Clinical research coordinator's judgments of vulnerability and risk: Medical versus psychiatric studies

Clinical research subjects with psychiatric illnesses are widely considered vulnerable, at risk for coercion, and lacking decision making capacity. Individuals with medical illness are considered less vulnerable despite similar threats to autonomy. Clinical Research Coordinators (CRCs) are in the forefront of clinical research and are in a critical role to evaluate such risks and capacities. Ethical guidelines and competency standards should guide their evaluations. However, the extent to which the guidelines and standards are considered and well understood by the CRCs is unknown.;This study examined the influence of illness type and severity on the perceptions of CRCs regarding study risk and subject vulnerability. Vignettes were developed describing hypothetical clinical trials. The trials represented medical and psychiatric illnesses and high or low severity of illness for two levels of severity (high/low), resulting in a 2x2 between subjects design. CRCs were randomly assigned to review one of the four vignettes and asked to provide ratings of vulnerability and risk for the subject population and clinical trial described in the vignette.;One hundred eighty one CRCs participated in the study, representing a 25% response rate. CRCs perceived subjects with a psychiatric condition to be more vulnerable and at risk than those with a medical condition (p<.001). Subjects with a higher illness severity were considered more at risk than those with a lesser illness severity (p<.001). Perceptions of vulnerability and risk were greater between high and low levels of severity when the illness type was psychiatric versus medical, specifically regarding legal risk and whether the benefits of study participation outweighed the risks (p<.001). Consent capability was considered far lower in individuals with psychiatric illness relative to those with medical illness, even when the severity level of the medical illness was high (p<.001).;This study illustrates bias of CRCs regarding vulnerability, coercion risk, and decisional capacity. Individuals with a psychiatric condition are perceived differently than those with a medical condition. The perceptions suggest a predisposition to inflate vulnerability in individuals with a psychiatric illness, while discounting such vulnerability in those with medical illnesses.