Vulnerable Populations

Definition

Vulnerable subjects are defined as persons who "have difficulty providing voluntary, informed consent arising from limitations in decision-making capacity…or situational circumstances…or because they are especially at risk for exploitation." (source: Ethical and Policy Issues in Research Involving Human Participants). Those groups are incapable of protecting their own interests and, therefore, at risk of mistreatment.

Groups Considered Vulnerable

In paragraph 111 (Criteria for IRB approval of research), the Final Rule alert IRBs who "should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons"

The Final Rule lists Additional Protections for three vulnerable populations:

  1. Pregnant Women, Human Fetuses and Neonates Involved in Research (45 CFR 46, Subpart B)

  2. Prisoners as Subjects to Biomedical and Behavioral Research (45 CFR 46, Subpart C)

  3. Children Involved as Subjects in Research (45 CFR 46, Subpart D)

Other examples of vulnerable groups are

  • Individuals with physical disabilities

  • Individuals with mental disabilities or cognitive impairments

  • Economically disadvantaged

  • Socially or educationally disadvantaged

  • Homeless

  • Terminally ill or very sick

  • Racial or ethnic minorities

  • Persons of uncertain immigration status

  • Institutionalized persons (for example, persons in correctional facilities, nursing homes, or mental health facilities)

  • Individuals of lower levels of hierarchical structures, such as students, employees, soldiers or other military personnel

What does that mean for the researcher?

As a researcher, you must consider additional protections for your subjects. The protections may include, but is are not limited to, creating a simplified consent form adjusted to the age or reading abilities of the subjects, creating other than on-paper consent forms, involving parents or legal guardians of minors or legally authorized representatives (LARs) in your research or consent form process, offering a specially arranged, friendly interview environment, providing reasonable accommodations or inviting an interpreter.

In your research protocol, make sure that you avoid physical control (subjects are physically forced to participate in research), coercion (use of a credible threat to control another person), undue influence (misuse of a position of power to influence others' decision), and manipulation (withholding information, or exaggerating). Explicitly state in your application what precautions are planned in order to avoid those types of abuse in your research. Be sensitive to hierarchical structures that might entail coercion or undue influence (examples include principals seeking enrollment in research from those who they directly supervise or faculty members recruiting students that they currently teach).

The ultimate guidelines:

  • Assure autonomous and informed decision of participation (respect for persons)

  • Do not take advantage of the group vulnerability and do not harm (beneficence)

  • Know the burden the group faces but do not exclude that group from your research (justice)

Full Review

Research proposals involving protected populations require full board review. When applying for the IRB review, you must allow more time (a few weeks) for the IRB to schedule a convened meeting and conduct a proper full review process. Thus, research that involves vulnerable populations, may require more than one semester to complete (not recommended for undergrad students).

More Information

For more details on vulnerable populations, follow the links below:

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