Overview of Policy, Ethical and Social Considerations in Genomic and Personalized Medicine

Genomic and Personalized Medicine

Volumn 1, Issue , 2013, Pages 392-404

  Haga, Susanne B ^a  

^a DUKE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84880524036     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-0-12-382227-7.00034-3     Document Type: Chapter

References (164)

1. Ahn S.M., Kim T.H., Lee S., et al. The first Korean genome sequence and analysis: full genome sequencing for a socio-ethnic group. Genome Res 2009, 19:1622-1629.
2. Altman R.B. Direct-to-consumer genetic testing: failure is not an option. Clin Pharmacol Ther July 2009, 86(1):15-17.
3. American College of Medical Genetics Board of Directors ACMG statement on direct-to-consumer genetic testing. Genet Med. January-February 2004, 6(1):60. http://www.acmg.net/resources/policies/Direct_Consumer_Testing.pdf.
4. American Medical Association, 2007. Resolution 522: direct to consumer advertising and provision of genetic testing. http://www.ama-assn.org/ama1/pub/upload/mm/467/522.doc.
5. Anonymous Standard issue. Nature 2010, 466:797.
6. Ashley, et al. Clinical assessment incorporating a personal genome. Lancet 2009, 375:1525-1535.
7. Association of British Insurers, 2011. ABI news release, Tuesday, 05 April 2011, Ref: 17/11: Insurance Genetics Moratorium extended to 2017. >. http://www.abi.org.uk/Media/Releases/2011/04/Insurance_Genetics_Moratori um_extended_to_2017.aspx.
8. Australian Law Reform Commission and Australian Health Ethics Committee of the National Health and Medical Research Council, 2003. Essentially yours: the protection of human genetic information in australia (ALRC 96). >. http://www.austlii.edu.au/au/other/alrc/publications/reports/96/.
9. Beaudet A.L. Which way for genetic-test regulation? Leave test interpretation to specialists. Nature 2010, 466:816-817.
10. Bennett C., Burton H., Fardon P. Competences, education and support for new roles in cancer genetics services: outcomes from the cancer genetics pilot projects. Familial Cancer 2007, 6:171-180.
11. Beskow L.M., Burke W. Offering individual genetic research results: context matters. Sci Transl Med 2010, 2:38cm20.
12. Bloss C.S., Schork N.J., Topol E.J. Effect of direct-to-consumerr genomewide profiling to assess disease risk. N Eng J Med 2011, 364:524-534.
13. Blue Cross Blue Shield Association Technology Evaluation Center Gene expression profiling for managing breast cancer treatment. Assessment Program 2005, 20:3.
14. Blue Cross Blue Shield Association Technology Evaluation Center, 2007. Actions taken by the medical advisory panel. >. http://www.bcbs.com/betterknowledge/tec/press/actions-taken-by-the-medic al-1.html.
15. Blue Cross Blue Shield Association Technology Evaluation Center Gene expression profiling in women with lymph-node-positive breast cancer to select adjuvant chemotherapy treatment. Assessment Program 2010, 25(1). http://www.bcbs.com/blueresources/tec/vols/25/25_01.pdf.
16. Bookman E.B., Langehorne A.A., Eckfeldt J.H., et al. Reporting genetic results in research studies: summary and recommendations of an NHLBI working group. Am. J. Med. Genet. A 2006, 140A:1033-1040.
17. Bredenoord A.L., Onland-Moret N.C., Van Delden J.J. Feedback of individual genetic results to research participants: in favor of a qualified disclosure policy. Hum Mutat 2011, [Epub.]. 10.1002/humu.21518.
18. Bredenoord A.L., Kroes H.Y., Cuppen E., Parker M., van Delden J.J. Disclosure of individual genetic data to research participants: the debate reconsidered. Trends Genet 2011, 27:41-47.
