email page print pageAll Topic Reviews
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 Life for a LifeA Life-Centered Approach to BioethicsA Matter of SecurityA 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 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 Moral ResponsibilityAgency and AnswerabilityAgency and ResponsibilityAgency, Freedom, and Moral ResponsibilityAging, Biotechnology, and the FutureAlbert Schweitzer's Reverence for LifeAlphavilleAltruismAmerican EugenicsAmerican PsychosisAn Anthology of Psychiatric EthicsAn Introduction to EthicsAn Introduction to Evolutionary EthicsAn Introduction to Kant's Moral Philosophy And a Time to DieAnimal LessonsAnimal RightsAnimals Like UsApplied Ethics in Mental Health CareAre Women Human?Aristotle on Practical WisdomAristotle's Ethics and Moral ResponsibilityAssisted Suicide and the Right to DieAutonomyAutonomy and the Challenges to LiberalismAutonomy, Consent and the LawBabies by DesignBackslidingBad PharmaBad SoulsBasic Desert, Reactive Attitudes and Free WillBeauty JunkiesBefore ForgivingBeing AmoralBeing YourselfBending Over BackwardsBending ScienceBernard WilliamsBetter Humans?Better Than WellBeyond ChoiceBeyond GeneticsBeyond HatredBeyond Humanity?Beyond LossBeyond LossBeyond Moral JudgmentBeyond the DSM StoryBias in Psychiatric DiagnosisBioethicsBioethicsBioethics and the BrainBioethics at the MoviesBioethics Beyond the HeadlinesBioethics Critically ReconsideredBioethics in a Liberal SocietyBioethics in the ClinicBiomedical EthicsBiomedical EthicsBiomedical EthicsBiomedical EthicsBiomedical Research and BeyondBiosBioscience EthicsBipolar ChildrenBluebirdBodies out of BoundsBodies, Commodities, and BiotechnologiesBody BazaarBoundBoundaries and Boundary Violations in PsychoanalysisBraintrustBrandedBreaking the SilenceBuffy the Vampire Slayer and PhilosophyCapital PunishmentCase Studies in Biomedical Research EthicsChallenging the Stigma of Mental IllnessCharacter and Moral Psychology Character as Moral FictionChild Well-BeingChildrenChildren's RightsChoosing ChildrenChoosing Not to ChooseClinical Dilemmas in PsychotherapyClinical EthicsCloningClose toYouCoercion as CureCoercive Treatment in PsychiatryCognition of Value in Aristotle's EthicsCognitive Disability and Its Challenge to Moral Philosophy Comfortably NumbCommonsense RebellionCommunicative Action and Rational ChoiceCompetence, Condemnation, and CommitmentComprehending CareConducting Insanity EvaluationsConfidential RelationshipsConfidentiality and Mental HealthConflict of Interest in the ProfessionsConsuming KidsContemporary Debates In Applied EthicsContemporary Debates in Moral TheoryContemporary Debates in Social PhilosophyContentious IssuesContesting PsychiatryCrazy in AmericaCreating CapabilitiesCreatures Like Us?Crime and CulpabilityCrime, Punishment, and Mental IllnessCritical Perspectives in Public HealthCritical PsychiatryCrueltyCultural Assessment in Clinical PsychiatryCutting to the CoreCyborg CitizenDamaged IdentitiesDeaf Identities in the MakingDeath Is That Man Taking NamesDebating 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 HealthDid My Neurons Make Me Do It?Difference and IdentityDigital HemlockDigital SoulDignityDisability BioethicsDisability, Difference, DiscriminationDisordered Personalities and CrimeDisorders of VolitionDisorientation and Moral LifeDivided Minds and Successive SelvesDoes Feminism Discriminate against Men?Does Torture Work?Double Standards in Medical Research in Developing CountriesDrugs and JusticeDworkin and His CriticsDying in the Twenty-First CenturyEarly WarningEconomics and Youth ViolenceEmbodied RhetoricsEmerging Conceptual, Ethical and Policy Issues in BionanotechnologyEmotional ReasonEmotions in the Moral LifeEmotions in the Moral LifeEmpathyEmpathy and Moral DevelopmentEmpathy and MoralityEmpirical Ethics in PsychiatryEncountering