Skip to Content
U.S. National Institutes of Health
Last Updated: 03/05/10

Legal and Ethical Issues

Ethical Collection of Specimens

How Federal Regulations Apply to Research on Human Specimens

Federal requirements to protect human subjects apply to most research on human specimens (such as cells, blood, and urine), residual diagnostic specimens and medical information.

The NIH has developed a user-friendly brochure to help investigators understand how the human subjects regulations 45CFR46 apply to their research. You may download this brochure, entitled “Research on Human Specimens: Are You Conducting Research Using Human Subjects?”

50-State Survey of Laws Regulating the Collection, Storage, and Use of Human Tissue Specimens and Associated Data for Research: