What are Vulnerable Populations?

IRB/URR

In the early stages of your research, you will need to decide on a population to study. There are many different factors that may guide the selection of your study population. Like as your research aims and the anticipated availability of participants. An important factor to consider in your selection is whether the population qualifies as a vulnerable population.

So, what exactly is a vulnerable population? A vulnerable population refers to a group of individuals who require greater protection against potential risks associated with participating in research. This need arises because they may face a higher likelihood of negative outcomes, possess a reduced capacity to provide informed consent, or be subject to special legal protections due to their unique circumstances. Below is a list of populations that Institutional Review Boards (IRBs) commonly consider to be vulnerable:

  • Children (i.e., minors or individuals under the legal age of consent)
  • Individuals who are incarcerated (i.e., prisoners)
  • Residents of a facility (such as a mental health facility, nursing home, treatment center, etc.)
  • Individuals with a life-threatening illness or condition (e.g., cancer, HIV/AIDS)
  • Individuals with a debilitating mental health condition or cognitive impairment
  • Pregnant women

Victims of traumatic events (e.g., abuse, natural disasters)

Individuals involved in a crisis (e.g., war, natural disaster)

Individuals who are economically disadvantaged

Any Individuals who are not fluent in the language the study is being conducted in (e.g., non-English speakers in studies conducted in the United States)

Elderly individuals (e.g., 65 years old or older)

Subordinates of the researcher (e.g., students, employees)

If you are studying a vulnerable population, the IRB will often require specific procedures to protect your participants. These procedures ensure the safety and well-being of those involved in your research. For instance, if you are studying children, you will need to have procedures for obtaining assent from the child, as well as consent from their parent or legal guardian. In any research involving vulnerable populations, the IRB will heavily scrutinize your study, not only in terms of its procedures but also its merit. In other words, you will need to demonstrate to the IRB that your study procedures are ethically sound, that the risks to participants are as minimal as possible, and that the scientific contributions and potential benefits of your study are significant enough to warrant exposing vulnerable individuals to the risks and burden of research participation.

Even if you demonstrate all of these factors in your IRB application, the IRB may still not approve your research. In rare cases, the IRB may reject studying a particular population, regardless of the ethical rigor and merit of your research. Therefore, it’s wise to discuss your plans with the IRB early. Especially if you intend to recruit from a vulnerable population. Discussing this early on may save you months of work on a proposal that the IRB might inevitably reject.

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