The legality of unlinked anonymous screening for HIV infection: the U.S. approach.

The purpose of this article is to describe the legal approach, and in particular, the specific statutory vehicle adopted by the U.S. with respect to unlinked anonymous screening, and to offer the U.S. approach as a possible model for those countries presently considering the implementation of unlinked HIV screening programs. Clear legal authorization for unlinked anonymous HIV testing is provided for by statute or regulation in the U.S. Federal regulations and various state laws specifically permit unlinked anonymous testing. Under these regulations and statutes, informed consent of a test subject is not required so long as testing is done for research purposes and the test results are not individually traceable to particular subjects.