Federal regulations identify specific populations as being especially vulnerable.
These populations have additional protections as outlined in Subparts B, C and D of the regulations.
Investigators must give special consideration to protecting the welfare of these vulnerable subjects, including:
- pregnant women, fetuses and neonates
- mentally disabled persons
- economically or educationally disadvantaged persons
- inclusion and exclusion criteria for selecting and recruiting participants
- informed consent and voluntarism
- coercion and undue influence
- confidentiality of data
- group characteristics such as economic, social, physical, and environmental conditions, so that the research incorporates additional safeguards for vulnerable subjects.
- not over-selecting or excluding certain groups based on perceived limitations or complexities associated with those groups. For example, it is not appropriate to target prisoners as research subjects merely because they are a readily available "captive" population.
- knowledge about applicable laws that bear on the decision-making abilities of potentially vulnerable populations.
- Having adequate procedures in place for assessing subjects' capacity, understanding, and informed consent or assent. When weighing the decision whether to approve or disapprove research involving vulnerable subjects, the IRB will look to see that such procedures are a part of the research plan.