References

Amber, D. (2000). Case at VCU brings ethics to forefront: Genetics researchers who elicit family medical histories cautioned about informed consent. The Scientist, 14(9), 1. Available: http://www.the-scientist.com/article/display/11831/[accessed July 12, 2009].

Aubert, G., and Lansdorp, P.M. (2008). Telomeres and aging. Physiological Reviews, 88, 557–579.

Australasian Biospecimen Network. (2007). Guidelines for Biorepository Protocols. (Revision 4, March). Available: http://www.abrn.net/pdf/ABN_SOPs_Review_Mar07_final.pdf [accessed February 18, 2010].

Bankhead, C. (2004). Privacy regulations have mixed impact on cancer research community. Journal of the National Cancer Institute, 96(23), 1,738–1,740.

Burman, W.J., Reves, R.R., Cohn, D.L., and Schooley, R.T. (2001). Breaking the camel’s back: Multicenter clinical trials and local institutional review boards. Annals of Internal Medicine, 134, 152–157.

Church, G.M. (2005). The Personal Genome Project. Molecular Systems Biology, 1:2005.0030 doi:10.1038/msb4100040. Available: http://thepersonalgenome.com/2005/12/church_on_the_p/ [accessed June 22, 2010].

Clayton, E.W. (2008). Data Access vs. Confidentiality: Balancing Risks and Benefits. Presentation at the Workshop on Collecting, Storing, Protecting, and Accessing Biological Data Collected in Social Surveys, November 17–18, National Research Council, Washington, DC.

Dalton, R. (2004). When two tribes go to war. Nature, 430(6999), 500–502.

DeRenzo, E.G., Biesecker, L.G., and Meltzer, N. (1997). Genetics and the dead: Implications for genetics research with samples from deceased persons. American Journal of Medical Genetics, 69(3), 332–334.

Deschênes, C., Cardinal, G., Knoppers, B.M., and Glass, K.C. (2001). Human genetic research, DNA banking and consent: A question of “form”? Clinical Genetics, 59(4), 221–239.

Dickson, S.P., Wang, K., Krantz, I., Hakonarson, H., and Goldstein, D.B. (2010). Rare variants create synthetic genome-wide associations. PLoS Biology, 8(1), e1000294.

Doyal, L., and Tobais, J. (Eds.). (2001). Informed Consent in Medical Research. London: BMJ Books.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 87
References Amber, D. (2000). Case at VCU brings ethics to forefront: Genetics researchers who elicit family medical histories cautioned about informed consent. The Scientist, (9), 1. Available: http:// www.the-scientist.com/article/display/11831/ [accessed July 12, 2009]. Aubert, G., and Lansdorp, P.M. (2008). Telomeres and aging. Physiological Reviews, , 557–579. Australasian Biospecimen Network. (2007). Guidelines for Biorepository Protocols. (Revision 4, March). Available: http://www.abrn.net/pdf/ABN_SOPs_Review_Mar07_final.pdf [accessed February 18, 2010]. Bankhead, C. (2004). Privacy regulations have mixed impact on cancer research community. Journal of the National Cancer Institute, (23), 1,738−1,740. Burman, W.J., Reves, R.R., Cohn, D.L., and Schooley, R.T. (2001). Breaking the camel’s back: Multicenter clinical trials and local institutional review boards. Annals of Internal Medicine, , 152−157. Church, G.M. (2005). The Personal Genome Project. Molecular Systems Biology, 1:2005.0030 doi:10.1038/msb4100040. Available: http://thepersonalgenome.com/2005/12/church_on_ the_p/ [accessed June 22, 2010]. Clayton, E.W. (2008). Data Access vs. Confidentiality: Balancing Risks and Benefits. Presentation at the Workshop on Collecting, Storing, Protecting, and Accessing Biological Data Collected in Social Surveys, November 17–18, National Research Council, Washington, DC. Dalton, R. (2004). When two tribes go to war. Nature, 0(6999), 500−502. DeRenzo, E.G., Biesecker, L.G., and Meltzer, N. (1997). Genetics and the dead: Implications for genetics research with samples from deceased persons. American Journal of Medical Genetics, (3), 332−334. Deschênes, C., Cardinal, G., Knoppers, B.M., and Glass, K.C. (2001). Human genetic research, DNA banking and consent: A question of “form”? Clinical Genetics, (4), 221−239. Dickson, S.P., Wang, K., Krantz, I., Hakonarson, H., and Goldstein, D.B. (2010). Rare variants create synthetic genome-wide associations. PLoS Biology, (1), e1000294. Doyal, L., and Tobais, J. (Eds.). (2001). Informed Consent in Medical Research. London: BMJ Books. 

