Beyond Regulations Ethics in Human Subject Research超越规范伦理在人类主体的研究.pptVIP

下载本文档

4
0
约2.66千字
约 15页
2018-06-18 发布于福建
举报
版权申诉

Beyond Regulations Ethics in Human Subject Research超越规范伦理在人类主体的研究.ppt

1、原创力文档（book118）网站文档一经付费（服务费），不意味着购买了该文档的版权，仅供个人/单位学习、研究之用，不得用于商业用途，未经授权，严禁复制、发行、汇编、翻译或者网络传播等，侵权必究。。
2、本站所有内容均由合作方或网友上传，本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺！文档内容仅供研究参考，付费前请自行鉴别。如您付费，意味着您自己接受本站规则且自行承担风险，本站不退款、不进行额外附加服务；查看《如何避免下载的几个坑》。如果您已付费下载过本站文档，您可以点击这里二次下载。
3、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等，请点击“版权申诉”（推荐），也可以打举报电话：400-050-0827(电话支持时间：9:00-18:30)。
4、该文档为VIP文档，如果想要下载，成为VIP会员后，下载免费。
5、成为VIP后，下载本文档将扣除1次下载权益。下载后，不支持退款、换文档。如有疑问请联系我们。
6、成为VIP后，您将拥有八大权益，权益包括：VIP文档下载权益、阅读免打扰、文档格式转换、高级专利检索、专属身份标志、高级客服、多端互通、版权登记。
7、VIP文档为合作方或网友上传，每下载1次，网站将根据用户上传文档的质量评分、类型等，对文档贡献者给予高额补贴、流量扶持。如果你也想贡献VIP文档。上传文档

Beyond Regulations Ethics in Human Subject Research超越规范伦理在人类主体的研究

March 2009 HRPP 201 Beyond Regulations: Ethics in Human Subject Research Beyond Regulations: Ethical Considerations in Research Presented by: Marisue Cody, PhD Deputy Director, PRIDE Objectives Describe the ethical underpinnings of human subjects protection Discuss how regulations do not address all concerns regarding human subjects protection Nazi experiments Used unconsenting concentration camp victims as subjects and subjected them to great pain, suffering, disfigurement, and death These were not therapeutic trials. The Nuremberg Code Set of ethical principles developed by U.S. military tribunal post WWII (1949) Consent Right to withdraw Weighing of risks and benefits Thalidomide tragedy Use in pregnant women resulted in thousands of babies born with digits or limbs Lead to 1962 Drug Amendments Act – prove efficacy not just safety The Declaration of Helsinki Issued by the World Medical Association (1964, amended 5x, 2000 most recent) Well-being of the human subject should take precedence over the interests of science and society Physician’s responsibility is to safeguard the health of the people Medical research should be subject to review, approval, and oversight of an independent ethics committee Studies identified by Henry Beecher NEJM 1966 – review of 22 unethical published studies including: Jewish Chronic Disease Hospital case: injected live cancer cells into patients without informing them Willowbrook case: injected isolated strains of hepatitis into institutionalized mentally retarded children to understand the natural history of the disease and effects of gamma globulin U.S. PHS syphilis study at Tuskegee 40-year research study designed to gain an understanding of the natural history of untreated latent syphilis During course of study, penicillin was identified to be effective treatment but subjects denied access to treatment National Research Act Mandated regulations to protect human subjects Created National Commission to examine ethical