An approach to community consultation prior to initiating an emergency research study incorporating a waiver of informed consent

Objectives: In November 1996, the Food and Drug Administration (FDA) and th e Department of Health and Human Services (DHHS) enacted rules allowing a n arrow exception to the requirement for prospective informed consent when en rolling critically ill patients in clinical research studies of emergency t reatments. These rules require that, prior to initiation of the study, the applicable institutional review board (IRB) assess the acceptability of the proposed research study to members of the community in which the research will be conducted. Specifically, the IRE must perform community consultatio n-a process during which community members learn about the proposed researc h and communicate their opinions regarding its acceptability to investigato rs or IRE representatives. The FDA and DHHS rules do not define specific ac ceptable methods for performing this community consultation. The objective of this study is to demonstrate the feasibility and utility of one proposed method for performing such community consultation. Methods: Parents of chi ldren being seen for minor traumatic injuries in three pediatric EDs were a sked to participate in a study regarding informed consent. After consent, a n instructor described to the parent a prospective, randomized, placebo-con trolled trial of phenytoin for the prophylaxis of posttraumatic seizures in children with severe closed head trauma. All parents were then asked wheth er they would have consented for their own child's participation, if their child had suffered such head injury. The parents were further asked to expl ain the reason(s) for their responses. Results: Parents of 227 children (ch ildren's mean +/- SD age 8.0 +/- 4.8 years, 57% male) were interviewed. Six ty-six percent of parents (149/227) stated they would give consent for thei r child's participation. Of the 149 consenting parents, 85% (126/149) cited potential benefit to their child, 72% (107/149) cited potential benefit to other children, and 60% (90/149) cited furthering medical knowledge. Of th e 78 nonconsenting parents (34% of total), 54% (42/78) cited fear of advers e effects, 39% (30/78) did not want their child to be a research subject in general, 27% (21/78) believed they needed to discuss participation with fa mily members who were unavailable, and 26% (20/78) stated they were unable to decide unless they were in the actual situation. Parental ethnicity and household income were found to influence the consent decision, while the pa rent's gender, religion, language, and educational level were not associate d with the consent decision. Conclusions: Community consultation regarding the acceptability of an emergency research protocol can be obtained via int erview techniques in the ED. This methodology may allow investigators to ob tain data on opinion from a targeted community for IRE consideration during the review of emergency research studies proposing a waiver of informed co nsent.