OCR for page 87
 CONDUCTING BIOSOCIAL SURVEYS Elger, B.S., and Caplan, A.L. (2006). Consent and anonymization in research involving biobanks: Differing terms and norms present serious barriers to an international framework. European Molecular Biology Organization Reports, (7), 661−666. Epel, E.S., Blackburn, E.H., Lin, J., Dhabhar, F.S., Adler, N.E., Morrow, J.D., and Cawthon, R.M. (2004). Accelerated telomere shortening in response to life stress. Proceedings of the National Academy of Sciences, 0(49), 17,312–17,315. Eriksson, S., and Helgesson, G. (2005). Potential harms, anonymization, and the right to withdraw consent to biobank research. European Journal of Human Genetics, (9), 1,071−1,076. Faden, R.R., and Beauchamp, T.L. (1986). A History and Theory of Informed Consent. New York: Oxford University Press. Fost, N., and Levine, R.J. (2007). The dysregulation of human subjects research. Journal of the American Medical Association, (18), 2,196−2,198. Greely, H.T. (1997). The control of genetic research: Involving the groups between. Houston Law Review, (5), 1,397−1,430. Greely, H.T. (1999). Breaking the stalemate: A prospective regulatory framework for unforeseen research uses of human tissue samples and health information. Wake Forest Law Review, (3), 737−766. Greely, H.T. (2007). The uneasy ethical and legal underpinnings of large-scale genomic biobanks. Annual Review of Genomics and Human Genetics, , 343−364. Greely, H.T. (2009). Collecting biomeasures in the PSID: Ethical and legal concerns. Biodemogra- phy and Social Biology, (2), 270−288. Hao, K., Li, C., Rosenow, C., and Hung Wong, W. (2004). Estimation of genotype error rate using samples with pedigree information: An application on the GeneChip Mapping 10K array. Genomics, (4), 623−630. Hauser, R. M., and Weir, D. (in press). Recent developments in longitudinal studies of aging in the United States. Submitted to Demography. Homer, N., Szelinger, S., Redman, M., Duggan, D., Tembe, W., Muehling, J., Pearson, J.V., Stephan, D.A., Nelson, S.F., and Craig, D.W. (2008). Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays. PLoS Genetics, (8), e1000167. Huizinga, D., Haberstick, B.C., Smolen, A., Menard, S., Young, S.E., Corley, R.P., Stallings, M.C., Grotpeter, J., and Hewitt, J.K. (2006). Childhood maltreatment, subsequent antisocial behav - ior, and the role of monoamine oxidase A genotype. Biological Psychiatry, 0(7), 677−683. Institute of Medicine. (2009). Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. S.J. Nass, L.A. Levit, and L.O. Gostin, Eds, Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule. Board on Health Sciences Policy and Board on Health Care Services. Washington, DC: The National Acad - emies Press. International Society for Biological and Environmental Repositories. (2005). Best practices for repositories I: Collection, storage, and retrieval of human biological materials for research. Cell Preservation Technology, (1), 5−48. International Society for Biological and Environmental Repositories. (2008). 2008 best practices for repositories: Collection, storage, retrieval, and distribution of biological materials for research. Cell Preservation Technology, (1), 3−58. Jones, N.L., and Sarata, A.K. (2008). Genetic Information: Legal Issues Relating to Discrimination and Privacy. CRS Report for Congress. Washington, DC: Congressional Research Service. Kapp, M.B. (2008). Biobanking human biological materials: Issues surrounding the collection of samples for use in future research. Pharmaceutical Medicine, (2), 75−84. Karr, A.F., Kohnen, C.N., Oganian, A., Reiter, J.P., and Sanil, A.P. (2006). A framework for evaluating the utility of data altered to protect confidentiality. American Statistician, 0(3), 224−232.

