Acquisti, Alessandro and Ralph Gross, “Predicting Social Security numbers from public data,” Proceedings of the National Academy of Sciences, 106 (2009), 10975–10980.
Australian Office of the Privacy Commissioner,
Privacy Impact Assessment Guide (
2010):
www.privacy.gov.au.
Benitez, Kathleen,
Grigorios Loukides, and
Bradley Malin, “
Beyond Safe Harbor: Automatic discovery of health information de-identification policy alternatives,”
Proceedings of the 1st ACM International Health Informatics Symposium (
New York:
Association for Computing Machinery,
2010), pp. 163–172:
http://hiplab.mc.vanderbilt.edu/people/malin/Papers/benitez_ihi.pdf.
Benitez, Kathleen and Bradley Malin, “Evaluating re-identification risks with respect to the HIPAA privacy rule,” Journal of the American Medical Informatics Association, 17 (2010), 169–177.
Bennett, Colin J., Regulating Privacy: Data Protection and Public Policy in Europe and the United States (Ithaca, NY: Cornell University Press, 1992).
Bennett, Colin J. and Charles D. Raab, The Governance of Privacy: Policy Instruments in a Global Perspective (Cambridge, MA: MIT Press, 2006).
Berg, Jessica W., Paul S. Appelbaum, Lisa S. Parker, and Charles W. Lidz, Informed Consent: Legal Theory and Clinical Practice (New York: Oxford University Press, 2001).
Beskow, Laura M., Lauren Dame, and E. Jane Costello, “Certificates of Confidentiality and compelled disclosure of data,” Science, 322 (2008), 1054–1055, and two responses and the authors’ reply, Science, 323 (2009), 1288–1290.
Bieber, Frederick K., Charles H. Brenner, and David Lazar, “Finding criminals through DNA of their relatives,” Science, 312 (2006), 1315–1316.
Biesecker, Leslie G., Joan E. Bailey-Wilson, Jack Ballantyne, et al., “DNA identifications after the 9/11 World Trade Center attack,” Science, 310 (2005), 1122–1123.
Biggs, Hazel, Healthcare Research Ethics and Law: Regulation, Review and Responsibility (Abingdon and New York: Routledge-Cavendish, 2010).
Brook, Emma L., Diana L. Rosman, and C. D’Arcy Holman, “Public good through data linkage: Measuring research outputs from the Western Australian Data Linkage System,” Australian and New Zealand Journal of Public Health, 32 (2008), 19–23.
Brownsword, Roger, “Consent in data protection law: Privacy, fair processing, and confidentiality,” in Serge Gutwirth, Yves Poullet, Paul De Hert, et al. (eds.), Reinventing Data Protection? (Dordrecht and London: Springer, 2009).
Burton, Paul R., Isabel Fortier, and Bartha M. Knoppers, “The global emergence of epidemiological biobanks: Opportunities and challenges,” in Muin J. Khoury, Sara R. Bedrosian, Marta Gwinn, et al. (eds.), Human Genome Epidemiology, second edn. (New York: Oxford University Press, 2010), pp. 77–99.
Burton, Paul R., Anna L. Hansell, Isabel Fortier, et al., “Size matters: Just how big is BIG? Quantifying realistic sample size requirements for human genome epidemiology,” International Journal of Epidemiology, 38 (2009), 263–273.
Canadian Institutes of Health Research,
Natural Sciences and Engineering Research Council of Canada, and
Social Sciences and Humanities Research Council of Canada,
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (second edn.,
2010):
www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf.
Caulfield, Timothy, Amy L. McGuire, Mildred Cho, et al., “Research ethics recommendations for whole-genome research: Consensus statement,” PLoS Biology, 6(3), e73.doi:10.1371/journal.pbio.0060073 (2008).
Cavoukian, Ann and
Khaled El Emam, “Dispelling the myths surrounding de-identification: Anonymization remains a strong tool for protecting privacy,” discussion paper on the website of the Ontario Information and Privacy Commissioner (
2011):
www.ipc.on.ca/images/Resources/anonymization.pdf.
Childress, James F., Eric M. Meslin, and Harold Shapiro (eds.), Belmont Revisited: Ethical Principles for Research with Human Subjects (Washington, DC: Georgetown University Press, 2005).
