TheBelmontReport-CTSPedia.ppt

Ethical Principles of Human Subjects Protection The Belmont Report The Common Rule The Belmont Report Purpose of the report is to provide three principles (prescriptive judgments) that will ‘assist researchers, subjects, reviewers and interested citizens with an understanding of the ethical issues inherent in HSR’ Statement consists of 3 parts Distinction between research and medical practice Establishment of 3 ethical principles Remarks regarding application of the principles The Belmont Report Practice Interventions designed solely to enhance the wellbeing of the patient and that have a reasonable expectation of success Research An activity designed to test an hypothesis, permit conclusions to be drawn, develop or contribute to generalizable knowledge The Belmont Report Three Ethical Principles Principle of respect for persons autonomy Principle of beneficence Principle of justice Respect for Persons Autonomy Enters research voluntarily and with adequate information Implies everyone is capable of self determination Matures during life span May be lost in whole or in part as a result of illness, mental disability or circumstances that restrict liberty Cannot exclude those incapable of self determination Respect for such situations requires protection Explicit requirement that each class of incompetent patient be considered on its own terms Third parties whose primary goal is to protect the subject from harm should be used and that these individuals be allowed to observe the research The Belmont Report - Three Ethical Principles Principle of respect for persons Individual autonomy Protection of individuals with reduced autonomy Principle of beneficence Requires a risk benefit assessment be made Maximize benefits and minimize harms Principle of justice Equitable distribution of research costs and benefits Beneficence Acts of kindness or charity that go beyond strict obligation Strict sense of obligation Do not harm Maximize possible benefits M