Navigating Clinical Trials: GCP, Ethical Considerations and Project Management - Essay Sample

Introduction

I am working at Contract Research Organization and belong to Project Management Division. I am a Project Manager who is handling some clinical trials. The process of performing clinical research is sensitive and costly and must be handled carefully since the exercise deals with human lives. Several ethical considerations are observed across the globe when recruiting and retaining research subjects in any organization. The concerns are contained and outlined in the Good Clinical Practice, a regulation that ensures that clinical trials are conducted, monitored, implemented, and reported ethically (Glickman et al., 2009). Since the subjects under test are human beings, a systematic selection must be made, and the parties must be taken through an informed consent process. The primary function of informed consent is to educate the participants regarding the risks, dangers, and possible outcomes they may experience after the exercise. Subject recruitment is also considered a significant issue, and there are guidelines explaining the process that should be followed (Glickman et al., 2009). The primary goal of this paper is to explain a concern of ethics that happened in the organization during clinical trials.

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In the United States, human beings selected for clinical trials are often paid and compensated for various reasons which are explained to them before they enroll in the program. The payments that are made to the human subjects cater for expenses like transport, food, and acts as a compensation for the time spent during the research (Morain et al., 2020). The Contract Research Organization has been compensating its subjects since it was established, but the issue became an ethical concern. Some people complained that it was against human rights for people to be given monetary compensation for research to be conducted using their bodies. The issue had to be handled critically through research to indicate whether the practice is wrong or right and to get a way forward.

Some of the complainants suggested that the monetary compensation given to those undergoing clinical trials is a strategy that firms use to lure unsuspecting people into the scheme. However, many companies in the United States have been compensating their subjects, siting the procedure as fair, necessary, and appropriate (Theriault, 2017). Some of the people who were concerned about paying subjects wanted to challenge the firm in court. The company thus had to comprehensively research and support its decision regarding the necessity of paying its clients for a good course.

Contract Research Organization argued that the United States Code of Federal Regulations that deal with clinical research do not clearly address the issue of payments for people who undergo clinical trials (Morain et al., 2020). Therefore, there is minimal guidance regarding what is expected and what should be done during the recruitment process. The firm's institutional review board is responsible for determining the right amount of money that should be paid to the subjects. However, the task is challenging due to the minimal guidelines regarding the issue in the law.

During the discussion, the Contract Research Organization explained that payments are made to enhance people to participate in the trials. It has also been discovered that reimbursing subjects leads to an increased response rate, and the adverse effects of payments are minimal. Recruitment also increases when people are paid (Glickman et al., 2009). First, participating in a clinical trial is an expensive process, and subjects may waste a lot of time and money. Therefore, some people fear to lose their money, and they may be discouraged from participating in such research. Thus, compensating them is fair to both parties, since the organization needs these people to run. Secondly, most individuals who report and are willing to participate in clinical trials in the organization often report that they feel that it is fair to be reimbursed for their effort and time (Glickman et al., 2009). Therefore, those people who were already participating in the research in the company at that time had no complaints whatsoever and did not complain that they were lured into the exercise by being offered money.

Some of the participants in the clinical trials in the company at that time were interview and asked to give their views regarding making payments. None of the participants indicated that they were tricked or coerced to participate in the research. Some subjects stated that they were participating due to curiosity, the desire and conviction to help others, while others said they were passionate about taking part in health advancement exercises (Theriault, 2017). There is minimal evidence that indicates that paying subjects to participate in clinical trials encourages them to be a part of the practice.

The ethical concerns form the complainants indicated that paying people to participate in clinical trials leads to bias and exploitation of the individual. However, the organization explained that the subjects selected are paid according to the type of research being carried out. For instance, a clinical trial regarding social behavior is often compensated with at least $50 to each participating individual. However, those in phase 1 could receive thousands of dollars. Therefore, no individual is overexploited since the process is transparent from the beginning to the end. According to research by various institutions, monetary compensation often encourages more people to participate (Morain et al., 2020). The participants also get access to medical treatment, as well. The company also pays individuals as an appreciation for accepting to engage in the study voluntarily.

Moreover, there is a need to conduct a risk-benefit analysis. The patients who are recruited to participate in clinical trials benefit from being compensated by being offered money, but they pose a risk to their health and other factors (Theriault, 2017). Some of the tests are a risk to health, and the subjects under research may use the funds to get proper treatment (Morain et al., 2020). However, the company admitted that paying human beings small amounts of money is exploitation, so their participants decide and negotiate the price they would like to get.

Another ethical concern regarding the payment of people who participate in clinical trials is that most subjects are not adequately compensated, yet the organization will significantly benefit from the research in the future. Moreover, some parents often participate in pediatric trials, whereby they enroll their children for the money offered by the firm. There is also the issue of enrolment bias, where the compensation attracts people from lower socioeconomic backgrounds (Glickman et al., 2009). The question of the enrolment bias may jeopardize results since the research outcomes are generalized. It was thus concluded that the firm needs to review its remuneration program to determine the fairest way of compensating research subjects who are enrolled in the company.

Another ethical issue that was raised regarding compensation is the payment of physicians who work at the firm. There were complaints that physicians who refer subjects for research are not adequately compensated. The company responded by saying that those who referred people were previously paid, but the process stopped due to conflicts of interest. The company embarked on devising alternative methods of compensating its physicians with minimal conflicts of interest.

According to the firm, the giving of incentives to those who make referrals is not a significant ethical concern since these individuals are salaried like other employees in other organizations. However, the company continues to offer monetary incentives to family doctors. According to research conducted at the center, the results indicated that the response rate of family doctors significantly rose after being offered financial incentives (Theriault, 2017). It is essential to compensate the doctors for their time and effort aside from their monthly salaries (Morain et al., 2020). When giving its response, the organization explained that most of the clinical trials are funded by various pharmaceutical companies in the United States and that doctors who recruit people have a minimal contribution to the study.

According to some complainants, there was an issue about informed consent. Informed consent is a crucial requirement and procedure that allows participants of research to be fully and comprehensively be made aware of the risks, their rights, and benefits that they will get from the trials (Theriault, 2017). When some individuals who were undergoing the trials were interviewed, a few explained that there as a verbal document, but no paperwork was done. The organization was sued and asked to explain the events that led to the breach of the National Research Act of the United States, which says that all the information must be documented on paper (Glickman et al., 2009). The trial individuals must be informed of their rights, beneficence, and be respected throughout the process. As a project manager, it is my job to oversee all the rules and regulations regarding ethics. Therefore, the company was wrong not to provide physical documentation to the individual under trial, and the matter was corrected immediately. The stakeholders who were liable for negligence were fired, and others were put on probation as the investigation continued.

Since that time, all the participants must be asked if they have been given the informed consent document (ICD). Some of the participants were also interviewed and asked to explain what they had been informed during their orientation. It was clear that the information given was not clear enough as it should be, and some participants were not aware of their rights. The issue of informed consent and how it should be conducted was reviewed from that moment. Workers in the department responsible for that duty were educated on how to perform the exercise effectively to prevent the occurrence of similar cases in the future.

Conclusion

In conclusion, there were ethical issues of concern in the firm Contract Research Organization that performs clinical trials. First, there was an issue involving the payment of individuals. Some concerns included paying individuals as a way of luring them into research that they would not otherwise engage in. However, the company explained that the compensation given to participants was supposed to pay time for their time and effort. Regarding the payments of physicians who refer people for trials, there was no need to give them monetary incentives, yet they receive a monthly salary. The final ethical concern was about informed consent where participants were not fully informed of their rights and there as no physical document.

References

Glickman, S. W., McHutchison, J. G., Peterson, E. D., Cairns, C. B., Harrington, R. A., Califf, R. M., & Schulman, K. A. (2009). Ethical and scientific implications of the globalization of clinical research. https://www.nejm.org/doi/full/10.1056/nejmsb0803929

Morain, S. R., Weinfurt, K., Bollinger, J., Geller, G., Mathews, D. J., & Sugarman, J. (2020). Ethics and collateral findings in pragmatic clinical trials. The American Journal of Bioethics, 20(1), 6-18. https://www.tandfonline.com/doi/abs/10.1080/15265161.2020.1689031

Theriault, R. L. (2017). Ethical Concerns When Cancer Patients Become Human Research Participants and Are Treated on Clinical Trials. In Ethical Challenges in Oncology (pp. 159-176). Academic Press. https://www.sciencedirect.com/science/article/pii/B9780128038314000105