Clinical trials investigating therapies for acutely and critically ill and injured patients in the earliest phases of treatment often can only be performed under regulations allowing for exception from informed consent (EFIC) for emergency research. Implementation of these regulations in multicenter clinical trials involves special challenges and opportunities. The Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART), the first EFIC trial conducted by the Neurological Emergencies Treatment Trials (NETT) network, combined centralized resources and coordination with retention of local control and flexibility to facilitate compliance with the EFIC regulations. Specific methods used by the NETT included common tools for community consultation and public disclosure, sharing of experiences and knowledge, and reporting of aggregate results. Tracking of community consultation and public disclosure activities and feedback facilitates empirical research on EFIC methods in the network and supports quality improvements for future NETT trials. The NETT model used in RAMPART demonstrates how EFIC may be effectively performed in established clinical trial networks.

Background: In 1996, the U.S. Food and Drug Administration approved regulations authorizing an exception from informed consent (EFIC) for research conducted in emergency settings when obtaining prospective informed consent is not possible due to the potential subject's critical illness or injury. The regulations require that investigators conduct community consultation (CC) efforts before initiating a study and require that institutional review boards review the results of CC prior to approving a study. However, little is known about how communities view EFIC research or the CC process.

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Background Exception from informed consent (EFIC) regulations for research in emergency settings contain unique requirements for community consultation and public disclosure. These requirements address ethical challenges intrinsic to this research context. Multiple approaches have evolved to accomplish these activities that may reflect and advance different aims. This scoping review was designed to identify areas of consensus and lingering uncertainty in the literature. Methods Scoping review methodology was used. Conceptual and empirical literature related to community consultation and public disclosure for EFIC research was included and identified through a structured search using Embase, HEIN Online, PubMed, and Web of Science. Data were extracted using a standardized tool with domains for major literature categories. Results Among 84 manuscripts, major domains included conceptual or policy issues, reports of community consultation processes and results, and reports of public disclosure processes and results. Areas of consensus related to community consultation included the need for a two‐way exchange of information and use of multiple methods. Public acceptance of personal EFIC enrollment is commonly 64% to 85%. There is less consensus regarding how to assess attitudes, what “communities” to prioritize, and how to determine adequacy for individual projects. Core goals of public disclosure are less well developed; no metrics exist for assessing adequacy. Conclusions Multiple methods are used to meet community consultation and public disclosure requirements. There remain no settled norms for assessing adequacy of public disclosure, and there is lingering debate about needed breadth and depth of community consultation.

Objective To assess principal investigators’ and study coordinators’ views and experiences regarding community consultation in a multi-center trial of prehospital treatment for status epilepticus conducted under an exception from informed consent for research in emergency settings. Methods Principal investigators and study coordinators at all 17 hubs for the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) were invited to complete a web-based survey regarding community consultation at their site for RAMPART. Major domains included: 1) perceived goals of community consultation; 2) experiences with and views of community consultation methods used; 3) interactions with IRB regarding community consultation; and 4) general satisfaction and lessons learned. Descriptive statistics were tabulated for Likert scale data; relevant themes were reported for text-based data. Results Twenty-eight individuals (16 coordinators and 12 investigators) representing all 17 RAMPART hubs completed the survey. Respondents considered multiple community consultation goals to be important, with least support for the role of community consultation in altering study design. All sites used multiple methods (median= 5). The most widely used, and generally favored, method was attending previously scheduled meetings of existing groups. Respondents expressed frustration with low attendance and responsiveness at open public meetings. Conclusions Coordinators and investigators in this trial viewed community consultation efforts as successful but reported real challenges generating public interest. Individuals with the condition under study were found to be more engaged and supportive of the trial. Respondents endorsed numerous potential goals of the community consultation process and often combined methods to achieve these goals.