<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="6.x">Drupal-Biblio</source-app><rec-number>5000</rec-number><ref-type>Journal Article</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Clayton, Ellen Wright</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">So What Are We Going to Do about Research Using Clinical Information and Samples?</style></title><secondary-title><style face="normal" font="default" size="100%">IRB: Ethics &amp; Human Research</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">Informed</style></keyword><keyword><style  face="normal" font="default" size="100%">Medical</style></keyword><keyword><style  face="normal" font="default" size="100%">Patients</style></keyword></keywords><taxonomies><taxonomy><style  face="normal" font="default" size="100%">Human Research Subjects</style></taxonomy><taxonomy><style  face="normal" font="default" size="100%">Science </style></taxonomy><taxonomy><style  face="normal" font="default" size="100%">Medicine</style></taxonomy><taxonomy><style  face="normal" font="default" size="100%">Biology</style></taxonomy></taxonomies><pubtype><style  face="normal" font="default" size="100%">Journal Article</style></pubtype><audience-level><style  face="normal" font="default" size="100%">ug</style></audience-level><dates><year><style  face="normal" font="default" size="100%">2004</style></year></dates><publisher><style face="normal" font="default" size="100%">Hastings Center</style></publisher><volume><style face="normal" font="default" size="100%">26</style></volume><pages><style face="normal" font="default" size="100%">14-15</style></pages><issn><style face="normal" font="default" size="100%">01937758</style></issn><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">Examines the impact of the guidance issued by the Office for Human Research Projections (OHRP) that promises dramatically to limit the need for informed consent and Institutional Review Board (IRB) review of the uses of medical records and tissue specimens under the Common Rule. Observation that so long as the investigator never has access to the identity of the patients, through agreement or policy, the IRB has no role; Enormous regulatory gap in which the majority of research involving databanks can be excluded from the Common Rule.</style></abstract><work-type><style face="normal" font="default" size="100%">Editorial</style></work-type><notes><style face="normal" font="default" size="100%">6Accession Number: 15109636; Clayton, Ellen Wright 1; Affiliation: 1: Rosalind E. Franklin Professor of Genetics and Health Policy and Director of Genetics and Health Policy Center, Vanderbilt University; Source Info: Nov/Dec2004, Vol. 26 Issue 6, p14; Subject Term: INFORMED consent (Medical law); Subject Term: MEDICAL ethics; Subject Term: MEDICAL laws &amp; legislation; Subject Term: MEDICAL care; Subject Term: MEDICAL records; Subject Term: PATIENTS; Subject Term: MEDICAL informatics; Number of Pages: 2p; Document Type: Editorial</style></notes></record></records></xml>