Clinical Trials Consent

EVIEW ARTICLE

THE CHANGING FACE OF CLINICAL TRIALS

Jeffrey M. Drazen, M.D., David P. Harrington, Ph.D., John J.V. McMurray, M.D., James H. Ware, Ph.D., Janet Woodcock, M.D., Editors

Informed Consent

Christine Grady, R.N., Ph.D., Steven R. Cummings, M.D., Michael C. Rowbotham, M.D., Michael V. McConnell, M.D., M.S.E.E., Euan A. Ashley, F.R.C.P., D.Phil., and Gagandeep Kang, M.D., Ph.D.

N Engl J Med 2017; 376:856-867March 2, 2017DOI: 10.1056/NEJMra1603773

 Comments open through April 5, 2017

IDEO

MyHeart Counts.

VIDEO

Example of Video Consent.

This multipart review provides an overview of innovative approaches to improving and expanding the informed consent process for researchers and participants, along with short essays covering specific areas of innovation.

THE CHANGING FACE OF INFORMED CONSENT

Christine Grady, R.N., Ph.D.

In the classic interaction in which informed consent is obtained for research, an investigator presents the potential participant with information regarding a new therapeutic, diagnostic, or prophylactic intervention and then asks the participant to read and sign a detailed written consent document. /.../