Federalwide Assurance for Protection of Human Subjects

  • Federalwide Assurance for Protection of Human Subjects (Health & Human Services)
    All of the Institution’s human subjects research activities, regardless of whether the research is subject to federal regulations, will be guided by the ethical principles in: (a) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, or (b) other appropriate ethical standards recognized by federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects, known as the Common Rule.

  • Federal Protection for Human Research Subjects: An Analysis of the Common Rule and Its Interactions with FDA Regulations and the HIPAA Privacy Rule (Federation of American Scientists) June 2, 2005.
    The Common Rule (45 CFR 46, Subpart A) governs research that is conducted on human beings if it is funded by one of 18 federal agencies. It requires a review of proposed research by an Institutional Review Board (IRB), the informed consent of research subjects, and institutional assurances of compliance with the regulations.