The concept of vulnerability and the attendant responsibility of researchers to provide special protections for research participants deemed to be vulnerable are considered to be foundational concepts in bioethics. However, not only do international and national guidelines differ in their definition of vulnerability, but they also vary with respect to who is to be considered vulnerable in research. This chapter describes the ways in which vulnerability has been defined by international and national guidelines, discusses the considerations deemed relevant by international and national guidance and writers on the topic, and concludes with thoughts on how the meaning of vulnerability might be communicated in teaching.
TopDefining Vulnerability In Research
Article 1 of the Nuremberg Code 1947 makes clear that the concept of vulnerability sat at its heart. It stated,
The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.
The concept of vulnerability received direct attention in the 1979 Belmont Report, issued by the United States National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. In its discussion of the principle, “Respect for Persons,” the Commission noted that persons with diminished autonomy required special protections due to their “dependent status and frequently compromised capacity for free consent” (United States National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979: 8). Diminished autonomy could be the result of age, illness or disability, or coercion. Further, in concluding that “racial minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as research subjects, owing to their ready availability in settings where research is conducted” (United States National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979: 9), the Commission linked the concept of vulnerability to the ethical principle of justice.
Since that time, various international and national documents promulgated to guide both researchers conducting investigations and research ethics committees reviewing research protocols have integrated the concept of vulnerability. Table 1 provides definitions of vulnerability that appear in various internationally recognized standards for the conduct of research involving human participants (Council for International Organizations of Medical Sciences, 2016; European Commission, 2010; International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 1996; World Medical Association, 2013), as well as those of several English-speaking countries engaged in intensive research efforts (Agency for Healthcare Research and Quality, 1998; Canadian Institutes of Health Research, 2014; Indian Council of Medical Research, 2017; Uganda National Council of Science and Technology, 2014).