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 |
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| container_title | The New England journal of medicine |
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| creator | 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 |
| description | 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 . . . |
| doi_str_mv | 10.1056/NEJMc1308015 |
| format | Article |
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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 . . .</description><identifier>ISSN: 0028-4793</identifier><identifier>EISSN: 1533-4406</identifier><identifier>DOI: 10.1056/NEJMc1308015</identifier><identifier>PMID: 23803134</identifier><language>eng</language><publisher>United States: Massachusetts Medical Society</publisher><subject>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</subject><ispartof>The New England journal of medicine, 2013-07, Vol.369 (2), p.e3-e3</ispartof><rights>Copyright © 2013 Massachusetts Medical Society. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c386t-edcd933701c3747056e0055e826f26415d4653c34c001c79117d84dfba7e3cd53</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.nejm.org/doi/pdf/10.1056/NEJMc1308015$$EPDF$$P50$$Gmms$$H</linktopdf><linktohtml>$$Uhttps://www.nejm.org/doi/full/10.1056/NEJMc1308015$$EHTML$$P50$$Gmms$$H</linktohtml><link.rule.ids>314,776,780,2746,2747,26082,27903,27904,52360,54042</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23803134$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Macklin, Ruth</creatorcontrib><creatorcontrib>Shepherd, Lois</creatorcontrib><creatorcontrib>Dreger, Alice</creatorcontrib><creatorcontrib>Asch, Adrienne</creatorcontrib><creatorcontrib>Baylis, Francoise</creatorcontrib><creatorcontrib>Brody, Howard</creatorcontrib><creatorcontrib>Churchill, Larry R</creatorcontrib><creatorcontrib>Coleman, Carl H</creatorcontrib><creatorcontrib>Cowan, Ethan</creatorcontrib><creatorcontrib>Dolgin, Janet</creatorcontrib><creatorcontrib>Downie, Jocelyn</creatorcontrib><creatorcontrib>Dresser, Rebecca</creatorcontrib><creatorcontrib>Elliott, Carl</creatorcontrib><creatorcontrib>Epright, M. Carmela</creatorcontrib><creatorcontrib>Feder, Ellen K</creatorcontrib><creatorcontrib>Glantz, Leonard H</creatorcontrib><creatorcontrib>Grodin, Michael A</creatorcontrib><creatorcontrib>Hoffman, William</creatorcontrib><creatorcontrib>Hoffmaster, Barry</creatorcontrib><creatorcontrib>Hunter, David</creatorcontrib><creatorcontrib>Iltis, Ana S</creatorcontrib><creatorcontrib>Kahn, Jonathan D</creatorcontrib><creatorcontrib>King, Nancy M.P</creatorcontrib><creatorcontrib>Kraft, Rory</creatorcontrib><creatorcontrib>Kukla, Rebecca</creatorcontrib><creatorcontrib>Leavitt, Lewis</creatorcontrib><creatorcontrib>Lederer, Susan E</creatorcontrib><creatorcontrib>Lemmens, Trudo</creatorcontrib><creatorcontrib>Lindemann, Hilde</creatorcontrib><creatorcontrib>Marshall, Mary Faith</creatorcontrib><creatorcontrib>Merz, Jon F</creatorcontrib><creatorcontrib>Miller, Frances H</creatorcontrib><creatorcontrib>Mohrmann, Margaret E</creatorcontrib><creatorcontrib>Morreim, Haavi</creatorcontrib><creatorcontrib>Nass, Meryl</creatorcontrib><creatorcontrib>Nelson, James L</creatorcontrib><creatorcontrib>Noble, John H</creatorcontrib><creatorcontrib>Reis, Elizabeth</creatorcontrib><creatorcontrib>Reverby, Susan M</creatorcontrib><creatorcontrib>Silvers, Anita</creatorcontrib><creatorcontrib>Sousa, Aron C</creatorcontrib><creatorcontrib>Spece, Roy G</creatorcontrib><creatorcontrib>Strong, Carson</creatorcontrib><creatorcontrib>Swazey, Judith P</creatorcontrib><creatorcontrib>Turner, Leigh</creatorcontrib><title>The OHRP and SUPPORT — Another View</title><title>The New England journal of medicine</title><addtitle>N Engl J Med</addtitle><description>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 . . .