When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards should be included in the study to protect the rights and welfare of these subjects.
Some populations are inherently vulnerable due to a lack of autonomy or ability to understand research procedures. Enrolling these population in prospective research requires specific IRB approval. Some populations may be considered vulnerable based upon the research topic or specific data being collected (e.g. undocumented student experience).
The New Study Application form specifically asks about vulnerable populations being targeted for research. A population is considered "targeted" for enrollment if that group is specifically being recruited as part of the inclusion criteria or the method(s) of recruitment make it extremely likely that population will be enrolled in the study (i.e. advertising study only on UIUC campus). Please note that prisoners are an exception to "targeted" for enrollment, no prisoner may be enrolled in research unless the IRB has specifically approved that population.
Federal regulations provide specific requirements for certain populations:
- Pregnant Women and Fetuses (45 CFR 46 Subpart B)
- Prisoners (45 CFR 46 Subpart C)
- Children (45 CFR 46 Subpart D)
- Mentally disabled/Cognitively Impaired (45 CFR 46.111(b))
- Economically or Educationally Disadvantaged (45 CFR 46.111(b))
Due to the potential for undue influence related to employment and/or education, UIUC also considers Faculty, Staff, and Students of the institution to be a vulnerable population.
Please review guidance documents related to the specific population you are considering for further information.
- RGD: Research Involving Pregnant Women and Fetuses
- RGD: Research Involving Prisoners
- RGD: Research Involving Children
- RGD: Research Involving Neonates
- RGD: Research Involving Economically or Educationally Disadvantaged Individuals