Clinical research is sorely needed to improve treatment of acute, life-threatening conditions such as sudden cardiac death and traumatic brain injury. Because patients with these conditions are severely ill and unable to give informed consent, research in emergency settings is ethically challenging. Federal regulations permit an exception from informed consent (EFIC) in emergency settings, but few EFIC studies have been approved, leaving crucial clinical questions unanswered. A significant challenge in EFIC research is the controversial requirement to consult communities in the area where research will be conducted. IRBs, investigators, and sponsors struggle with this requirement, as the goals of community consultation and the methods for achieving those goals remain unclear. This project is a unique collaboration with the Neurological Emergency Treatment Trials (NETT) group, is embedded within NETT trials on status epilepticus (RAMPART) and traumatic brain injury (PROTECT III). It is designed to improve understanding of the process of community consultation and community views on EFIC research.
Its specific aims are to: 1. Assess the views and experiences of patients enrolled in the RAMPART trial regarding EFIC. 2. Conduct a systematic exploratory study of community consultation in the RAMPART trial. 3. Use metrics from Aim 2 to conduct a comprehensive prospective evaluation of different community consultation methods in the PROTECT III Trial. 4. Develop policy recommendations for EFIC research and community consultation. The project will take place in two phases and employ multiple methods. The first phase will involve interviews and surveys with investigators and IRB members, observation of community consultation efforts, and in-depth interviews with enrolled participants in RAMPART, a study of pre-hospital treatment of status epilepticus. The second phase will use metrics developed from the first phase to assess community consultation efforts proposed and conducted in PROTECT III, a Phase III study of progesterone in closed head trauma. This unique collaboration is an excellent training opportunity and will produce valuable data for investigators seeking to improve treatment for cardiovascular and neurologic emergencies.