Claudot, Frédérique, François Alla, Jeanne Fresson, et al., “Ethics and observational studies in medical research: Various rules in a common framework,” International Journal of Epidemiology, 38 (2009), 1104–1108.
Collins, Francis, The Language of Life: DNA and the Revolution of Personalized Medicine (New York: HarperCollins, 2010).
Corrigan, Oonagh, John McMillan, Kathleen Liddell, et al. (eds.), The Limits of Consent: A Socio-ethical Approach to Human Subject Research in Medicine (Oxford University Press, 2009).
Council for International Organizations of Medical Sciences, “International Guidelines for Epidemiological Studies” (Geneva,
2009), available via:
www.cioms.ch.
Council of Europe, “Recommendation of the Committee of Ministers to member states on the protection of individuals with regard to automatic processing of personal data in the context of profiling” (
2010), CM/Rec(2010)13:
https://wcd.coe.int/wcd/ViewDoc.jsp?id=1710949&Site=CM.
Davies, Kevin, The $1,000 Genome: The Revolution in DNA Sequencing and the New Era of Personalized Medicine (New York: Free Press, 2010).
Detels, Roger, Robert Beaglehole, Mary Ann Lansang, and Martin Gulliford, Oxford Textbook of Public Health, fifth edn. (Oxford University Press, 2009).
Domingo-Ferrer, Josep and Emmanouil Magkos (eds.), Privacy in Statistical Databases (Berlin: Springer-Verlag, 2010).
Eriksson, Nicholas J., Michael Macpherson, Joyce Y. Tung, et al., “Web-based, participant-driven studies yield novel genetic associations for common traits,” PLoS Genetics, 6(6), e1000993. doi:10.1371/journal.pgen.1000993 (2010).
Fabsitz, Richard R.,
Amy McGuire,
Richard Sharp,
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,”
Circulation: Cardiovascular Genetics,
3 (
2010),
574–580:
http://circgenetics.ahajournals.org/content/3/6/574.full.
Faden, Ruth R., Thomas L. Beauchamp, and Nancy M. P. King, A History and Theory of Informed Consent (New York: Oxford University Press, 1986).
Flood, Colleen M. (ed.), Data Data Everywhere: Access and Accountability? (Montreal, Quebec and Kingston, Ontario: McGill-Queen’s University Press, 2011).
Friedman, Lawrence M., Curt D. Furberg, and David L. DeMets, Fundamentals of Clinical Trials, fourth edn. (New York: Springer, 2010).
Gibson, Greg, and Gregory P. Copenhaver, “Consent and Internet-enabled human genomics,” PLoS Genetics, 6(6), e1000965. doi:10.1371/journal.pgen.1000965 (2010).
Gitschier, Jane, “Inferential genotyping of Y chromosomes in Latter-Day Saints founders and comparison to Utah samples in the HapMap project,” American Journal of Human Genetics, 84 (2009), 251–258.
Goodman, Richard A. (ed.), Law in Public Health Practice, second edn. (New York: Oxford University Press, 2007).
Gostin, Lawrence O., Public Health Law: Power, Duty, Restraint, second edn. (Berkeley, CA: University of California Press, 2009)
Gottweis, Herbert and Alan Petersen (ed.), Biobanks: Governance in Comparative Perspective (London: Routledge, 2008).
Green, Eric D., Mark S. Guyer, and the US National Human Genome Research Institute, “Charting a course for genomic medicine from base pairs to bedside,” Nature, 470 (2011), 204–213.
Groebner, Valentin, Who Are You? Identification, Deception, and Surveillance in Early Modern Europe (New York: Zone Books, 2007).
Gutwirth, Serge, Yves Poullet, Paul De Hert, et al. (eds.), Reinventing Data Protection? (Dordrecht and London: Springer, 2009).
Hardcastle, Rohan, Law and the Human Body: Property Rights, Ownership and Control (Oxford and Portland, OR: Hart Publishing, 2009).
Hindorff, L. A.,
J. MacArthur,
A. Wiseet al., “A catalog of published genome-wide association studies”:
www.genome.gov/gwastudies.
