The OHRP and SUPPORT — Another View

The OHRP and SUPPORT — Another View

A group of physicians, bioethicists, and scholars in allied fields agrees with the Office for Human Research Protections about the informed-consent documents in SUPPORT. To the Editor: We are a group of physicians, bioethicists, and scholars in allied fields who agree with the Office for Human Resea...

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Veröffentlicht in:The New England journal of medicine 2013-07, Vol.369 (2), p.e3-e3
Hauptverfasser: Macklin, Ruth, Shepherd, Lois, Dreger, Alice, Asch, Adrienne, Baylis, Francoise, Brody, Howard, Churchill, Larry R, Coleman, Carl H, Cowan, Ethan, Dolgin, Janet, Downie, Jocelyn, Dresser, Rebecca, Elliott, Carl, Epright, M. Carmela, Feder, Ellen K, Glantz, Leonard H, Grodin, Michael A, Hoffman, William, Hoffmaster, Barry, Hunter, David, Iltis, Ana S, Kahn, Jonathan D, King, Nancy M.P, Kraft, Rory, Kukla, Rebecca, Leavitt, Lewis, Lederer, Susan E, Lemmens, Trudo, Lindemann, Hilde, Marshall, Mary Faith, Merz, Jon F, Miller, Frances H, Mohrmann, Margaret E, Morreim, Haavi, Nass, Meryl, Nelson, James L, Noble, John H, Reis, Elizabeth, Reverby, Susan M, Silvers, Anita, Sousa, Aron C, Spece, Roy G, Strong, Carson, Swazey, Judith P, Turner, Leigh
Format: Artikel
Sprache:eng
Schlagworte:
Ethics, Research
Humans
Infant, Newborn
Informed Consent
Oxygen - blood
Pulmonary Surfactants - therapeutic use
Therapeutic Human Experimentation - ethics
United States
United States Office of Research Integrity
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Zusammenfassung:A group of physicians, bioethicists, and scholars in allied fields agrees with the Office for Human Research Protections about the informed-consent documents in SUPPORT. To 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 . . .
ISSN:0028-4793
1533-4406
DOI:10.1056/NEJMc1308015