Compliance In Focus

What is electronic informed consent?

U.S. federal regulations governing the protection of human subjects in research have been in existence for more than 30 years. The Department of Health, Education, and Welfare first published regulations for the protection of human subjects in 1974, and the Department of Health and Human Services (HHS) revised them in the early 1980s. To promote uniformity, understanding, and compliance with human subject protections, U.S. federal departments and agencies adopted the revised version of the regulations in 1991; subpart A of 45 Code of Federal Regulations (CFR) part 46 was created. This is often referred to as the “Common Rule” or “Protection of Human Subjects Regulations”.

Medical research has led to many important medical discoveries that make our lives better. When medical research studies are completed, researchers can share the information with the medical community around the world at conferences or via peer-reviewed journals; and the results of these studies often help doctors provide better and more improved care to their patients.