Holman, C.D’ArcyJ.,
A. John Bass,
Diana L. Rosman,
et al., “
A decade of data linkage in Western Australia: Strategic design, applications and benefits of the WA data linkage system,”
Australian Health Review,
32 (
2008),
766–777:
www.publish.csiro.au/?act=view_file&file_id=AH080766.pdf.
Homer, Nils, Szabolcs Szelinger, Margot Redman, et al., “Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays,” PLoS Genetics, 4(8), e1000167. doi:10.1371/journal.pgen.1000167 (2008).
Hrynaszkiewicz, Iain, Melissa L. Norton, Andrew J. Vickers, and Douglas G. Altman, “Preparing raw clinical data for publication: Guidance for journal editors, authors, and peer reviewers,” BMJ, 340 (2010), 304–307.
Infectious Diseases Society of America, William Burman and Robert Daum, “Grinding to a halt: The effects of the increasing regulatory burden on research and quality improvement efforts,” Clinical Infectious Diseases, 49 (2009), 328–335.
Institute of Medicine (US), Committee on Health Research and the Privacy of Health Information, Sharyl J. Nass, Laura A. Levit, and Lawrence O. Gostin (eds.), Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research (Washington, DC: National Academies Press, 2009).
Institute of Medicine (US), Roundtable on Translating Genomic-Based Research for Health, workshop summary, “Challenges and opportunities in using residual newborn screening samples for translational research” (Washington, DC: National Academies Press, 2010).
Jacobs, Kevin B., Meredith Yeager, Sholom Wacholder, et al., “A new statistic and its power to infer membership in a genome-wide association study using genotype frequencies,” Nature Genetics, 41 (2009), 1253–1257.
Kaye, Jane and Mark Stranger (eds.), Principles and Practice in Biobank Governance (Farnham: Ashgate, 2009).
Kayser, Manfred and Peter de Knijff, “Improving human forensics through advances in genetics, genomics and molecular biology,” Nature Reviews Genetics, 12 (2011), 179–192.
Kho, Michelle E.,
Mark Duffett,
Donald J. Willison,
et al., “
Written informed consent and selection bias in observational studies using medical records: Systematic review,”
BMJ,
12, 338:b866 (
2009):
www.bmj.com/content/338/bmj.b866.full.pdf.
Khoury, Muin J., Sara R. Bedrosian, Marta Gwinn, et al. (eds.), Human Genome Epidemiology, second edn. (New York: Oxford University Press, 2010).
Kohane, Isaac S., “Using electronic health records to drive discovery in disease genomics,” Nature Reviews Genetics, 12 (2011), 417–428.
Laurie, Graeme, Genetic Privacy (Cambridge University Press, 2002).
Laurie, Graeme, “Reflexive governance in biobanking: On the value of policy led approaches and the need to recognize the limits of law,” Human Genetics, 130 (2011), 347–356.
Lee, Lisa M. and Lawrence O. Gostin, “Ethical collection, storage, and use of public health data,” Journal of the American Medical Association, 302 (2009), 82–84.
Lenk, Christian, Nils Hoppe, Katherina Beier, and Claudia Wiesemann (eds.), Human Tissue Research: A European Perspective on the Ethical and Legal Challenges (Oxford University Press, 2011).
Lin, Zhen, Art B. Owen, and Russ B. Altman, “Genomic research and human subject privacy,” Science, 303 (2004), 183.
Loukides, Grigorios, Aris Ghoulalas-Divanis, and Bradley Malin, “Anonymization of electronic medical records for validating genome-wide association studies,” Proceedings of the National Academy of Sciences, 107 (2010), 7898–7903.
Lowrance, William W. and FrancisS. Collins, “Identifiability in genomic research,” Science, 317 (2007), 600–602.
Macleod, Una and
Graham C. M. Watt, “
The impact of consent on observational research: A comparison of outcomes from consenters and non consenters to an observational study,”
BMC Medical Research Methodology,
8:15 (
2008):
www.biomedcentral.com/1471-2288/8/15.
Manolio, Teri A., “Genomewide association studies and assessment of the risk of disease,” New England Journal of Medicine, 363 (2010), 166–176.