19. Bunin G.R., Kazak A.E., Mitelman O. Informing subjects of epidemiologic study results. Children's cancer group. Pediatrics 1996, 97:486-491.
20. Burchard E.G., Ziv E., Coyle N., et al. The importance of race and ethnic background in biomedical research and clinical practice. N Engl J Med 2003, 348:1170.
21. Bustamante C.D., Burchard E.G., De la Vega F.M. Genomics for the world. Nature 2011, 475:163-165.
22. Butler D. Human genome at ten: science after the sequence. Nature 2010, 465:1000-1001.
23. Cambon-Thomsen A. The social and ethical issues of post-genomic human biobanks. Nature Rev Genet 2004, 5:866-873.
24. Carlson J.J., Henrikson N.B., Veenstra D.L., Ramsey S.D. Economic analyses of human genetics services: a systematic review. Genet Med 2005, 7:519-523.
25. Caulfield T., McGuire A.L., Cho M., et al. Research ethics recommendations for whole-genome research: consensus statement. PLoS Biol 2008, 6(3):e73.
26. CCMG CCMG statement on direct-to-consumer genetic testing. CCMG ethics and public policy committee. Clin Genet 2012, 81:1-3.
27. Challen K., Harris H.J., Julian-Reynier C., et al. Genetic education and non genetic health professionals: educational providers and curricula in Europe. Genet Med 2005, 7:302-310.
28. Chapman M.A., Lawrence M.S., Keats J.J., et al. Initial genome sequencing and analysis of multiple myeloma. Nature 2011, 471:467-472.
29. Clemerson J.P., Payne K., Bissell P., Anderson C. Pharmacogenetics, the next challenge for pharmacy?. Pharm World Sci 2006, 28:126-130.
30. Collins F.S. Testimony before the subcommittee on health committee on energy and commerce. United States House of Representatives May 22, 2003, http://www.genome.gov/11007447.
31. Collins F.S., Green E.D., Guttmacher A.E., Guyer M.S. U.S. National Human Genome Research Institute. A vision for the future of genomics research. Nature 2003, 422:835-847.
32. Cooper R.S., Kaufman J.S., Ward R. Race and genomics. N Engl J Med 2003, 348:1166.
33. Corvol H., De Giacomo A., Eng C., et al. Genetic ancestry modifies pharmacogenetic gene-gene interaction for asthma. Genetics of Asthma in Latino Americans (GALA) Study: study of African-Americans, Asthma, Genes and Environments (SAGE) investigators. Pharmacogenet Genomics 2009, 19:489-496.
34. Couzin-Frankel J. What would you do?. Science 2011, 331:662-665.
35. Department of Justice, Canada, 2005. Promoting equality: a new vision. >. http://www.canada.justice.gc.ca/chra/en/toc.html.
36. Dixon-Woods M., Jackson C., Windridge K.C., Kenyon S. Receiving a summary of the results of a trial: qualitative study of participants' views. BMJ 2006, 332:206-210.
37. European Parliament, 2000. Charter of fundamental rights of the European Union. Article 21 (Non-discrimination). >. http://www.europarl.europa.eu/charter/pdf/text_en.pdf.
38. European Society of Human Genetics Statement of the ESHG on direct-to-consumer genetic testing for health-related purposes. Eur J Hum Genet 2010, 18:1271-1273.
39. Evans J.P., Green R.C. Direct to consumer genetic testing: avoiding a culture war. Genet Med 2009, 11:568-569.
40. Evans R.W., Williams G.E., Baron H.M., et al. The economic implications of noninvasive molecular testing for cardiac allograft rejection. Am J Transplant 2005, 5:1553-1558.
41. Fabsitz R.R., McGuire A., Sharp R.R., et al. Ethical and practical guidelines for reporting genetic research results to study participants: updated guidelines from a National Heart, Lung, and Blood Institute working group. Circ Cardiovasc Genet 2010, 3:574-580.
