Grant: Project Grant - Priority Announcement: Patient-Oriented Research

Before a patient can be enrolled into a medical research study, he or she must give permission (called consent) to the researchers to do so. But what happens when someone is too sick to give permission, like when they are having a stroke? Currently, researchers usually try to find a family member to give permission on behalf of the sick person. Often, family members can't be found, don't know what to say, and feel lots of pressure to answer. Othewise, researchers may enroll the patient without asking for permission. We would like to try to involve patients as much as possible in the decision-making. That's why we are trying to develop a new way of gaining permission from patients ahead of time to include them in studies when they might be too sick to give permission at the time. We call this ADVANCED CONSENT. We want to see if we can identify people at risk of having a stroke, ask them about giving consent in advance, and then see if any of the people who agreed to participate would later come back to the hospital in a situation where they were too sick to sign up for a study at that time. If we are able to show that this program can work, we want to share our findings with stroke researchers around the world, and we hope that lots of other studies will also do this and involve patients as much as possible about research in stroke. Our work has 4 distinct steps: 1. We want to ask doctors, ethicists, and patients about what they think about advanced consent, both through giving them questionnaires and asking them questions in groups 2. We want to develop the ethics of advanced consent - why it's better to do this than use other methods of getting patient permission 3. We want to design a plan to approach patients about enrolling in the advanced consent program 4. Finally, we want to ask the patients how they feel about advanced consent, in principle and in relation to a specific trial