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Vulnerable Subjects

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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

Pregnant Women, the Fetus and Neonates of Uncertain Viability

Research Involving Prisoners

Other National Commission Reports

General References on the Concept of Vulnerability

Vulnerable Subjects

Guidance on who is a child and Subpart D protections for children as research subjects.

Subpart B protections for research involving pregnant women & the fetus; requirements under PA law.

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Guidance on assessing capacity and who can serve as a legally authorized representative.

Subpart C protections for prisoners as study subjects.