BBH_310w_Research_Ethics_Lecture_SP09 - Research Ethics...

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Unformatted text preview: Research Ethics From the "Code" to BBH 310w Introduction What are the ethical limits (if any) of the scientific endeavor? Should science merely be conducted for the sake of knowledge? Should ethical considerations enter into the conversation of research at all? Overview History and Selected Examples Nuremberg Code 18th World Medical Assembly in Helsinki, Finland Tuskegee Syphilis Study Institutional Review Boards Current Regulations Discussion of Minimal Risk History Prior to 1940's Almost no constraints on human subjects research Bound only by the internal ethical guide of the researcher Post 1947 In response to Nazi physician research, codification of research guidelines Information on Nuremberg Trial and aftermath available at: Nuremberg Code (1947) In August 1947, the Nazi War Crimes Tribunal condemned the "medical experiments" performed on thousands of concentration camp prisoners by Nazi Physicians as "Crimes against Humanity" In the verdict, the judges included a section called "Permissible Medical Experiments." These "Permissible Medical Experiments" became the "Nuremberg Code" prototype for research ethics Set forth 10 guidelines for ethical human subjects research The 10 Guidelines of the Nuremburg Code 1. 1. Voluntary Informed Consent of subject The experiment should yield fruitful results for the good of society The experiment should be designed and based on previous work in animals (where applicable) or disease so that the results justify having performed the experiment 1. The Nuremburg Code Guidelines 1. All unnecessary physical and mental suffering or injury should be avoided No experiment shall be conducted where death or disability is expected a priori, except, perhaps, where experimenters serve as subjects There should be no more than minimal risk involved in the study 1. 1. The Nuremburg Code Guidelines 1. All care should be taken to protect subjects from even the remote possibilities of injury, death, or disability Only scientifically qualified individuals should conduct experiments The research subject has the right to end participation whenever they see fit The experimenter must, if there is ANY evidence or speculation of injury, disability, or death to participants, terminate the experiment 1. 1. 1. Helsinki Code (1964) Developed by the World Medical Association for the medical research made distinction between therapeutic and non-therapeutic research The Declaration was the first significant effort of the medical community to regulate itself Informed consent as a central requirement for ethical research allows for surrogate consent when the research participant is incompetent, physically or mentally incapable of giving consent, or a minor research with these groups should only be conducted when the research is necessary to promote the health of the population represented, and when this research cannot be performed on legally competent persons Helsinki Code The Declaration includes in its 32 principles the statement that: "the benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods." Response of the Medical and Scientific Community Kefauver-Harris Bill Passed to ensure greater drug safety in the US after thalidomide (a new sleeping pill) found to cause birth defects in thousands of babies born in Western Europe Example of unethical research practices Tuskegee Syphilis Study "Study" looking at developmental course of syphilis in Whites and Blacks Conducted by the United States Public Health Service Study ran from 1932-1972 Tuskegee Syphilis Study (cont.) Sample: 600 Poor Southern Black males 400 infected with Syphilis 200 Controls Subjects were not treated for syphilis even after a treatment was discovered and distributed to other afflicted populations Governmental response 40 years after the study began... In 1972, an ad hoc advisory panel by the Department of Health, Education and Welfare (DHEW) was convened to examine the study and find ways to assure that such experiments would never again be conducted. Among the recommendations of the panel was the request that Congress establish a "permanent body with the authority to regulate, at least, all federallysupported research involving human subjects. Congress responded by passing the National Research Act of 1974 20 Years later.... 60 years after the study began... In 1992, after a number of Congressional hearings, the United States government and President Bill Clinton issued an official apology to the families and subjects of the Tuskegee Syphilis study The Federal government continues to compensate the surviving study participants and the families of deceased participants Institutional Review Boards (IRB) Established through the National Research Act of 1974 Purpose is to review federally funded research Insure that all federal guidelines are followed Grant approval for federally funded research to be conducted and/or continued at a particular site IRBs (cont.) Two arms (Specific to PSU) Research involving animals Institutional Animal Care and Use Committee (IACUC) Research involving human participants Social Science IRB Biomedical IRB IRB at PSU All persons who have any contact with data or research at PSU must take and pass the university's "Training Module" online There are two training modules Animal research training module Human participant research module This is a requirement of ALL researchers at PSU President Spanier (research in HDFS) Undergraduate research assistants "Acceptable" Levels of Risk Minimal not greater than what is associated with daily normal life Greater than minimal If.. presents prospect of direct benefit to subject presents possibility of general benefits or In summary Research ethics is both Institutional Federally-mandated Institutional Review Board Personal Lots more leeway if you are a corporation conducting research using private money Goes beyond issues of human subjects to all aspects of research, from collection, to analysis, to reporting of results ...
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