OCR for page 87
 REFERENCES Levine, R.J. (1982). Commentary on the readability of consent forms. IRB: A Review of Human Subjects Research, (1), 8−9. Levine, R.J. (1988). Ethics and Regulations of Clinical Research (2nd ed.). New Haven, CT: Yale University Press. Levine, R.J. (2001). Institutional review boards: A crisis in confidence. Annals of Internal Medicine, (2), 161−163. Levine, R.J. (2006). Empirical research to evaluate ethics committees’ burdensome and perhaps unproductive policies and practices: A proposal. Journal of Empirical Research on Human Research Ethics, (3), 1−4. Lindau, S.T., Hoffmann, J.N., Lundeen, K., Jaszczak, A., McClintock, M.K., and Jordan, J.A. (2009). Vaginal self-swab specimen collection in a home-based survey of older women: Meth - ods and applications. Journal of Gerontology: Social Sciences, B(S1), i106–i118. Littenberg, B., and MacLean, C.D. (2006). Passive consent for clinical research in the age of HIPAA. Journal of General Internal Medicine, (3), 207−211. Little, R.J.A., and Rubin, D.B. (2002). Statistical Analysis with Missing Data (2nd ed.). Malden, MA: Wiley-Interscience. Lowrance, W.W. (2006a). Privacy, Confidentiality, and Identifiability in Genomic Research. Discus- sion document for workshop convened by the National Human Genome Research Insti - tute, October, Bethesda, MD. Available: http://www.genome.gov/Pages/About/OD/Reports Publications/IdentifiabilityWorkshopWhitePaper.pdf [accessed June 15, 2008]. Lowrance, W.W. (2006b). Summary of the NHGRI Workshop on Privacy, Identifiability, and Con- fidentiality in Genomic Research. Workshop convened by the National Human Genome Research Institute, October, Bethesda, MD. Available: http://www.genome.gov/19519198 [accessed June 15, 2008]. Lunshof, J.E., Chadwick, R., Vorhaus, D.B., and Church, G.M. (2008). From genetic privacy to open consent. Nature Reviews Genetics, (5), 406−411. Malin, B., and Sweeney, L. (2004). How (not) to protect genomic data privacy in a distributed network: Using trail re-identification to evaluate and design anonymity protection systems. Journal of Biomedical Informatics, (3), 179−192. Malinowski, M.J. (2005). Taking genomics to the biobank: Access to human biological samples and medical information. Louisiana Law Review, (43), 43−67. Marmot, M., and Steptoe, A. (2008). Whitehall II and ELSA: Integrating epidemiological and psychobiological approaches to the assessment of biological indicators. In National Research Council, Biosocial Surveys (pp. 42−59). Committee on Advances in Collecting and Utilizing Biological Indicators and Genetic Information in Social Science Surveys, M. Weinstein, J.W. Vaupel, and K.W. Wachter, Eds. Committee on Population, Division of Behavioral and Social Sciences and Education. Washington DC: The National Academies Press. Martin, J., and Marker, D.A. (2007). Informed consent: Interpretations and practice on social surveys. Social Science and Medicine, (11), 2,260−2,271. McGuire, A.L., Fisher, R., Cusenza, P., Hudson, K., Rothstein, M.A., McGraw, D., Matteson, S., Glaser, J., and Henley, D.E. (2008). Confidentiality, privacy, and security of genetic and ge - nomic test information in electronic health records: Points to consider. Genetics in Medicine, 0(7), 495−499. Meslin, E.M. (2006). Shifting paradigms in health services research ethics: Consent, privacy, and the challenges for IRBs. Journal of General Internal Medicine, (3), 279–280. Meslin, E.M., and Quaid, K.A. (2004). Ethical issues in the collection, storage, and research use of human biological materials. Journal of Laboratory and Clinical Medicine, (5), 229−234. National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. (2009). Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age. Committee on Ensuring the Utility and Integrity of Research Data in a Digital Age. Committee on Science, Engineering, and Public Policy, Policy and Global Affairs Division. Washington, DC: The National Academies Press.

