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The electronic form of this document may be cited in the following style:
Human Genome Program, U.S. Department of Energy, DOE Human Genome Program Contractor-Grantee Workshop IV, 1994.

Abstracts scanned from text submitted for November 1994 DOE Human Genome Program Contractor-Grantee Workshop. Inaccuracies have not been corrected.

Protecting Genetic Privacy by Regulating the Collection, Analysis, Use, and Storage of DNA and Information Obtained from DNA Analysis

George J. Annas, Leonard H. Glantz, and Patricia A. Roche
Health Law Department, Boston University School of Public Health, Boston, MA

Both DNA samples and information derived from genetic analysis of DNA samples are maintained in various facilities which may be termed "DNA databanks." The use of both the samples and the information obtained from them could be regulated by attempting to regulate the activities of such banks. Our analysis, however, has concluded that there is such a variety of what may be seen as DNA databanks that it makes more sense to directly regulate the activities of all people who collect, analyze, store and use information obtained from DNA samples. Since the activities involved often cross state lines, and uniform regulations are desirable, federal regulation is to be greatly preferred to state or local regulation. We began this research project in early 1993 by focusing on six questions: (1) how is genetic information different from medical information?; (2) when should it be permissible to collect DNA samples from individuals?; (3) when is consent required to store DNA samples and information derived from them?; (4) who owns genetic material and genetic information?; (5) who should have access to stored DNA and genetic information obtained from it; and (6) should time limits be set on the storage of DNA? [1]

The answers to these six questions led us to others, and ultimately led us to draft a "Genetic Privacy Act" the purpose of which is to provide legal rules for the collection, analysis, storage, and use of DNA samples and the genetic information obtained from them.[2] The Act, which complements current federal proposals to protect medical information but moves beyond them, establishes rules to protect genetic privacy by requiring explicit authorization for the collection of DNA samples for genetic analysis, limiting the uses that can be made of DNA samples and the genetic information obtained from them, and setting forth penalties for violation of the rules. The full text of the Act, together with a detailed explanation of its provisions, will be available.

This research was funded by the Office of Health and Environmental Research of the DOE (DE-FG02-93ER61626).

[1] Annas GJ. Privacy rules for DNA databanks: protecting coded future diaries' JAMA 1993; 270:2346-50.
[2] Protecting genetic privacy (interview with George Annas) Trial Aug 1994; 30(8):43-46.