<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="6.x">Drupal-Biblio</source-app><rec-number>6555</rec-number><ref-type>Journal Article</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Hamrell, Michael R.</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Raising Suspicions with the Food and Drug Administration: Detecting Misconduct</style></title><secondary-title><style face="normal" font="default" size="100%">Science &amp; Engineering Ethics</style></secondary-title><short-title><style face="normal" font="default" size="100%">Raising Suspicions with the Food and Drug Administration: Detecting Misconduct</style></short-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">Clinical</style></keyword><keyword><style  face="normal" font="default" size="100%">data management</style></keyword><keyword><style  face="normal" font="default" size="100%">FDA</style></keyword><keyword><style  face="normal" font="default" size="100%">Fraud</style></keyword><keyword><style  face="normal" font="default" size="100%">Human Research Subjects</style></keyword><keyword><style  face="normal" font="default" size="100%">MEDICINE</style></keyword><keyword><style  face="normal" font="default" size="100%">Misconduct</style></keyword><keyword><style  face="normal" font="default" size="100%">SCIENCE</style></keyword><keyword><style  face="normal" font="default" size="100%">United</style></keyword></keywords><taxonomies><taxonomy><style  face="normal" font="default" size="100%">Misconduct</style></taxonomy><taxonomy><style  face="normal" font="default" size="100%">Human Research Subjects</style></taxonomy><taxonomy><style  face="normal" font="default" size="100%">Data Management</style></taxonomy><taxonomy><style  face="normal" font="default" size="100%">Science </style></taxonomy><taxonomy><style  face="normal" font="default" size="100%">Medicine</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%">2010</style></year></dates><volume><style face="normal" font="default" size="100%">16</style></volume><pages><style face="normal" font="default" size="100%">697-704</style></pages><issn><style face="normal" font="default" size="100%">13533452</style></issn><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">This article describes the clinical Bioresearch Monitoring (BIMO) oversight program of the US Food and Drug Administration (FDA) assesses the quality and integrity of data submitted to the FDA for new product approvals and human subjects protection during clinical studies. BIMO performs routine random inspections, and on occasion the FDA will conduct a directed inspection of a specific site or study to look for problems that may have previously been identified. The inspection of a clinical study sometimes uncovers evidence of research fraud or misconduct and it must be decided how to deal with the investigator and the suspect data. While monitoring is one way to decrease misconduct, training is also another option, and this approach helps to ensure that all individuals involved understand the rules and the consequences of research misconduct. </style></abstract><doi><style face="normal" font="default" size="100%">10.1007/s11948-010-9232-4</style></doi><issue><style face="normal" font="default" size="100%">4</style></issue><work-type><style face="normal" font="default" size="100%">Article</style></work-type><accession-num><style face="normal" font="default" size="100%">55613095</style></accession-num><notes><style face="normal" font="default" size="100%">Hamrell, Michael R. 1; Email Address: michael@moriahconsultants.com; Affiliation: 1: MORIAH Consultants, 4481 Paloma Lane, Yorba Linda, CA 92886-2832, USA; Source Info: Dec2010, Vol. 16 Issue 4, p697; Subject Term: CLINICAL trials; Subject Term: MISCONDUCT in office; Subject Term: FRAUD; Subject Term: UNITED States; Author-Supplied Keyword: Clinical research; Author-Supplied Keyword: FDA oversight; Author-Supplied Keyword: Fraud; Author-Supplied Keyword: Misconduct; Company/Entity: UNITED States. Food &amp; Drug Administration; Number of Pages: 8p; Document Type: Article</style></notes></record></records></xml>