Legal Issues in Scientific Research
In recent years, regulatory and law enforcement authorities responsible for combating fraud and abuse have focused greater attention on the scientific research process, in particular, the process of seeking reimbursement for research costs, the process of performing clinical research, and the potent...
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Veröffentlicht in: | JAMA : the journal of the American Medical Association 2002-01, Vol.287 (1), p.85-91 |
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container_title | JAMA : the journal of the American Medical Association |
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creator | Kalb, Paul E Koehler, Kristin Graham |
description | In recent years, regulatory and law enforcement authorities responsible
for combating fraud and abuse have focused greater attention on the scientific
research process, in particular, the process of seeking reimbursement for
research costs, the process of performing clinical research, and the potential
improper remuneration of researchers or research subjects. This article describes
how the federal False Claims Act, which allows the government to recover treble
damages plus substantial penalties from persons who knowingly submit false
claims or make false statements to the government, has been used to achieve
a number of multimillion-dollar settlements with research institutions. The
article also discusses instances of temporary suspension of research activities
at a number of prominent institutions and the investigation of illegal "inducements"
or "kickbacks" provided by manufacturers to researchers and by research institutions
to patients. |
doi_str_mv | 10.1001/jama.287.1.85 |
format | Article |
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for combating fraud and abuse have focused greater attention on the scientific
research process, in particular, the process of seeking reimbursement for
research costs, the process of performing clinical research, and the potential
improper remuneration of researchers or research subjects. This article describes
how the federal False Claims Act, which allows the government to recover treble
damages plus substantial penalties from persons who knowingly submit false
claims or make false statements to the government, has been used to achieve
a number of multimillion-dollar settlements with research institutions. The
article also discusses instances of temporary suspension of research activities
at a number of prominent institutions and the investigation of illegal "inducements"
or "kickbacks" provided by manufacturers to researchers and by research institutions
to patients.</description><identifier>ISSN: 0098-7484</identifier><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.287.1.85</identifier><identifier>PMID: 11754713</identifier><identifier>CODEN: JAMAAP</identifier><language>eng</language><publisher>Chicago, IL: American Medical Association</publisher><subject><![CDATA[Bioethics ; Biological and medical sciences ; Biomedical Research ; Fraud ; Fraud - legislation & jurisprudence ; Law ; Liability, Legal ; Medical research ; Medical sciences ; Miscellaneous ; Public health. Hygiene ; Public health. Hygiene-occupational medicine ; Reimbursement Mechanisms - economics ; Reimbursement Mechanisms - legislation & jurisprudence ; Research - economics ; Research - legislation & jurisprudence ; Research Subjects ; Research Support as Topic - legislation & jurisprudence ; Scientific Misconduct - legislation & jurisprudence ; Settlements & damages ; United States]]></subject><ispartof>JAMA : the journal of the American Medical Association, 2002-01, Vol.287 (1), p.85-91</ispartof><rights>2002 INIST-CNRS</rights><rights>Copyright American Medical Association Jan 2, 2002</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-a326t-4d5b613cfc4c757db990cc0c4e36e60cbb4e83b6d7ac1b2920012a52a5a8ca673</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jama/articlepdf/10.1001/jama.287.1.85$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.287.1.85$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,314,780,784,3339,27923,27924,76360,76363</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=13418407$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11754713$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kalb, Paul E</creatorcontrib><creatorcontrib>Koehler, Kristin Graham</creatorcontrib><title>Legal Issues in Scientific Research</title><title>JAMA : the journal of the American Medical Association</title><addtitle>JAMA</addtitle><description>In recent years, regulatory and law enforcement authorities responsible
for combating fraud and abuse have focused greater attention on the scientific
research process, in particular, the process of seeking reimbursement for
research costs, the process of performing clinical research, and the potential
improper remuneration of researchers or research subjects. This article describes
