What should be considered in seeking informed consent from individuals with diminished decision-making capacity?
The HHS regulations are silent on the consent procedures specific to subjects with impaired decision-making capacity, for example, as a result of trauma, mental retardation, some forms of mental illness, or dementia, whether temporary, progressive, or permanent. The regulations do require that the IRB ensure that “additional safeguards have been included in the study to protect the rights and welfare” of all subjects that are “likely to be vulnerable to coercion or undue influence.” The regulations include “mentally disabled persons” in this category (45 CFR 46.111(b)). In research involving adult subjects with mental illnesses or cognitive impairments, the IRB and investigator(s) must be knowledgeable about the condition and any level of impairment that is likely to be present in the subject population. The regulations do speak to the fact that the IRB must possess “the professional competence necessary to review specific research activities” (45 CFR 46.107(a)). This is achieved eithe
