Principles, organization, and operation of a DNA bank for clinical trials: A Department of Veterans Affairs cooperative study

Philip W. Lavori; Heidi Krause-Steinrauf; Mary Brophy; Joel Buxbaum; Jennifer Cockroft; David R. Cox; Louis Fiore; Henry T. Greely; Harry Greenberg; Edward W. Holmes; Lorene M. Nelson; Jeremy Sugarman

doi:10.1016/S0197-2456(02)00193-9

Principles, organization, and operation of a DNA bank for clinical trials: A Department of Veterans Affairs cooperative study

Philip W. Lavori, Heidi Krause-Steinrauf, Mary Brophy, Joel Buxbaum, Jennifer Cockroft, David R. Cox, Louis Fiore, Henry T. Greely, Harry Greenberg, Edward W. Holmes, Lorene M. Nelson, Jeremy Sugarman

Research output: Contribution to journal › Article › peer-review

34 Scopus citations

Abstract

The mapping and sequencing of the human genome promises rapid growth in understanding the genetically influenced mechanisms that underlie human disease. To realize this promise fully, it is necessary to relate genetic information to clinical phenotypes. Genetic tissue banking in clinical studies provides opportunities to analyze the genetic contribution to variation in response to treatments. The challenges to progress are likely to come from the complex organizational, social, political, and ethical issues that must be resolved in order to put clinical and DNA bank information together. Concerns about subjects' rights, informed consent, privacy, and ownership of genetic material require attention in the development of DNA banks. In this paper we describe one approach to the solution of these problems that was adopted by one clinical trials group, the Department of Veterans Affairs Cooperative Studies Program.

Original language	English (US)
Pages (from-to)	222-239
Number of pages	18
Journal	Controlled clinical trials
Volume	23
Issue number	3
DOIs	https://doi.org/10.1016/S0197-2456(02)00193-9
State	Published - 2002
Externally published	Yes

Keywords

DNA banking
Ethics
Genes
Pharmacogenomics

ASJC Scopus subject areas

Pharmacology

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10.1016/S0197-2456(02)00193-9

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Lavori, P. W., Krause-Steinrauf, H., Brophy, M., Buxbaum, J., Cockroft, J., Cox, D. R., Fiore, L., Greely, H. T., Greenberg, H., Holmes, E. W., Nelson, L. M., & Sugarman, J. (2002). Principles, organization, and operation of a DNA bank for clinical trials: A Department of Veterans Affairs cooperative study. Controlled clinical trials, 23(3), 222-239. https://doi.org/10.1016/S0197-2456(02)00193-9

Lavori, PW, Krause-Steinrauf, H, Brophy, M, Buxbaum, J, Cockroft, J, Cox, DR, Fiore, L, Greely, HT, Greenberg, H, Holmes, EW, Nelson, LM & Sugarman, J 2002, 'Principles, organization, and operation of a DNA bank for clinical trials: A Department of Veterans Affairs cooperative study', Controlled clinical trials, vol. 23, no. 3, pp. 222-239. https://doi.org/10.1016/S0197-2456(02)00193-9

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abstract = "The mapping and sequencing of the human genome promises rapid growth in understanding the genetically influenced mechanisms that underlie human disease. To realize this promise fully, it is necessary to relate genetic information to clinical phenotypes. Genetic tissue banking in clinical studies provides opportunities to analyze the genetic contribution to variation in response to treatments. The challenges to progress are likely to come from the complex organizational, social, political, and ethical issues that must be resolved in order to put clinical and DNA bank information together. Concerns about subjects' rights, informed consent, privacy, and ownership of genetic material require attention in the development of DNA banks. In this paper we describe one approach to the solution of these problems that was adopted by one clinical trials group, the Department of Veterans Affairs Cooperative Studies Program.",

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note = "Funding Information: The opinions expressed herein are the opinions of the authors and do not represent official position of the Department of Veterans Affairs. This work was funded by the Department of Veterans Affairs Cooperative Studies Program as CSP#478. ",

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doi = "10.1016/S0197-2456(02)00193-9",

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AU - Buxbaum, Joel

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AU - Cox, David R.

AU - Fiore, Louis

AU - Greely, Henry T.

AU - Greenberg, Harry

AU - Holmes, Edward W.

AU - Nelson, Lorene M.

AU - Sugarman, Jeremy

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KW - Pharmacogenomics

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Principles, organization, and operation of a DNA bank for clinical trials: A Department of Veterans Affairs cooperative study

Abstract

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