I am writing with concern regarding the issue of outsourcing clinical trials for the birth control patch. I have learned that a global healthcare company is considering outsourcing clinical trials for a new female birth control patch to an undeveloped country. I understand that the process would save the company time and resources to be used in obtaining research approval in the U.S. I also realize the need for the firm to take this action as it will benefit all stakeholders involved.
However, I would like to raise a few concerns about the ethical perspective of the matter. While conducting such birth control trials in an underdeveloped country, there are many issues of concern to emerge especially amongst the underinsured and uninsured individuals. Some of such matters include post-trial access, post-trial care, ancillary care, compensation for related research harm, and the ethical scrutiny in interfering with the reproduction system. Thus, the practice of outsourcing clinical trials for new female birth control raises ethical distresses.
In most underdeveloped or developing countries, the number of uninsured and underinsured people outweighs that of the insured. As shown in figure 2, the U.S. is experiencing a high level of uninsured people yet it is a developed country. This means that underdeveloped countries will have a high level of underinsured and uninsured. Low levels of income and unemployment significantly contribute to the state of uninsured and underinsured.
According to Cho et al. (2018a), clinical trials targets both insured and uninsured so long as the participants qualify based on the research criteria. Clinical trials are procedures to test treatments that have not yet been proven and in this case, a birth control patch. The study will require the researchers to engage young healthy women in the trial without the assurance that the results will be positive. In worse cases, participants could experience negative effects of the reproduction preventive treatment under trial. Hence, uninsured or underinsured individuals would spend inappropriate costs in treating the harm of the trials.
One of the ethical issues surrounding this practice is post-trail care. In underdeveloped countries, the governments pay at least 51% of the general health expenses (Cho et al., 2018a). The rest of the medical expenses are paid by patients who have no health insurance cover. Therefore, the high number of women to participate in the birth control trial will be either uninsured or underinsured. As seen in fig 1, uninsured participants raise ethical concerns about post-trial care (Tolbert et al., 2020). The global health company intends to save more money meaning that it will not offer post-trial care. Post-trial care will be necessary for the women who may be negatively affected by the birth control patch. Henceforth, it is unethical to engage uninsured individuals in research and leave them to suffer from trial-related effects.
The clinical trials will not offer participants with post-trial access since it is not locally based. Study participants may need post-trial access to the birth control patches which will not be available (Cho et al., 2018b). Outsourcing the trials means that once the research is done, the researchers will come back to the U.S. Consequently, the research subjects will be troubled in need of continued care that they cannot access. It is unethical for the company to leave the participants without access to needs they unable to meet.
During the clinical tests, the subjects will need ancillary care which may not be provided without insurance. The extra care the participants may need during the trials but may not be covered by the researchers hence should be covered by insurance (Cho et al., 2018a).
Therefore, if the participants are not insured or are inadequately insured will have to spend their money for such needs. It is therefore unethical for the company to continue with the research if it is not in a position to offer the subjects ancillary care. The organization should also be in a position to offer the participants with adequate compensation for study-related harm. In underdeveloped countries, qualified study subjects are likely to accept any amount for compensation due to the high level of poverty. Paying such people less for harm implicated by the trials is unethical and is considered as taking advantage of the participants. Therefore, if the company is not ready to adequately compensate the participants should not outsource the trials.
The last ethical issue is regarding the control of the female reproductive system. Globally, reproductive health raises many ethical issues especially when it comes to interfering with the functioning of the reproductive system (Cho et al., 2018b). The ethics practices assert that the procreation rule to continue reproduction should be obeyed. Thus, using birth control methods to prevent women from conceiving is wrong. For the same reason, the company should consider the moral obligation of the use of birth control methods.
In conclusion, outsourcing clinical trials for the new birth control patch poses many ethical concerns which make the practice difficult. Young women in underdeveloped countries are mostly uninsured. Engaging them in clinical trials exposes them to the vulnerability of lack of post-trial care, access, and even study-related harm. Based on reports from past clinical trials, the firm will not cover the post-test financial and health needs for the subjects. Therefore, it will be unethical for the global health company to outsource the tests.
Cho, H. L., Danis, M., & Grady, C. (2018a). Post-trial responsibilities beyond post-trial access. The Lancet, 391(10129), 1478-1479. Web.
Cho, H. L., Danis, M., & Grady, C. (2018b). The ethics of uninsured participants accessing healthcare in biomedical research: A literature review. Clinical Trials, 15(5), 509-521. Web.
Tolbert, J., Orgera, K., & Damico, A. (2020). Key facts about the uninsured population. KFF. Web.