Save the Date!
ISBER 2012 Annual Meeting & Exhibits
Westin Bayshore Hotel
Vancouver, British Columbia, Canada
May 15-18, 2012

Have a Resource to Include?

 

If you have a publication that you think should be considered for addition to this Bibliography, please contact isber@asip.org

 

 

 

 

 

 

 

 

 

 

Bibliography

Establishing a Tissue Bank

Establishment and Management of a Comprehensive Biorepository for Integrated High throughput Genomics and Proteomics Research: 131-143 (www.tibetsjournal.org Click on "abstracts" on the left hand side and the article is under the subheading "Biomedical Informatics/Bioinformatics")

Eiseman E, Bloom G, Brower J, et al. Case Studies of Existing Human Tissue Repositories: "Best Practices" for a Biospecimen Resource for the Genomic and Proteomic Era. RAND, 2003 (I think you already have this one).

Winickoff DE, Winickoff RN. The charitable trust as a model for genomic biobanks, N Engl J Med 349 (2003):1180-1184.

Schilsky RL, Dressler LM, Bucci D, Monovich L. et al. Cooperative Group tissue banks as research resources: the Cancer and Leukemia Group B Tissue Repositories. Clin Cancer Res 8(2002):943-948.

Lavori PW, Krause-Steinrauf H, Brophy M, et al. Principles, organization, and operation of a DNA bank for clinical trials: a Department of Veterans Affairs cooperative study. Controlled Clin Trials 23(2002):222-239.

Merz JF, Sankar P, Taube SE, LiVolsi VA. Use of human tissues in research: clarifying clinician and researcher roles and information flows. J Investig Med 45(1997):252-7.

Informed Consent Issues

McQuillan GM, Porter KS, Agelli M, Kington R. Consent for genetic research in a general population: the NHANES experience. Genet Med 5(2003):35-42.

Malone T, Catalano PJ, O'Dwyer PJ, Giantonio B. High rate of consent to bank biologic samples for future research: the Eastern Cooperative Oncology Group experience. J Natl Cancer Inst. 94(2002):769-771.

Wendler D, Emanuel E. The debate over research on stored biological samples: what do sources think? Arch Int Med 162(2002):1457-1462.

Stegmayr B, Asplund K. Informed consent for genetic research on blood stored for more than a decade: a population based study. BMJ 325(2002):634-635.

Deschênes M, Cardinal G, Knoppers BM, Glass KC. Human genetic research, DNA banking and consent: a question of "form"? Clin Genet 59(2001):221-239.

Beskow LM, Burke W, Merz JF, et al. Informed consent for population-based research involving genetics. JAMA 286(2001):2315-21. (Recommendations from a multidisciplinary group assembled by the CDC.)

Annas GJ. Reforming informed consent to genetic research. JAMA 286(2001):2326-2328.

Daly MB, Offit K, Li F, Glendon G, Yaker A, et al. Participation in the cooperative family registry for breast cancer studies: issues of informed consent. J Natl Cancer Inst. 92(2000):452-456.

Weir R. The ongoing debate about stored tissue samples, research and informed consent (Background paper commissioned by the NBAC, available at URLs cited for the NBAC report, in Vol. II, "Commissioned Papers".)

Greely HT. Breaking the stalemate: a prospective regulatory framework for unforeseen research uses of human tissue samples and health information. Wake Forest L Rev 34(1999):737-66.

Note: A model informed consent document for future unspecified research use of specimens collected during routine medical care, developed and tested by NCI and the National Action Plan on Breast Cancer, is available through the NCI Cancer Diagnosis Program website

Privacy and Confidentiality Issues

Anderlik MR, Rothstein MA. Privacy and confidentiality of genetic information: what rules for the new science? Annu Rev Genomics and Hum Genet 2(2001):401-33.

Anderlik MR, Rothstein MA. Canavan decision favors researchers over families, JL Med. & Ethics 31(2003):450-453.

Winickoff DE. Governing population genomics: law, bioethics, and biopolitics in three case studies, Jurimetrics J 43(2003):187-228.

Pullman D, Latus A. Clinical trials, genetic add-ons, and the question of benefit-sharing. Lancet 362(2003):242-244.

Merz JF, Magnus D, Cho MK, Caplan AL. Protecting subjects' interests in genetics research. Am J Hum Genet 70:965-971, 2002.

Dalton R. Tribe blasts 'exploitation' of blood samples. Nature 420(2002):111.

Andrews L. Genes and patent policy: rethinking intellectual property rights. Nature Rev Genet 3(2002):803-8.

Note: An issue of Academic Medicine, Vol. 77, No. 12 (Dec. 2002, Part 2), was devoted to DNA patents.

IRB Review of Tissue Banking Protocols

McWilliams R, Hoover-Fong J, Hamosh A, Beck S, Beaty T, Cutting G. Problematic variation in local instituational review of a multicenter genetic epidemiology study. JAMA 290(2003):360-366.

