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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.

DNA Banking and DNA Databanking by Academic and Commercial Laboratories

J.E. McEwen[1,2] and P.R. Reilly[1]
[1]Eunice Kennedy Shriver Center, Division of Social Science, Ethics, and Law, Waltham, Massachusetts, [2]Boston College Law School, Newton, Massachusetts

The advent of DNA-based testing is giving rise to DNA banking (the long-term storage of cells, transformed cell lines, or extracted DNA for subsequent retrieval and analysis) and DNA databanking (the indefinite storage of information derived from DNA analysis, such as the linkage profiles of persons at risk for a particular genetic disease)[1]. The large scale acquisition and storage of DNA and DNA data has important implications for the privacy rights of individuals [2,3].

A survey of 148 academically based and commercial DNA diagnostic laboratories was conducted to determine: (1) the extent of their DNA banking activities; (2) their policies and experiences regarding access to DNA samples and data; (3) the quality assurance measures they employ; and (4) whether they have written policies and/ or depositor's agreements addressing specific issues. These issues include: (1) who may have access to DNA samples and data (e.g., the depositor; his or her physician, spouse/ partner, adult children, or other relatives; other third parties); (2) whether scientists may have access to anonymous samples or data for research use; (3) whether they have plans to contact depositors or retest samples if improved tests for a disorder become available; (4) disposition of samples at the end of the contract period, if the laboratory ceases operations, if storage fees are unpaid, or after a death or divorce; (5) the consequence of unauthorized release, loss, or accidental destruction of samples; and (6) whether depositors may share in profits from the commercialization of tests or treatments developed in part from studies of stored DNA.

The results suggest that many laboratories are banking DNA, that many have already amassed a large number of samples, and that a significant number plan to further develop DNA banking as a laboratory service over the next two years. Few laboratories have developed written policies governing DNA banking--and fewer still have drafted documents that define the rights and obligations of the parties. There may be a need for increased regulation of DNA banking and DNA databanking and for better defined policies with respect to protecting individual privacy.

This work was funded by the DOE Genome Program (DE-FG02-9lER61237, P.R. Reilly, P.I.) MCH grant MCJ-259151-02-0, and Department of Mental Retardation of the Commonwealth of Massachusetts Contract 1000-10003-SC.

[1] Reilly, P.R. (1992) DNA banking. Am. J. Hum. Genet. 51, 1169-1170.
[2] American Society of Human Genetics, Ad Hoc Committee on DNA Technology. (1988) DNA banking and DNA analysis: Points to consider. Am. J. Hum. Genet 42, 781-83.
[3] Annas, G.J. (1993) Privacy rules for DNA databanks. JAMA 270, 2346-2350