RAA RAMPART Study to Begin Soon

The National Institutes of Health-sponsored research study known as RAMPART, has been approved by the Virginia Commonwealth University Institutional Review Board and will begin enrolling patients in Richmond during the summer of 2009. This study is designed to determine which of two standard treatments for unconscious patients having continuous seizures is most effective at stopping the […]

June 13, 2009; 4:50 PM • by Oregon Hill

This study is designed to determine which of two standard treatments for unconscious patients having continuous seizures is most effective at stopping the seizure quickly. Protocol trained paramedics in the City of Richmond will be administering the treatments. Since patients qualifying for the study are unconscious, they cannot give consent. Instead the study is conducted under the Federal Exception to Informed Consent regulatory provisions, which require community consultation (to determine the public’s support of the proposed study) and disclosure before, during, and after study completion.

In the last six months, we have conducted community consultation by holding numerous meetings with community groups. The meetings were announced using flyers, bus ads, newspaper ads, mass emails, radio, and calls to community groups. Our meetings specifically targeted and reached out to specific groups of individuals who have known seizures and/or are at high risk of having a seizure. The vast majority of attendees at each of the meetings were highly supportive of the project.

Anyone who wishes NOT to be included in the study (should they have seizures) can request an “opt out” bracelet, which is available free of charge: Phone, 804-828-6047; email, HYPERLINK “mailto:rampart@vcu.edu” rampart@vcu.edu; website, HYPERLINK “http://sitemaker.umich.edu/vcu/home” http://sitemaker.umich.edu/vcu/home.

Editor’s note: There was a presentation of this at an Oregon Hill Neighborhood Association meeting a few months ago.