MARC Record from marc_columbia

LEADER: 14412pam a22003974a 4500
001 4360006
005 20221102203010.0
008 030616s2003 mdu b 001 0 eng
010 $a 2003013887
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020 $a0801878136 (pbk. : alk. paper)
035 $a(OCoLC)ocm52471681
035 $a(NNC)4360006
035 $a4360006
040 $aDNLM/DLC$cDLC$dYDX$dNLM$dOrLoB-B
042 $apcc
050 00 $aR853.H8$bE825 2003
060 00 $a2004 A-525
060 10 $aW 20.5$bE832 2003
082 00 $a174/.28$221
245 00 $aEthical and regulatory aspects of clinical research :$breadings and commentary /$cedited by Ezekiel J. Emanuel [and others].
260 $aBaltimore :$bJohns Hopkins University Press,$c2003.
300 $axxxv, 490 pages ;$c28 cm
336 $atext$btxt$2rdacontent
337 $aunmediated$bn$2rdamedia
504 $aIncludes bibliographical references and index.
505 00 $gPt. I.$tScandals and Tragedies of Research with Human Participants: Nuremberg, the Jewish Chronic Disease Hospital, Beecher, and Tuskegee -- $g1.$tU.S. Medical Researchers, the Nuremberg Doctors Trial, and the Nuremberg Code: A Review of Findings of the Advisory Committee on Human Radiation Experiments /$rRuth R. Faden, Susan E. Lederer and Jonathan D. Moreno -- $g2.$tThe Jewish Chronic Disease Hospital Case /$rJay Katz /$rEdited by Alexander Morgan Capron and Eleanor Swift Glass -- $g3.$tEthics and Clinical Research /$rHenry K. Beecher -- $g4.$tRacism and Research: The Case of the Tuskegee Syphilis Study /$rAllan M. Brandt -- $gPt. II.$tEthical and Regulatory Guidance for Research with Humans -- $g5.$tThe Nuremberg Code /$rNuremberg Military Tribunal, U.S. v. Karl Brandt, et al -- $g6.$tThe Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects /$rThe World Medical Association -- $g7.$tThe Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research /$rThe National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research -- $g8.$tThe Common Rule, Title 45 (Public Welfare), Code of Federal Regulations, Part 46 (Protection of Human Subjects), Subparts A-D /$rU.S. Department of Health and Human Services, National Institutes of Health and Office for Human Research Protections -- $g9.$tThe International Ethical Guidelines for Biomedical Research Involving Human Subjects /$rThe Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO) -- $g10.$tThe ICH Harmonised Tripartite Guideline - Guideline for Good Clinical Practice (ICH-GCP Guideline) /$rThe International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use -- $gPt. III.$tThe Ethics of Clinical Trial Design -- $gSect. 1.$tThe Distinction between Research and Treatment -- $g11.$tResearch and Practice /$rRobert J. Levine -- $g12.$tDemarcating Research and Treatment: A Systematic Approach for the Analysis of the Ethics of Clinical Research /$rBenjamin Freedman, Abraham Fuks and Charles Weijer -- $gSect. 2.$tThe Ethics of Randomized Clinical Trials: Clinical Equipoise -- $g13.$tOf Mice but Not Men: Problems of the Randomized Clinical Trial /$rSamuel Hellman and Deborah S. Hellman -- $g14.$tEquipoise and the Ethics of Clinical Research /$rBenjamin Freedman -- $g15.$tRandomized Controlled Trials: Lessons from ECMO /$rRobert D. Truog -- $gSect. 3.$tThe Role of Placebos in Clinical Research -- $g16.$tThe Continuing Unethical Use of Placebo Controls /$rKenneth J. Rothman and Karin B. Michels -- $g17.$tPlacebo-Controlled Trials and the Logic of Clinical Purpose /$rBenjamin Freedman -- $g18.$tPlacebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments, Part 1: Ethical and Scientific Issues /$rRobert Temple and Susan S. Ellenberg -- $g19.