Populations are considered vulnerable if there are concerns about their ability to understand information presented to them and make reasoned decisions about participation in research. These populations include the following:

• Children
• People with psychiatric, cognitive, or developmental disorders
• Institutionalized individuals who might experience coercion regarding participation (e.g., prisoners).

Special protections exist for vulnerable populations in terms of review and informed consent. For example, research with children must secure the consent of parents.
Investigators should review the specific federal regulations designed to provide special protections for vulnerable populations at the following website:

US Department of Health and Human Services Code of Federal Regulations for Human Subjects