Basu S, Martin SW, Phillips RM, Puri R. Obtaining archived pathological material for biomedical research. Lancet 361(2003):1394.

Rothstein MA. The role of IRBs in research involving commercial biobanks. JL Med & Ethics 30(2002):105-108.

Merz JF, Leonard DG, Miller ER. IRB review and consent in human tissue research. Science. 283(1999):1647-8.

Adams MA, Prentice E, Oki G. Inquiry: ethical considerations in informed consent for potential future use of human tissue samples. IRB (March-Apr 1996):6-7.

Pharmacogenomics

Consortium on Pharmacogenetics, Pharmacogenetics: Ethical and Regulatory Issues in Research and Clinical Practice, 2002

Buchanan A, Califano A, Kahn J, et al. Pharmacogenetics: ethical issues and policy options. Kennedy Inst Ethics J 12(2002):1-15.

Robertson JA. Consent and privacy in pharmacogenetic testing. Nature Genet 28(2001):207-9.

Rothstein MA, Epps PG. Ethical and legal implications of pharmacogenomics. Nature Rev Genet 2001;2:228-31.

Spallone P, Wilkie T. The research agenda in pharmacogenetics and biological sample collections-a view from the Wellcome Trust. New Genetics and Society. 19(2000):193-205.

Collection and Use of Samples from Newborns

Pelias MK, Markward NJ. Newborn screening, informed consent, and future use of archived tissue samples. Genet Testing 5(2001):179-185.

Commercial Biobanks

Anderlik MR. Commercial biobanks and genetic research. Am J Pharmacogenomics 3(2003):203-215.

Rose H. The rise and fall of UmanGenomics-the model biotech company? Nature 425(2003):123-124. POLICY STATEMENTS

American Society of Human Genetics. Statement on informed consent for genetic research. Am J Hum Genet 59(1996):471-474, also available at http://www.ashg.org/genetics/ashg/policy/pol-25.htm.

Clayton EW, Steinberg KK, Khoury MJ, et al. Informed consent for genetic research on stored tissue samples. JAMA 274(1995):1786-92 (consensus statement from NIH-CDC working group).

International

Cardinal G, Deschenes M, Knoppers BM, Hudson T et al. Proposed statement of principles on the ethical conduct of human genetic research involving populations. 1:2 GE3LS 4 (2003), also available at http://www.rmga.qc.ca/doc/ENONCE2002.ENG.pdf

Books

Knoppers BM (Ed.). Populations and Genetics: Legal and Socio-Ethical Perspectives. The Hague: Martinus Nijhoff (in press).

Andrews, Mehlman, Rothstein - Genetics: Ethic, Law, and Policy.  West Group, St. Paul, MN, 2002

Becker PR, Porter BJ: Banking of Specimens and Quality Assurance/Quality Control, NIST. NOAA Technical Memorandum NOS-NCCOS-CCEHBR-0003. PA Fair and LJ Hansen,eds. Report of the Sea Turtle Health Assessment Workshop, 2-3 February 1998, Part I: Background and Information Needs., US Dept of Commerce,Washington, DC, Dec. 1998.

Dessauer, H. C. and M. S. Hafner (eds.). 1984. Collections of Frozen Tissues: Value, Management, Field and Laboratory Procedures, and Directory of Existing Collections. Association of Systematics Collections, Washington, D.C.

Dessauer, H. C., C. J. Cole and M. S. Hafner. 1996. Collection and storage of tissues. pp. 29-50. In: D. M. Hillis, C. Moritz and B. K. Mable (eds.), Molecular Systematics, 2nd. Ed. Sinauer Associates, Sunderland, MA.

 

Gunter E, Reid J, Ayal N, Kilbourne B. Archival specimen tracking and retrieval operations (ASTRO) software: Improving repository functions, and suggested public health considerations for the BEST2001 project. Proceedings of the International Workshop on Ultra-Long-Term Cryogenic Preservation Network of Biological and Environmental Specimens, Osaka, Japan, Nov. 1997.

Stenson, A. J. and T. S. Gray. 1999. The politics of genetic resource control. St. Martins Press, New York.

Winn DM, Gunter EW, Reichman MM. Biological specimen banks: a resource for molecular epidemiologic studies. In: Molecular Epidemiology: Principles and Practices, P. Shulte, F. Perera, eds. San Diego: Academic Press, 1993, 217-234.

Articles

Baird, P. and F. Simione 2000. The strategic case for a centralized biorepository. SIM News 50 (2): 57-62.

 

Bartley SL, Gunter EW. Laboratory practice and archival storage of biological specimens. Toxicology and Industrial Health, 12(3-4):477-80, 1996.

Gunter EW. Biological and environmental specimen banking at the Centers for Disease Control and Prevention. Chemosphere, 34 (9/10/):1945-53, 1997.