Implementation of the Exception From Informed Consent Regulations in a Large Multicenter Emergency Clinical Trials Network: The RAMPART Experience

Abstract

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.

ICU research: the impact of invasiveness on informed consent

“…This is in contradiction with some current rules that would allow a waiving of consent for observational studies [29]. The suggested requirement for dual consent in which one person should be the family or ICU doctor might be a solution regarding the exceptional and specific circumstances of emergencies [30,31]. Our results were also consistent with literature in which between 50 and 86 % of respondents accepted deferred consent [22,32,33].…”

Community Consultation for Prehospital Research: Experiences of Study Coordinators and Principal Investigators

“…Two sites reported using random-digit dialing surveys, and 3 sites conducted large surveys at public events or Emergency Departments. Aggregated, network-wide estimates of the total numbers of each type of event and numbers of participants have been previously reported (8). …”

“…Generating interest and finding individuals willing to talk about a study appear to be major challenges, as evidenced by the fact that 21 such events previously reported across the network involved only 256 participants (8). In contrast, respondents found attending existing meetings (particularly of seizure support groups) more productive.…”

“…All sites developed community consultation plans locally (8). We surveyed the principal investigator and coordinator at all 17 NETT hub sites regarding their views on and experiences with community consultation for RAMPART.…”

Balancing Ethical Goals in Challenging Individual Participant Scenarios Occurring in a Trial Conducted with Exception from Informed Consent

“…5 The case studies presented here are cases reported to the HSWG for discussion of ethical challenges that arose during the conduct of the ProTECT-III trial. The cases present the complexities of consent by an LAR within the context of an EFIC study.…”