Understanding Incidental Findings in the Context of Genetics and Genomics

Clayton E. W. Ross L. , “Implications of Disclosing Individual Results of Clinical Research,” JAMA 295, no. 1 (2006): 37; Partridge A. Winer E. , “Informing Clinical Trial Participants about Study Results,” JAMA 288, no. 3 (2002): 363–365; Shalowitz D. I. Miller F. G. , “Disclosing Individual Results of Clinical Research: Implications of Respect for Participants,” JAMA 294, no. 6 (2005): 737–740.

Illes J. , “Incidental Findings in Brain Imaging Research,” Science 311, no. 5762 (2006): 783–784.

See Clayton Ross , supra note 1; Renegar G. , “Returning Genetic Research Results to Individual: Points-to-Consider,” Bioethics 20, no. 1 (2006): 24–36.

Check E. , “James Watson's Genome Sequenced: Discoverer of the Double Helix Blazes Trail for Personal Genomics,” Nature (June 1, 2007), available at <http://www.nature.com/news/2007/070528/full/news070528–10.html> (last visited February 7, 2008).

Levy S. , “The Diploid Genome Sequence of an Individual Human,” PLoS Biology 5, no. 10 (2007): e254.

Shendure J. , “Advanced Sequencing Technologies: Methods and Goals,” Nature Reviews Genetics 5, no. 5 (2004): 335–344.

See Levy , supra note 5.

Redon R. , “Global Variation in Copy Number in the Human Genome,” Nature 444, no. 7118 (2006): 444–454.

Wong K. , “A Comprehensive Analysis of Common Copy-Number Variations in the Human Genome,” American Journal of Human Genetics 80, no. 1 (2007): 91–104.

McPherson R. , “A Common Allele on Chromosome 9 Associated with Coronary Heart Disease,” Science 316, no. 5830 (2007): 1488–1491; Helgadottir A. , “A Common Variant on Chromosome 9p21 Affects the Risk of Myocardial Infarction,” Science 316, no. 5830 (2007): 1491–1493.

McGuire A. L. , “The Future of Personal Genomics,” Science 317, no. 5845 (2007): 1687.

See Shalowitz Miller , supra note 1; Illes J. , “Discovery and Disclosure of Incidental Findings in Neuroimaging Research,” Journal of Magnetic Resonance Imaging 20, (2004): 743–747; Wendler D. Emanuel E. , “The Debate Over Research on Stored Biological Samples: What Do Sources Think?” Archives of Internal Medicine 162, no. 13 (2002): 1457–1462.

Id. (Shalowitz and Miller).

See Renegar , supra note 3; Ravitsky V. Wilfond B. , “Disclosing Individual Genetic Results to Research Participants,” American Journal of Bioethics 6, no. 6 (2006): 8–17.

Stanford Center for Biomedical Ethics, “Reporting Results,” available at <http://cirge.standford.edu/library/reporting_results.html> (last visited March 24, 2008).

Id. (Ravitzky and Wilfond); National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance , Rockville, MD, 1999; National Heart Lung and Blood Institute, Working Group on Reporting Genetic Results in Research Studies: Meeting Summary , Bethesda, MD, 2004, available at <http://www.nhlbi.nih.gov/meetings/workshops/gene-results.htm> (last visited February 7, 2008).

ACMG Laboratory Practice Committee Working Group, “ACMG Recommendations for Standards for Interpretation of Sequence Variations,” Genetics in Medicine 2, no. 5 (2000): 302–303.

See National Bioethics Advisory Commission, supra note 15.

Centers for Medicare and Medicaid Services, “Clinical Laboratory Improvement Amendments,” available at <http://www.cms.hhs.gov/CLIA/> (last visited February 7, 2008).

See Ravitzky Wilfond , supra note 14.

See Illes , supra note 2.

Terry S. Boyd C. , “Researching the Biology of PXE: Partnering in the Process,” American Journal of Medical Genetics 106, no. 3 (2001): 177–184; Terry S. , “Advocacy Groups as Research Organizations: The PXE International Example,” Nature Reviews Genetics 8, no. 2 (2007): 157–164.

Clayton E. , “Informed Consent and Genetic Research,” in Rothstein M. , ed., Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era (New Haven, CT: Yale University Press, 1997): 126–136.

Office for Human Research Protections, Department of Health and Human Services, Guidance on Research Involving Coded Private Information or Biological Specimens , Rockville, MD, 2004, available at <www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf> (last visited February 7, 2008).

See Ravitsky Wilford , supra note 14.

McGuire A. L. , “Research Ethics and the Challenge of Whole Genome Sequencing,” Nature Reviews Genetics 9, no. 2 (2007): 152–156.

See Clayton Ross , supra note 1.

Belsky L. Richardson H. , “Medical Researchers' Ancillary Clinical Care Responsibilities,” BMJ 328, no. 7454 (2004): 1494–1496.

Tabor H. Cho M. , “Ethical Implications of Array CGH in Complex Phenotypes: Points to Consider in Research,” Genetics in Medicine 9, no. 9 (2007): 626–631; Magnus D. Cho M. , “Issues in Oocyte Donation for Stem Cell Research,” Science 308, no. 5729 (2006): 1747–1748.