Research with Special Populations

Vulnerable Populations and Additional Groups Requiring Special Consideration

To ensure the rights and welfare of participants are protected, additional safeguards are required for populations that include individuals susceptible to coercion, undue influence, or increased risk of harm in research. Depending on the nature of the research being conducted, the risks may vary for particular groups. The IRB protocol application should specify what populations are being enrolled and what protections or additional steps are in place to minimize risk for vulnerable populations and groups requiring special consideration.

The federal regulations identify the following populations as vulnerable:

• Pregnant Participants & Fetuses
• Neonates
• Prisoners
• Children

Page updated July, 2026