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Define ethics

Why are ethics necessary in research?. To insure the protection of human and animal subjectsTo insure that research outcomes are achieved using moral and appropriate guidelinesFor the purpose of clarifying that research contributes to the body of knowledge constituting the background of a discipline.

Samuel
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Define ethics

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    1. Define ethics…

    3. Three Guiding Principles of Human Subject Protection Autonomy Beneficence Justice

    4. Autonomy - the capacity of individuals to make their own life decisions; self- determination

    5. Beneficence - the obligation to attend to the well-being of individuals; principle of “do no harm”

    6. Justice - fairness in the research process; equitable distribution of benefits and burdens; subject selection performed without bias

    7. What are Institutional Review Boards and why do we have them???

    8. A Little History (unfortunately there is lots more…) Tuskegee study Failure to treat subjects Failure to tell subjects they weren’t being treated Subjects not chosen randomly Failure to use successful treatments developed after the start of the study World War II and Nazi Experimentation subjects not allowed to choose whether to participate subject selection biased justice was ignored “treatments” were not valid by any stretch of science

    9. … more history The Jewish Chronic Disease Hospital study (1963) where patients hospitalized for a chronic disease gave oral informed consent without full details of the study; they were then injected with cancer cells but not told they were getting cancer cells Willowbrook study (1963-1969) children in a state hospital for the mentally retarded were injected with hepatitis virus so that researchers could study the natural history of the virus in this population. Parents consented but had been told the children would get the virus anyway because of terrible conditions in the facility

    10. Actions Arising from Violations of Subjects’ Rights The Nuremburg Code of 1947 The Declaration of Helsinki and continuing revisions The Belmont Report and continuing revisions

    11. The Nuremburg Code of 1947 Occurred as a result of Nazi war crimes emphasized that participants in research should voluntarily consent to participate can consent only after being informed of the study procedures studies can only be performed by qualified individuals

    12. Declaration of Helsinki, 1964 The International Code of Ethics for Biomedical Research Concept of independent review of research by qualified individuals not associated with the project Right to refuse publication for work not done in accordance with the accords

    13. The Belmont Report (1979) Finalized report on the decisions made for the protection of human subjects starting in 1974 Standardizes requirements for informed consent and Institutional Review Board procedures intended to insure autonomy, beneficence, and justice

    14. IRB Membership Both genders must be represented Multiple professional groups must be represented One non-scientific member One member separate from the institution Committee members must be able to judge submitted studies

    15. www.uab.edu/irb

    16. Ethical Responsibilities of the Researcher Honesty and integrity in every phase of research To do clinical research that is meaningful To be competent and have expertise in the area under investigation Publication of research outcomes, being honest and thorough in the documentation of such outcomes To give credit to collaborators Conducting data analysis through procedures which are appropriate and to not manipulate the data to achieve results the investigator wants

    17. Control Groups What are they? Why are they necessary?

    18. Elements of Informed Consent

    19. What is included in Informed Consent? Patient/participant is fully informed of purpose, procedures, risks and discomforts, benefits, and alternatives All information is confidential and anonymous Consent Form written in lay language Researcher available to answer questions at any time Consent must be voluntary Special consideration for vulnerable populations Free to withdraw consent at any time

    20. What ethical violations did you find in the UAB study on the web page?

    21. Violations in Dermatology Drug Study Conflicts of interest PI failed to take responsibility for the study Falsification of data Failure to tell subjects of other interventions Failure to tell subjects when study results proved false Falsification of information from PI to IRB Failure of IRB to intervene when fraud was discovered Failure of PI to insist on writing up results instead of letting the company do it Competition between overseeing agencies at the federal level

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