Federal Protection for Human Research Subjects: An Analysis of the Common Rule and Its Interactions with FDA Regulations and teh HIPAA Privacy Rule

The Common Rule (45 CFR 46, Subpart A) governs research that isconducted on human beings if it is funded by one of 18 federalagencies. It requires a review of proposed research by an InstitutionalReview Board (IRB), the informed consent of research subjects, andinstitutional assurances of compliance with the regulations. In 1974, 45CFR 46 was published following some cases of harm to humansubjects, such as those caused by thalidomide drug trials and theUnited States Public Health Service syphilis study in Tuskeegee, Alabama