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Anger and Forgiveness"Are You There Alone?"10 Good Questions about Life and DeathA Casebook of Ethical Challenges in NeuropsychologyA Companion to BioethicsA Companion to BioethicsA Companion to GenethicsA Companion to GenethicsA Companion to Muslim EthicsA Cooperative SpeciesA Critique of the Moral Defense of VegetarianismA Delicate BalanceA Fragile LifeA Life for a LifeA Life-Centered Approach to BioethicsA Matter of SecurityA Mirror Is for ReflectionA Mirror Is for ReflectionA Natural History of Human MoralityA Philosophical DiseaseA Practical Guide to Clinical Ethics ConsultingA Question of TrustA Sentimentalist Theory of the MindA Short Stay in SwitzerlandA Tapestry of ValuesA Very Bad WizardA World Without ValuesAction and ResponsibilityAction Theory, Rationality and CompulsionActs of ConscienceAddiction and ResponsibilityAddiction NeuroethicsAdvance Directives in Mental HealthAfter HarmAftermathAgainst AutonomyAgainst BioethicsAgainst HealthAgainst MarriageAgainst Moral 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and ScienceCutting to the CoreCyborg CitizenDamaged IdentitiesDeaf Identities in the MakingDeath Is That Man Taking NamesDebating ProcreationDebating Same-Sex MarriageDecision Making, Personhood and DementiaDecoding the Ethics CodeDefining DifferenceDefining Right and Wrong in Brain ScienceDefining the Beginning and End of LifeDelusions of GenderDementiaDemocracy in What State?Demons of the Modern WorldDescriptions and PrescriptionsDesert and VirtueDesire, Practical Reason, and the GoodDestructive Trends in Mental HealthDeveloping the VirtuesDid My Neurons Make Me Do It?Difference and IdentityDigital HemlockDigital SoulDignityDignityDisability BioethicsDisability, Difference, DiscriminationDiscrimination against the Mentally IllDisordered Personalities and CrimeDisorders of VolitionDisorientation and Moral LifeDivided Minds and Successive SelvesDoes Feminism Discriminate against Men?Does Torture Work?Doing HarmDouble Standards in Medical Research in Developing CountriesDown GirlDrugs 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ProfessionsEthicsEthicsEthicsEthics and AnimalsEthics and ScienceEthics and the A PrioriEthics and the Discovery of the UnconsciousEthics and the Metaphysics of MedicineEthics at the CinemaEthics at the End of LifeEthics Case Book of the American Psychoanalytic AssociationEthics Done RightEthics ExpertiseEthics for EveryoneEthics for PsychologistsEthics for the New MillenniumEthics in CyberspaceEthics in Everyday PlacesEthics in Health CareEthics In Health Services ManagementEthics in Mental Health ResearchEthics in PracticeEthics in PsychiatryEthics in PsychologyEthics in Psychotherapy and CounselingEthics of PsychiatryEthics without OntologyEthics, Culture, and PsychiatryEthics, Sexual Orientation, and Choices about ChildrenEvaluating the Science and Ethics of Research on HumansEvilEvil GenesEvil in Modern ThoughtEvil in Modern ThoughtEvolution, Gender, and RapeEvolutionary Ethics and Contemporary BiologyEvolutionary Psychology and ViolenceEvolved MoralityExperiments in 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JusticeGender in the MirrorGenetic PoliticsGenetic ProspectsGenetic ProspectsGenetics of Original SinGenetics of Original SinGenocide's AftermathGetting RealGluttonyGood WorkGoodness & AdviceGreedGroups in ConflictGrowing Up GirlGut FeminismHabilitation, Health, and AgencyHandbook for Health Care Ethics CommitteesHandbook of BioethicsHandbook of Children's RightsHandbook of PsychopathyHappinessHappiness and the Good LifeHappiness Is OverratedHard FeelingsHard LuckHardwired BehaviorHarmful ThoughtsHeal & ForgiveHealing PsychiatryHealth Care Ethics for PsychologistsHeterosyncraciesHistorical and Philosophical Perspectives on Biomedical EthicsHoly WarHookedHookedHow Can I Be Trusted?How Fascism WorksHow Propaganda WorksHow to Do Things with Pornography How to Make Opportunity EqualHow Universities Can Help Create a Wiser WorldHow We HopeHow We Think About DementiaHuman BondingHuman Dignity and Assisted DeathHuman Dignity and Assisted DeathHuman EnhancementHuman GoodnessHuman Identity and 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About School ViolenceLearning from Baby PLeaving YouLectures on the History of Political PhilosophyLegal and Ethical Aspects of HealthcareLegal Aspects of Mental CapacityLegal ConceptionsLegal InsanityLegalizing ProstitutionLet Them Eat ProzacLevelling the Playing FieldLiberal