NatureEncountering the Sacred in PsychotherapyEngendering International HealthEnhancing EvolutionEnhancing Human CapacitiesEnoughEros and the GoodErotic InnocenceErotic MoralityEssays on Derek Parfit's On What MattersEssays on Free Will and Moral ResponsibilityEthical Choices in Contemporary MedicineEthical Conflicts in PsychologyEthical Dilemmas in PediatricsEthical Issues in Behavioral ResearchEthical Issues in Dementia CareEthical Issues in Forensic Mental Health ResearchEthical Issues in the New GeneticsEthical LifeEthical Reasoning for Mental Health ProfessionalsEthical TheoryEthical WillsEthically Challenged ProfessionsEthicsEthicsEthicsEthics and AnimalsEthics and ScienceEthics and the A PrioriEthics and the Discovery of the UnconsciousEthics and the Metaphysics of MedicineEthics at the CinemaEthics Case Book of the American Psychoanalytic AssociationEthics Done RightEthics ExpertiseEthics for EveryoneEthics for PsychologistsEthics for the New MillenniumEthics in CyberspaceEthics 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 EthicsExploding the Gene MythExploiting ChildhoodFacing Human SufferingFact and ValueFaking ItFalse-Memory Creation in Children and AdultsFat ShameFatal FreedomFellow-Feeling and the Moral LifeFeminism and Its DiscontentsFeminist Ethics and Social and Political PhilosophyFeminist TheoryFinal ExamFirst Do No HarmFirst, Do No HarmFlashpointFlesh WoundsForced to CareForgivenessForgivenessForgiveness and LoveForgiveness and ReconciliationForgiveness and RetributionFoucault and the Government of DisabilityFoundational Issues in Human Brain MappingFoundations of Forensic Mental Health AssessmentFree WillFree Will And Moral ResponsibilityFree Will and Reactive AttitudesFree Will, Agency, and Meaning in LifeFree?Freedom and ValueFreedom vs. InterventionFriendshipFrom Darwin to HitlerFrom Disgust to HumanityFrom Enlightenment to ReceptivityFrom Morality to Mental HealthFrom Silence to VoiceFrontiers of 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 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 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 EnhancementHuman GoodnessHuman Identity and BioethicsHuman TrialsHumanism, What's That?Humanitarian ReasonHumanityHumanizing MadnessI am Not Sick I Don't Need Help!I Was WrongIdentifying Hyperactive ChildrenIf That Ever Happens to MeImproving Nature?In Defense of FloggingIn Defense of SinIn Love With LifeIn Our Own ImageIn the FamilyIn the Land of the DeafIn the Name of IdentityIn the Wake of 9/11In Two MindsInformed Consent in Medical ResearchInnovation in Medical TechnologyInside Assisted LivingInside EthicsIntelligence, Race, and GeneticsIntensive CareIs Human Nature Obsolete?Is Long-Term Therapy Unethical?Is There a Duty to Die?Is There an Ethicist in the House?Issues in Philosophical CounselingJudging Children As ChildrenJust a DogJust BabiesJust CareJustice for ChildrenJustice for HedgehogsJustice in RobesJustice, Luck, and KnowledgeJustifiable ConductKant on Moral AutonomyKant's Theory of VirtueKids of CharacterKilling McVeighLack of CharacterLack of CharacterLaw and the BrainLearning About School ViolenceLeaving YouLectures on the History of Political PhilosophyLegal and Ethical Aspects of HealthcareLegal Aspects of Mental CapacityLegal ConceptionsLegalizing 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 MattersMedical Enhancement and PosthumanityMedical Research for HireMedicalized MasculinitiesMedically Assisted DeathMeditations for the HumanistMelancholia and MoralismMental Health Professionals, Minorities and the PoorMental Illness, Medicine and LawMerit, Meaning, and Human BondageMetaethical SubjectivismMill's UtilitarianismMind FieldsMind WarsMind WarsModern Theories of JusticeModernity and TechnologyMoney ShotMonsterMoral Acquaintances and Moral DecisionsMoral ClarityMoral CultivationMoral Development