Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2012 Apr;19(4):448-54.
doi: 10.1111/j.1553-2712.2012.01328.x.

Implementation of the exception from informed consent regulations in a large multicenter emergency clinical trials network: the RAMPART experience

Robert Silbergleit  1 , Michelle H Biros, Deneil Harney, Neal Dickert, Jill Baren; NETT Investigators
Collaborators, Affiliations
Multicenter Study

Implementation of the exception from informed consent regulations in a large multicenter emergency clinical trials network: the RAMPART experience

Robert Silbergleit et al. Acad Emerg Med. 2012 Apr.

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.

Trial registration: ClinicalTrials.gov NCT00809146.

PubMed Disclaimer

References

    1. Cearnal L. The birth of the NETT: NIH-funded network will launch emergency neurological trials. Ann Emerg Med. 2006;48(6):726–8. - PubMed
    1. Federal Register. 21 CFR 50.24 Exception from informed consent requirements for emergency research. Federal Register. 1996;61(192):51498–531. - PubMed
    1. Baren JM, Biros MH. The research on community consultation: an annotated bibliography. Acad Emerg Med. 2007;14:346–52. - PubMed
    1. Mosesso VN, Jr, Brown LH, Greene HL, et al. Conducting research using the emergency exception from informed consent: the Public Access Defibrillation (PAD) Trial experience. Resuscitation. 2004;61(1):29–36. - PubMed
    1. Schmidt TA, Lewis RJ, Richardson LD. Current status of research on the federal guidelines for performing research using an exception from informed consent. Acad Emerg Med. 2005;12:1022–6. - PubMed

Publication types

Associated data