Which of the following statements about protected health information are correct?
A. The Privacy Rule protects all "individually identifiable health information" held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper, or oral.
B. "Individually identifiable health information" is information, including demographic data, that relates to: — the individual's past, present or future physical or mental health or condition, — the provision of health care to the individual, or — the past, present, or future payment for the provision of health care to the individual, and that identifies the individual or for which there is a reasonable basis to believe it can be used to identify the individual.
C. The Privacy Rule excludes from protected health information employment records that a covered entity maintains in its capacity as an employer and education and certain other records subject to, or defined in, the Family Educational Rights and Privacy Act, 20 U.S.§1232g.
D. There are no restrictions on the use or disclosure of de-identified health information.
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