42. Farkas D.H., Holland C.A. Direct-to-consumer genetic testing:two sides of the coin. J Mol Diagn 2009, 11:263-265.
43. Federal Trade Commission, 2006. Facts for consumers: at-home genetic tests: a healthy dose of skepticism may be the best Prescription. >. http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea02.htm.
44. Fernandez C.V., Kodish E., Taweel S., Shurin S., Weijer C. Disclosure of the right of research participants to receive research results: an analysis of consent forms in the Children's Oncology Group. Cancer 2003, 97:2904-2909.
45. Fernandez C.V., Kodish E., Weijer C. Informing study participants of research results: an ethical imperative. IRB 2003, 25(3):12-19.
46. Fernandez C.V., Kodish E., Weijer C. Importance of informed consent in offering to return research results to research participants. Med Pediatr Oncol 2003, 41:592-593.
47. Food and Drug Administration, 2005a. Guidance for industry and FDA staff. Class II special controls guidance document: drug metabolizing enzyme genotyping system. http://www.fda.gov/cdrh/oivd/guidance/1551.pdf.
48. Food and Drug Administration, 2005b. Guidance for industry and FDA staff. Class II special controls guidance document: instrumentation for clinical multiplex test systems. >. http://www.fda.gov/cdrh/oivd/guidance/1546.pdf.
49. Food and Drug Administration, 2006a. Draft guidance for industry and FDA staff - Commercially Distributed analyte specific reagents (ASRs): frequently asked questions. >. http://www.fda.gov/cdrh/oivd/guidance/1590.pdf.
50. Food and Drug Administration, 2006b. Draft guidance for industry, clinical laboratories, and FDA staff - In vitro diagnostic multivariate index assays. >. http://www.fda.gov/cdrh/oivd/guidance/1610.pdf.
51. Food and Drug Administration, 2006c. Guidance for industry and review staff. Recommended approaches to integration of genetic toxicology study results. >. http://www.fda.gov/cder/guidance/6848fnl.pdf.
52. Food and Drug Administration, 2007a. Center for devices and radiological health, center for biologic evaluation and research. Draft Guidance for Industry, Clinical Laboratories, and FDA Staff: In Vitro Diagnostic Multivariate Index Assays. Available online at: . http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm071455.pdf.
53. Food and Drug Administration, 2007b. Guidance for industry and FDA staff. Pharmacogenetic tests and genetic tests for heritable markers. >. http://www.fda.gov/cdrh/oivd/guidance/1549.pdf.
54. Food and Drug Administration, 2007c. Center for devices and radiological health, center for biologic evaluation and research. guidance for industry and FDA staff. Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions. Available online at: . http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/ guidancedocuments/ucm071269.pdf.
55. Food and Drug Administration Notice of public meeting: oversight of laboratory developed tests; public meeting; request for comments (FDA-2010-N-0274). Federal Register 2010, 75:34,463-34,464.
56. Food and Drug Administration Notice of public meeting: molecular and clinical genetics panel of the medical devices advisory committee. Federal Register 2011, 76:6623-6624.
57. Foster M. Genetics and social identity after the HapMap. Nat Rev Genet 2005, 6:879.
58. Godard B., Marshall J., Laberge C., Knoppers B.M. Strategies for consulting with the community: the cases of four large-scale genetic databases. Sci Eng Ethics 2004, 10:457-477.
59. Goddard K.A., Robitaille J., Dowling N.F., et al. Health-related direct-to-consumer genetic tests: a public health assessment and analysis of practices related to Internet-based tests for risk of thrombosis. Public Health Genomics 2009, 12:92-104.
60. Gollust S.E., Wilfond B.S., Hull S.C. Direct-to-consumer sales of genetic services on the Internet. Genet Med 2003, 5:332-337.
61. Government Accountability Office, 2006. Nutrigenetic testing: tests purchased from four web sites mislead consumers (GAO-06-977T). >. http://www.gao.gov/new.items/d06977t.pdf.
