Research Involving Vulnerable Populations

The Office of Human Subject Protection provides guidelines for research involving vulnerable populations per Regulation 45 CFR 46. The Council for International Organizations of Medical Sciences (CIOMS) provides a succinct and useful definition of vulnerable populations:

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.

Realizing there are many possible ways to define who is vulnerable in the research context, the SMC IRB considers the following categories to be vulnerable populations:

• Children (<18 years old)
• Pregnant women
• Human fetuses or neonates
• Individuals who are terminally ill or very sick
• Individuals with physical disabilities
• Individuals with mental disabilities or cognitive impairments
• Socioeconomically disadvantaged
• Racial or ethnic minorities
• Prisoners
• Institutionalized persons (e.g., persons in correctional facilities, nursing homes, or mental health facilities)

Additional Resources that describe Vulnerable Populations:

US Department of Health and Human Services’ Office for Human Research Services

The Council for International Organizations of Medical Sciences (CIOMS) Guidelines 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 with a vulnerable group instead of with a group that is more able to protect themselves.

There are two important types of vulnerability:

1. Decisional impairment, whereby potential subjects lack the capacity to make autonomous decisions in their own interest, perhaps as a result of undue influence/inducement
2. Situational/positional vulnerability, whereby potential participants may be subjected to coercion

The Belmont principle of respect for persons is not upheld when subjects are unduly influenced; that is, when they are offered an “excessive, unwarranted, inappropriate, or improper reward” in an effort to secure their participation in a research study. Such offers may lead individuals to participate in studies to which they would otherwise have strong objections based on risk tolerance and personal values or preferences.

Whereas undue influence refers to an offer of reward, coercion involves an “overt or implicit threat of harm or reprisal” in order to obtain compliance with a request to participate in research. Coercion occurs when someone is in a position to make potential subjects worse off if they do not participate. This power imbalance may very well interfere with a potential subject’s capacity to choose or act voluntarily. For example, a student might enroll in a study due to fear of receiving a poor grade in a class, or a provider might threaten to withdraw services unless a client participates in a study. Coercion can also take more subtle forms, such as when workplace culture encourages staff participation in research, and those who decline may be seen as outsiders who are not committed to organizational goals.

There are several safeguards researchers can employ when studies involve vulnerable populations. For example, where students are involved, the instructor (researcher) could arrange to have data collected by an independent third party so that they do not know who participated and cannot access identifiable data until course grades have been assigned. Data collection during regular class meetings should be avoided as loss of instructional time may be considered a loss of benefit. When course credit is issued for research participation, students should have the option to complete an alternate assignment that is comparable in terms of time, effort, and educational benefit.

In work settings, researchers must ensure employees understand that participation is not required as a condition of employment. Employees should not be recruited or consented directly by a member of their current department, and supervisors and peers should not be informed of an employee’s decision to participate. When supervisors or administrators are part of the research team, they should only review aggregate data that has been stripped of identifiers.

With regard to cognitive impairment, the primary issue is impaired consent capacity, which occurs along a continuum in a wide range of conditions and circumstances. Decisions as to whether individuals with known cognitive impairment may be enrolled in a particular study should be based on the extent to which the research questions could be answered by studies involving subjects with full consent capacity, and whether the project may contribute to the current or future welfare of the study (cognitively impaired) population.

Adapted from University of Michigan

Research with children requires additional caution for recruitment and data collection. Please refer to the Office for Human Research Protection website for specific details about these requirements. Below is an overview of what must be included in the appendices submitted with your IRB application when conducting research involving minors.

Consent Process

• Parental/Guardian permission must be obtained.
• Child assent or consent must be obtained.

Sample forms are available here. Include the parental/guardian consent form and child assent or consent form in the appendices.

Data Collection in Schools

• Researcher must obtain a letter of invitation for data collection from the school site(s). The letter must come from the appropriate level of authority (e.g., school principle or district superintendent) and be signed on official letterhead.
• District websites provide guidance for receiving permission as their protocols vary.

Exemption Category

• If you are a teacher-researcher utilizing standard educational practice (e.g., assignments, exams, class activities, etc.) as your data, the Category 4 exemption applies.
• If you are supplementing the aforementioned data with survey(s) or interviews, your study is non-exempt.