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 journalArticle

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 languageEnglish (US)
Pages (from-to)222-239
Number of pages18
JournalControlled clinical trials
Volume23
Issue number3
DOIs
StatePublished - Jun 22 2002
Externally publishedYes

Keywords

  • DNA banking
  • Ethics
  • Genes
  • Pharmacogenomics

ASJC Scopus subject areas

  • Pharmacology

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  • Cite this

    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