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What does it mean to be vulnerable?
There are many possible ways to define who is vulnerable in the research context. Some would include the following: those who are ill (dependent on clinician for care), ethnic or racial minorities, non-English speakers, children, the economically disadvantaged, adults with diminished capacity. If one includes all of these groups, then almost everyone will qualify. The Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects provides a succinct and useful definition; Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other needed attributes to protect their own interests.
The CIOMS Guidelines also state that Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are selected, the means of protecting their rights and welfare must be strictly applied. Investigators need to explain why they have chosen to conduct the research in children or other vulnerable group instead of in a group that is more able to protect themselves. The desire to protect must be balanced with the need to conduct research in order to advance medical science in order to benefit those same vulnerable populations.
Special Protections in the FDA Regulations
The FDA did not add any equivalent protections for these population until 2001, when a draft rule created Subpart D protections for children similar but not identical to the Subpart D protections in the Common Rule. The final rule promulgating the Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products was published in the Federal Register in February 2013. The FDA regulations still do not include the equivalent of the Common Rule's Subparts B or C.
Resources from the National Commission and Related Subpart Regulations
The National Commission issued three reports related to groups deserving of additional protections in the research context provide the basis for the additional protections incorporated into the Common Rule. Many of the recommendations and wording from these reports became incorporated into Subparts B, C and D of 45 CFR 46 (below).
Children in Research
- National Commission Report: Research Involving Children
- Subpart D - Additional Protections for Children Involved as Subjects in Research
- FDA Subpart D - Additional Safeguards for Children in Clinical Investigations
Pregnant Women, the Fetus and Neonates of Uncertain Viability
- National Commission Report: Research on the Fetus
- Subpart B - Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
Research Involving Prisoners
- National Commission Report: Research Involving Prisoners
- Subpart C - Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
Other National Commission Reports
- The other National Commission Reports, including the Belmont Report can be accessed in OHRP's Archive
General References on the Concept of Vulnerability
- Macklin R. Bioethics, Vulnerability and Protection
- Levine et al. The limitations of "vulnerability" as a protection for human research participants
- Jecker. Protecting the vulnerable
- VanderWalde. Vulnerability as the inability of researchers to act in the best interest of a subject
- Kottow. The Vulnerable and the Susceptible
- Rogers et al. Rethinking the vulnerability of minority populations in research
- Beattie. Research participation of individuals with dementia