62. Government Accountability Office, 2010. Direct-to-consumer genetic tests: misleading test results are further complicated by deceptive marketing and other questionable practices (GAO-10-847T). http://www.gao.gov/products/GAO-10-847T.
63. Green E.D., Guyer M.S., et al. Charting a course for genomic medicine from base pairs to bedside. National Human Genome Research Institute. Nature 2011, 470(7333):204-213.
64. Green R.C., Roberts J.S., Cupples L.A., et al. Disclosure of APOE genotype for risk of Alzheimer's disease. N Engl J Med 2009, 361:245-254.
65. Gurwitz D., Weizman A., Rehavi M. Education: teaching pharmacogenomics to prepare future physicians and researchers for personalized medicine. Trends Pharmacol Sci 2003, 24:122-125.
66. Guttmacher A.E., Jenkins J., Uhlmann W.R. Genomic medicine: who will practice it? A call to open arms. Am J Med Genet 2001, 106:216-222.
67. Haga S.B., Ginsburg G.S. Prescribing BiDil: is it black and white?. J Am Coll Cardiol 2006, 48:12-14.
68. Haga S.B., Kawamoto K., Agans R., Ginsburg G.S. Consideration of patient preferences and challenges in storage and access of pharmacogenetic test results. Genet Med 2011, 13(10):887-890.
69. Haga S.B., O'Daniel J. Public perspectives regarding data-sharing practices in genomics research. Public Health Genomics 2011, 14(6):319-324.
70. Hall D., Ybazeta G., Destro-Bisel G., Petzl-Erler M.L., Di Renzo A. Variability at the uridine diphosphate glucuronosyltransferase 1A1 promoter in human populations and primates. Pharmacogenetics 1999, 9:591-599.
71. Hatin W.I., Nur-Shafawati A.R., Zahri M.K., et al. Population genetic structure of peninsular Malaysia Malay sub-ethnic groups. PLoS One 2011, 6(4):e18312.
72. Heaney C., Tindall G., Lucas J., Haga S.B. Researcher practices on returning genetic research results. Genet Test Mol Biomarkers 2010, 14:821-827.
73. Helgadottir A., Manolescu A., Helgason A., et al. A variant of the gene encoding leukotriene A4 hydrolase confers ethnicity-specific risk of myocardial infarction. Nat Genet 2006, 38:68-74.
74. HM Government and Association of British Insurers, 2005. Concordat and moratorium, genetics and insurance. >. http://www.dh.gov.uk/assetRoot/04/10/60/50/04106050.pdf.
75. Hoeyer K. Science is really needed - that's all I know. Informed consent and the non-verbal practices of collecting blood for genetic research in Sweden. New Genet Soc 2003, 22:224-229.
76. Hoeyer K., Olofsson B.O., Mjörndal T., Lynöe N. Informed consent and biobanks: a population-based study of attitudes towards tissue donation for genetic research. Scand J Public Health 2004, 32:224-229.
77. Promoting Safe and Effective Genetic Testing in the United States: Final Report of the Task Force on Genetic Testing 1997, Johns Hopkins University Press, Baltimore. N.A. Holtzman, M.S. Watson (Eds.).
78. Hudson K., Javitt G., Burke W., Byers P. ASHG Statement on direct-to-consumer genetic testing in the United States. Obstet Gynecol 2007, 110:1392-1395.
79. Hunter D.J., Khoury M.J., Drazen J.M. Letting the genome out of the bottle - will we get our wish?. N Engl J Med 2008, 358:105-107.
80. Institute of Medicine Implications for Health and Social Policy 1994, National Academy Press, Washington, DC.
81. Institute of Medicine Committee on Health Literacy Health Literacy: A Prescription to End Confusion 2004, National Academies Press, Washington, DC.
