Human Subjects Research Regulations and Review …：人体研究法规和审查….pptVIP

Human Subjects Research:Regulations and Review Issues Florida Gulf Coast University October 23, 1998 Jeffrey M. Cohen, Ph.D. The University at Albany, SUNY Topics Why do we have IRBs? Definitions IRB Review of Research Informed Consent Risk in Social Behavioral Research Vulnerable Populations Research on the Internet WHY DO WE HAVE IRBs? Philosophical Basis Historical Basis Regulatory Basis Philosophical Basis for IRBs Immanuel Kant (1724-1804): “For all rational beings come under the law that each of them must treat itself and all others never merely as means, but in every case at the same time as ends in themselves.” Philosophical Basis for IRBs The Belmont Report Basic Ethical Principles: Respect for Persons - Individual autonomy - Protection of individuals with reduced autonomy Beneficence - Maximize benefits and minimize harms Justice - Equitable distribution of research costs and benefits Historical Basis for IRBs NUREMBERG: During the Nuremberg War Crimes Trials, 23 German doctors were charged with crimes against humanity for “performing medical experiments upon concentration camp inmates and other living human subjects, without their consent, in the course of which experiments the defendants committed the murders, brutalities, cruelties, tortures, atrocities, and other inhuman acts.” Historical Basis for IRBs The Nuremberg Code (1947) As part of the verdict, the Court enumerated some rules for “Permissible Medical Experiments”, now known as the “Nuremberg Code”. These rules include: voluntary consent, benefits outweigh risks, and the ability of the subject to terminate participation. Historical Basis for IRBs Tuskegee Syphilis Study: American medical research project conducted by the U.S. Public Health Service from 1932 to 1972, examined the natural course of untreated syphilis in black American men. The subjects, all impoverished sharecroppers from Macon County, Alabama, were unknowing participants in the study; t