The Genetic Privacy Act is a proposal for legislation governing collection, analysis, storage, and use of DNA samples and the genetic information obtained from them. This first legislative product of the U.S. Human Genome Project's Ethical, Legal, and Social Issues (ELSI) component was presented to the DOE-NIH Joint ELSI Working Group in December 1994. Drafted as a federal statute to provide uniformity, the act has been introduced into six state legislatures. It could also be used as a guideline by professional societies until Congress acts. George Annas, Leonard Glantz, and Patricia Roche (Boston University School of Public Health) authored the proposal with funding from the DOE ELSI program.

The Genetic Privacy Act complements and moves beyond current federal proposals for protecting medical information. It would require explicit authorization to collect DNA samples for genetic analysis, limit uses of the samples and genetic information obtained from them, and set forth penalties for violations. The act aims to protect individual privacy while permitting genetic analysis for medical and identification purposes and legitimate research.

Under the act, anyone who collects a DNA sample such as blood, saliva, hair, or other tissue for genetic analysis is required to

* provide specific verbal information and a written notice of rights and assurances before sample collection,
* obtain written authorization containing required information,
* restrict access as authorized by the sample source, and
* abide by the source's instructions regarding maintenance and destruction of DNA samples.

Special rules regarding DNA sample collection and research are set forth for minors, incompetent persons, pregnant women, and embryos. Research is permitted on nonidentifiable samples when not forbidden by the sample's source; on individually identifiable DNA samples, research is prohibited unless specifically authorized by the source.

The overarching premise of the act is that no stranger should have or control identifiable DNA samples or genetic information about an individual unless the source specifically (1) authorizes the collection of DNA samples for analysis and the creation of genetic information and (2) retains access to and control over its dissemination. Rules protecting genetic privacy must be clear and made known to the medical, scientific, business, and law enforcement communities and the public.