Protected Class of Human Subjects

Populations who may be more vulnerable to coercion or undue influence when participating as research subjects, including children, prisoners, decisionally impaired individuals, economically or educationally disadvantaged persons, and other vulnerable populations, who are thus afforded additional protections by the Federal regulations (see additional subparts of 45 CFR Part 46) and/or the IRB. DOE and DOE site employees are considered vulnerable subjects when participating in research and additional care must be taken to ensure their participation is truly voluntary (e.g., by ensuring they do not report to members of the research team) and that data collected about them is kept confidential.