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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?

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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."

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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

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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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Whichofthefollowingitemsarefamousethicscodes&guidelinesintendedfortheprotectionofhumansubjects?

A. NurembergCode(1947)
B. DeclarationofHelsinki(1964-multiplerevisions-2013)
C. TheBelmontReport(1979)
D. CIOMS/WHOInternationalGuidelines(1993,2002,&2015)&ICH/GCP-InternationalConferenceonHarmonization-GoodClinicalPractice(1996&2016)

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