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Working with Human SubjectsResearch OversightWhy is oversight needed?HistoryHistory – Nuremberg CodeHistory – Nuremburg CodeEffect of the Nuremberg codeHistory: Declaration of HelsinkiHistory: Beecher ArticleThe Public Health Service Syphilis Study (1932-1971)Tuskegee Syphilis studySlide 12But …Recent Events: Death of a Normal VolunteerRecent Events: Death on Gene Therapy TrialSlide 16Wichita Jury Case (1953)Milgram “Obedience to Authority Study” (1963)Milgram study, continuedZimbardo "Simulated Prison" (1973)Restaurant Letter Study (2001)Restaurant letter, cont’dAs a result of events of this type…The National Commission asked to..ConsequencesThe Belmont ReportPrinciples of the Belmont ReportRespect for PersonsElements of autonomy:Rules derived from principle of respect for persons:BeneficenceBeneficence, continuedRules derived from principle of beneficenceSlide 34JusticeJustice, continuedRules derived from principle of JusticeThe Common RuleSome basic definitions:Research participantWhen does research require protection of human subjects?Studies not considered researchVulnerable populationsThe Institutional Review BoardRole and Responsibility of IRBIRB CompositionAuthority of IRBSubmitting protocols for reviewTypes of IRB ReviewFull board review (quorum review)Expedited reviewExpedited review (cont’d)Expedited ReviewAdministrative reviewAdministrative reviewSlide 56Protocol PreparationProtocol StatementProtocol statementSlide 60AbstractConsent and assent formsDiscussion (Elements)DiscussionSlide 65Slide 66AttachmentsInformed ConsentSlide 69Consent FormConsent formSlide 72Consent FormAssent FormSpecial situationsCommunity-based researchSlide 77Slide 78Internet-based researchSlide 80Slide 81Slide 82HIPAA RulesHIPAAConflict of InterestSlide 86What’s an investigator supposed to do?The Human Subjects OfficeGoals of University PolicyCriteria for IRB ApprovalResponsibility of InvestigatorsCourse Directed Human Subjects Activity (HSA)Student HSA projects that are not submitted to the Human Subjects Office must fall within the parametersPowerPoint PresentationSlide 95Slide 96Working with Human SubjectsCSCI 4800/6800Spring 2007Eileen Kraemer, Yin XiongResearch OversightResearch involving human subjects require oversightWhy?Why is oversight needed?Human subjects have not always been well protected.Privacy issues for individuals are a growing social concernResearch is big business with substantial financial interests.The future impact of such issues as genetic engineering, cloning, gene therapy, pharmacogenomics, etc. is unknown.HistoryCelsus, 1st century physicianperfomed experiments on condemned criminals in EgyptHis defense:"It is not cruel to inflict on a few criminals sufferings which may benefit multitudes of innocent people through all centuries." Times have changed ….History – Nuremberg CodeAt the end of World War II, 23 Nazi doctors and scientists were put on trial for the murder of concentration camp inmates who were used as research subjects.However, no accepted standards existed regarding the conduct of human research. The court found that it could not convict the defendants of violating the rights of research subjects. However, the court did convict 15 of the 23 defendants of murder. Result:7 condemned to death by hanging8 sentenced to prison from 10 years to life8 acquittedHistory – Nuremburg CodeThe court included in its judgment ten points describing required elements for conducting research with humans. These points became known as the Nuremberg Code, and included the following ideas:Informed consent is essential. Research should be based on prior animal work. The risks should be justified by the anticipated benefits. Only qualified scientists must conduct research. Physical and mental suffering must be avoided. Research in which death or disabling injury is expected should not be conducted.Effect of the Nuremberg codeThe Code had little impact on researchers in the United States, who thought that:the principles in the Code were already implicit in their workit was simply a document to condemn the Nazi atrocities and to convict the Nazi doctors. Problems with the code:did not have the strength of lawapplied to only non-therapeutic human subjects research.History:Declaration of Helsinki1964 - the World Medical Association develops a code of research ethics which came to be known as the Declaration of Helsinki. reinterpretation of the Nuremberg Code + addressed medical research with therapeutic intent. Journal editors began to require that research be performed in accordance with the Declaration.History:Beecher ArticleBeecher HK. "Ethics and Clinical Research" NEJM June 16, 1966described 22 examples of research studies with controversial ethics that had been conducted by reputable researchers and published in major journals."medicine is sound, and most progress is soundly attained;" However, if unethical research is not prohibited it will "do great harm to medicine.“ heightened awareness to the problem of unethical human subjects researchThe Public Health Service Syphilis Study (1932-1971)a.ka. - "Tuskeegee Syphilis Study" designed initially to make treatment available to African-American men with syphilis, although at the time the study began there was no known effective treatment. After funding to make drugs available was cut, the study became a natural history study. Hundreds of men with syphilis and hundreds of men without syphilis (serving as controls) were enrolled into the study.Tuskegee Syphilis studymen were recruited without their informed consentwere deliberately misinformed about the need for some of the procedures.e.g., spinal taps were described as necessary and special "free treatment." Even after penicillin was found to be a safe and effective treatment for syphilis in the 1940's, the men were denied antibiotics. Collusion with military and local doctors to prevent treatment.Continued until 1972.Resulted in 28 deaths, 100 cases of disability, and 19 cases of congenital syphilis (children born with syphilis)Tuskegee Syphilis studyEthical problems:lack of informed consentdeceptionwithholding informationwithholding available treatmentputting men and their families at riskexploitation of a vulnerable group of subjects who would not benefit from participation.But


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UGA CSCI 4800-6800 - HumanSubjects

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