Version Date: June 16, 2016
The purpose of this document is to provide guidance on the inclusion of vulnerable populations in human subjects research, specifically the information that needs to be provided to the IRB when vulnerable populations will be subjects.
A population may be considered vulnerable because their enrollment involves issues of coercion and undue influence and may require additional safeguards to protect their rights and welfare or because their enrollment requires special consent processes (e.g. assent from children and parental permission from parents). The federal regulations specify certain groups as being vulnerable, outlined in 45 CFR 46.111(b), which include children, prisoners, pregnant women, mentally disabled persons, and economically or educationally disadvantaged persons. Other groups may be considered vulnerable populations based on regulatory criteria, state law or other factors. These include, but are not limited to: wards of the state, emancipated minors, fetuses, individuals receiving mental health services, individuals with impaired decision-making capacity and veterans.
The Vulnerable Group Checklist page asks study teams to identify any vulnerable groups that they will enroll in their study.
The Vulnerable Justifications page is where study teams are required to justify the inclusion of vulnerable populations and detail the procedures being implemented to safeguard the rights and welfare of each vulnerable group that may be enrolled.
The Vulnerable Group Checklist page will display for the following application types if study activities involve interaction or intervention with human subjects: Full review, Exemption, and Non-exempt medical records applications. The Vulnerable Justifications page will display any time a vulnerable population is selected on the Vulnerable Group Checklist page.
Study teams should select the appropriate boxes when they intend to knowingly enroll a subject that falls into a vulnerable population. This would include situations where:
1) A vulnerable population is part of the aim of the research project. Examples include research directed at children, pregnant women, or the elderly.
2) A vulnerable group is likely to be enrolled based on the type of research being performed. For example, research aimed at health disparities in inner cities may require the selection of poor/uninsured subjects and non-English speaking subjects.
3) The study team is aware that a subject is from a vulnerable group and would enroll that subject.
The application indicates that a vulnerable subject population should be selected when the study involves “targeted” enrollment and that vulnerable populations do not need to be selected if their enrollment is “incidental.” The Health Sciences IRBs consider the enrollment of a vulnerable population to be “targeted” if the study team will be aware that a subject is from a vulnerable group (as a result of interaction with the subject or collection of specific information about the subject) and does not wish to exclude them. “Incidental” enrollment is limited to situations where a study team is unaware that a subject is from a vulnerable group, such as a medical record review or interview study in which pregnancy status or whether the patient is a prisoner is not collected.
Because federal regulations require additional considerations to safeguard the rights and welfare of subjects who are potentially vulnerable, study teams should not knowingly enroll a subject from a vulnerable group if enrollment of subjects in that vulnerable group has not been approved by the IRB.
The requirements to enroll a vulnerable population vary by the particular population. In all cases, the study team must provide detailed justification as to why the enrollment of a vulnerable population is necessary to answer the research question, ensure the generalizability of results, and the appropriate population to ensure the equitable selection of subjects. This information should be provided in Q3.1 of the “Subjects: Vulnerable Justification” page. In providing justification, it is important to keep in mind that, in accordance with the Belmont Report, the IRB typically requires that research be conducted on the least vulnerable subject population possible. For example, if a condition or disease is not prevalent in children, the IRB would expect a study to test a treatment for that disease/condition in adults and obtain data prior to enrolling children.
The study team must describe the additional safeguards in place to protect the rights and welfare of subjects in each vulnerable population that may be enrolled. The specific procedures will vary by the nature of the study and the vulnerable population involved. In many cases, special procedures related to recruitment, consent, payments, and ongoing participation may be needed. This information should be provided in Q3.2 of the “Subjects: Vulnerable Justification” page.
Specific regulatory requirements must be met if a study involves children, pregnant women, fetuses, or prisoners. In addition, there are special regulations if veterans enrolled at the VA and state laws that apply to individuals with impaired decision-making capacity. The application and protocol should provide sufficient justification as to why it’s appropriate to enroll the particular vulnerable population and what measures are in place to specifically protect the rights and welfare of that population (e.g. assent of minor subjects with parental permission).
Study teams should not preemptively include a vulnerable population unless there is reason to think that a specific vulnerable population is likely to be enrolled or situations in which enrollment into a study would be time sensitive (e.g. enrollment of a non-English speaker into a cancer treatment study). As described above, enrolling a vulnerable population requires justifying the inclusion of the vulnerable population and outlining the procedures in place to adequately safeguard the rights of those subjects. It may also require the use of special consent processes and consent forms. Including these populations unnecessarily may create unneeded delays during the IRB review process for the study team.
If a study is not approved for the enrollment of a vulnerable population but an eligible subject from that population is identified and interested in participating, a change of protocol would need to be submitted to allow for their enrollment. Please note that in some cases, such as individuals who are considered prisoners under the federal regulations, the IRB must have a special composition (i.e., inclusion of a prisoner representative) in order to review and approve the inclusion of prisoners as a subject population. Please contact the HS IRBs office if this issue arises in a study and we can assist in walking you through the process for approval.
Additional Resources for Working with Vulnerable Populations
Review of Research Involving Vulnerable Participants
What should I consider before conducting research with vulnerable populations?
Equitable Selection of Research Participants Guidance
Subject Recruitment and Screening Procedures
Guidance on Informed Consent Processes