Does Healthcare Reform Involve Research On Human Subjects?
Every time an experiment on human subjects in proposed in our hospital (or any hospital in the United States for that matter), there is an exquisitely sensitive tuning fork that exists to protect human subjects: the investigational review board or “IRB.” Any researcher who has ever brought a research proposal before an IRB knows that any hint of potential harm to a human subject that exists in a research project will kill the proposal faster than you can say “boo.”
An IRB submission is required for all research projects using human subjects in accordance with the Federal Policy for the Protection of Human Rights 45 CFR 46, the Food and Drug Administration (FDA) regulations 21 CFR 50, 56 , and with the Federalwide Assurance granted by the H.H.S. Office of Human Research Protections (OHRP). Every doctor, nurse, hospital administrator, drug or device company involved in human research knows this. Read more »
*This blog post was originally published at Dr. Wes*