<< Previous Section | < Previous Page | Next Page > | Next Section >> Common Rule The Common Rule is a federal policy regarding Human Subjects Protection that applies to 17 Federal agencies and offices. It does not apply to federal agencies that have not signed the agreement (e.g., Department of Labor, etc.) The main elements of the Common Rule include: Requirements for assuring compliance by research institutions Requirements for researchers' obtaining and documenting informed consent Requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping. The Common Rule includes additional protections for certain vulnerable research subjects. Subpart B provides additional protections for pregnant women, in vitro fertilization, and fetuses Subpart C contains additional protections for prisoners Subpart D does the same for children. DHHS Regulations are provided in 45 CFR, Part 46. http://www.access.gpo.gov/nara/cfr/waisidx_99/45cfr46_99.html FDA Regulations are detailed in 21 CFR, Part 50, and 21 CFR, Part 56. You can review these at http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=199945 An institution with a DHHS approved Federal Wide Assurance typically agrees to apply DHHS regulations to all research regardless of the funding source, including research that is internally funded and collaborative research across institutions << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 2 Quick Links Research in Humans History of Rules About Research in Humans Definitions Federal Mandate Respect for Persons Beneficence Justice Common Rule IRB Mission Cases Bibliography Chapter 2 Download (PDF)