What if my study includes individuals from vulnerable populations, such as prisoners, children, or persons who are cognitively impaired?
Federal regulations require additional safeguards for persons from vulnerable populations. For example, parental consent must be obtained prior to including children in research, unless this requirement is waived by the IRB. Consent from a legally authorized representative is needed for persons whose cognitive impairment limits their ability to understand research procedures or to provide legally effective consent. If your study includes individuals from vulnerable populations, please contact us for additional guidance.
Related Questions
- My study involves a vulnerable population (e.g., minors, pregnant women, prisoners, mentally disabled, etc.). Do I need to do anything extra?
- Are there special considerations for gaining consent for data sharing from children or vulnerable or elderly populations?
- How can consent be obtained from children or from persons with an impaired ability to understand a consent form?
