Subjects in research protocols may be considered vulnerable for different reasons, and therefore the safeguards incorporated into protocols to protect them will vary. One classification scheme for identifying vulnerability in subjects identifies five different types-cognitive or communicative, institutional or deferential, medical, economic, and social. Each of these types of vulnerability requires somewhat different protective measures. Certain populations and certain potential research subjects may exhibit multiple types of vulnerability (for example, participants might be poor, seriously ill, and not conversant in English). Protocols must address each of the vulnerabilities presented by the intended study population.
The following table contains links to a description of each of the categories of vulnerability, as well as additional information on including subjects with each type of vulnerability in a research protocol. Links to additional information on specific vulnerable populations are also provided.
Protecting Vulnerable Subjects
- Overview
- Ethical guidelines and principals
- Categories of vulnerability - Specific vulnerable populations
- Acceptable risk with vulnerable subjects
- Unanticipated encounters with vulnerable subjects
- Regulations
- Additional resources and links
| Category of Vulnerable Subject | Specific Vulnerable Population (Example) |
Note: The description of these categories of vulnerable subjects was copied (in part) from the National Bioethics Advisory Commission report, Ethical and Policy Issues in Research Involving Human Participants, Chapter 4.