Federal Regulations, Guidance and State Laws Pertaining to Human Research

There are a variety of federal regulations that apply to human research. In addition, the Office of Human Research Protections (OHRP) and the US Food and Drug Administration (FDA) have issued guidance documents and other materials that reflect their agency's current thinking. This page provides quick links to the most commonly accessed regulations and guidance documents. In addition to federal regulations, there are California state laws that pertain to human research.  All questions about the application and interpretation of State law must be directed to CHLA legal counsel.