that the firm has no mandate to ask them to give up their legal rights (Raich, Plomer, & Coyne, 2001). Moreover, the participants would be educated that the document may lack information that would release a doctor or the facility from liability in case of negligence during the research.

With the training, the participants would have all the information to enable them to make the right decisions, especially due to the risks involved. The entire process would be outlined and explained sufficiently, and no detail left out. The participants would thus have a chance to make an educated decision on whether to begin the trial or quit (Dickert et al., 2017). Moreover, it would be ethical to explain any new information that would affect the participants while researching the new pneumonia vaccine. Participants would also be granted the chance to ask questions before, during, and after the trials (Raich et al., 2001). It would also be essential to explain who would be liable in the case of a negligent act and the benefits that would be given.

Before issuing an informed consent document to the participants, it would be ensured that they are sufficiently educated about the risks they are exposed to more than the benefits they would gain (Raich et al., 2001). Such a procedure would ensure that people do not agree to participate in the clinical trial for the remunerations they would receive (Dickert et al., 2017). Clinical trials can be risky since drugs are introduced into the body of a healthy human being, and adverse reactions may occur as a result.

Conclusion

In summary, the essay explains an issue that affected participants of a clinical trial involving a pneumonia vaccine. Investigations indicated that some of the human subjects that were used lacked sufficient information regarding the risks and benefits involved, among other essential issues. As a project manager, several changes would have been made to correct the situation. The participants would have been thoroughly trained before signing the document, and those incapable of doing so would be advised to get legal representation.

References

Catania, G., Dal Molin, A., Diaz, N., Bagnasco, A., Zanini, M., Aleo, G., ... & Lacamera, A. (2019). CN39 Quality of informed consent in clinical trials patients. Annals of Oncology, 30(Supplement_5), mdz274-008. https://www.bmj.com/content/356/bmj.j463

Dickert, N. W., Eyal, N., Goldkind, S. F., Grady, C., Joffe, S., Lo, B., ... & Wendler, D. (2017). Reframing consent for clinical research: a function-based approach. The American Journal of Bioethics, 17(12), 3-11. https://www.tandfonline.com/doi/abs/10.1080/15265161

Raich, P. C., Plomer, K. D., & Coyne, C. A. (2001). Literacy, comprehension, and informed consent in clinical research. Cancer investigation, 19(4), 437-445. https://www.tandfonline.com/doi/abs/10.1081/CNV-100103137.2017.1388448