The Opt-out Approach in Research to Benefit Public Health Is "Opting Out" In?

For their results to be generalizable, clinical trials and observational studies must enroll patients from diverse backgrounds that are representative of the population. Acute stroke studies face unique recruitment challenges because most interventions are time-sensitive and people with stroke have potentially reduced capacity to make or communicate their preferences. The justified mistrust of research and misunderstanding of clinical trials among potential participants are particular detriments to studies that rely on broad enrollment of large representative samples to draw reliable conclusions.1 Many important, large-scale trials have been delayed or closed because of poor recruitment, with the largest recruitment gaps, at least in the United States, due to declined consent in currently underrepresented populations.1 © American Academy of Neurology.