耕莘护理专科学校-首页.ppt

Ethical ConsiderationInformed Consent 指導教授：林佳靜教授 報告者：林美良、江倫志、郭梅珍 報告日期：98.10.13  Introduction History background Basic Ethical Principles Ethical issue in Human Research Ethical Issue in Research to Use Data Sets Ethical issue in Animal Research Professional ethical misconducts Guidelines of Ethical Consideration in Research Informed Consent IRB Case Discuss Introduction Moral ?refers to the individual values and self-constraints Ethic ?refers to the mechanism provided by either a committee or similar organization whose main role is to conduct ethical assessment ?institutional policy refers to the rules set up by the institutions themselves Law ?refers to the governments imposition of constraints ?regulations、acts、decrees、orders、codes、administrative rules or guidelines ?on organizations and individuals Introduction What is the research ethics？ ?It is a criterion or principle for what is “right” or“good”in the research process. ?One kind of strict self-request morals or the value system that the researcher should behave himself. The researchers must have higher moral requirement than the general communicants. History background The Nuremberg Code The Nuremberg Code was adopted by the United Nations General Assembly in 1948 the first major international document to provide guidelines on research ethics provide a basis for modern standards on human research The Nuremberg Code (con’t) participants are able to consent free from coercion (i.e., outside pressure) they comprehend the risks and benefits involved states that researchers should minimize risk and harm make sure that risks do not significantly outweigh potential benefits appropriate study designs guarantee participants freedom to withdraw at any time Declaration of Helsinki At the 18th World Medical Assembly in Helsinki, Finland, the World Medical Association adopted 12 principles to guide physicians on ethical considerations related to biomedical research. It emphasizes the distinction betw