What should I consider before conducting research with vulnerable populations?

Frequently Asked Question

Vulnerable populations are those research participants who are likely to be vulnerable to coercion or undue influence or lack decision-making capacity, including:
  • Those designated vulnerable groups, such as children, prisoners, pregnant women, fetuses, neonates, mentally disabled persons, or economically or educationally disadvantaged persons, and
  • Those who may be vulnerable because of a physical condition, severe illness or pain, psychological or emotional condition, status relationship with a member of the research team, cultural or political factors or other circumstances

UW-Madison IRBs will ensure that research procedures include adequate additional safeguards, when necessary, to protect the rights and welfare of these participants consistent with ethical principles and applicable federal regulations, state law and institutional policies.

Note that the Department of Veterans Affairs (VA) policies prohibit the participation of children, prisoners, neonates and fetuses in VA research protocols.  Although the Department of Veterans Affairs (VA) does not prohibit research involving pregnant women, local Madison VA does not allow the inclusion of pregnant women in research that falls under its purview.

For more information, see the below document(s).
HRPP: Review of Research Involving Vulnerable Participants

HRPP: Equitable Selection of Research Participants Guidance

HRPP: Research with Adult Participants Lacking Capacity to Consent

Keywords:FAQ, children, minors, prisoners, pregnant women, fetus, fetuses, neonates, mentally disables, disadvantaged, status relationship, vulnerable groups, adolescent status relationship coercion stigmatizing huber law   Doc ID:22223
Owner:Stella K.Group:Health Sciences IRBs
Created:2012-01-12 15:03 CDTUpdated:2015-10-13 15:16 CDT
Sites:Health Sciences IRBs
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