Statement of Problem
Enrollment of subjects into emergency research clinical trials provides special challenges to the protection of human subjects. Over the past decade, many clinical trials and scholarly projects conducted both within NIH emergency trials networks and external to them have accumulated experience and findings related to these challenges. These experiences and findings, however, are not necessarily accessible to others in the field and may not be available to inform future research. This is particularly true of the experience of conducting emergency research in the pre-hospital setting, in which patients are enrolled in the ambulance while under the care of paramedics during emergency medical services (EMS) responses. Similarly, the ROC and NETT networks have accumulated extensive scholarly work and operational expertise related to implementation of community consultation and public disclosure required for exception from informed consent (EFIC) for emergency research, but do not have a systematic way to communicate and translate that into templates for good practices for SIREN and other emergency trialists external to the network. Finally, as our experience with patient engagement in planning clinical research has increased, and as a consequence of our empirical ethics research interviewing past emergency trial participants, it has become clear how little is known about the experience of family members of patients with critical emergency illness and injury. The impact of that experience on both patient and family member outcomes, and on emergency research participation and retention, is potentially important but poorly understood.
These supplements are an opportunity to optimize NIH’s stewardship of emergency medicine research conducted under EFIC or in the pre-hospital setting. It will enhance the collection of data that will contribute to shaping clinical practice in the emergency setting, and strengthen public trust in this critical arena of biomedical research. Engagement of an independent research group for data gathering and evaluation activities will facilitate rapid progress toward this opportunity; importantly, it will also enhance the objectivity of the process.
Supplemental Specific Aims
We propose a pair of administrative supplements to the SIREN Clinical Coordinating Center (CCC) and SIREN Data Coordinating Center (DCC) to address these knowledge gaps. These are discrete additional aims within the existing scope and charge of the network, but require additional resources. These aims are:
- To assess and summarize the range of research practices currently used to involve and prepare EMS paramedics for their roles in clinical trials that enroll subjects in the prehospital setting, and to understand the experiences of paramedics and EMS directors involved in these trials.
- To formulate generalizable and annotated procedures for SIREN and the larger emergency research community from the lessons learned by ROC and NETT investigators related to the conduct of EFIC trials including prior administrative and regulatory strategies, and the results of previous funded and unfunded research projects about community consultation and public disclosure conducted in the networks.
- To plan and initiate assessments of the experiences, needs, and emotional health of family members of victims of cardiac arrest and severe neurotrauma, with particular exploration of the effect of presence during resuscitation, availability of peer support, and decision making with respect to research participation.