The Apomediated World: Regulating Research When Social Media Has Changed Research

Eysenbach G. , “Medicine 2.0: Social Networking, Collaboration, Participation, Apomediation, and Openness,” Journal of Medical Internet Research 10, no. 3 (2008): e22, available at <http://www.jmir.org/2008/3/e22/> (last visited April 11, 2013).

See also O'Connor D. , “Apomediation and Ancillary Care: Researchers' Responsibilities in Health-Related Online Communities,” IJIRE 3, no. 1 (2010): 87–103.

Swan M. , “DIYgenomics Crowdsourced Health Research Studies: PersonalWellness and Preventive Medicine through Collective Intelligence,” AAAI Spring Symposium Series, North America (March 2012): 54–59, available at <www.aaai.org/ocs/index.php/SSS/SSS12/paper/view/4293/4681> (last visited Apr 22, 2013).

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Dockser Marcus A. , “ALS Study Shows Social Media's Value as a Research Tool,” Wall Street Journal, April 25, 2011, available at <http://online.wsj.com/article/SB10001424052748704489604576283010994997034.html> (last visited April 11, 2013).

Zamosky L. , “Patients' Use of Social Media Spurs More Clinical Research,” iHealthBeat, September 17, 2012, available at <http://www.ihealthbeat.org/features/2012/patients-use-of-social-media-spurs-more-clinical-research.aspx> (last visited April 11, 2013).

Steakley L. , “Countdown to Medicine X: Sourcing Data for Clinical Research from Online Social Networks,” Scope, September 26, 2012, available at <http://scopeblog.stanford.edu/2012/09/26/countdown-to-medicine-x-sourcing-data-for-clinical-research-from-online-social-networks/> (last visited April 11, 2013).

Several of the public commentaries on the proposed changes do mention social media platforms, particularly Facebook. I address these commentaries later in the paper.

Fornai F. , “Lithium Delays Progression of Amyotrophic Lateral Sclerosis,” Proceedings of the National Academy of Sciences of the United States of America 105, no. 6 (February 12, 2008): 2052–2057.

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See Marcus Dockser , supra note 3.

Blue Chip Patient Recruitment, Engaging E-Patients in Clinical Trials Through Social Media (2011), available at <http://bcpatientrecruitment.com/images/stories/whitepapers/BlueChip_SocialMedia_5–2011.pdf> (last visitedApr 22, 2013).

Morrison N. , “Blue Chip Gives Social Networking in Patient Recruitment the Thumbs Up,” Outsourcing-Pharma website, available at <http://www.outsourcing-pharma.com/Clinical-Development/Blue-Chip-gives-social-networking-in-patient-recruitment-the-thumbs-up> (last visited April 11, 2013).

See Wicks Vaughan Massagli Heywood , supra note 6, at 411.

See Howe J. , “Crowdsourcing: A Definition,” available at <www.crowdsourcing.com> (last visited April 11, 2013).

E. Estellés-Arolas and Fernando González-Ladrón-de-Guevara, “Towards and Integrated Crowdsourcing Definition,” Journal of Information Science 38, no. 2 (April 2012): 189–200.

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Kamel Boulos M. N. , “Crowdsourcing, Citizen Sensing and Sensor Web Technologies for Public and Environmental Health Surveillance and Crisis Management: Trends, OGC Standards and Application Examples,” International Journal of Health Geographics 10, no. 67 (December 21, 2011), available at <http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3271966/> (last visited April 11, 2013);

Behrend T. S. Sharek D. J. Meade A. W. Wiebe E. N. , “The Viability of Crowdsourcing for Survey Research,” Behavior Research Methods 43, no. 3 (September 2011): 800–813.

Swan M. , “Crowdsourced Health Research Studies: An Important Emerging Complement to Clinical Trials in the Public Health Research Ecosystem,” Journal of Medical Internet Research 14, no. 2 (March-April 2012): e46, available at <http://www.jmir.org/2012/2/e46/> (last visited April 11, 2013).

Swan M. Hathaway K. Hogg C. McCauley R. Volrath A. , “Citizen Science Genomics as a Model for Crowdsourced Preventive Medicine Research,” Journal of Participatory Medicine 2 (December 23, 2010), available at <http://www.jopm.org/evidence/research/2010/12/23/citizen-science-genomics-as-a-model-for-crowdsourced-preventive-medicine-research/> (last visited April 11, 2013).

See Swan , supra note 13.