Education in a Knowledge SocietyLiberal EugenicsLife After FaithLife at the BottomLife, Sex, and IdeasListening to the WhispersLiving ProfessionalismLosing Matt ShepardLostLuckyMad in AmericaMad PrideMadhouseMaking Another World PossibleMaking Babies, Making FamiliesMaking Genes, Making WavesMaking Sense of Freedom and ResponsibilityMalignantMasculinity Studies and Feminist TheoryMeaning and Moral OrderMeaning in LifeMeaning in Life and Why It MattersMeans, Ends, and PersonsMeans, Ends, and PersonsMedical Enhancement and PosthumanityMedical Research for HireMedicalized MasculinitiesMedically Assisted DeathMeditations for the HumanistMelancholia and MoralismMental Health Professionals, Minorities and the 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RightnessMovies and the Moral Adventure of LifeMurder in the InnMy Body PoliticMy Brain Made Me Do ItMy Sister's KeeperMy Sister's KeeperMy WayNano-Bio-EthicsNarrative MedicineNarrative ProsthesisNatural Ethical FactsNatural-Born CybogsNaturalized BioethicsNeither Bad nor MadNeoconservatismNeonatal BioethicsNeurobiology and the Development of Human MoralityNeuroethicsNeuroethicsNeuroethicsNew Takes in Film-PhilosophyNew Waves in EthicsNew Waves in MetaethicsNietzsche on Ethics and PoliticsNo Child Left DifferentNo Impact ManNormative EthicsNormativityNothing about us, without us!Oath BetrayedOf War and LawOn ApologyOn Being AuthenticOn EvilOn Human RightsOn The Stigma Of Mental IllnessOn the TakeOn Virtue EthicsOn What MattersOn What We Owe to Each OtherOne ChildOne Nation Under TherapyOne World NowOne World NowOur Bodies, Whose Property?Our Bodies, Whose Property?Our Daily MedsOur Faithfulness to the PastOur Posthuman FutureOut of EdenOut of Its MindOut of the ShadowsOverdosed AmericaOxford Handbook of Psychiatric EthicsOxford Studies in Normative EthicsOxford Studies in Normative Ethics, Volume 7Oxford Textbook of Philosophy of PsychiatryPassionate DeliberationPatient Autonomy and the Ethics of ResponsibilityPC, M.D.Perfecting VirtuePersonal AutonomyPersonal Autonomy in SocietyPersonal Identity and EthicsPersonalities on the PlatePersonhood and Health CarePersons, Humanity, and the Definition of DeathPerspectives On Health And Human RightsPharmaceutical FreedomPharmacracyPharmageddonPhilosophy and This Actual WorldPhilosophy of BiologyPhilosophy of Technology: The Technological ConditionPhysician-Assisted DyingPicturing DisabilityPilgrim at Tinker CreekPlaying God?Playing God?Political EmotionsPornlandPowerful MedicinesPractical Autonomy and BioethicsPractical EthicsPractical Ethics for PsychologistsPractical RulesPragmatic BioethicsPragmatic BioethicsPragmatic NeuroethicsPraise and BlamePreferences and Well-BeingPrimates and PhilosophersPro-Life, Pro-ChoiceProcreation and ParenthoodProfits Before People?Progress in BioethicsProperty in the BodyProzac As a Way of LifeProzac on the CouchPsychiatric Aspects of Justification, Excuse and Mitigation in Anglo-American Criminal Law Psychiatric EthicsPsychiatry and EmpirePsychological Concepts and Biological PsychiatryPsychology and Consumer CulturePsychology and LawPsychotropic Drug Prescriber's Survival GuidePublic Health LawPublic Health Law and EthicsPublic PhilosophyPunishing the Mentally IllPunishmentPursuits of WisdomPutting Morality Back Into PoliticsPutting on VirtueQuality of Life and Human DifferenceRaceRadical HopeRadical VirtuesRape Is RapeRe-creating MedicineRe-Engineering Philosophy for Limited BeingsReason's GriefReasonably ViciousReckoning With HomelessnessReconceiving Medical EthicsRecovery from SchizophreniaRedefining RapeRedesigning HumansReducing the Stigma of Mental IllnessReflections on Ethics and ResponsibilityReflections On How We LiveReframing Disease ContextuallyRefusing CareRefuting Peter Singer's Ethical TheoryRegard for Reason in the Moral MindRelative JusticeRelativism and Human RightsReligion ExplainedReprogeneticsRescuing JeffreyRespecting AnimalsResponsibilityResponsibility and PsychopathyResponsibility and PunishmentResponsibility and PunishmentResponsibility from the MarginsResponsible GeneticsRethinking CommodificationRethinking Informed Consent in BioethicsRethinking Mental Health and DisorderRethinking RapeReturn to ReasonRevolution in PsychologyRightsRights, Democracy, and Fulfillment in the Era of Identity PoliticsRisk and Luck in Medical EthicsRobert NozickRousseau and the Dilemmas of Modernity Rule of Law, Misrule of MenRun, Spot, RunRunning on RitalinSatisficing and MaximizingSchadenfreudeSchizophrenia, Culture, and