$tThe Ethics of Placebo-Controlled Trials: A Middle Ground /$rEzekiel J. Emanuel and Franklin G. Miller -- $gSect. 4.$tThe Ethics of Phase I Research -- $g20.$tOn the Nature and Ethics of Phase I Clinical Trials of Cancer Chemotherapies /$rMortimer B. Lipsett -- $g21.$tThe Changing Landscape of Human Experimentation: Nuremberg, Helsinki, and Beyond /$rGeorge J. Adams -- $gPt. IV.$tThe Ethics of Research Participant Recruitment -- $gSect. 1.$tJustifications for the Recruitment of Research Participants -- $g22.$tPhilosophical Reflections on Experimenting with Human Subjects /$rHans Jonas -- $g23.$tExperimentation on Trial: Why Should One Take Part in Medical Research? /$rDavid Heyd -- $gSect. 2.$tAccess to Research -- $g24.$tWanted: Single, White Male for Medical Research /$rRebecca Dresser -- $g25.$tWhy Should We Include Women and Minorities in Randomized Controlled Trials? /$rCharles Weijer and Robert A. Crouch -- $g26.$tThe Duty to Exlude: Excluding People at Undue Risk from Research /$rCharles Weijer and Abraham Fuks -- $gSect. 3.$tPayment of Research Participants -- $g27.$tWhat's the Price of a Research Subject? Approaches to Payment for Research Participation /$rNeal Dickert and Christine Grady -- $g28.$tJustice for the Professional Guinea Pig /$rTrudo Lemmens and Carl Elliott -- $g29.$tPaying People to Participate in Research: Why Not? /$rPaul McNeill -- $gPt. V.$tInformed Consent in Research -- $g30.$tConsent Issues in Human Research /$rRobert J. Levine -- $g31.$tInformed (But Uneducated) Consent /$rFranz J. Ingelfinger -- $g32.$tA Moral Theory of Informed Consent /$rBenjamin Freedman -- $g33.$tIs Informed Consent Always Necessary for Randomized, Controlled Trials? /$rRobert D. Truog, Walter Robinson, Adrienne Randolph and Alan Morris -- $g34.$tHuman Experimentation and Human Rights /$rJay Katz -- $g35.$tSubject Interview Study /$rThe President's Advisory Committee on Human Radiation Experiements -- $g36.$tFalse Hopes and Best Data: Consent to Research and the Therapeutic Misconception /$rPaul S. Appelbaum, Loren H. Roth, Charles W. Lidz, Paul Benson and William Winslade -- $g37.$t"Therapeutic Misconception" and "Recruiting Doublespeak" in the Informed Consent Process /$rMark Hochhauser -- $gPt. VI.$tClinical Research with Special Populations -- $gSect. 1.$tPeople with Cognitive Impairments -- $g38.$tResearch Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity /$rThe National Bioethics Advisory Commission -- $g39.$tAre Research Ethics Bad for Our Mental Health? /$rRobert Michels -- $g40.$tCaring about Risks: Are Severely Depressed Patients Competent to Consent to Research? /$rCarl Elliott -- $gSect. 2.$tChildren -- $g41.$tThe NIH Trials of Growth Hormone for Short Stature /$rCarol A. Tauer -- $g42.$tIn loco parentis: Minimal Risk as an Ethical Threshold for Research upon Children /$rBenjamin Freedman, Abraham Fuks and Charles Weijer -- $g43.$tMinors' Assent, Consent, or Dissent to Medical Research /$rSanford Leikin -- $gSect. 3.$tCaptive Populations: Soldiers, Prisoners, Students -- $g44.$tConvenient and Captive Populations /$rJonathan D. Moreno -- $g45.$tMedical Experimentation on Prisoners /$rCarl Cohen -- $g46.$tStudents, Grades, and Informed Consent /$rHarold F. Gamble -- $g47.$tAgainst Special Protections for Medical Students /$rNancy R. Angoff -- $gPt. VII.$tSpecial Topics in Research Ethics -- $gSect. 1.$tGenetics Research -- $g48.