and RealityMoral Dilemmas in Real LifeMoral DimensionsMoral EntanglementsMoral FailureMoral LiteracyMoral MachinesMoral MindsMoral OriginsMoral Panics, Sex PanicsMoral ParticularismMoral PerceptionMoral PsychologyMoral Psychology: Volume IVMoral RealismMoral RelativismMoral RepairMoral Responsibility and Alternative PossibilitiesMoral Status and Human LifeMoral StealthMoral Theory at the MoviesMoral TribesMoral Value and Human DiversityMoral, Immoral, AmoralMoralismMorality and Self-InterestMorality in a Natural WorldMorality, Moral Luck and ResponsibilityMorals, Rights and Practice in the Human ServicesMorals, Rights and Practice in the Human ServicesMore Than HumanMotive and 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 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 Textbook of Philosophy of PsychiatryPassionate DeliberationPatient Autonomy and the Ethics of ResponsibilityPC, M.D.Perfecting VirtuePersonal AutonomyPersonal Autonomy in SocietyPersonal Identity and EthicsPersonhood and Health CarePersons, Humanity, and the Definition of DeathPerspectives On Health And Human RightsPharmacracyPharmageddonPhilosophy 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 How We LiveReframing Disease ContextuallyRefusing CareRefuting Peter Singer's Ethical TheoryRelative JusticeRelativism and Human RightsReligion ExplainedReprogeneticsRescuing JeffreyResponsibilityResponsibility 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 MenRunning on RitalinSatisficing and MaximizingSchizophrenia, 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 TemperamentSeeing the LightSelf-ConstitutionSelf-Made MadnessSelf-Trust and Reproductive AutonomySentimental RulesSex Fiends, Perverts, and PedophilesSex OffendersSexual DevianceSexual EthicsSexual PredatorsSexualized BrainsShaping Our SelvesShock TherapyShould I Medicate My Child?ShunnedSick to Death and Not Going to Take It AnymoreSickoSide EffectsSidewalk StoriesSister CitizenSkeptical FeminismSocial Inclusion of People with Mental IllnessSocial JusticeSociological Perspectives on the New GeneticsSome We Love, Some We Hate, Some We EatSovereign VirtueSpiral of EntrapmentSplit DecisionsSticks and StonesStories MatterSubjectivity and Being SomebodySuffering, Death, and IdentitySuicide ProhibitionSurgery JunkiesSurgically Shaping ChildrenTaking Morality SeriouslyTaming the Troublesome ChildTechnology and the Good Life?TestimonyText and Materials on International Human RightsThe Aims of Higher EducationThe Almost MoonThe Altruistic BrainThe American Psychiatric Publishing Textbook of Forensic PsychiatryThe Animal ManifestoThe 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 Code for Global EthicsThe Colonization Of Psychic SpaceThe Commercialization of Intimate LifeThe Common ThreadThe Connected SelfThe Constitution of AgencyThe Creation of PsychopharmacologyThe Criminal BrainThe Decency WarsThe Difficult-to-Treat Psychiatric PatientThe Disability PendulumThe Disability Rights Movement: From Charity to ConfrontationThe Domain of ReasonsThe Double-Edged HelixThe Duty to ProtectThe Emotional Construction of MoralsThe End of Ethics in a Technological SocietyThe End of Stigma?The Essentials of New York Mental Health LawThe Ethical BrainThe Ethical Dimensions of the Biological and Health SciencesThe Ethics of BioethicsThe Ethics of ParenthoodThe Ethics of SightseeingThe Ethics of the FamilyThe Ethics of the LieThe Ethics of TransplantsThe Ethics ToolkitThe Evolution of Mental Health LawThe Evolution of MoralityThe FamilyThe Fat Studies ReaderThe Forgiveness ProjectThe Form of Practical KnowledgeThe Fountain of YouthThe Freedom ParadoxThe Future of Assisted Suicide and EuthanasiaThe Future of Human NatureThe Good BookThe Good LifeThe Great BetrayalThe Handbook of Disability StudiesThe Healing VirtuesThe High Price of MaterialismThe History of Human RightsThe