SubjectivityScience and EthicsScience in the Private InterestScience, Policy, and the Value-Free IdealScience, Seeds and CyborgsScratching the Surface of BioethicsSecular Philosophy and the Religious 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CulpabilityThe Age of CulpabilityThe Aims of Higher EducationThe Almost MoonThe Altruistic BrainThe American Psychiatric Publishing Textbook of Forensic PsychiatryThe Animal ManifestoThe Animals' AgendaThe Art of LivingThe Autonomy of MoralityThe Beloved SelfThe Best Things in LifeThe Big FixThe Bioethics ReaderThe Biology and Psychology of Moral AgencyThe Blackwell Guide to Medical EthicsThe Body SilentThe BondThe Book of LifeThe Burden of SympathyThe Cambridge Companion to Virtue EthicsThe Cambridge Companion to Virtue EthicsThe Cambridge Textbook of BioethicsThe Case against Assisted SuicideThe Case Against PerfectionThe Case Against PunishmentThe Case for PerfectionThe Case of Terri SchiavoThe Challenge of Human RightsThe Character GapThe Code for Global EthicsThe Colonization Of Psychic SpaceThe Commercialization of Intimate LifeThe Common ThreadThe Connected SelfThe Constitution of AgencyThe Cow with Ear Tag #1389The Creation of PsychopharmacologyThe Criminal BrainThe Decency 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InsanityThe Second SexismThe Second-Person StandpointThe Silent World of Doctor and PatientThe Sleep of ReasonThe Social Psychology of Good and EvilThe Social Psychology of MoralityThe Social Psychology of MoralityThe Speed of DarkThe Stem Cell ControversyThe Stem Cell ControversyThe Story of Cruel and UnusualThe Story WithinThe Stubborn System of Moral ResponsibilityThe Suicide TouristThe Terrible GiftThe Theory of OptionsThe Therapy of DesireThe Trauma of Psychological TortureThe Trauma of Psychological TortureThe Triple HelixThe Trolley Problem MysteriesThe Trouble with DiversityThe Truth About the Drug CompaniesThe Ugly LawsThe Varieties of Religious ExperienceThe Virtue of Defiance and Psychiatric EngagementThe Virtues of FreedomThe Virtues of HappinessThe Virtuous Life in Greek EthicsThe Virtuous PsychiatristThe Voice of Breast Cancer in Medicine and BioethicsThe War Against BoysThe War for Children's MindsThe Whole ChildThe Woman RacketThe Worldwide Practice of TortureTherapy with ChildrenThieves of VirtueThree Generations, No ImbecilesTimes of Triumph, Times of DoubtTolerance Among The VirtuesTolerance and the Ethical LifeTolerationToxic PsychiatryTrauma, Truth and ReconciliationTreatment Kind and FairTrusting on the EdgeTry to RememberUltimate JudgementUnborn in the USA: Inside the War on AbortionUndermining ScienceUnderstanding AbortionUnderstanding CloningUnderstanding EmotionsUnderstanding EvilUnderstanding Kant's EthicsUnderstanding Moral ObligationUnderstanding Physician-Pharmaceutical Industry InteractionsUnderstanding TerrorismUnderstanding the GenomeUnderstanding the Stigma of Mental IllnessUnderstanding Treatment Without ConsentUnhingedUnprincipled VirtueUnsanctifying Human Life: Essays on EthicsUnspeakable Acts, Ordinary PeopleUp in FlamesUpheavals of ThoughtUsers and Abusers of PsychiatryValue-Free Science?Values and Psychiatric DiagnosisValues in ConflictVegetarianismViolence and Mental DisorderVirtue EthicsVirtue, Rules, and JusticeVirtue, Vice, and PersonalityVirtues and Their VicesVoracious Science and Vulnerable AnimalsVulnerability, Autonomy, and Applied EthicsWar Against the WeakWar, Torture and TerrorismWarrior's DishonourWeaknessWelfare and Rational CareWhat are you staring at?What Genes Can't DoWhat Have We DoneWhat Is a Human?What Is Good and WhyWhat Is Good and WhyWhat Is the Good Life?What Price Better Health?What Should I Do?What We Owe to Each OtherWhat Would Aristotle Do?What's Good on TVWhat's Normal?What's Wrong with Children's RightsWhat's Wrong with Homosexuality?What's Wrong With Morality?When Is Discrimination Wrong?Who Holds the Moral High Ground?Who Owns YouWho Qualifies for Rights?Whose America?Whose View of Life?Why Animals MatterWhy Animals MatterWhy Does Inequality Matter?Why Honor MattersWhy I Burned My Book and Other Essays on DisabilityWhy Not Kill Them All?Why Punish? How Much?Why Some Things Should Not Be for SaleWisdom, Intuition and EthicsWithout ConscienceWomen and Borderline Personality DisorderWomen and MadnessWondergenesWould You Kill the Fat Man?Wrestling with Behavioral GeneticsWriting About PatientsYou Must Be DreamingYour Genetic DestinyYour Inner FishYouth Offending and Youth Justice Yuck!
