Persons and Groups: Protection of Research Participants with Vulnerabilities as a Process

Conceptualisations of vulnerability of research participants in the international standards of ethics of research involving humans underwent a shift from a group-membership (categorical) to an individual-oriented (analytic) approach to vulnerability. However, the categorical view has not been jettisoned completely, and so its role needs to be examined or explained. It is argued in this chapter that a restricted use of the categorical approach can be justified if protection of vulnerable research participants is seen against the background of the dynamics of study design, review and implementation, and if recognition and protection of participants with vulnerabilities is construed as a process in which researchers and ethics review bodies are involved rather than as a labelling device. From this perspective, the suitability of approach to conceptualisation of vulnerability depends on the kind and scope of the available information on participants. The process of study design, ethics review, and implementation involves different users of the ethics standards at different stages in the lifetime of a project: researchers and members of ethics review bodies. The concepts of individual vulnerability (in the analytic approach) and that of group-membership vulnerability (in the categorical approach) can play their protective roles complementarily in the process of identification of vulnerabilities of participants and protection of participants with vulnerabilities.