Patient-Centered Approaches to Research Enrollment Decisions in Acute Cardiovascular Disease [Methods Study], United States, 2014-2019

Some research studies, called clinical trials, test treatments to see if they are safe and effective for patients. Before patients enroll in a trial, researchers ask patients for informed consent. In informed consent, a doctor or researcher explains what the trial is about and the benefits and risks of taking part. Patients then choose whether to enroll in the trial. If a patient is too sick to decide, a surrogate, such as a family member or friend, can decide on the patient's behalf.
Trials that test treatments in health emergencies, such as heart attack or stroke, may need a different informed consent process. Emergency situations can be stressful, and patients may have little time to learn about the trial.
In this study, the research team worked with patients and surrogates who had experience with informed consent for trials in health emergencies. They created a new informed consent process to use for trials about stroke and heart attack.