Introduction to Regulation and Policies

The current system of laws, regulations, and policies applicable to human subjects research is not the result of a concerted effort. Part of the system is a collection of ethical statements (e.g., the Belmont Report, the Nuremberg Code) put forth at different times by different commissions with limited authority or influence, or with a limited focus. The guidelines issued by some government entities (e.g., the National Institutes for Health (NIH)) do not apply to all types of human subjects research, nor do they carry the weight of statutory law. A large part of the system consists of rules and regulations that were written or adopted by different administrative agencies (e.g., the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP)) at different times.

Though some regulations have now been codified, many were originally produced by executive branch offices operating independently and for a limited audience. The wide variety of federal agencies regulating some form of human subjects research is illustrated by the following noninclusive list: the Department of Defense, the Veterans Administration, the Department of Energy, the U.S. Coast Guard, the Bureau of Prisons, the Census Bureau, the Federal Highway Administration, human subjects and health care agencies within the Department of Health and Human Services, the Centers for Disease Control, the Department of Education, the Environmental Protection Agency, and the Social Security Administration.

The following relevant links for regulatory guidance are available at this Web site:

UIUC Policies

The Common Rule

Common Rule Subparts

Food and Drug Administration (FDA) Regulations

Office for Human Research Protections

Protected Health Information (PHI) Regulations issued under HIPAA

State of Illinois Laws and Regulations

Selected Funding Agency Guidelines