Shannon W. Stephens, EMTP, CCEMTP

I am a paramedic and researcher, specializing in the design and execution of clinical trials in emergency care. With over 25 years of experience, I have established myself as a content expert in bioethics and the regulatory pathways of “Exception From Informed Consent” studies. I have developed a novel and innovative way of conducting “community consultation and public disclosure”, one of the key regulatory steps mandated by the Department of Health and Human Services and the Food and Drug Administration. This new method leverages the power of social media and other interactive media platforms and can be executed centrally, thus limiting the work of the local investigators. This approach has gained widespread acceptance by Institutional Review Boards, Ethics Committees, and participating clinical sites and is the model used for over 170 enrollment sites, from 6 different multicenter clinical trial networks in the United States.