• Ruth Macklin, Lois Shepherd, Alice Dreger, Adrienne Asch, Francoise Baylis, Howard Brody, Larry R Churchill, Carl H Coleman, Ethan Cowan, Janet Dolgin, Jocelyn Downie, Rebecca Dresser, Carl Elliott, M Carmela Epright, Ellen K Feder, Leonard H Glantz, Michael A Grodin, William Hoffman, Barry Hoffmaster, David Hunter, Ana S Iltis, Jonathan D Kahn, Nancy M P King, Rory Kraft, Rebecca Kukla, Lewis Leavitt, Susan E Lederer, Trudo Lemmens, Hilde Lindemann, Mary Faith Marshall, Jon F Merz, Frances H Miller, Margaret E Mohrmann, Haavi Morreim, Meryl Nass, James L Nelson, John H Noble, Elizabeth Reis, Susan M Reverby, Anita Silvers, Aron C Sousa, Roy G Spece, Carson Strong, Judith P Swazey, and Leigh Turner.
• N. Engl. J. Med.. 2013 Jun 26.

AbstractTo the Editor: We are a group of physicians, bioethicists, and scholars in allied fields who agree with the Office for Human Research Protections (OHRP) that the informed-consent documents that were used in the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) were seriously inadequate.(1) The aims of the SUPPORT study were commendable, and the study addressed important clinical issues. Nevertheless, however complex and important a study may be, the consent process must be clear enough to enable informed decision making. The U.S. Code of Federal Regulations (45CFR46.116) includes the following requirements for informed consent: "A statement that the study . . .

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