OCR for page 87
0 CONDUCTING BIOSOCIAL SURVEYS National Cancer Institute. (2007). National Cancer Institute Best Practices for Biospecimen Re - sources. Washington, DC: Author. National Human Genome Research Institute. (2008). Cases of Genetic Discrimination. Available: http://www.genome.gov/12513976 [accessed June 26, 2009]. National Institutes of Health. (2006). Data Sharing Workshop for Behavioral and Social Studies that Collect Genetic Data: Workshop Highlights. Workshop of the Behavioral and Social Research Program of the National Institute on Aging, Bethesda, MD. Available: http://www. nia.nih.gov/NR/rdonlyres/AF0997F6-0C16-4A76-96C0-D3780F00E6D4/7292/2006Aug_ Genetics_Data_Sharing_Highlights_09_01_06_.PDF [accessed June 23, 2009]. National Institutes of Health. (2007). NIH Data Sharing Policy. Available: http://grants.nih.gov/ grants/policy/data_sharing/ [accessed June 20, 2008]. National Institutes of Health. (2009). Certificates of Confidentiality Kiosk. Available: http://grants. nih.gov/grants/policy/coc/ [accessed June 16, 2009]. National Institutes of Health, Office for Human Research Protections, Association of American Medical Colleges, and American Society of Clinical Oncology. (2005). Alternative Models of IRB Review: Workshop Summary Report. Available: http://www.hhs.gov/ohrp/sachrp/ documents/AltModIRB.pdf [accessed July 12, 2009]. National Research Council. (1993). Private Lives and Public Policies: Confidentiality and Accessibil- ity of Government Statistics. Panel on Confidentiality and Data Access, Committee on Na- tional Statistics, Commission on Behavioral and Social Sciences and Education. Washington, DC: National Academy Press. National Research Council. (2000). Improving Access to and Confidentiality of Research Data: Report of a Workshop. Committee on National Statistics, C. Mackie and N.Bradburn, Eds. Commission on Behavioral and Social Sciences and Education. Washington, DC: National Academy Press. National Research Council. (2003). Protecting Participants and Facilitating Social and Behavioral Science Research. Panel on Institutional Review Boards, Surveys, and Social Science Research. C.F. Citro, D.R. Iigen, and C.B. Marrett, Eds. Committee on National Statistics and Board on Behavioral, Cognitive, and Sensory Sciences. Division of Behavioral and Social Sciences and Education. Washington, DC: The National Academies Press. National Research Council. (2005). Expanding Access to Research Data: Reconciling Risks and Op- portunities. Panel on Data Access for Research Purposes, Committee on National Statistics, Division of Behavioral and Social Sciences and Education. Washington, DC: The National Academies Press. National Research Council. (2007). Putting People on the Map: Protecting Confidentiality with Linked Social−Spatial Data. Panel on Confidentiality Issues Arising from the Integration of Remotely Sensed and Self-Identifying Data. M.P. Gutmann and P.C. Stern, Eds. Committee on the Human Dimensions of Global Change. Division of Behavioral and Social Sciences and Education. Washington, DC: The National Academies Press. National Research Council. (2008). Biosocial Surveys. Committee on Advances in Collecting and Uti- lizing Biological Indicators and Genetic Information in Social Science Surveys. M. Weinstein, J.W. Vaupel, and K.W. Wachter, Eds. Committee on Population, Division of Behavioral and Social Sciences and Education. Washington, DC: The National Academies Press. Nolte, M.A., and Keller, J.J. (2004). Research Use of Restricted Data: The HRS Experience. Paper presented at Joint Statistical Meetings 2004, August, Toronto, Canada. Available: http://www. amstat.org/Sections/Srms/Proceedings/y2004/Files/Jsm2004-000274.pd f [accessed June 24, 2009]. Nosowsky, R., and Giordano, T.J. (2006). The Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy rule: Implications for clinical research. Annual Review of Medicine, , 575−590.

