What To Know About Clinical Research With Vulnerable, Cognitively Impaired Patients

As researchers, we need to consider how we simultaneously protect patients who are cognitively impaired or may become cognitively impaired during a study with the need to include this population as part of our research. Unlike children, pregnant women, and prisoners, the current Code of Federal Regulations for the Protection of Human Subjects (45 CFR Part 46) does not contain specific guidance for the protection of subjects with cognitive impairment in clinical trials.