Code of Federal Regulations TITLE 45: PUBLIC WELFARE: DEPARTMENT OF HEALTH AND HUMAN SERVICES: PART 45. PROTECTION OF HUMAN SUBJECTS, 46.406 (January 15, 2009), available at <http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.406> (last visited April 11, 2013.

Code of Federal Regulations Title 45: Public Welfare: Department of Health and Human Services: Part 45. Protection of Human Subjects, 46.101 (January 15, 2009), available at <http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101> (last visited April 11, 2013).

Katz M. , “PatientsLikeMe: Connecting People, Conducting Human Subjects Research,” Mayo Clinic Center for Social Media, September 12, 2011, available at <http://socialmedia.mayoclinic.org/2011/09/12/patientslikeme-connecting-people-conducting-human-subjects-research/> (last visited April 11, 2013).

See Eysenbach , supra note 1.

See Rothman D. J. , Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making (New York: BasicBooks, 1991);

A. R. Jonsen, The Birth of Bioethics (New York: Oxford University Press, 1998).

See, variously, Rothman , supra note 20: 127–189;

Jonsen , supra note 20: 90–165;

S. Reverby, Examining Tuskegee: The Infamous Syphilis Study and Its Legacy (Chapel Hill: University of North Carolina Press, 1999);

Moreno J. , “Goodbye to All That: The End of Moderate Protectionism in Human Subjects Research?” The Hastings Center Report 31, no. 3 (May-June 2001): 9–17;

Mastroianni A. Kahn J. , “Swinging on the Pendulum: Shifting Views of Justice in Human Subjects Research,” The Hastings Center Report 31, no. 3 (May-June 2001): 21–28;

Goodman J. McElligott A. Marks L. , “Making Human Bodies Useful: Historicizing Medical Experiments in the Twentieth Century,” in Goodman J. McElligott A. Marks L. , eds., Useful Bodies: Humans in the Service of Medical Science in the Twentieth Century (Baltimore: Johns Hopkins University Press, 2003): At 1–26. On the idea that research regulations enable medical research to be conducted on healthy people as much as they restrain the practice, see Laura Stark, Behind Closed Doors: IRBs and the Making of Ethical Research (Chicago: University of Chicago Press, 2012).

See Reverby , supra note 21;

Howell J. D. Hayward R. A. , “Writing Willowbrook, Reading Willowbroook: The Recounting of a Medical Experiment,” in Goodman McElligott Marks , eds., supra note 21, at 190–214;

Mulford R. D. , “Experimentation on Human Beings,” Stanford Law Review, 20, no. 1 (November 1967): 99–117;

Mitford J. , “Experiments Behind Bars: Doctors, Drug Companies and Prisoners,” Atlantic Monthly 23, 1 (January 1973): 138–168.

Beecher H. K. , “Ethics and Clinical Research,” New England Journal of Medicine 274, no. 24 (June 16, 1966): 1354–1360.

Blue Chip Patient Recruitment, Engaging E-Patients in Clinical Trials Through Social Media (2011), available at <http://bcpatientrecruitment.com/images/stories/whitepapers/BlueChip_SocialMedia_5–2011.pdf> (last visited April 22, 2013).

See Blue Chip Patient Recruitment, supra note 23, at 2.

PatientsLikeMe, “Clinical Trial Awareness,” PatientsLikeMe, available at <http://partners.patientslikeme.com/products-and-services/patient-recruiting/clinical-trial-awareness/> (last visited April 11, 2013).

See Inspire, available at <http://www.inspire.com/> (last visited April 11, 2013).

Army of Women, available at <http://www.armyofwomen.org> (last visited April 11, 2013);

TrialX, available at <http://trialx.com/> (last visited January 22, 2013).

Morrison N. , “Blue Chip Gives Social Networking in Patient Recruitment the Thumbs Up,” Outsourcing-Pharma website, available at <http://www.outsourcing-pharma.com/Clinical-Development/Blue-Chip-gives-social-networking-in-patient-recruitment-the-thumbs-up> (last visited April 11, 2013).

Some questions have been addressed in the following: Soo-Jin Lee S. Crawley L. , “Research 2.0: Social Networking and Direct-to-Consumer (DTC) Genomics,” American Journal of Bioethics 9, nos. 6–7 (2009): 35–44;

O'Connor D. , “Apomediation and the Significance of Social Networking,” American Journal of Bioethics 9, nos. 6–7 (2009): 25–27.

See Cuda-Kroen , supra note 3.

Id.

See Mastroianni Kahn , supra note 21, at 21–28.