The book Innovation in Medical Technology: Ethical Issues and Challenges is not the sort of reading one does for pure and simple enjoyment. The text is not jargon-filled, nor is it packed with difficult, multisyllabic words that make it impossible to read. It is not what one would call easy reading, though. As is mentioned in the Preface (p. x), it is "written for those interested in studying the ethical, legal, and social policy aspects of biomedical science, medical practice, and their regulation." The authors also suggest that that the most appreciative audience of such a book would be those with "familiarity with the guidelines, regulations, and laws that govern medical research and ... practice." Such recommendations for the audience seems fair and reasonable, as the subject material is surely not for everyone.
This book is a follow-up of sorts to a forum held in Washington, D.C. in 2003 by the Lasker Foundation. The forum was to investigate how unproven, new technologies are used, as well as discussion of ethical issues therein. The distinction between innovation and research in medical practice, and ethical considerations that are inherent in both, were discussed at great length at this forum. Participants reviewed fictional (but possible) case studies in preparation for their discussion. The case studies are also included in the book, and provide a good framework for the book's discussion as well. Using new technology or discoveries, or using an old piece of equipment in a new way, or an existing drug for something other than it was originally tested for, are considered innovations. There is no overseer like the FDA, there are no Institutional Review Boards (IRBs) and there is no strict structure or strictly-written guidelines for innovations such as this. On the other hand is research -- hypothesis-based, rigidly-tested, overseen by IRBs and other rules and regulators. The book discusses the similarities and differences of these two methods of introducing new and innovative ideas and technology into medicine, and the ethical concerns and considerations of each.
Following a description of the difference between innovation and research in medical practice, this book first provides a history of human research and human research ethics. It is rather frightening to read about research conducted with apparent disregard for ethical concerns, indeed for the patients at all, including fairly recent times (through the 1970s). The famous Tuskegee syphilis study, for example, was from 1932 to 1972. After the history are the chapters including case studies and questions for discussion. These chapters include discussion of off-label drug use, surgery, assisted reproduction and neuroimaging.
Ethical concerns and considerations of human subjects -- never forgetting that subjects are indeed human --are worthy concerns of innovation and research. As reminders of this, as well as for details referenced in the historical chapter, Eaton and Kennedy include as appendices the Nuremburg Code, the Declaration of Helsinki and the Department of Health and Human Services (DHHS) Regulations for the Protection of Human Subjects.
Case studies are used as a way to provide thoughtful situations to stimulate reflection and discussion. While the cases are fictional, they certainly have a basis in reality, and are examples of cutting-edge topics, very relevant in society today. The discussion points that follow the cases are very thought-provoking and would certainly be good conversation-starters for a forum such as that the Lasker Foundation hosted, or at a medical innovations or ethics conference. Just because we have the technology to do something, does that mean we should? Or must? Does the ability to do it make it ethically sound? Another point that is mentioned is another that is very real in our modern society, especially in the U.S.A., and that is the legal, malpractice concern.
The forum and the book include recommendations for the future of medical innovation and research, and that is one of the later chapters. One of the identified concerns is that medical innovation does not provide hard data like research does. Also, the concern for a lack of protective measures that are part of formal research, but are not a part of medical innovations (outside of research). The model recommended by Eaton and Kennedy, is the Massachusetts General Hospital's Innovative Diagnostics and Therapeutics Committee. This committee reviews new technology for determination of its deployability (necessity, safety etc).
The authors recognize that it is through solid, painstaking and careful research that data and conclusive scientific results are disseminated. But it may be through imagination that the idea for a research study came about in the first place, as doctors suggest the innovative off-label use of a drug, or a new technique for helping infertile couples conceive. They indicate that, while innovation and research are different and distinct, there is a undeniable relationship between them that is possibly symbiotic. The two are probably both necessary for advancements.
© 2008 Margaret Riley
Margaret Riley, M.S., R.N. -- has been a Critical Care nurse in a highly acute ICU in the Denver Metro Area since graduation from nursing school. She continues to work occasionally in that setting, but now works full-time as a faculty member at her Alma Mater.
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