Patients’ competence to consent to neurobiological research

Progress has been made defining the standards for determining subjects’ competence to consent to research: abilities to communicate a choice, understand relevant information, appreciate the nature of the situation and its consequences, and manipulate information rationally. Available data show clearly that persons with mental illness display a spectrum of decisionmaking abilities, with many performing well, but some doing quite poorly. More attention now is required to identifying the degree of capacity required for competent consent to projects with varying risk/benefit characteristics. Practical means are also required for screening for subjects with impaired capacities, attempting to improve their performance, and providing substituted consent when their deficiencies are intractable.

Keywords:

• Competence
• informed consent
• research
• decisionmaking