Research Ethics James Madison University的研究伦理杰姆斯麦迪逊大学.pptVIP

Research Ethics The Protection of Human Subjects Presented by Carolyn Strong, CIM Research Coordinator Office of Sponsored Programs Administration JMAC Bldg 6, Suite 26 Phone: (540) 568-2318 Email: strongcd@ IRB Mission To oversee and review all research projects that involve research with human subjects. It is important to note that the IRB reviews all projects, not just externally supported activities. These reviews include faculty/ student research and classroom activities as well. See IRB Policy for more details: /JMUpolicy/1104.shtml IRB Membership At least 5 members At least 1 scientist At least 1 non-scientist At least 1 person not affiliated with the institution Members with varying backgrounds Diverse membership (gender, race, cultural background) IRB Responsibilities SAFEGUARD THE RIGHTS AND WELFARE OF HUMAN SUBJECTS Authority of the IRB The IRB’s decision to deny approval of a protocol (or to deny permission to recruit subjects on-campus) cannot be overridden by the president, any member of the administration, or the Board of Trustees of the institution. **THE IRB’S DECISION IS FINAL! Definitions Research “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Definitions Human subjects “living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or  interaction with the individual, or (2) identifiable private information.” Brief History 1947 – (26) Nazi physicians are tried at Nuremberg, Germany, for research atrocities performed on prisoners of war. This results in the Nuremberg Code, the first internationally recognized code of research ethics, issued by the Nazi War Crimes Tribunal (a prototype for later codes of ethics) Brief History 1940s – A series of research abuses starts in Tuskegee, Alabama. In one study on the natural history of untreated