Vulnerable Subjects

Who are considered "vulnerable subjects"?

People who are especially susceptible to coercion or undue influence are considered vulnerable subjects. They may include

What does the UCSC IRB look for with respect to vulnerable subjects?

When research involves vulnerable subjects, the IRB will look to ensure that the researcher provides appropriate additional safeguards to protect their wellbeing. Researchers may be asked to explain their justification for selecting vulnerable groups of individuals in their research project. When feasible, the initial contact with vulnerable individuals should be made by or through people who have no connection with the research, in order to preserve the subjects' privacy and autonomy. If the participants are not literate and the consent presentation is oral, researchers should ensure all requirements for obtaining documented consent are followed, including submission of a written version of the proposed presentation for IRB review and approval. Under certain circumstances, a witness may need to be present when vulnerable participants document their consent.
Due in part to the legacy of research-related exploitation among these groups, if a research project will involve prisoners or children, federal law and university policy impose additional requirements. These relate to selection of subjects, risk assessment, obtaining consent, and so forth. Please contact ORCA with any questions about research projects with these vulnerable groups and allow extra time for processing of your protocol application.