82. Jacobs B., Roffenbender J., Collmann J., et al. Bridging the divide between genomic science and indigenous peoples. J Law Med Ethics 2010, 38:684-696.
83. James K.M., Cowl C.T., Tilburt J.C., et al. Impact of direct-to-consumer predictive genomic testing on risk perception and worry among patients receiving routine care in a preventive health clinic. Mayo Clin Proc 2011, 86:933-940.
84. Javitt G. Which way for genetic-test regulation? Assign regulation appropriate to the level of risk. Nature 2010, 466:817-818.
85. Jenkins J., Calzone K.A. Establishing the essential nursing competencies for genetics and genomics. J Nurs Scholarsh 2007, 39:10-16.
86. Kahn J.D. From disparity to difference: how race-specific medicines may undermine policies to address inequalities in health care. S Calif Interdiscipl Law J 2005, 15:105-129.
87. Kahn S. On the future of genomic data. Science 2011, 331:728-729.
88. Katsnelson A. Genomes by the thousands. Nature 2010, 467:1026-1027.
89. Kaufman D., Murphy J., Erby L., Hudson K., Scott J. Veterans' attitudes regarding a database for genomic research. Genet Med 2009, 11:329-337.
90. Kaye J., Boddington P., de Vries J., Hawkins N., Melham K. Ethical implications of the use of whole genome methods in medical research. Eur J Hum Genet 2010, 18:398-403.
91. Kettis-Lindblad A., Ring L., Viberth E., Hansson M.G. Perceptions of potential donors in the Swedish public towards information and consent procedures in relation to use of human tissue samples in biobanks: a population-based study. Scand J Public Health 2007, 35:148-156.
92. Klimentidis Y.C., Divers J., Casazza K., Beasley T.M., Allison D.B., Fernandez J.R. Ancestry-informative markers on chromosomes 2, 8 and 15 are associated with insulin-related traits in a racially diverse sample of children. Hum Genomics 2011, 5:79-89.
93. Knoppers B.M., Joly Y., Simard J., Durocher F. The emergence of an ethical duty to disclose genetic research results: international perspectives. Eur J Hum Genet 2006, 14:1170-1178.
94. Kollek R., Petersen I. Disclosure of individual research results in clinico-genomic trials: challenges, classification and criteria for decision-making. J Med Ethics 2011, 37:271-275.
95. Lander E.S. Initial impact of the sequencing of the human genome. Nature 2011, 470:187-197.
96. Levy S., Sutton G., Ng P.C., et al. The diploid genome sequence of an individual human. PLoS Biol 2007, 5(10):e254. 10.1371/journal.pbio.0050254.
97. Lewis J.A., Calzone K.M., Jenkins J. Essential nursing competencies and curricula guidelines for genetics and genomics. MCN Am J Matern Child Nurs. 2006, 31:146-155.
98. Lin Z., Owen A.B., Altman R. Genomic research and human subject privacy. Science 2004, 305:183.
99. Lupski, et al. Whole-genome sequencing in a patient with Charcot-Marie-tooth neuropathy. N Eng J Med 2010, 362:1181-1191.
100. MacNeil S.D., Fernandez C.V. Offering results to research participants. BMJ 2006, 332:188-189.
101. MacNeil S.D., Fernandez C.V. Attitudes of research ethics board chairs towards disclosure of research results to participants: results of a national survey. J Med Ethics 2007, 33:549-553.
102. Mao X., Bigham A.W., Mei R., et al. A genomewide admixture mapping panel for Hispanic/Latino populations. Am J Hum Genet 2007, 80:1171-1178.
103. Mardis E.R., Ding L., Dooling D.J., et al. Recurring mutations found by sequencing an acute myeloid leukemia genome. N Engl J Med 2009, 361:1058-1066.
