PURPOSE

The inclusion of certain groups of participants who may be vulnerable to undue influence or coercion may require additional protection. When the University of Utah Institutional Review Board (IRB) reviews research involving vulnerable populations, the IRB applies any additional federal regulations, VA requirements, state and local laws, as applicable.

SCOPE

This policy applies to human subject research conducted at the University of Utah.

POLICY

The University of Utah IRB evaluates whether additional safeguards have been included in the study to protect the rights and welfare of participants who may be vulnerable to undue influence.

Research Involving Prisoners

New study submissions including prisoners as research participants are reviewed by the convened IRB with a designated prisoner representative present and the prisoner representative must be assigned as a reviewer. If these review conditions cannot be met, the review must be deferred to the next available meeting with a prisoner representative present. Expedited review procedures may be allowed for continuing reviews if a determination was made that the research involves no greater than minimal risk for the prison population being studied and for amendments that are minor modifications (see SOP 402: Expedited Review). The expedited reviewer must be an IRB member who is a prisoner representative.

For research involving prisoners that includes interaction with prisoners and is eligible for expedited review (e.g., surveys), a prisoner representative must be assigned as the designated expedited reviewer. A determination must be made that the research involves no greater than minimal risk for the prison population being studied. Expedited review of amendments and continuing review must be assigned to a prisoner representative.

For research involving prisoners that does not include direct interaction and is eligible for expedited review (e.g., studies using existing data or records), a prisoner representative may be assigned as the designated expedited reviewer although this is not required. A determination must be made that the research involves no greater than minimal risk for the prison population being studied. Review of amendments and continuing review by a prisoner representative is not required for these studies.

Research Involivng Other Vulnerable Populations

New study submissions, amendments, and continuing review applications involving other vulnerable populations may be reviewed by the convened board or by expedited review. The IRB requires at least one or more individuals who are knowledgeable about or have experience in working with these participants to be part of the review process.

The University of Utah IRB reviews research involving vulnerable populations according to applicable requirements and guidelines and makes determinations using the IRB reviewer checklist. If the research includes a vulnerable population that does not have additional protections specified in the federal regulations, the board will evaluate the research proposal to ensure that precautions are taken to protect the participants.

The IRB adheres to guidelines posted on the IRB website regarding vulnerable populations and any required additional protections that the IRB must consider.