Vulnerable Subjects

This chapter explores a variety of issues related to the participation of vulnerable subjects in research including the definition of vulnerability; categories of vulnerable subjects; criticisms of classifying subjects or populations as vulnerable; arguments for providing additional protections for vulnerable subjects; arguments for including vulnerable subjects in research; evolving approaches to the protection vs. exclusion dilemma; the types of additional protections for vulnerable subjects; federal regulations and international guidance pertaining to vulnerable subjects; and ethical issues related to enrolling children, prisoners, pregnant women, students, employees, and adults with impaired decision-making abilities in research. The chapter also applies ethical principles, including the principles of trust, justice, beneficence, nonmaleficence, and respect for persons, to research with vulnerable subjects. The chapter concludes by arguing that there are no simple solutions to the protection vs. inclusion dilemma and that the best way forward is to carefully consider the different factors in favor of inclusion or exclusion of vulnerable participants for each study, such as the risks of the research, the ability of the subject to provide informed consent, and the importance of the research for promoting the health of the population of which the group is a member.