$tStructuring the Review of Human Genetics Protocols: Gene Localization and Identification Studies /$rKathleen Cranley Glass, Charles Weijer, Roberta M. Palmour, Stanley H. Shapiro, Trudo Lemmens and Karen Lebacqz -- $g49.$tStructuring the Review of Human Genetics Protocols, Part II: Diagnostic and Screening Studies /$rKathleen Cranley Glass, Charles Weijer, Trudo Lemmens, Roberta M. Palmour and Stanely H. Shapiro -- $g50.$tStructuring the Review of Human Genetics Protocols, Part III: Gene Therapy Studies /$rKathleen Cranley Glass, Charles Weijer, Denis Cournoyer, Trudo Lemmens, Roberta M. Palmour, Stanley H. Shapiro and Benjamin Freedman -- $g51.$tProtecting the Privacy of Family Members in Survey and Pedigree Research /$rJeffrey R. Botkin -- $gSect. 2.$tStored Human Biological Specimens -- $g52.$tStatement on Informed Consent for Genetic Research /$rThe American Society of Human Genetics -- $g53.$tInformed Consent for Genetic Research on Stored Tissue Samples /$rEllen Wright Clayton, Karen K. Steinberg, Muin J. Khoury, Elizabeth Thomson, Lori Andrews, Mary Jo Ellis Kahn, Loretta M. Kopelman and Joan O. Weiss -- $g54.$tUse of Human Tissues in Research: Clarifying Clinician and Researcher Roles and Information Flows /$rJon F. Merz, Pamela Sankar, Sheila E. Taube and Virginia LiVolsi -- $gSect. 3.$tHuman Embryos and Stem Cells -- $g55.$tReport of the Human Embryo Research Panel, Volume 1 /$rAd Hoc Group of Consultants to the Advisory Committee to the Director, NIH -- $g56.$tThe Inhuman Use of Human Beings: A Statement on Embryo Research /$rThe Ramsey Colloquium -- $g57.$tEthical Issues in Human Stem Cell Research /$rNational Bioethics Advisory Commission -- $g58.$tCreating Embryos for Research: On Weighing Symbolic Costs /$rMaura A. Ryan --
505 80 $gSect. 4.$tDrug Challenge and Drug Washout Studies -- $g59.$tDrug-Free Research in Schizophrenia: An Overview of the Controversy /$rPaul S. Appelbaum -- $g60.$tPsychiatric Symptom-Provoking Studies: An Ethical Appraisal /$rFranklin G. Miller and Donald L. Rosenstein -- $gSect. 5.$tResearch with Communities -- $g61.$tA Model Agreement for Genetic Research in Socially Identifiable Populations /$rMorris W. Foster, Deborah Bernsten and Thomas H. Carter -- $g62.$tGroups as Gatekeepers to Genomic Research: Conceptually Confusing, Morally Hazardous, and Practically Useless /$rEric T. Juengst -- $g63.$tProtecting Communities in Research: Current Guidelines and Limits of Extrapolation /$rCharles Weijer, Gary Goldsand and Ezekiel J. Emanuel -- $g64.$tProtecting Communities in Biomedical Research /$rCharles Weijer and Ezekiel J. Emanuel -- $gSect. 6.$tInternational Research -- $g65.$tUnethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries /$rPeter Lurie and Sidney M. Wolfe -- $g66.$tHuman Rights and Maternal-Fetal HIV Transmission Prevention Trials in Africa /$rGeorge J. Annas and Michael A. Grodin -- $g67.$tAZT Trials and Tribulations /$rRobert A. Crouch and John D. Arras -- $g68.$tFair Benefits for Research in Developing Countries /$rParticipants in the 2001 Conference on Ethical Aspects of Research in Developing Countries -- $g69.$tEthical Imperialism? Ethics in International Collaborative Clinical Research /$rMarcia Angell -- $g70.$tEthics Are Local: Engaging Cross-Cultural Variation in the Ethics for Clinical Research /$rNicholas A. Christakis -- $g71.$tEthical and Regulatory Challenges in a Randomized Control Trial of Adjuvant Treatment for Breast Cancer in Vietnam /$rRichard R. Love and Norman C. Fost -- $gPt. VIII.