HorizonThe Idea of JusticeThe Ideal of NatureThe Illusion of Freedom and EqualityThe Immortal Life of Henrietta LacksThe Importance of Being UnderstoodThe Insanity OffenseThe Joy of SecularismThe Language PoliceThe Last Normal ChildThe Last UtopiaThe Limits of MedicineThe LobotomistThe Love CureThe Lucifer EffectThe Manual of EpictetusThe Mark of ShameThe Meaning of NiceThe Medicalization of SocietyThe Merck DruggernautThe Mind Has MountainsThe Modern Art of DyingThe Modern SavageThe Moral ArcThe Moral BrainThe Moral Demands of MemoryThe Moral FoolThe Moral MindThe Moral Psychology HandbookThe Moral, Social, and Commercial Imperatives of Genetic Testing and ScreeningThe Most Good You Can DoThe Myth of ChoiceThe Myth of the Moral BrainThe Nature of NormativityThe New Disability HistoryThe New Genetic MedicineThe New Religious IntoleranceThe Offensive InternetThe Origins of FairnessThe Oxford Handbook of Animal EthicsThe Oxford Handbook of Ethics at the End of LifeThe Perfect BabyThe Philosophy of NeedThe Philosophy of PornographyThe Philosophy of PsychiatryThe Politics Of LustThe Portable Ethicist for Mental Health Professionals The Power of Religion in the Public SphereThe Price of PerfectionThe Price of TruthThe Problem of PunishmentThe Prosthetic ImpulseThe Psychology of Good and EvilThe Psychology of Good and EvilThe PsychopathThe Purity MythThe Pursuit of PerfectionThe Relevance of Philosophy to LifeThe Right Road to Radical FreedomThe Right to Be ParentsThe Righteous MindThe Root of All EvilThe Rules of 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 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 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 VicesWar Against the WeakWar, Torture and TerrorismWarrior's DishonourWeaknessWelfare and Rational CareWhat Genes Can't DoWhat 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 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 widespread existence of Institutional Review Boards (IRBs) at educational and professional institutions across the country has brought to the surface a lively debate regarding ethical concerns in research involving human participants. Dennis J. Mazur captures the main themes of this debate in Evaluating the Science and Ethics of Research on Humans: A Guide for IRB Members.
Mazur cleverly dissects the key functions that an IRB is expected to fulfill and the challenges that it is likely to face, while he highlights the responsibilities of both researchers and IRB members in ensuring that the rights of research participants are protected. His work brings to the surface the fundamental ambiguities of the terrain upon which an IRB is expected to navigate and the controversies that unmistakably follow. At the core of all the ambiguities appears to be the contentious issue of what qualifies as "research" and thus of what constitutes the target (some would say "the victim") of the work of an IRB. The Code of Federal Regulations Title 45 describes research involving human subjects as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge". This definition appears innocuously unambiguous until it is interpreted by the actual "users", that is, individuals involved in some form of data collection, analysis, and dissemination (either directly as researchers or indirectly as IRB members evaluating research prior to its implementation). For instance, would a systematic investigation of the paintings of some living artists constitute research? Would this type of investigation require IRB review if no interviews are planned with the artists? Interestingly, even if the investigator might reasonably argue that this form of "research" is "exempt" under Title 45, the IRB is still entrusted with determining the "exempt" status of the project, thereby forcing the investigator to complete an IRB proposal and the IRB to screen the proposal.
