Informed Consent for Research on Medical Practices
Authors: Mildred K. Cho, David Magnus, Benjamin S. Wilfond
Journal: Annals of Internal Medicine (2015)

Letters3 November 2015Informed Consent for Research on Medical PracticesMildred K. Cho, PhD, David Magnus, PhD, and Benjamin S. Wilfond, MDMildred K. Cho, PhDFrom Stanford Center for Biomedical Ethics, Stanford, California, and Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, Washington.Search for more papers by this author, David Magnus, PhDFrom Stanford Center for Biomedical Ethics, Stanford, California, and Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, Washington.Search for more papers by this author, and Benjamin S. Wilfond, MDFrom Stanford Center for Biomedical Ethics, Stanford, California, and Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, Washington.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/L15-5152-2 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:We agree with Ms. Shepherd and colleagues that analyzing data (and even crafting commentaries) independent of authors' agendas is challenging. However, they did not heed this lesson about their own biases and, as a result, make mistakes of both fact and interpretation.As a result of current regulations, treating medical records research (where consent is usually not required) differently from that involving randomization is common. A new proposed guidance from the Office for Human Research Protections would go further in codifying this difference and would make it virtually impossible for institutional review boards to apply federal regulations regarding ... Author, Article, and Disclosure InformationAffiliations: From Stanford Center for Biomedical Ethics, Stanford, California, and Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, Washington.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0166. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoAttitudes Toward Risk and Informed Consent for Research on Medical Practices Mildred K. Cho , David Magnus , Melissa Constantine , Sandra Soo-Jin Lee , Maureen Kelley , Stephanie Alessi , Diane Korngiebel , Cyan James , Ellen Kuwana , Thomas H. Gallagher , Douglas Diekema , Alexander M. Capron , Steven Joffe , and Benjamin S. Wilfond Informed Consent for Research on Medical Practices Lois Shepherd , Ruth Macklin , Nancy M.P. King , Alice Dreger , and Nolan A. Wages Informed Consent for Research on Medical Practices Lois Shepherd , Ruth Macklin , Nancy M.P. King , Alice Dreger , and Nolan A. Wages Metrics Cited byStakeholder perspectives regarding alternate approaches to informed consent for comparative effectiveness researchRecent controversies on comparative effectiveness research investigations: Challenges, opportunities, and pitfalls 3 November 2015Volume 163, Issue 9Page: 725-726KeywordsDisclosureForecastingPopulation statistics ePublished: 3 November 2015 Issue Published: 3 November 2015 Copyright & PermissionsCopyright © 2015 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...