how the federal False Claims Act, which allows the government to recover treble
damages plus substantial penalties from persons who knowingly submit false
claims or make false statements to the government, has been used to achieve
a number of multimillion-dollar settlements with research institutions. The
article also discusses instances of temporary suspension of research activities
at a number of prominent institutions and the investigation of illegal "inducements"
or "kickbacks" provided by manufacturers to researchers and by research institutions
to patients.</description><subject>Bioethics</subject><subject>Biological and medical sciences</subject><subject>Biomedical Research</subject><subject>Fraud</subject><subject>Fraud - legislation & jurisprudence</subject><subject>Law</subject><subject>Liability, Legal</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Miscellaneous</subject><subject>Public health. Hygiene</subject><subject>Public health. Hygiene-occupational medicine</subject><subject>Reimbursement Mechanisms - economics</subject><subject>Reimbursement Mechanisms - legislation & jurisprudence</subject><subject>Research - economics</subject><subject>Research - legislation & jurisprudence</subject><subject>Research Subjects</subject><subject>Research Support as Topic - legislation & jurisprudence</subject><subject>Scientific Misconduct - legislation & jurisprudence</subject><subject>Settlements & damages</subject><subject>United States</subject><issn>0098-7484</issn><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkMtLw0AQhxdRbK0ePXiRoOgtcTf7zLEUH4WC4OMcZicb3ZKkNdsc_O9daaXgMDCH-Ri-3xByzmjGKGV3S2ghy43OWGbkARkzyU3KZWEOyZjSwqRaGDEiJyEsaSzG9TEZMaal0IyPyfXCfUCTzEMYXEh8l7yid93G1x6TFxcc9Ph5So5qaII7280JeX-4f5s9pYvnx_lsukiB52qTikpaxTjWKFBLXdmioIgUhePKKYrWCme4VZUGZDYv8miTg4wNBkFpPiG327vrfvUVdTZl6wO6poHOrYZQRmEVk6kIXv0Dl6uh76JbmbOYUAppInS5gwbbuqpc976F_rv8yx6Bmx0AAaGpe-jQhz3HBTOC_mpdbLn46f22EJIZ_gPSJG3H</recordid><startdate>20020102</startdate><enddate>20020102</enddate><creator>Kalb, Paul E</creator><creator>Koehler, Kristin Graham</creator><general>American Medical Association</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7QL</scope><scope>7QP</scope><scope>7TK</scope><scope>7TS</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope></search><sort><creationdate>20020102</creationdate><title>Legal Issues in Scientific Research</title><author>Kalb, Paul E ; Koehler, Kristin Graham</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a326t-4d5b613cfc4c757db990cc0c4e36e60cbb4e83b6d7ac1b2920012a52a5a8ca673</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Bioethics</topic><topic>Biological and medical sciences</topic><topic>Biomedical Research</topic><topic>Fraud</topic><topic>Fraud - legislation & jurisprudence</topic><topic>Law</topic><topic>Liability, Legal</topic><topic>Medical research</topic><topic>Medical sciences</topic><topic>Miscellaneous</topic><topic>Public health. 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for combating fraud and abuse have focused greater attention on the scientific
research process, in particular, the process of seeking reimbursement for
research costs, the process of performing clinical research, and the potential
improper remuneration of researchers or research subjects. This article describes
how the federal False Claims Act, which allows the government to recover treble
damages plus substantial penalties from persons who knowingly submit false
claims or make false statements to the government, has been used to achieve
a number of multimillion-dollar settlements with research institutions. The
article also discusses instances of temporary suspension of research activities
at a number of prominent institutions and the investigation of illegal "inducements"
or "kickbacks" provided by manufacturers to researchers and by research institutions
to patients.</abstract><cop>Chicago, IL</cop><pub>American Medical Association</pub><pmid>11754713</pmid><doi>10.1001/jama.287.1.85</doi><tpages>7</tpages></addata></record> |
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issn | 0098-7484 1538-3598 |
language | eng |
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source | MEDLINE; American Medical Association Journals |
subjects | Bioethics Biological and medical sciences Biomedical Research Fraud Fraud - legislation & jurisprudence Law Liability, Legal Medical research Medical sciences Miscellaneous Public health. Hygiene Public health. Hygiene-occupational medicine Reimbursement Mechanisms - economics Reimbursement Mechanisms - legislation & jurisprudence Research - economics Research - legislation & jurisprudence Research Subjects Research Support as Topic - legislation & jurisprudence Scientific Misconduct - legislation & jurisprudence Settlements & damages United States |
title | Legal Issues in Scientific Research |
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