104. Matchar D.B., Thakur M.E., Grossman I., et al. Testing for Cytochrome P450 Polymorphisms in Adults With Non-Psychotic Depression Treated With Selective Serotonin Reuptake Inhibitors (SSRIs) 2006, Agency for Healthcare Research and Quality, Rockville, MD, Evidence Report/Technology Assessment No. 146. AHRQ Publication No. 07-E002.
105. McBride C.M., Wade C.H., Kaphingst K.A. Consumers' views of direct-to-consumer genetic information. Annu Rev Genomics Hum Genet 2010, 11:427-446.
106. McGuire A.L., Gibbs R.A. Genetics. No longer de-identified. Science 2006, 312:370-371.
107. McGuire A.L., Caulfield T., Cho M.K. Research ethics and the challenge of whole-genome sequencing. Nat Rev Genet 2008, 9:152-156.
108. Melas P.A., Sjöholm L.K., Forsner T., et al. Examining the public refusal to consent to DNA biobanking: empirical data from a Swedish population-based study. J Med Ethics 2010, 36:93-98.
109. Mello M.M., Wolf L.E. The Havasupai Indian tribe case - lessons for research involving stored biologic samples. N Engl J Med 2010, 363:204-207.
110. Metcalfe S., Hurworth R., Newstead J., Robins R. Needs assessment study of genetics education for general practitioners in Australia. Genet Med 2002, 4:71-77.
111. Mitchell R., Waldby C. National biobanks: clinical labor, risk production, and the creation of biovalue. Sci Technol Hum Values 2010, 35:330-355.
112. Monaghan G., Ryan M., Seddon R., Hume R., Burchell B. Genetic variation in bilirubin UPD-glucuronosyltransferase gene promoter and Gilbert's syndrome. Lancet 1996, 347:578-581.
113. Moorjani P., Patterson N., Hirschhorn J.N., et al. The history of African gene flow into southern Europeans, Levantines, and Jews. PLoS Genet 2011, 7(4):e1001373.
114. Murphy J., Scott J., Kaufman D., Geller G., LeRoy L., Hudson K. Public expectations for return of results from large-cohort genetic research. Am J Bioeth 2008, 8(11):36-43.
115. Murphy J., Scott J., Kaufman D., Geller G., LeRoy L., Hudson K. Public perspectives on informed consent for biobanking. Am J Public Health 2009, 99:2128-2134.
116. Narang A., Jha P., Rawat V., Mukhopadhyay A., Dash D., Indian Genome Variation Consortium, et al. Recent admixture in an Indian population of African ancestry. Am J Hum Genet 2011, 89:111-120.
117. National Coalition for Health Professional Education in Genetics, 2005. Core competencies in genetics essential for all health-care professionals. >. http://www.nchpeg.org/core/Corecomps2005.pdf.
118. National Health Service's National Genetics Education and Development Centre and the Skills for Health, 2007. Competences for genetics in clinical practice. >. http://www.geneticseducation.nhs.uk/develop/index.asp?id=44.
119. National Institutes of Health and US Department of Energy, Working Group on Ethical Legal and Social Implications of Human Genome Research, 1997. Promoting safe and effective genetic testing in the United States. Available online at . http://www.genome.gov/10001733.
120. O'Daniel J., Haga S. Public perspectives on returning genetics and genomics research results. Public Health Genomics 2011, 14(6):344-355.
121. O'Roak B.J., et al. Exome sequencing in sporadic autism spectrum disorders identifies severe de novo mutations. Nature Genet 2011, 43(6):585-589.
122. Parra E.J., Marcini A., Akey J., et al. Estimating African American admixture proportions by use of population-specific alleles. Am J Hum Genet 1998, 63:1839-1851.
123. Partridge A.H., Burstein H.J., Gelman R.S., Marcom P.K., Winer E.P. Do patients participating in clinical trials want to know study results?. J Natl Cancer Inst 2003, 95:491-492.
124. Partridge A.H., Hackett N., Blood E., et al. Oncology physician and nurse practices and attitudes regarding offering clinical trial results to study participants. J Natl Cancer Inst 2004, 96:629-632.