Manson, Neil C. and Onora O’Neill, Rethinking Informed Consent in Bioethics (Cambridge University Press, 2007).
Martens, Patricia, “How and why does it ‘work’ at the Manitoba Centre for Health Policy? A model of data linkage, interdisciplinary research, and scientist/user interactions,” in Colleen M. Flood (ed.), Data Data Everywhere: Access and Accountability? (Montreal, Quebec and Kingston, Ontario: McGill-Queen’s University Press, 2011), pp. 137–150.
Mayer-Schönberger, Viktor, “Generational development of data protection in Europe,” in Philip E. Agre and Marc Rotenberg (eds.), Technology and Privacy: The New Landscape (Cambridge, MA: MIT Press, 1977), pp. 219–241.
McCarty, Catherine A.,
Rex L. Chisholm,
Christopher G. Chute,
et al., “
The eMERGE Network: A consortium of biorepositories linked to electronic medical records data for conducting genomic studies,”
Medical Genomics,
4(13) (
2011):
www.biomedcentral.com/content/pdf/1755-8794-4-13.pdf.
McGuire, Sean E. and
Amy L. McGuire, “
Don’t throw the baby out with the bathwater: Enabling a bottom-up approach in genome-wide association studies,”
Genome Research,
18 (
2008),
1683–1685:
http://genome.cshlp.org/content/18/11/1683.full.
Meystre, Stephane M.,
F. Jeffrey Friedlin,
Brett R. South,
et al., “
Automatic de-identification of textual documents in the electronic health record: A review of recent research,”
BMC Medical Research Methodology,
10(70) (
2010):
www.biomedcentral.com/1471-2288/10/70.
Miller, Franklin G. and Alan Wertheimer (eds.), The Ethics of Consent: Theory and Practice (New York: Oxford University Press, 2010).
Murtagh, Madeleine, J. Ipek Demir, Jennifer R. Harris, and Paul R. Burton, “Realizing the promise of population biobanks: A new model for translation,” Human Genetics, 130 (2011), 333–345.
National Research Council (US), Panel on Collecting, Storing, Accessing, and Protecting Biospecimens and Biodata in Biosocial Surveys, Robert M. Hauser, Maxine Weinstein, Robert Pool, and Barney Cohen (eds.), Conducting Biosocial Surveys: Collecting, Storing, Accessing, and Protecting Biospecimens and Biodata (Washington, DC: National Academies Press, 2010).
National Research Council (US), Panel on Confidentiality Issues Arising from the Integration of Remotely Sensed and Self-Identifying Data, Myron P. Gutmann and Paul C. Stern (eds.), Putting People on the Map: Protecting Confidentiality with Linked Social-Spatial Data (Washington, DC: National Academies Press, 2007).
O’Neill, Onora, Autonomy and Trust in Bioethics (Cambridge University Press, 2002).
Percival, Thomas, Medical Ethics, or A Code of Institutes and Precepts Adapted to the Professional Conduct of Physicians and Surgeons, third edn. (London: John Henry Parker, 1849), available gratis from Google Books.
Piwowar, Heather A., Michael J. Becich, Howard Bilofsky, and Rebecca S. Crowley, on behalf of the caBIG Data Sharing and Intellectual Capital Workspace, “Towards a data sharing culture: Recommendations for leadership from academic health centers,” PLoS Medicine, 5(9), e183. doi:10.1371/journal.pmed.0050183 (2008).
Price, David, Human Tissue in Transplantation and Research: A Model Legal and Ethical Donation Framework (Cambridge University Press, 2010).
Pulley, Jill, Ellen Clayton, Gordon R. Bernard, et al., “Principles of human subjects protections applied in an opt-out, de-identified biobank,” Clinical and Translational Science, 3 (2010), 42–48.
Regan, Priscilla M., Legislating Privacy: Technology, Social Values, and Public Policy (Chapel Hill, NC: University of North Carolina Press, 1995).
Richards, Martin, Adrienne Hunt, and Graeme Laurie, “UK Biobank Ethics and Governance Council: An exercise in added value,” in Jane Kaye and Mark Stranger (eds.), Principles and Practice in Biobank Governance (Farnham: Ashgate, 2009), pp. 229–242.
