LEADER 05623nam 2200781 450 001 9910456303403321 005 20200520144314.0 010 $a1-281-99633-5 010 $a9786611996338 010 $a1-4426-7659-0 024 7 $a10.3138/9781442676596 035 $a(CKB)2430000000001828 035 $a(EBL)3255184 035 $a(OCoLC)923070874 035 $a(SSID)ssj0000301378 035 $a(PQKBManifestationID)11217749 035 $a(PQKBTitleCode)TC0000301378 035 $a(PQKBWorkID)10260728 035 $a(PQKB)10542111 035 $a(CaBNvSL)thg00600909 035 $a(MiAaPQ)EBC3255184 035 $a(MiAaPQ)EBC4671665 035 $a(DE-B1597)479198 035 $a(OCoLC)987921952 035 $a(DE-B1597)9781442676596 035 $a(Au-PeEL)EBL4671665 035 $a(CaPaEBR)ebr11257369 035 $a(CaONFJC)MIL199633 035 $a(OCoLC)958579381 035 $a(EXLCZ)992430000000001828 100 $a20160913h20062006 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aLaw and ethics in biomedical research $eregulation, conflict of interest, and liability /$fedited by Trudo Lemmens and Duff R. Waring 210 1$aToronto, [Ontario] ;$aBuffalo, [New York] ;$aLondon, [England] :$cUniversity of Toronto Press,$d2006. 210 4$dİ2006 215 $a1 online resource (278 p.) 300 $aIncludes index. 311 $a0-8020-8643-8 320 $aIncludes bibliographical references and index. 327 $tFrontmatter -- $tContents -- $tAcknowledgments -- $tIntroduction / $rLemmens, Trudo / Waring, Duff R. -- $t1. Uninformed Consent: The Case of Jesse Gelsinger / $rGelsinger, Paul L. -- $tPart One: Regulation -- $t2. Questions and Challenges in the Governance of Research Involving Humans: A Canadian Perspective / $rGlass, Kathleen Cranley -- $t3. Swinging on the Pendulum: Shifting Views of Justice in Human Subjects Research / $rMastroianni, Anna / Kahn, Jeffrey -- $tPart Two: Conflict of Interest -- $t4. The Ethical and Legal Foundations of Scientific 'Conflict of Interest' / $rKrimsky, Sheldon -- $t5. Self-Censorship / $rBrown, James Robert -- $t6. Promoting Integrity in Industry- Sponsored Clinical Drug Trials: Conflict of Interest Issues for Canadian Health Sciences Centres / $rFerris, Lorraine E. / Naylor, C. David -- $t7. The Human Subjects Trade: Ethical, Legal, and Regulatory Remedies to Deal with Recruitment Incentives and to Protect Scientific Integrity / $rLemmens, Trudo / Miller, Paul B. -- $tPart Three: Liability -- $t8. Bringing Research into Therapy: Liability Anyone? / $rThomson, Mary M. -- $t9. Legal Liability for Harm to Research Participants: The Case of Placebo-Controlled Trials / $rWaring, Duff R. / Glass, Kathleen Cranley -- $t10. Her Majesty's Research Subjects: Liability of the Crown in Research Involving Humans / $rHalwani, Sana -- $tContributors -- $tIndex 330 $aWhen a young man named Jesse Gelsinger died in 1999 as a result of his participation in a gene transfer research study, regulatory agencies in the United States began to take a closer look at what was happening in medical research. The resulting temporary shutdown of some of the most prestigious academic research centres confirmed what various recent reports in the United States as well as Canada had claimed; that the current system of regulatory oversight was in need of improvement.Law and Ethics in Biomedical Research uses the Gelinger case as a touchstone, illustrating how three major aspects of that case - the flaws in the regulatory system, conflicts of interest, and legal liability - embody the major challenges in the current medical research environment. Editors Trudo Lemmens and Duff R. Waring, along with a host of top scholars in the field, demonstrate why existing models of research review and human subject protection are in need of improvement, and how more stringent regulatory and legal means can be used to strengthen the protection of research subjects and the integrity of research.The contributors also address conflicts of interest, paying particular attention to the growing commercialization of medical research, as well as the legal liability of scientific investigators, research institutions, and governmental agencies. Legal liability is a growing concern in medical research and this fascinating study is, in the international context, one of the first to explore the liability of various parties involved in the research enterprise. 606 $aHuman experimentation in medicine$zCanada 606 $aMedicine$xResearch$xLaw and legislation$zCanada 606 $aMedicine$xResearch$xMoral and ethical aspects$zCanada 606 $aMedicine$xResearch$xLaw and legislation$zUnited States 606 $aMedicine$xResearch$xMoral and ethical aspects$zUnited States 606 $aHuman experimentation in medicine$zUnited States 608 $aElectronic books. 615 0$aHuman experimentation in medicine 615 0$aMedicine$xResearch$xLaw and legislation 615 0$aMedicine$xResearch$xMoral and ethical aspects 615 0$aMedicine$xResearch$xLaw and legislation 615 0$aMedicine$xResearch$xMoral and ethical aspects 615 0$aHuman experimentation in medicine 676 $a344.7104196 702 $aLemmens$b Trudo 702 $aWaring$b Duff William Ramus$f1955- 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910456303403321 996 $aLaw and ethics in biomedical research$92489195 997 $aUNINA