Ethical Issues in Big Data Health Research: Currents in Contemporary Bioethics

Think Exist website, available at <http://thinkexist.com/quotes/j._robert_oppenheimer/> (last visited May 4, 2015).

Halamka J. D. , “Early Experiences with Big Data at an Academic Medical Center,” Health Affairs 33, no. 7 (2014): 1132–1138, at 1132.

Khoury M. J. Ioannidis J. P. A. , “Big Data Meets Public Health,” Science 346, no. 6213 (2014): 1054–1055; Lane J. eds., Privacy, Big Data and the Public Good: Frameworks for Engagement (New York: Cambridge University Press, 2014); Roski J. Bo-Linn G. W. Andrews T. A. , “Creating Value in Health Care through Big Data: Opportunities and Policy Implications,” Health Affairs 33, no. 7 (2014): 1115–1122; Schwartz P. M. , “Information Privacy in the Cloud,” University of Pennsylvania Law Review 161, no. 6 (2013): 1623–1662.

Hoffman S. Podgurski A. , “Big Bad Data: Law, Public Health, and Biomedical Databases,” Journal of Law, Medicine & Ethics 40, no. 1 (2012): 56–60; Ruths D. Pfeffer J. , “Social Media for Large Studies of Behavior,” Science 346, no. 6213 (2014): 1063–1064.

See Terry N. P. , “Big Data Proxies and Health Privacy Exceptionalism,” Health Matrix 24, no. 1 (2014): 65–108 (discussing ways in which health privacy may be protected in an age of big data).

See, e.g., Mayer-Schonberger V. Cukier K. , Big Data (New York: Mariner Books, 2014): At 57–58 (describing how Target used predictive analytics to correlate the purchase of unscented lotion with pregnancy).

HealthMap Ebola Tracker, “2014 Ebola Outbreaks,” available at <http://health-map.org/ebola/#timeline> (last visited May 4, 2015).

Ginsburg J. , “Detecting Influenza Epidemics Using Search Engine Query Data,” Nature 457, no. 7232 (2009): 1012–1014. But see Butler D. , “When Google Got Flu Wrong,” Nature 494, no. 7436 (2013): 155–156 (criticizing methodology of original study).

Broniatowski D. A. Paul M. J. Dredze M. Letter , “Twitter: Big Data Opportunities,” Science 345, no. 6193 (2014): 148.

Kramer A. D. I. Guillory J. E. Hancock J. T. , “Experimental Evidence of Massive Scale Emotional Contagion through Social Networks,” Proceedings of the National Academy of Sciences, U.S.A. 111, no. 24 (2014): 8788–8790. But see Verma I. M. , “Editorial Expression of Concern and Correction,” Proceedings of the National Academy of Sciences 111, no. 29 (2014): 10779 (editor-in-chief's statement of concern that the collection of data did not include any informed consent or an opportunity to opt out of the study). See also Fiske S. T. Hauser R. M. , “Protecting Human Research Participants in the Age of Big Data,” Proceedings of the National Academy of Sciences 111, no. 8 (2014): 13675–13676.

Rudder C. , “We Experiment on Human Beings!” (July 28, 2014), available at <http://blog.okcupid.com/index/php/we-experiment-on-human-beings/> (last visited May 4, 2015).

It has been argued that this research violates state research laws, in particular, Maryland's. See Dance S. , “Facebook, OkCupid Research Raises New Ethical Questions in Use of ‘Big Data,”’ available at <http://articles.baltimoresun.com/2014-09-26/business/bs-bz-facebook-okcupid-20140925_1_big-data-users-professors> (last visited May 4, 2015).

For a further discussion, see Klitzman R. Appelbaum P. S. , “Facebook's Emotion Experiment: Implications for Research Ethics,” available at <http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=7002&blogid=140&terms=facebook+and+%23filename+*.html> (last visited May 4, 2015).

Institute of Medicine, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health through Research (Washington, D.C.: The National Academies Press, 2009).

See Rothstein M. A. , “Improve Privacy in Research by Eliminating Informed Consent? IOM Report Misses the Mark,” Journal of Law, Medicine & Ethics 37, no. 4 (2009): 507–512 (criticizing IOM report).

See Institute of Medicine, supra note 14, at 35.