$tThe Behavior of Clinical Investigators: Conflicts of Interest -- $g72.$tUnderstanding Financial Conflicts of Interest /$rDennis F. Thompson -- $g73.$tFinder's Fees for Research Subjects /$rStuart E. Lind -- $g74.$tConflicts of Interests and the Validity of Clinical Trials /$rBaruch A. Brody -- $g75.$tIn Whose Best Interest? Breaching the Academic-Industrial Wall /$rJoseph B. Martin and Dennis L. Kasper -- $gPt. IX.$tScientific Misconduct -- $gSect. 1.$tAltering Data: Fraud, Fabrication, and Falsification -- $g76.$tPressure to Publish and Fraud in Science /$rPatricia K. Woolf -- $g77.$tScience, Statistics, and Deception /$rJohn C. Bailar III -- $g78.$tData Torturing /$rJames L. Mills -- $g79.$tPreventing Scientific Misconduct /$rDouglas L. Weed -- $gSect. 2.$tRules of Authorship -- $g80.$tWhen Authorship Fails: A Proposal to Make Contributors Accountable /$rDrummond Rennie, Veronica Yank and Linda L. Emanuel -- $gSect. 3.$tProblems in the Publication of Research Methods and Findings -- $g81.$tUnderreporting Research Is Scientific Misconduct /$rIain Chalmers -- $g82.$tThe CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized Trials /$rDavid Moher, Kenneth F. Schulz and Douglas Altman -- $gPt. X.$tChallenges to the Institutional Review Board System -- $g83.$tMonitoring Clinical Research: An Obligation Unfulfilled /$rCharles Weijer, Stanley H. Shapiro, Abraham Fuks, Kathleen Cranley Glass and Myriam Skrutkowska -- $g84.$tEthics Review for Sale? Conflict of Interest and Commercial Research Review Boards /$rTrudo Lemmens and Benjamin Freedman -- $g85.$tThe Institutional Review Board and Beyond: Future Challenges to the Ethics of Human Experimentation /$rHarold Edgar and David J. Rothman -- $g86.$tA Central Institutional Review Board for Multi-institutional Trials /$rMichaele C. Christian, Jacquelyn L. Goldberg, Jack Killen, Jeffrey S. Abrams, Mary S. McCabe, Joan K. Mauer and Robert E. Wittes -- $gApp. A.$tPhase I Treatment of Adults with Recurrent Supratentorial High-Grade Glioma with Gliadel Wafers Plus Temodar -- $gApp. B.$tA Phase I Study of Intra-arterial Onyx-015 for Squamous Cell Cancer of the Head and Neck -- $gApp. C.$tCohort-Varying Information Insert for Form for Consent to Participate in a Phase I Study /$rBenjamin Freedman -- $gApp. D.$tNitric Oxide Inhalation Therapy for Myocardial Ischemia in Patients with Coronary Artery Disease -- $gApp. E.$tDouble-Blind Drug Crossover and Withdrawal Project -- $gApp. F.$tInformation and Consent Letter for Hemochromatosis Study -- $gApp. G.$tNational Action Plan on Breast Cancer (NAPBC) Consent Form for Use of Tissue for Research -- $gApp. H.$tPatient Written Consent Form for Review of Medical Records -- $gApp. I.$tA Descriptive Study of the Views and Experiences of Persons Involved in a Measles Vaccine Study.
650 0 $aHuman experimentation in medicine$xMoral and ethical aspects.$0http://id.loc.gov/authorities/subjects/sh2008105860
650 0 $aClinical trials$xMoral and ethical aspects.
650 0 $aMedical ethics.$0http://id.loc.gov/authorities/subjects/sh85082929
650 12 $aEthics, Research.$0https://id.nlm.nih.gov/mesh/D032984
650 22 $aResearch Subjects.$0https://id.nlm.nih.gov/mesh/D035842
700 1 $aEmanuel, Ezekiel J.,$d1957-$0http://id.loc.gov/authorities/names/n89222624
856 41 $3Table of contents$uhttp://www.loc.gov/catdir/toc/ecip045/2003013887.html
852 00 $boff,hsl$hR853.H8$iE825 2003