What are the criteria for IRB review of a clinical trial protocol?
A. Risks … are minimized; risks are justified by anticipated benefits, if any, to the subjects or the importance of the knowledge to be gained.
B. The benefits & goals of the study are clear; the study protocol is ethically reasonable.
C. Subjects will be selected and treated fairly.
D. Informed consent is adequate.
What are thereview standards ofNIH IRB?
A. Proposed research design sound/will not unnecessarily expose subjects to risk.
B. Risks reasonable in relation to benefits and knowledge to be gained. Risks to subjects are minimized.
C. Are there equitable subject selection? & how about additional safeguards for vulnerable participants?
D. How is informed consent implemented and gained? How is the privacy/confidentiality of participants protected?
WhataretheethicalargumentsabouttheyoungschizophreniapatientDanMarkingson'sdeathin2004inMinnesota?
A. In2004,UniversityofMinnesotaresearchparticipantDanMarkingsonwithschizophreniacommittedsuicidewhileenrolledinanindustry-sponsoredpharmaceuticaltrialcomparingthreeFDA-approvedatypicalantipsychotics:Seroquel(quetiapine),Zyprexa(olanzapine),andRisperdal(risperidone).DanwasadmittedintotheUniversityofMinnesotaMedicalCenterinFairviewin2003.Butveryquickly,hisdaily800mgdosesofSeroquelstartedtoworsenhisdelusions.Inresponse,hismotherMaryWeissfranticallysentletters,emails,andcalledthestudycoordinatorstotryandtakehersonoutoftheprogram.ButtheadministrationbannedMarkingsonfromleavingthestudy,threateningtoputhimintoamentalfacilityifhetriedtodropout.Weisswasshockedbythisuntilshelearnedakeyfactabouttheprogram:herson'sparticipationwasworth$15,000totheschool.Unabletoleavetheprogram,Markingson'sdelusionsbecameworseuntilheeventuallycommittedsuicidebystabbinghimselftodeathintheshower.Asuicidenoteread,"Iwentthroughthisexperiencesmiling!"Devastated,hismothersuedtheschool,whichrefusedtotakeresponsibilityforitsactions.Markingsonwasoneoffivetrialsubjectstoattemptsuicide,andoneoftwowhosucceededintakingtheirownlives.
B. WritingonthecircumstancessurroundingMarkingson'sdeathinthestudy,whichwasdesigned&fundedbySeroquelmanufacturerAstraZeneca,UniversityofMinnesotaProfessorofBioethicsCarlElliottnotedthatMarkingsonwasenrolledinthestudyagainstthewishesofhismother,MaryWeiss,&thathewasforcedtochoosebetweenenrollinginthestudyorbeinginvoluntarilycommittedtoastatementalinstitution.
C. FurtherinvestigationrevealedfinancialtiestoAstraZenecabyMarkingson'spsychiatrist,Dr.StephenC.Olson,oversightsandbiasesinAstraZeneca'strialdesign,&theinadequacyofuniversityInstitutionalReviewBoard(IRB)protectionsforresearchsubjects.
D. A2005FDAinvestigationclearedtheuniversity.Nonetheless,controversyaroundthecasehascontinued.AlthoughtheUniversityavoidedlegalliabilityforthedeath,theinstitution'sdefensiveposture—spearheadedbyitstoplawyers—inflictedseriousdamageonitsreputation.Lawyersshouldheedethicalrulesthatadviseattorneystoconsidernotonlytheirclients'legalinterests,but"moral,economic,socialandpoliticalfactorsthatmayberelevanttotheclient'ssituation."
Which of the following items can protect human subjects?
A. International ethical codes and guidelines
B. US ethical regulations, policies & laws
C. Laws, regulations, policies and official statements from other jurisdictions and reputable academic organizations
D. Institutional ethics policies and guidelines
Ethical clinical research should focus its scientific validity considerations on:
A. choice of proper endpoints – e.g. blood glucose control
B. choice of design – e.g. randomized double blinded control or noninferiority or superiority
C. choice of procedures – e.g. measures of outcome, length of follow-up
D. statistical methods (e.g. power, sample size, methods, & level of significance) & feasibility
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