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Vulnerable Populations

People who are considered vulnerable are those who require greater protection than normal against the potential risks of participation in a project/study. For example, they may have difficulty providing voluntary, informed consent due to limitations in decision-making capacity or situational circumstances or because they are especially at risk for exploitation. Vulnerabilities ultimately relate to challenges to the ethical principles of respect for persons, beneficence, and justice. In general, given USU's mission and decision to be a minimal-risk institution, most projects/studies will not be approved if they target vulnerable populations. Some common vulnerable populations include:

  • Children (under 18 or the age of majority)
  • Pregnant women
  • Individuals who are incarcerated (prisoners)
  • Individuals with a debilitating mental health/psychiatric condition (e.g., PTSD, depression, bipolar disorder)
  • Individuals with a cognitive impairment
  • Residents of a facility (such as a mental health facility, nursing home, treatment center)
  • Individuals with a life-threatening illness or condition (e.g., cancer, HIV/AIDS)
  • Individuals who are educationally or economically disadvantaged
  • Older adults (people over 65 years of age)
  • Indigenous peoples
  • Individuals who have experienced traumatic events (e.g., abuse, death, natural disasters)
  • Individuals involved in a crisis (e.g., war, natural disaster)
  • Veterans
  • Homeless/unsheltered individuals
  • Individuals who identify as LGBTQ+ (Lesbian, Gay, Bisexual, Transgender, Queer/Questioning)
  • Immigrants or refugees
  • 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)
  • Individuals with diagnosable addictions
  • Subordinates of the researcher (e.g., employees, students, or teachers when the researcher is a supervisor, instructor, or principal) - Not permitted at USU by doctoral students

Often, research will include people who fit in the above categories by chance. That is, if you are conducting a survey among employees at a software company, you might have people in your sample who are pregnant, who have experienced trauma, or who are living with a life-threatening illness. The concerns from an IRB perspective arise when targeting a vulnerable population. For example, a study that surveys only pregnant women or only those who have experienced trauma, etc. If you are proposing to target a vulnerable population, you will need to demonstrate to the IRB that your procedures are ethically sound, that the risks to participants are as minimal, 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 participation. Again, given USU's mission and the goals of the doctoral programs, it would be rare that a student would propose to target a vulnerable population (and if your study does, your chair should reach out to the IRB as soon as possible for guidance).

Given the DBA and EdD programs at USU, the most common vulnerable population that is considered is subordinates of the researcher. If you are an employer, supervisor, team lead, teacher, principal, or in some other sort of leadership role, it is common to propose research ideas that would include the participation of people who are in roles subordinate to you. While you likely have the best of intentions (bettering the lives of those around you), conducting research on your employees, team members, students, etc. is not permitted at USU.

This is because the programs at USU are designed to be completed expeditiously, and research on subordinates requires a lengthy full board review. A full board review is required because the IRB is tasked with being "particularly cognizant" of participants who may be vulnerable to coercion or undue influence, particularly during the informed consent process, which must minimize the possibility of coercion or undue influence [45 CFR 46.116(a)(2)]. 

Subordinates (employees, students, teachers, etc.) may experience a perceived or real sense of coercion to enroll in a study. They may anticipate negative effects based on a choice to not participate, and they may feel pressured to participate in the study, particularly if data collection occurs during a work shift, course, or program. Foreseeable negative impacts could include fears about how managers or peers will treat them. For example, declining to enroll in a study conducted by management could lead to a full spectrum of issues such as tense relationships, lower performance evaluation, job loss, etc., or the fear of such consequences. Students may be concerned about negative repercussions related to their position as a student (i.e., grades, future letters of recommendation, assistantships, etc.) if the investigator is an instructor, major professor, advisor, or active in their field of study.

Pressure is heightened if the researcher personally invites subordinates to participate or is directly involved with data collection—it is very difficult to say "no" to one's boss or instructor. Alternatively, a person may believe that participating will garner favor or benefit (e.g., better grades, favor with a supervisor, etc.). Finally, some circumstances beyond the student and employment context could also expose people to actual or perceived coercion or undue influence to enroll in a study. While such access involves different concerns than those related to employment or student status, researchers must pay attention to any power imbalance (for example, parents who opt out of research conducted at their child's preschool may worry about relationships with care providers).

To sum up, because of their inherent vulnerability, subordinates in research are not permitted in research conducted by doctoral students at USU. Thus, if a subordinate population is of interest to you, you are encouraged to find a similar population outside of your organization.