125. Partridge A.H., Wong J.S., Knudsen K., et al. Offering participants results of a clinical trial: sharing results of a negative study. Lancet 2005, 365:963-964.
126. Pasaniuc B., Zaitlen N., Lettre G., et al. Enhanced statistical tests for GWAS in admixed populations: assessment using African Americans from CARe and a Breast Cancer Consortium. PLoS Genet 2011, 7(4):e1001371.
127. Pelak K., Shianna K.V., Ge D., et al. The characterization of twenty sequenced human genomes. PLoS Genet 2010, 6(9):e1001111. 10.1371/journal.pgen.1001111.
128. Phillips K.A., Van Bebber S.L. A systematic review of cost-effectiveness analyses of pharmacogenomic interventions. Pharmacogenomics 2004, 5:1139-1149.
129. Porteous T., Bond C., Robertson R., Hannaford P., Reiter E. Electronic transfer of prescription-related information: comparing views of patients, general practitioners, and pharmacists. Br J Gen Pract. 2003, 53:204-209.
130. Roberts J.S., Shalowitz D.I., Christensen K.D., et al. Returning individual research results: development of a cancer genetics education and risk communication protocol. J Empir Res Hum Res Ethics 2010, 5:17-30.
131. Rosenberg N.A., Pritchard J.K., Weber J.L., et al. Genetic structure of human populations. Science 2002, 298:2381-2385.
132. Royal C.D., Novembre J., Fullerton S.M., et al. Inferring genetic ancestry: opportunities, challenges, and implications. Am J Hum Genet 2010, 86:661-673.
133. Sankar P., Cho M.K., Condit C.M., et al. Genetic research and health disparities. JAMA 2004, 291:2985-2989.
134. Santos L. Genetic research in native communities. Prog Commun Health Partnersh 2008, 2:321-327.
135. Schickedanz A.D., Herdman R.C. Direct-to-consumer genetic testing: the need to get retail genomics right. Clin Pharmacol Ther 2009, 86:17-20.
136. Schulz C.J., Riddle M.P., Valdimirsdottir H.B., Abramson D.H., Sklar C.A. Impact on survivors of retinoblastoma when informed of study results on risk of second cancers. Med Pediatr Oncol 2003, 41:36-43.
137. Schuster S.C., Miller W., Ratan A., et al. Complete Khoisan and Bantu genomes from southern Africa. Nature 2010, 463:943-947.
138. Secretary's Advisory Committee on Genetics, Health and Society, 2007. Policy issues with undertaking a new large U.S. Population cohort study of genes, environment, and disease. >. http://www.oba.od.nih.gov/oba/sacghs/reports/SACGHS_LPS_report.pdf.
139. Secretary's Advisory Committee on Genetics, Health, and Society, 2008. U.S. system of oversight of genetic testing: a response to the charge of the secretary of health and human services. >. http://www.oba.od.nih.gov/oba/SACGHS/reports/SACGHS_oversight_report.pdf .
140. Secretary's Advisory Committee on Genetics, Health, and Society, 2010. Direct-to-consumer genetic testing. >. http://www.oba.od.nih.gov/oba/sacghs/reports/SACGHS_DTC_Report_2010.pdf.
141. Secretary's Advisory Committee on Genetic Testing, 2000. Enhancing the oversight of genetic testing: recommendations of the SACGT. >. http://www4.od.nih.gov/oba/sacgt/reports/oversight_report.htm.
142. Secretary's Advisory Committee on Genetic Testing, 2001. Development of a Classification Methodology for Genetic Tests: Conclusions and Recommendations of SACGT. Available online at: . http://oba.od.nih.gov/oba/sacgt/reports/Addendum_final.pdf.
143. Seldin M.F., Pasaniuc B., Price A.L. New approaches to disease mapping in admixed populations. Nat Rev Genet 2011, 12:523-528.
