IRB FAQs – Special Populations

What is considered a vulnerable population?

Vulnerable research participants are persons who are relatively or absolutely incapable of protecting their own interests. The researcher and research team should be cognizant of the special problems of research involving vulnerable populations, justify the proposed involvement of these populations in the research, and include additional safeguards for their safety and welfare. These populations include:

  • Fetuses, neonates and children;
  • Individuals with impaired decision-making capacity (cognitively impaired, traumatized, sedated, intoxicated, etc.);
  • Prisoners;
  • The terminally ill;
  • Students or employees;
  • Individuals whose first language is not English;
  • Individuals who are at risk of civil or criminal liability; and
  • Economically or educationally disadvantaged persons.

Where can I find governmental regulations for special populations?

DHHS Title 45, Code of Federal Regulations, Part 46.

  • Subpart B of the regulations addresses additional protections extended to research involving fetuses, pregnant women and human in vitro fertilization.
  • Subpart C pertains to protection of prisoners who are participants in human subject research.
  • Subpart D addresses protections for children who participate in research. The regulations can be found online.
  • Title 21, Code of Federal Regulations, Part 50, Subpart D addresses additional protections extended to research involving children in FDA-regulated human research.

What happens if a participant becomes a prisoner during the course of a research study?

If a research participant, while taking part in a study, becomes a prisoner, and the relevant research proposal was not reviewed and approved by the IRB without applying the additional regulations for protections for prisoners in research, the investigator must promptly notify the IRB. All research interactions and interventions with, and obtaining identifiable private information about, the now incarcerated prisoner-participant must be suspended immediately, unless doing so will put that individual at risk. Upon receipt of the investigator’s report that a previously enrolled research participant has become a prisoner, and if the investigator wishes to have the individual continue to participate in the research, the IRB must promptly re-review the proposal in accordance with the requirements of subpart C (additional protections for prisoners in research). If the research is supported by federal funds, IRB approval is not sufficient to allow the study on that one prisoner to continue. The institution(s) engaged in the research involving the prisoner participant must send a certification to OHRP and wait for a letter of authorization in reply. Otherwise, the prisoner participant must be withdrawn from the study.

OHRP allows one important exception to the requirement that all research interactions or interventions with, and obtaining identifiable private information about, the now incarcerated prisoner-participant must cease until the regulatory requirements for research involving prisoners are met. In special circumstances in which the investigator asserts that it is in the best interest of the participant to remain in the research study while incarcerated, the participant may continue in the research until the requirements of subpart C are satisfied. The investigator must promptly notify the IRB of this occurrence, so that the IRB can re-review the study. Some regulations governing the use of prisoners may not apply to these circumstances and the staff in the UMCIRB office will keep the investigator informed of what, if any, additional actions must be taken.