The new regulations (NIH and FDA) allowing for a waiver of obtaining informed consent in emergency research require that investigators consult the community and make an attempt to find the family members who could give consent. Neither requirement is well defined. This study will evaluate alternative approaches to meeting both of these requirements, using as its base a study of brain injury patients being conducted under an approved waiver. The community-consultation portion will compare: (1) consulting an IRB; (2) consulting patients/family members in the emergency center waiting room; (3) conducting a random dial community survey (4) conducting a series of community meetings. Participants in each approach will fill out a questionnaire after being given standardized information about the brain injury study currently being conducted. The results will be compared to see if the resource-intensive methods (3) and (4) yield different results than the less intensive methods (1) and (2). The results of all four methods will be compared with questionnaire results from patients/family members obtained three months after participation in the head injury study. This will show whether methods (1)-(4) actually indicate what participants felt about participation. The full set of data will indicate the least resource-intensive approach to community consultation which reliably corresponds to subject attitudes about participation. The finding-the-family portion will compare three approaches: (1) telephoning done at the emergency center to numbers found on patient identification; (2) a more aggressive phone approach using experienced investigators calling nearby phone numbers using a criss-cross directory and other databases; (3) an on-the-street, locate-the-family effort using on-call experienced licensed investigators. The investigators will compare the percentage of families found using each of these techniques in a 36 month time-block randomized trial. This set of data will determine whether or not the resource intensive methods are more effective in finding families in time to make a decision about participation (6 hours) and whether or not this impacts upon enrollment.
| Contant, Charles; McCullough, Laurence B; Mangus, Lorna et al. (2006) Community consultation in emergency research. Crit Care Med 34:2049-52 |