Presidential Commission for the Study of Bioethical Issues, Moral Science: Protecting Participants in Human Subjects Research (2011): At 70, available at <www.bioethics.gov/node/558> (last visited May 4, 2015).

The Common Rule currently permits a waiver of consent where the only record linking the subject and the research would be an informed consent document, the research is minimal risk, and the main risk is a breach of confidentiality. 45 C.F.R. § 46.117(c). The IOM Report would make even personally identifiable research subject to waiver of consent.

Katz J. , Statement of Committee Member Jay Katz, Final Report of the Advisory Committee on Human Radiation Experiments (New York: Oxford University Press, 1996): At 545.

Harris J. , “Scientific Research is a Moral Duty,” Journal of Medical Ethics 31, no. 4 (2005): 242–248; Rhodes R. , “In Defense of the Moral Duty to Participate in Biomedical Research,” American Journal of Bioethics 8, no. 10 (2008): 37–38; Schaefer G. O. Emanuel E. J. Wertheimer A. , “The Obligation to Participate in Biomedical Research,” Journal of the American Medical Association 302, no. 1 (2009): 67–72.

Rennie S. , “Viewing Research Participation as a Moral Obligation: In Whose Interest?” Hastings Center Report 41, no. 2 (2011): 40–47.

Rothstein M. A. , “Privacy and Confidentiality,” in Joly Y. Knoppers B.M. , eds., Routledge Handbook of Medical Law and Ethics (New York: Routledge, 2015): At 52.

Rothstein M. A. , “Research Privacy under HIPAA and the Common Rule,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 154–159.

Altman R. B. , “Data Re-Identification: Societal Safeguards,” Science 339, no. 6117 (2013): 1032–1033.

Beauchamp T. L. Childress J. F. , Principles of Biomedical Ethics, 7th ed. (New York: Oxford University Press, 2013): At 107.

See Rothstein , supra note 15, at 510–511 (discussing studies).

Rothstein M. A. , “Is Deidentification Sufficient to Protect Health Privacy in Research?” American Journal of Bioethics 10, no. 9 (2010): 3–11.

See Jones J. H. , Bad Blood: The Tuskegee Syphilis Experiment (New York: Free Press, 1993) (presenting a detailed history of the study).

Tilousi v. Arizona State Univ. Bd. of Regents, 2005 WL 6199562 (D. Ariz., March 3, 2005). See Drabiak-Syed K. , “Lessons from Havasupai Tribe v. Arizona State University Board of Regents: Recognizing Group, Cultural, and Dignitary Harms as Legitimate Risks Warranting Integration into Research Practice,” Journal of Health & Biomedical Law 6, no. 2 (2010): 175–225.

Grimes v. Kennedy Krieger Inst., Inc., 782 A.2d 807 (Md. 2001). See Buchanan D. R. , “Justice and Fairness in the Kennedy Krieger Institute Lead Paint Study: The Ethics of Public Health Research on Less Expensive, Less Effective Interventions,” American Journal of Public Health 96, no. 5 (2008): 781–787 (reviewing Kennedy Krieger case).

See Skloot R. , The Immortal Life of Henrietta Lacks (New York: Crown, 2010) (describing the scientific research undertaken without any consent).

Koenig B. A. , “Have We Asked Too Much of Informed Consent?” Hastings Center Report 44, no. 4 (2014): 33–34.

Falagas M. E. , “Informed Consent: How Much and What Do Patients Understand?” American Journal of Surgery 198, no. 3 (2009): 420–435; Henderson G. , “Is Informed Consent Broken?” American Journal of Medical Sciences 342, no. 4 (2011): 267–272; King W. T. Heubi J. E. , “Comprehension Testing in Informed Consent,” American Journal of Bioethics Empirical Bioethics 5, no. 3 (2014): 39–54.

To maximize the benefits of direct involvement by physician-investigators while minimizing the possibility of objective or subjective coercion, it might be helpful to use a two-stage informed consent process. At the first stage, a research coordinator or similar person would review the research protocol, and if the individual indicates a willingness to participate, then the physician-investigator would follow up with a personal visit to reiterate the assurances in the informed consent document and underscore his or her personal commitment to the ethical conduct of the research.

See Institute of Medicine, supra note 14, at 209.

Rothstein M. A. Shoben A. B. , “Does Consent Bias Research?” American Journal of Bioethics 13, no. 4 (2013): 27–37.