Bioengineering and World Health Summary of Lecture 10Ethics of Clinical ResearchCase I:Tuskegee Syphilis Study Case I:Tuskegee Syphilis Study Case I:Tuskegee Syphilis Study Case II: Willowbrook StudiesCase II: Willowbrook StudiesCase III: Jewish Chronic Disease Hospital StudyCase III: Jewish Chronic Disease Hospital StudyCase IV: San Antonio Contraceptive StudyCase IV: San Antonio Contraceptive StudyNuremberg Code: 1949Belmont Report: 1979Belmont Report: What is research?Respect for PersonsBeneficenceJusticeApplication of Belmont ReportInformed Consent Assessment of Risks & BenefitsSelection of Subjects Case I:Tuskegee Syphilis StudyCase II: Willowbrook StudiesCase III: Jewish Chronic Disease Hospital StudyCase IV: San Antonio Contraceptive StudyRole of IRBReal ControversiesBioengineering and World HealthLecture ElevenSummary of Lecture 10 Difficulties associated with HIV vaccine: Many forms of the virus Virus mutates rapidly Virus attacks the immune system Need to stimulate cell & Ab mediated immunity HIV vaccines in trials: Animal trials Æ Live, attenuated viral vaccines Human trials Æ Subunit vaccines, only Ab response Human Trials Æ Carrier vaccines, good Ab response, some CTL response Early Human Trials Æ DNA vaccinesEthics of Clinical Research Humans have not always treated each other humanely in the name of science Ethics of Clinical Research Famous Case Studies Codes governing ethical conduct of research: Nuremberg Code Belmont Report Case Studies Revisited Functions of the IRB Applications to current controversiesCase I:Tuskegee Syphilis Study Goal: Examine natural history of untreated syphilis Subjects: 400 black men with syphilis 200 normal controlsCase I:Tuskegee Syphilis Study Experiment: 1932: Standard Rx: injection of compounds containing heavy metals Treatment reduced mortality but heavy metals thought to cause syphilis complications Treatment withheld from infected men 1942: Death rate 2X as high in treatment group 1940s: Penicillin available Men not informed of this Study continued until 1972 when first publicizedCase I:Tuskegee Syphilis Study Consent Process: No informed consent Men misinformed that some study procedures (spinal taps) were free ‘extra treatment’Case II: Willowbrook Studies Goal: Understand natural history of infectious hepatitis Subjects: Children at Willowbrook State School An institution for ‘mentally defective persons’ Experiment: Carried out from 1963-1966 Subjects deliberately infected with hepatitis Fed extracts of stool from infected persons Injected with purified virus Vast majority of children admitted acquired hepatitisCase II: Willowbrook Studies Consent Process Parents gave consent Due to crowding, Willowbrook was at times closed to new patients Hepatitis project had its own space In some cases, only way to gain admission was to participate in the studyCase III: Jewish Chronic Disease Hospital Study Goal: Study rejection of cancer cells Healthy patients reject cancer cell implants quickly Cancer patients reject cancer cell implants much more slowly Is this due to decreased immunity because of presence of cancer or is it manifestation of debility? Subjects: Patients hospitalized with various chronic debilitating diseases Experiment: Took place in 1963 Patients injected with live liver cancer cellsCase III: Jewish Chronic Disease Hospital Study Consent Process: Negotiated orally, but not documented Patients not told that cancer cells would be injected because this might scare them unnecessarily Investigators justified this because they were reasonably certain the cancer cells would be rejectedCase IV: San Antonio Contraceptive Study Goal: Which side effects of OCP are due to drug? Which are by-products of every-day life? Subjects: 76 Impoverished Mexican-American women with previous multiple pregnancies Patients had come to a public clinic seeking contraceptive assistance.Case IV: San Antonio Contraceptive Study Experiment: Took place in the 1970s Randomized, double-blind, placebo controlled trial Cross-over design All women were instructed to use vaginal cream as contraceptive during the study 11 women became pregnant during study, 10 while using placebo Consent Process: None of the women were told study involved placeboNuremberg Code: 1949 Voluntary consent of the human subject is absolutely essential Experiment should yield fruitful results for good of society, obtainable in no other way Experiments should avoid all unnecessary mental and physical suffering No experiment should be performed if it is believed that death or disabling injury may occurBelmont Report: 1979 From Dept. of Health, Education & Welfare Statement of: Basic ethical principles and guidelines to resolve ethical problems associated with conduct of research with human subjects Three basic ethical principles: Respect for persons Beneficence JusticeBelmont Report: What is research? Clinical Practice: Interventions designed solely to enhance well-being of an individual patient that have a reasonable expectation of success Research: An activity to test a hypothesis Permit conclusions to be drawn Contribute to generalizable knowledge Usually described in formal protocol that sets forth an objective and procedures to reach that objectiveRespect for Persons All individuals should be treated as autonomous agents Demands that subjects enter into research: Voluntarily With enough information to make a decision Persons with diminished autonomy are entitled to special protection Prisoners ChildrenBeneficence Make efforts to secure patients’ well-being Do No Harm Maximize possible benefits Minimize possible harms One should not injure one person regardless of benefits that may come to othersJustice Who should receive benefits of research and who should bear its burdens? Some ways to distribute burdens & benefits: To each person an equal share To each person according to individual need To each person according to individual effort 19thCentury: Poor ward patients were research subjects Wealthy private patients received benefits of research Selection of research subjects must be
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