</description><subject>Ethics, Research</subject><subject>Humans</subject><subject>Infant, Newborn</subject><subject>Informed Consent</subject><subject>Oxygen - blood</subject><subject>Pulmonary Surfactants - therapeutic use</subject><subject>Therapeutic Human Experimentation - ethics</subject><subject>United States</subject><subject>United States Office of Research Integrity</subject><issn>0028-4793</issn><issn>1533-4406</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNpt0EFLwzAYBuAgipvTm2cpqODBapIvaZrjGNMp0425eS1dkrKNtZ1Ji3jzR_gL_SVGN0XE7_JdHl5eXoQOCb4gmEeX993bO0UAx5jwLdQkHCBkDEfbqIkxjUMmJDTQnnML7I8wuYsaFGIMBFgTnY5nJhj0RsMgLXTwMBkOB6Nx8P76FrSLspoZGzzOzfM-2snSpTMHm99Ck6vuuNML-4Prm067HyqIoyo0WmkJIDBRIJjw7QzGnJuYRhmNGOGaRRwUMOWLKCEJETpmOpumwoDSHFrobJ27suVTbVyV5HOnzHKZFqasXUJASkkFiainx3_ooqxt4dt9Kc65pLFX52ulbOmcNVmysvM8tS8JwcnnfMnv-Tw_2oTW09zoH_y9lwcna5DnLinMIv8_5wP8wnCC</recordid><startdate>20130711</startdate><enddate>20130711</enddate><creator>Macklin, Ruth</creator><creator>Shepherd, Lois</creator><creator>Dreger, Alice</creator><creator>Asch, Adrienne</creator><creator>Baylis, Francoise</creator><creator>Brody, Howard</creator><creator>Churchill, Larry R</creator><creator>Coleman, Carl H</creator><creator>Cowan, Ethan</creator><creator>Dolgin, Janet</creator><creator>Downie, Jocelyn</creator><creator>Dresser, Rebecca</creator><creator>Elliott, Carl</creator><creator>Epright, M. 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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</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c386t-edcd933701c3747056e0055e826f26415d4653c34c001c79117d84dfba7e3cd53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Ethics, Research</topic><topic>Humans</topic><topic>Infant, Newborn</topic><topic>Informed Consent</topic><topic>Oxygen - blood</topic><topic>Pulmonary Surfactants - therapeutic use</topic><topic>Therapeutic Human Experimentation - ethics</topic><topic>United States</topic><topic>United States Office of Research Integrity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Macklin, Ruth</creatorcontrib><creatorcontrib>Shepherd, Lois</creatorcontrib><creatorcontrib>Dreger, Alice</creatorcontrib><creatorcontrib>Asch, Adrienne</creatorcontrib><creatorcontrib>Baylis, Francoise</creatorcontrib><creatorcontrib>Brody, Howard</creatorcontrib><creatorcontrib>Churchill, Larry R</creatorcontrib><creatorcontrib>Coleman, Carl H</creatorcontrib><creatorcontrib>Cowan, Ethan</creatorcontrib><creatorcontrib>Dolgin, Janet</creatorcontrib><creatorcontrib>Downie, Jocelyn</creatorcontrib><creatorcontrib>Dresser, Rebecca</creatorcontrib><creatorcontrib>Elliott, Carl</creatorcontrib><creatorcontrib>Epright, M. 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Carmela</au><au>Feder, Ellen K</au><au>Glantz, Leonard H</au><au>Grodin, Michael A</au><au>Hoffman, William</au><au>Hoffmaster, Barry</au><au>Hunter, David</au><au>Iltis, Ana S</au><au>Kahn, Jonathan D</au><au>King, Nancy M.P</au><au>Kraft, Rory</au><au>Kukla, Rebecca</au><au>Leavitt, Lewis</au><au>Lederer, Susan E</au><au>Lemmens, Trudo</au><au>Lindemann, Hilde</au><au>Marshall, Mary Faith</au><au>Merz, Jon F</au><au>Miller, Frances H</au><au>Mohrmann, Margaret E</au><au>Morreim, Haavi</au><au>Nass, Meryl</au><au>Nelson, James L</au><au>Noble, John H</au><au>Reis, Elizabeth</au><au>Reverby, Susan M</au><au>Silvers, Anita</au><au>Sousa, Aron C</au><au>Spece, Roy G</au><au>Strong, Carson</au><au>Swazey, Judith P</au><au>Turner, Leigh</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The OHRP and SUPPORT — Another View</atitle><jtitle>The New England journal of medicine</jtitle><addtitle>N Engl J Med</addtitle><date>2013-07-11</date><risdate>2013</risdate><volume>369</volume><issue>2</issue><spage>e3</spage><epage>e3</epage><pages>e3-e3</pages><issn>0028-4793</issn><eissn>1533-4406</eissn><abstract>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 . . .</abstract><cop>United States</cop><pub>Massachusetts Medical Society</pub><pmid>23803134</pmid><doi>10.1056/NEJMc1308015</doi><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0028-4793 |
| ispartof | The New England journal of medicine, 2013-07, Vol.369 (2), p.e3-e3 |
| issn | 0028-4793 1533-4406 |
| language | eng |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; New England Journal of Medicine |
| subjects | 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 |
| title | The OHRP and SUPPORT — Another View |
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