Rotimi, Charles N., and Lynn B. Jorde, “Ancestry and disease in the age of genomic medicine,” New England Journal of Medicine, 363 (2010), 1551–1558.
Sleeboom-Faulkner, Margaret (ed.), Human Genetic Biobanks in Asia: Politics of Trust and Scientific Advancement (London: Routledge, 2009).
Solove, Daniel J., Understanding Privacy (Cambridge, MA: Harvard University Press, 2008).
Steinmann, Michael, Peter Sýora, and Urban Wiesing (eds.), Altruism Reconsidered: Exploring New Approaches to Property in Human Tissue (Farnham: Ashgate, 2009).
Strom, Brian L., Stephen E. Kimmel, and Sean Hennessy (eds.), Pharmacoepidemiology, fifth edn. (Chichester: Wiley-Blackwel, 2012).
UK House of Lords, Committee on Privacy, Report of the Committee on Privacy, Kenneth Younger, chair (Home Office, Cmnd 5012, H. M. Stationery Office, 1972).
US Department of Health and Human Services, Office for Human Research Protections, “Guidance on research involving coded private information or biological specimens” (
2008):
www.hhs.gov/ohrp/policy/cdebiol.html.
US Department of Health and Human Services, Office for Human Research Protections “Guidance on the Genetic Information Nondiscrimination Act: Implications for investigators and Institutional Review Boards” (
2009):
www.hhs.gov/ohrp/policy/gina.pdf.
US Department of Health and Human Services, Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children, briefing paper, “Considerations and recommendations for national guidance regarding the retention and use of residual dried blood spot specimens after newborn screening” (
2009):
www.cchconline.org/pdf/HHSRectoBankBabyDNA042610.pdf.
US National Committee on Vital and Health Statistics, letter to the Secretary of Health and Human Services, “Recommendations regarding sensitive health information” (November 10,
2010):
www.ncvhs.hhs.gov/101110lt.pdf.
Valdez, Rodolfo, Muin J. Khoury, and Paula W. Yoon, “The use of family history in public health practice: the epidemiologic view,” in Muin J. Khoury, Sara R. Bedrosian, Marta Gwinn, et al. (eds.), Human Genome Epidemiology, second edn. (New York: Oxford University Press, 2010), pp. 579–593.
Visscher, Peter M. and William G. Hill, “The limits of individual identification from sample allele frequencies: Theory and statistical analysis,” PLoS Genetics, 5(10), e1000628. doi:10.1371/journal.pgen.1000628 (2009).
Vollmann, Jochen and Rolf Winau, “Informed consent in human experimentation before the Nuremberg code,” BMJ, 313 (1996), 1445–1447.
Wacks, Raymond, Personal Information: Privacy and the Law (Oxford: Clarendon Press, 1989).
Walport, Mark and Paul Brest on behalf of 17 signatory organizations, “Sharing research data to improve public health,” The Lancet, 377 (2011), 537–539.
Warner, Malcolm and Michael Stone, The Data Bank Society: Organizations, Computers and Social Freedom (London: George Allen & Unwin, 1970).
Wartenberg, Daniel and W. Douglas Thompson, “Privacy versus public health: The impact of current confidentiality rules,” American Journal of Public Health, 100 (2010), 407–412.
Weindling, Paul, Nazi Medicine and the Nuremberg Trials: From Medical War Crimes to Informed Consent (Basingstoke: Palgrave Macmillan, 2004).
Westin, Alan F., Privacy and Freedom (New York: Atheneum, 1967).
Westin, Alan F. and Michael A. Baker, Databanks in a Free Society (New York: Quadrangle Books, 1972).
Widdows, Heather and Caroline Mullen (ed.), Governance of Genetic Information: Who Decides? (Cambridge University Press, 2009).
Willison, Don, Elaine Gibson, and Kim McGrail, “A roadmap to research uses of electronic health information,” in Colleen M. Flood (ed.), Data Data Everywhere: Access and Accountability? (Montreal, Quebec and Kingston, Ontario: McGill-Queen’s University Press, 2011), pp. 233–251.