The ambiguities surrounding the real-life applications of the term "research" bring to life the essential conundrum faced by IRBs across the country and the grumbling that envelops their work. In a nutshell, it is not the function of protecting subjects that makes many investigators uneasy with IRBs, but the fact that they are a regulatory body requiring "unnecessary" work in areas where human participants are unlikely to be at risk. Many of these investigators angrily ask why they could not be entrusted with the task of determining whether their research involves minimal risk (i.e., research that does not harm or produce discomfort to participants greater than that ordinarily experienced in every day life or during routine physical or psychological examinations). They argue that they, the investigators, are, de facto, those who are ultimately responsible for all the research activities and outcomes. Unfortunately, the controversy regarding who should be entrusted with the task of evaluating a research project's risks and benefits finds fertile ground in what investigators perceive as the frequent lack of consistency in the evaluations produced by IRBs. Most notably, some argue that changes in the membership of an IRB can mysteriously make the criteria used to evaluate proposals more or less stringent, magically transform the appeal procedures from burdensome to trouble-free (or vice versa), and, overall, change the duration and quality of the review process in ways that are difficult to describe as objective.
For the most part, the fact that IRBs have the authority to approve research projects before such projects can be undertaken, and the perceived lack of standardization of the review process (across time within an IRB and across IRBs at different institutions) conspire to create the perception of IRBs as imposing an unfair burden to honest and hard-working investigators whose main goal is to advance knowledge in their field of expertise. Of course, this perception is magnified by stories of unreasonable requests made by a few, clearly malfunctioning, IRBs. One blatant example of such requests is the one recently reported in a New York Times article by Patricia Cohen (February 28th) regarding an investigator asked to have his subjects, who were members of a preliterate tribe, sign an informed consent form. The isolated nature of these episodes cannot compete with the vividness with which they are remembered, and they help foster in the minds of many investigators negative images of IRBs as committees prone to overreaching and abuse of power.
Undeniably, perceptions of unfairness based on lack of uniformity in the review process combined with vivid references to unreasonable (albeit isolated) requests make the work of IRBs across the country controversial. This is one good reason for reading Evaluating the Science and Ethics of Research on Humans. It provides a detailed and impartial description of the functions of the IRB to those who are (or will soon be) members and to those who plan to submit proposals. While exposing possible areas of conflict, it offers a way of reconciling the view of applicants and IRB members under one set of reasonable and practical guiding principles. Even though there is no denying that IRB proposals demand additional labor from investigators, they are portrayed as a valuable exercise for determining the benefits and perils of research endeavors. As a result, the burden that writing IRB proposals places on investigators is overshadowed by the role that they can play as educational tools within the review process. Indeed, IRB proposals, by forcing investigators to explain to others their research plans, demand that investigators meticulously examine the motives behind their research and the ways in which it is conducted. As such, the review process offers investigators an outside skeptical audience, largely removed from the investigators' research community, and, by doing so, it performs a constructive (rather than disruptive) role in the development and implementation of research projects.
If IRBs are not to be feared or despised because they serve a useful function within the research enterprise, one might ask whether some changes in the review process should be introduced to make reviewing less cumbersome and its outcomes more uniform. Mazur does not dwell much on these possibilities and mostly focuses on the status quo. Furthermore, although Mazur's extensive experience in medical research on human participants inspires and enriches his examination of the relationship between the practice of research and the need to protect the rights of research volunteers, it also limits the breath of his examination.
Notwithstanding the focus on medical research and the limited attempt to envision a future of more functional and less error-prone IRBs, Evaluating the Science and Ethics of Research on Humans is a well-written and informative narrative of the inner workings of IRBs. It is a must-read for those who are (or will be) members of an IRB and for those who need to submit a proposal. Arguably, changes in the ways IRBs function are needed, and IRB members have the possibility of developing more efficient, practical guidelines for the review process. Mazur's book provides an exceptional opportunity for acknowledging the current functional problems of IRBs and for considering solutions that are mindful of the basic principle of academic freedom.
© 2007 Maura Pilotti
Maura Pilotti, Ph.D., Department of Psychology, Dowling College, New York. Dr. Pilotti is Chair of the Dowling College IRB.