Investigators, who are interested in research with the special classes of subjects discussed here, should refer to [46.111] for more information or contact IRB staff.
Certain groups of persons are especially vulnerable research subjects. They include:
- children and minors;
- individuals with impaired decision-making capacity;
- economically or educationally disadvantaged persons;
- persons who are in a subordinate relationship to researchers (such as students, employees, or patients).
In general, when an IRB is considering research with especially vulnerable subjects, the IRB can approve research that is of minimal risk or will benefit subjects directly. If the research involves more than minimal risk and does not benefit the subject directly, the study may be subject to approval by the Secretary of Health and Human Services.