144. Shalowitz D.I., Miller F.G. Disclosing individual results of clinical research: implications of respect for participants. JAMA 2005, 294:737-740.
145. Simon C.M., L'Heureux J., Murray J.C., et al. Active choice but not too active: public perspectives on biobank consent models. Genet Med 2011, 13:821-831.
146. Smith M.W., Patterson N., Lautenberger J.A., et al. A high-density admixture map for disease gene discovery in african americans. Am J Hum Genet 2004, 74(5):1001-1013.
147. Snowdon C., Garcia J., Elbourne D. Reactions of participants to the results of a randomised controlled trial: exploratory study. BMJ 1998, 317(7150):21-26.
148. Su Y., Howard H.C., Borry P. Users' motivations to purchase direct-to-consumer genome-wide testing: an exploratory study of personal stories. J Commun Genet 2011, 2:135-146.
149. Testimony of Thomas Hamilton, Director, Survey and Certification Group and Judy Yost, Director, Division of Laboratories and Acute Care, Centers for Medicaid Services. November 12-14, 2006. Eleventh Meeting of the Secretary's Advisory Committee on Genetics, Health and Society. Available online at: . http://oba.od.nih.gov/SACGHS/sacghs_past_meeting_2006_nov_13.html.
150. Torrance N., Mollison J., Wordsworth S., et al. Genetic nurse counsellors can be an acceptable and cost-effective alternative to clinical geneticists for breast cancer risk genetic counselling. Evidence from two parallel randomised controlled equivalence trials. Br. J. Cancer. 2006, 95:435-444.
151. Tupasela A., Sihvo S., Snell K., Jallinoja P., Aro A.R., Hemminki E. Attitudes towards biomedical use of tissue sample collections, consent, and biobanks among Finns. Scand J Public Health 2010, 38:46-52.
152. UK Human Genetics Commission, 2010. A common framework of principles for direct-to-consumer genetic testing services. http://www.hgc.gov.uk/UploadDocs/DocPub/Document/HGC%20Principles%20for% 20DTC%20genetic%20tests%20-%20final.pdf.
153. US House of Representatives, 2008. Genomics and Personalized Medicine Act of 2008 (H.R. 6498). Introduced by Representative Kennedy.
154. US House of Representatives, 2010. Genomics and Personalized Medicine Act of 2010 (HR 5440).
155. US Senate, 2007a. Laboratory Test Improvement Act (S. 736). Introduced by Senators Kennedy and Smith.
156. US Senate, 2007b. Genomics and Personalized Medicine Act of 2007 (S. 976). Introduced by Senators Obama and Burr.
157. Via M., Ziv E., Burchard E.G. Recent advances of genetic ancestry testing in biomedical research and direct to consumer testing. Clin Genet 2009, 76:225-235.
158. Wadman M. Fifty genome sequences reveal breast cancer's complexity. Nature News 2011, http://www.nature.com/news/2011/110402/full/news.2011.203.html.
159. Wallace H. Most gene test sales are misleading. Nat Biotechnol 2008, 26:1221.
160. Wang J. Personal Genomes: for one and for all. Science 2011, 331:690.
161. Wang J., Wang W., Li R., et al. The diploid genome sequence of an Asian individual. Nature 2008, 456:60-65.
162. Wheeler D.A., Srinivasan M., Egholm M., et al. The complete genome of an individual by massively parallel DNA sequencing. Nature 2008, 452:872-876.
163. Weigmann K. Racial medicine: here to stay? The success of the International HapMap Project and other initiatives may help to overcome racial profiling in medicine, but old habits die hard. EMBO Rep 2006, 7:246-249.
164. Zika E., Paci D., Schulte in den Bäumen T., et al. Biobanks in Europe: Prospects for Harmonization and Networking 2010, Joint Research Centre, European Commission, http://ftp.jrc.es/EURdoc/JRC57831.pdf.