Who ought to receive the benefits of research and bear its burdens?
• Giving guidance to ensure sound research design, scientific integrity, and determining if the research contributes to generalizable knowledge and is worth exposing subjects to risk. Human subject research conducted at the NIH must meet high ethical and scientific standards. It must be designed, reviewed, approved, and implemented in accord with accepted ethical principles and the U.S. Department of Health and Human Services (45 CFR 46) and U.S. Food and Drug Administration (21 CFR 50 and 56) regulations for the protection of human subjects. The NIEHS IRB is part of the Human Subject Protection Program of the NIH.