Dockser Marcus A. , “When Research Gets Really Personal: The DIY Clinical Trial,” Wall Street Journal, March 30, 2012, available at <http://blogs.wsj.com/health/2012/03/30/when-medicine-really-gets-personal-the-diy-clinical-trial> (last visited April 11, 2013).

See Wicks Vaughan Massagli Heywood , supra note 6.

Chretien K. C. Ryan Greysen S. Chretien J.-P. Kind T. , “Online Posting of Unprofessional Content by Medical Students,” Journal of the American Medical Association 302, no. 12 (2009): 1309–1315;

Torvik K. Singbeil C. , “What Goes Online Is on the Record,” Canadian Nurse 104, no. 5 (2008): 21;

Guseh J. S. II Brendel R. W. Brendel D. H. , “Medical Professionalism in the Age of Online Social Networking,” Journal of Medical Ethics 35, 9(2009): 584–586.

Annas G. J. , “Medical Privacy and Medical Research – Judging the New Federal Regulations,” New England Journal of Medicine 346, 3(2002): 216–220.

U.S. Department of Health and Human Services, available at <http://www.hhs.gov/ocr/privacy/> (last visited April 11, 2013).

Paul I. , “Facebook Users Don't Trust Site on Privacy Issues,” PCWorld, May 15, 2012, available at <http://www.pcworld.com/article/255615/facebook_users_dont_trust_site_on_privacy_issues.html> (last visited April 11, 2013).

O'Brien K. J. , “Germans Reopen Investigation on Facebook Privacy,” New York Times, August 15, 2012, available at <http://www.nytimes.com/2012/08/16/technology/germans-reopen-face-book-privacy-inquiry.html> (last visited April 11, 2013).

Mui C. , “Facebook's Privacy Issues Are Even Deeper Than We Knew,” Forbes, August 8, 2011, available at <http://www.forbes.com/sites/chunkamui/2011/08/08/facebooks-privacy-issues-are-even-deeper-than-we-knew/> (last visited April 11, 2013).

Thornhill T. , “Google Will Know More about You Than Your Partner,” Daily Mail, March 2, 2012, available at <http://www.dailymail.co.uk/sciencetech/article-2091508/Google-privacy-policy-Search-giant-know-partner.html> (last visited April 11, 2013).

Gaudin S. , “Google Privacy Change Draws ‘Firestorm,”’ ComputerWorld, March 2, 2012, available at <http://www.computerworld.com/s/article/9224820/Google_privacy_change_draws_firestorm_> (last visited April 11, 2013).

All comments are available through <http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=HHS-OPHS-2011-0005> (last visited April 11, 2013).

For example: Chew C. Eysenbach G. , “Pandemics in the Age of Twitter: Content Analysis of Tweets during the 2009 H1N1 Outbreak,” PLoS One, 5, no. 11 (2010): e14118, available at <http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0014118> (last visited April 11, 2013);

Signorini A. Segre A. M. Polgreen P. M. , “The Use of Twitter to Track Levels of Disease Activity and Public Concern in the U.S. during the Influenza A H1N1 Pandemic,” PLoS ONE 6, no. 5 (2011): e19467, available at <http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0019467> (last visited April 11, 2013).

All comments are available through <http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=HHS-OPHS-2011-0005> (last visited April 11, 2013).

Interestingly, social and behavioral scientists have seen this shift as a way to avoid IRB scrutiny, arguing in comment #1102 that Facebook updates are “publicly available” and thus any research into them (or similarly ‘public’ social media content) should qualify for expedited review. See: American Educational Research Association et al., Social and Behavioral Science White Paper on Advanced Notice for Proposed Rulemaking (ANPRM) Federal Register 44512–531 (July 26, 2011), ID Docket HHS-OPHS-2011-0005: 12, available at <http://www.regulations.gov/#!documentDetail;D=HHS-OPHS-2011-0005-1102> (last visited April 11, 2013).

See Wicks Vaughan Massagli Heywood , supra note 6.

See, for example, Gawande A. , “A Lifesaving Checklist,” New York Times, December 30, 2007;

Nassir Ghaemi S. Goodwin F. K. , “The Ethics of Clinical Innovation in Psychopharmacology: Challenging Traditional Bioethics,” Philosophy, Ethics and Humanities in Medicine 2, no. 26 (2007), available at <http://www.peh-med.com/content/2/1/26> (last visited April 11, 2013);

Z. M. Schrag, Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009 (Baltimore: Johns Hopkins University Press, 2010).