Several research populations are described as “vulnerable” or requiring extra attention or protection in federal regulations. Additional care for vulnerable groups requires the organization to treat them with respect and new strategies to address their problems or critical conditions. No matter what functions the organization performs, care for these groups must exist in project plans and planned future elements of operations (Resnik, 2018). For clinical organizations, hospitals, and any bases connected with the implementation of medical activities, vulnerable groups have to be in the plans.
First, it is worth outlining which groups are considered vulnerable or particular facilities to outline future activities. First, there are pregnant women, fetuses, and newborns, the first and specific group who always need extra care because they are most exposed to the environment for the future (Office for Human Research Protections, n.d.). Second, children, students and employees, and minorities are another group that has difficulty providing some categories of support for rights and livelihoods. Third, prisoners and the economically and/or educationally disadvantaged are a particular group characterized by problems in the socio-economic sphere and requiring protection. Fourth, persons with AIDS/HIV and terminally ill subjects – a group that needs the care to create the best possible living conditions. Each group of vulnerable subjects requires a solution to the ethical question of their presence (practical or theoretical) in some company activities.
It is worth beginning with the most ethical and comprehensive approach to addressing the problems of vulnerable objects. The categorical approach used to be very popular, which attributed only one criterion of vulnerability to each person: this means that a pregnant lesbian cannot be considered under both categories at once (Ivanova et. al., 2017). Either her pregnancy or her commitment to minorities should define her vulnerable group. This approach is wrong because it does not consider multiple vulnerabilities and does not give complete protection to the person (Gordon, 2020). The contextual approach is justified by its versatility and consideration of the nature of exposure and therefore allows corrective action based on all data about the person from specific sites. It provides a step-by-step view of whether the research is ethical and meets all the measures for the person’s safety.
Based on the all issues above, a proposal should be made to create a committee that will only look at vulnerable groups. First of all, the committee should reinforce the idea that research is not incompetent and that vulnerable persons are capable of making independent decisions about their participation. Their rights must be respected, and all persons must be protected, but informed consent for research must be ethical (Gordon, 2020). In addition, pressure to participate is also unacceptable. Therefore, the committee must monitor how consents are developed and how they are applied.
The committee must also create a template of guidelines and policies that will be applied to regulate the relationships that arise in a particular category of vulnerability. The committee must define the ethical arguments for vulnerable sites (Bracken-Roche et al., 2020). It is recommended that principles be laid down on which future research will be built. These principles should be based on respect for the individual and their merits to the study and integrity and fairness. Violations of the regulations carry specific obligations, the failure to comply with which also leads to some penalties and restrictions. It is essential to understand that an ethical review must be performed on every future study to preserve each person’s status and show respect for the work done.
Based on principles of ethics and respect, the committee should rely not only on the value of the research itself but also on the identities of vulnerable subjects. The last decade has seen a significant increase in clinical trials involving vulnerable groups – this is a good and helpful idea, but protection is not always at the forefront. No matter how valuable and necessary the research is, one should not violate the ethical foundations and resort to pressuring the population to participate in the study.
Rationale for the Recommendations and their Implementation
To demonstrate the need for ethical principles and the rights and freedoms of vulnerable subjects, it is worth preparing the audience for the very notion of vulnerability in advance. According to various theories about persons and their data, vulnerability is defined as instability arising from one cause beyond the person’s control (Ivanova et. al., 2017). I will resort to population statistics for the audience to delve in and decide on a committee. It will be in the form of a presentation that will show charts and record the geographic category of the populations. It will allow the audience to understand that vulnerability is an unstable trait, so investing in it and protecting it is necessary for every person.
When identifying vulnerable targets, the legal side of the issue is necessary: the target categories are regimented, and there are also recommendations. Often legal issues cause more excitement because everyone wants to be an honest citizen. I would also like to resort to evidence-based practice and mention recent studies that have demonstrated the connection between the ethics of clinical trials and their variability depending on the study group. We need to draw the audience’s attention to the fact that vulnerable groups generally receive less support and protection than they need. It is the responsibility of Institutional Review Board leaders to address this problem because clinical trials will not lose their relevance.
References
Bracken-Roche, D., Bell, E., Macdonald, M. E., & Racine, E. (2020). The concept of ‘vulnerability’ in research ethics: an in-depth analysis of policies and guidelines. Health Research Policy and Systems, 15(8). Web.
Gordon, B. G. (2020). Vulnerability in research: basic ethical concepts and general approach to review. Ochsner Journal March, 20(1), 34-38. Web.
Ivanova, E., Getov, I., & Lebanova, H. (2017). Ethical aspects of vulnerable group of patients in clinical trials. In (Ed.), Clinical trials in vulnerable populations. IntechOpen.
Office for Human Research Protections (n.d.). Vulnerable populations. HHS.gov. Web.
Resnik, D. B. (2018). Vulnerable Subjects. In The ethics of research with human subjects. International library of ethics, law, and the new medicine, 74. Springer, Cham.