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Vulnerable Populations

Federal regulations require that IRBs give special consideration to protecting the welfare of individuals belonging to one or more vulnerable populations. Potentially vulnerable populations include research participants who are:

  • Children / minors
  • Pregnant
  • Susceptible to coercion or undue influence (e.g., homeless, prisoners, institutionalized, terminally ill, socially or economically disadvantaged)
  • Unable to comprehend the research and its potential risks (e.g., educationally disadvantaged or suffering mental illness, dementia, etc.)
  • At higher risk for harm and/or economic, social, or legal consequences (e.g., individuals answering survey questions about their HIV status, drug use, sexual assault, etc.)

Increased protections for certain populations (pregnant women, prisoners, and children) have been established by federal regulations which are highlighted here along with an additional University-specific population.