For a long time, medical research has been conducted on human volunteers who risk their own well-being for the common good of society. The protection of human rights and the defense of ethical norms are fundamental to sound medical research. The globalization of science and medicine moved clinical trials abroad to low and middle income countries (LMIC). Since, otherwise, these communities might have little or no access to this level of care, are researchers providing a public health benefit or are they exploiting economically disadvantaged communities to serve the most prosperous ones abroad? Some wonder if experimentation is completely ethical.
In 1964, the World Medical Association published the Declaration of Helsinki, which was revised seven times in the following years with additional clarification notes. Emphasizing the primacy of the rights and interests of the individual subject, he introduced the concepts of compensation for damages and access to benefits discovered in research. It specifically addressed the use of placebos and the needs of vulnerable study populations. Instead of adding more regulations for economically vulnerable populations in order to “protect” them from choosing the best of their limited options, their autonomous choice must be respected, but with a better application of the principle of “justice”, as already stated in the Belmont Report.
Attention to vulnerability is also important from the ethical perspective of the fair distribution of benefits and burdens. Taken together, these studies highlight the need for policy makers to clearly outline and define the concerns that vulnerability is intended to cover and evaluate the alignment of these points of view with those of research stakeholders. However, it is not clear how the wide range of “other vulnerable groups” relates to this definition or what characteristics are believed to make them vulnerable. For example, in TCPS2, obligations towards those in vulnerable circumstances are implicit in the basic principles of the policy: respect for people, concern for well-being and justice.
Despite its important intended purpose and its widespread use, there is considerable disagreement in the academic literature about the meaning and delimitation of vulnerability, due to the perception of a lack of guidance in research ethics standards. Following the publication of the scandalous Tuskegee syphilis study in 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research published the Belmont Report. It does not identify what these errors or prejudices could consist of and, since concern for vulnerability is presented as a fundamental principle, interpretation cannot be guided by other ethical principles. By increasing the amount of compensation, researchers are not impairing the judgment of potential subjects, but are shifting the weighting of risks versus benefits for a particular population towards a different judgment.
They can recruit people from populations that will receive the benefits of research directly or from other populations with a corresponding obligation to ensure that they receive the benefits of research. The report presents a conceptualization of vulnerability based on consent that lacks clarity as to the characteristics of the vulnerability it intends to attack. Vulnerability is not an inherent quality of an individual or group, but rather describes the situation or circumstances that may make a person vulnerable in the context of a specific project or research environment. In this article, I suggested an analytical process to determine if certain vulnerable populations need more protection or better implementation of existing ethical principles and regulatory requirements.
The Belmont Report requires that research be fair in the sense that the selection of the target population is appropriate and that the benefits and burdens of research, both for individuals and for classes of people, are distributed equitably. Academics and policy makers continue to struggle over the meaning of the word “vulnerable” in the context of research ethics. .
