Research with Vulnerable Populations
Vulnerable populations of human research participants are groups of people who have either historically been coerced or forced to participate in research or who may not have the language, education, or decision-making skills to decide for themselves whether to participate in research. For this reason, members of vulnerable populations are afforded additional layers of protection under Title 45 Section 46 of the Code of Federal Regulations.
- Subpart B, issued in1975, and most recently revised in 2001, provides additional protections for pregnant women, human fetuses, and neonates involved in research.
- Subpart C, issued in 1978, provides additional protections pertaining to biomedical and behavioral research involving prisoners as subjects.
- Subpart D, issued in 1983, provides additional protections for children involved as subjects in research.
However, the regulations do not limit considerations of vulnerability in research to only these three categories of subjects. Many other groups or individuals can be vulnerable to coercion or undue influence, may have limited autonomy to freely consent, or may not be fully able to understand the research and what participation entails. Some examples:
- Persons who are decisionally challenged
- Persons who are educationally disadvantaged
- Persons who are economically disadvantaged
- Persons who do not speak English
- Persons who are undocumented
- Persons engaged in illegal activity
- Students recruited by their professors or advisors for research participation
- Patients recruited by their doctor, caregiver, or primary health professional
Even within a vulnerable group of subjects, some individuals may be more vulnerable than others. For example, children who are wards of the state may need additional protections when they are engaged in research as subjects than children who have a parent or guardian.
Vulnerability may also change over time and during the course of a research study. In a medical study, for example, a severely-ill hospitalized patient may not be able to understand what is being asked of him and a legally-authorized representative may be approved to be his decision-maker for participation in the research. However, when the patient recovers and regains his decision-making capacity, he can and should be given the opportunity to provide or withdraw his own consent.