Variation of community consultation and public disclosure for a pediatric multi-centered "Exception from Informed Consent" trial

Background:The US federal regulation “Exception from Informed Consent for Emergency Research,” 21 Code of Federal Regulations 50.24, permits emergency research without informed consent under limited conditions. Additional safeguards to protect human subjects include requirements for community consultation and public disclosure prior to starting the research. Because the regulations are vague about these requirements, Institutional Review Boards determine the adequacy of these activities at a local level. Thus, there is potential for broad interpretation and practice variation.Aim:To describe the variation of community consultation and public disclosure activities approved by Institutional Review Boards, and the effectiveness of this process for a multi-center, Exception from Informed Consent, pediatric status epilepticus clinical research trial.Methods:Community consultation and public disclosure activities were analyzed for each of the 15 participating sites. Surveys were conducted with participants enro...