OCR for page 87
 REFERENCES Office for Human Research Protections. (2008). Guidance on Research Involving Coded Private Information or Biological Specimens. Available: http://www.hhs.gov/ohrp/humansubjects/ guidance/cdebiol.htm [accessed July 14, 2009]. Office of Biorepositories and Biospecimen Research. (2008). Custodianship and Ownership Issues in Biospecimen Research: Symposium–Workshop, Summary. Paper prepared by Rose Li and Associates for the National Cancer Institute. Offit, K. (2008). Genomic profiles for disease risk: Predictive or premature? Journal of the American Medical Association, (11), 1,353−1,355. Organisation for Economic Co-operation and Development. (2007). OECD Best Practice Guidelines for Biological Resource Centres. Paris: Author. Rothstein, M.A. (2005). Expanding the ethical analysis of biobanks. Journal of Law, Medicine, & Ethics, (1), 89−101. Rothstein, M.A. (2008). Is GINA worth the wait? Journal of Law, Medicine & Ethics, (1), 174–178. Saunders, I.W., Brohede, J., and Hannan, G.N. (2007). Estimating genotyping error rates from Mendelian errors in SNP array genotypes and their impact on inference. Genomics, 0(3), 291−296. Shickle, D. (2006). The consent problem within DNA biobanks. Studies in History and Philosophy of Science Part C—Studies in History and Philosophy of Biological and Biomedical Sciences, (3), 503−519. Shostak, J. (2006). De-identification of Clinical Trials Data Demystified. Paper presented at PharmaSUG SAS conference, May, Bonita Springs, FL. Strouse, D.S. (2005). Informed consent to genetic research on banked human tissue. Jurimetrics Journal, , 135–152. Twitchell, K.T. (2003). Bloodborne pathogens: What you need to know—Part I. American Associa- tion of Occupational Health Nurses Journal, (1), 38−45. UK Biobank. (2007). UK Biobank Ethics and Governance Framework. Available: http://www. ukbiobank.ac.uk/docs/EGFlatestJan20082.pdf [accessed June 20, 2008]. United Nations Educational, Scientific and Cultural Organization. (2002). Human Genetic Data: Preliminary Study by the IBC on its Collection, Processing, Storage and Use . Paris: Author. Available: http://portal.unesco.org/shs/en/files/2138/10563744931Rapfinal_gendata_en.pdf/ Rapfinal_gendata_en.pdf [accessed June 16, 2009]. U.S. Department of Health and Human Services. (2000). Standards for Privacy of Individually Identifiable Health Information. Available: http://aspe.hhs.gov/admnsimp/final/pvcguide1. htm [accessed June 26, 2009]. U.S. Department of Health and Human Services. (2003). Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule. Washington, DC: Author. Available: http://privacyruleandresearch.nih.gov/pdf/HIPAA_Booklet_4-14-2003.pdf [accessed June 26, 2009]. U.S. Department of Health and Human Services. (2005a). Are You a Covered Entity? Available: http://www.cms.hhs.gov/HIPAAGenInfo/06_AreYouaCoveredEntity.as p [accessed July 10, 2009]. U.S. Department of Health and Human Services. (2005b). Protection of Human Subjects. Available: http://www.hhs.gov/ohrp/documents/OHRPRegulations.pdf [accessed June 26, 2009]. U.S. House of Representatives. (2008). Genetic Information Nondiscrimination Act of 00. H.R. 493, 110th Congress. Washington, DC: U.S. Government Printing Office. Vaught, J.B., Lockhart, N., Thiel, K.S., and Schneider, J.A. (2007). Ethical, legal, and policy issues: Dominating the biospecimen discussion. Cancer Epidemiology, Biomarkers, & Prevention, (12), 2,521−2,523. Vollman, J., and Winau, R. (1996). Informed consent in human experimentation before the Nuremberg code. British Medical Journal, (7070), 1,445−1,449.

OCR for page 87
 CONDUCTING BIOSOCIAL SURVEYS Wade, N. (2010). A new way to look for diseases’ genetic roots. The New York Times. Available: http://www.nytimes.com/2010/01/26/science/26gene.html [accessed March 29, 2010]. Weir, R.F., and Olick, R.S. (2004). The Stored Tissue Issue: Biomedical Research, Ethics, and Law in the Era of Genomic Medicine. New York: Oxford University Press. Wellcome Trust. (2003). Sharing Data from Large-Scale Biological Research Projects: A System of Tripartite Responsibility. Report of a meeting organized by the Wellcome Trust and held on January 14–15, Fort Lauderdale, FL. Available: http://www.genome.gov/Pages/Research/ WellcomeReport0303.pdf [accessed June 22, 2010]. Westin, A.F. (2007). How the Public Views Privacy and Health Research. Available: http://www. iom.edu/Object.File/Master/48/528/%20Westin%20IOM%20Srvy%20Rept%2011-1107. pdf [accessed November 11, 2008]. Westin, A.F. (2008, November). Americans’ Changing Concerns About Health Privacy. Presentation at the Workshop on Collecting, Storing, Protecting, and Accessing Biological Data Collected in Social Surveys, November 17–18, National Research Council, Washington, DC. Widom, C.S., and Brzustowicz, L.M. (2006). MAOA and the “cycle of violence”: Childhood abuse and neglect, MAOA genotype, and risk for violent and antisocial behavior. Biological Psychiatry, 0(7), 684−689. Wolf, L.E., Croughan, M., and Lo, B. (2002). The challenges of IRB review and human subjects protections in practice-based research. Medical Care, 0(6), 521−529. World Health Organization. (1998). Proposed International Guidelines on Ethical Issues in Medi- cal Genetics and Genetic Services. Report of a WHO meeting on ethical issues in medical genetics. Geneva: Author. Available: http://www.who.int/genomics/publications/en/ethical guidelines1998.pdf [accessed June 16, 2009]. World Medical Association. (1964). Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects. Available: http://www.cirp.org/library/ ethics/helsinki/ [accessed June 17, 2009]. Zimmern, R.L., and Kroese, M. (2007). The evaluation of genetic tests. Journal of Public Health, (3), 246−250.