Y học - Chapter 5: Ethical concerns in research

Nazi Experimentation in WWII “medical experiments” Nuremberg War Crime Trials Nuremberg Code – basic principles to govern research involving human subjects Tuskegee Syphilis Study PHS project related to untreated syphilis Highlights deception and informed consent Human radiation experiments

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Chapter 5Ethical Concerns in ResearchHistorical Perspective on EthicsNazi Experimentation in WWII“medical experiments”Nuremberg War Crime TrialsNuremberg Code – basic principles to govern research involving human subjectsTuskegee Syphilis StudyPHS project related to untreated syphilisHighlights deception and informed consentHuman radiation experimentsEthical Standards for the Protection of Research Participants Nuremberg Code (1947) – first set of guidelinesHelsinki Declaration (1964) – medical researchBelmont Report (1979) – fundamental document for current federal regulations in USCommon Rule (1991) – 45 C.F.R. 46 Federal rules that govern research involving human participants in the USInstitutional Review Boards (IRB)Basic Principles of Belmont ReportRespect for persons Proclaims individuals capable of self-determination; thus voluntary consent is essentialBeneficenceObligates researchers to maximize potential benefits and minimize possible harmJusticeRequires the benefits and burdens of research be fairly distributedInformed ConsentArguably the most important ethical standardRefers to telling research participants about all aspects of the research that might reasonably influence their decision to participateFour important elementsSubjects are fully aware of nature and purpose of research projectConsent is voluntarily givenPerson has legal capacity to give consentResponsibility for obtaining consent rests with researcherProtecting Vulnerable SubjectsParticular precautions must be taken to protect the welfare of subjects that might be considered especially vulnerable or at risk for some reasonThe following types of subjects might be considered to be vulnerable: children, handicapped, cardiac rehab patients, welfare recipients, prisoners, pregnant women, patients in a mental hospital, etc.Privacy & ConfidentialityPrivacy – refers to the capacity of individuals to control when and under what conditions others have access to their behaviors, beliefs, and valuesConfidentiality – refers to treating subject information or responses in a manner so that it is not linked to any specific individual who participated in a study single-subject research requires particular cautionNormally addressed through informed consentInstitutional Review BoardsIRBs established by federal mandate to assure compliance with governmental regulationsIRBs have authority to approve, require modifications, or disapprove researchIRB approval required before any aspect of the research involving human subjects may commenceCategories of IRB ReviewExempt from reviewExpedited reviewFull reviewDependent upon amount of risk presentCriteria for IRB ApprovalRisks to subjects are minimizedRisks to subjects are reasonable in relation to anticipated benefitsSelection of subjects is equitable in relation to the purpose of the research and its settingInformed consent will be sought from each prospective subject or their legal representativeInformed consent will be appropriately documentedProvisions for monitoring data collected to ensure safety of subjectsProvisions to protect privacy of subjects and to maintain confidentiality of dataDisclosure of ResultsResearch investigations normally result in some disclosure of the results of the study (e.g., paper, published article, presentation)The preeminent ethical obligation in this regard is not to disclose inaccurate, deceptive, or fraudulent research resultsTo do so undermines the very nature of the scientific process!Proper establishment of authorship.Scientific MisconductAccording to the U.S. Public Health Service . . .“Misconduct” means fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting researchEthical Obligations in ResearchResearcher is responsible for his/her subjectsResearcher is responsible for his/her own actions and those of any research aidesSubjects must provide informed consentResearcher protects subjects from harm, danger, and discomfortMaintain anonymity and confidentialitySubjects should not be coercedResearcher has responsibility after the investigation is complete to safeguard subject dataHonest disclosure of results
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