Introduction to Vulnerable Populations
The Office for Human Research Protections (OHRP) has identified populations in need of special protections in research. IRBs must apply additional regulations and criteria and give special consideration to recruitment, subject selection, informed consent, privacy, and confidentiality issues before approving research involving these populations:
- Children, Minors
- Decisionally Impaired Persons
- Elderly and Aged Persons
- International Research Subjects
- Minorities (including Women)
- Pregnant Women, Fetuses, and Neonates
- Prisoners
- Students and Employees
- Terminally Ill Patients
- Traumatized and Comatose Patients
The complete OHRP guidelines can be found at http://www.hhs.gov/ohrp/irb/irb_guidebook.htm.