Sage Journals: Discover world-class research

Abstract

A medical information commons (MIC) is a networked data environment utilized for research and clinical applications. At three deliberations across the U.S., we engaged 75 adults in two-day facilitated discussions on the ethical and social issues inherent to sharing data with an MIC. Deliberants made recommendations regarding opt-in consent, transparent data policies, public representation on MIC governing boards, and strict data security and privacy protection. Community engagement is critical to earning the public's trust.

Get full access to this article

View all access options for this article.

References

National Research Council, 2011, Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease (Washington, DC: The National Academies Press); E.J. Topol, “The Big Medical Data Miss: Challenges in Establishing an Open Medical Resource,” Nature Reviews Genetics 16, no. 5 (2015): 253–254, available at <http://dx.doi.org/10.1038/nrg3943> (last visited March 1, 2019); LunaDNA, LunaDNA, Home Page, available at <http://www.lunadna.com> (last visited July 25, 2018); UK Biobank, UK Biobank, Home Page, available at <http://www.ukbiobank.ac.uk> (last visited July 25, 2018); CARTaGENE, CARTaGENE, Home Page, available at <http://www.carta-gene.qc.ca/en/home> (last visited July 25, 2018); deCODE genetics, Unrivaled capabilities, Science, available at <http://www.decode.com/research> (last visited July 25, 2018); S.F. Terry, R. Shelton, G. Biggers, D. Baker, and K. Edwards, “The Haystack is Made of Needles,” Genetic Testing and Molecular Biomarkers 17, no. 3 (2013): 175–177, available at <http://dx.doi.org/10.1089/gtmb.2012.1542> (last visited March 1, 2019); E. Vayena and A. Blasimme, “Biomedical Big Data: New Models of Control Over Access, Use and Governance,” Bioethical Inquiry 14, no. 4 (2017): 501–513, available at <http://dx.doi.org/10.1007/s11673-017-9809-6> (last visited March 1, 2019)

Biobanks in this context are repositories of human biological material (e.g., DNA, RNA, tissue, organs, cells) and associated data that can be used in many types of research.

S.A.

Adams and

Petersen , “Precision Medicine: Opportunities, Possibilities, and Challenges for Patients and Providers,” Journal of the American Medical Informatics Association 23, no. 4 (2016): 787–790, available at <http://dx.doi.org/10.1093/jamia/ocv215> (last visited March 1, 2019).

M.V.

Olson

, “Prevision Medicine at the Crossroads,” Human Genomics 11, no. 23 (2017), available at <https://doi.org/10.1186/s40246-017-0119-1> (last visited March 1, 2019).

P.A.

Deverka ,

M.A.

Majumder ,

A.G.

Villanueva ,

Anderson , et al., “Creating a Data Resource: What Will It Take to Build a Medical Information Commons?” Genome Medicine 9, no. 84 (2017): 1-5, available at <https://genomemedicine.biomed-central.com/articles/10.1186/s13073-017-0476-3> (last visited January 17, 2019).

Elenko ,

Underwoord , and

Zohar , “Defining Digital Medicine,” Nature Biotechnology 33, no. 5 (2015): 456–461, available at <http://dx.doi.org/10.1038/nbt.3222> (last visited March 1, 2019).

R.L.

Fleurence

et al ., “Launching PCORnet, A National Patient-Centered Clinical Research Network,” Journal of the American Medical Informatics Association: JAMIA 21, no. 4 (2014): 578–582, available at <http://dx.doi.org/10.1136/amiajnl-2014-002747> (last visited March 1, 2019); F. Dwamena et al., “Interventions for Providers to Promote a Patient-Centred Approach in Clinical Consultations,” Cochrane Database of Systematic Reviews no. 12 (2012): CD003267, available at <http://dx.doi.org/10.1002/14651858.CD003267.pub2> (last visited March 1, 2019); A. Blasimme and V. Effy, “Becoming Partners, Retaining Autonomy: Ethical Considerations on the Development of Precision Medicine,” BMC Medical Ethics 17, no. 67 (2016), available at <http://dx.doi.org/10.1186/s12910-016-0149-6> (last visited March 1, 2019).

See P.A. Deverka, supra note 5.

Cambon-Thomsen ,

Rial-Sebbag , and

B.M.

Knoppers , “Trends in Ethical and Legal Frameworks for the use of Human Biobanks,” The European Respiratory Journal 30, no. 2 (2007): 373–382, available at <http://dx.doi.org/10.1183/09031936.00165006> (last visited March 1, 2019); E.W. Clayton, “Informed Consent and Biobanks,” The Journal of Law, Medicine & Ethics 33, no. 1 (2005): 15–21, available at <http://dx.doi.org/10.1111/j.1748-720X.2005.tb00206.x> (last visited March 1, 2019); E.M. Meslin and M.K. Cho, “Research Ethics in the Era of Personalized Medicine: Updating Science's Contract with Society,” Public Health Genomics 13, no. 6 (2010): 378–384, available at <http://dx.doi.org/10.1159/000319473> (last visited March 1, 2019); J. Murphy, J. Scott, D. Kaufman, G. Geller, L. LeRoy, and K. Hudson, “Public Perspectives on Informed Consent for Biobanking,” American Journal of Public Health 99, no. 12 (2009): 2128–2134, available at <http://dx.doi.org/10.2105/AJPH.2008.157099> (last visited March 1, 2019); D.E. Winickoff and R.N. Winickoff, “The Charitable Trust as a Model for Genomic Biobanks,” The New England Journal of Medicine 349, no. 12 (2003): 1180–1184, available at <http://dx.doi.org/10.1056/NEJMsb030036> (last visited March 1, 2019); J. Murphy, J. Scott, D. Kaufman, G. Geller, L. LeRoy, and K. Hudson, “Public Expectations for Return of Results from Large-cohort Genetic Research,” American Journal of Bioethics 8, no. 11 (2008): 36–43, available at <http://dx.doi.org/10.1080/15265160802513093> (last visited March 1, 2019); D.J. Kaufman, J. Murphy-Bollinger, J. Scott, and K.L. Hudson, “Public Opinion about the Importance of Privacy in Biobank Research,” American Journal of Human Genetics 85, no. 5 (2009): 643–654, available at <http://dx.doi.org/10.1016/j.ajhg.2009.10.002> (last visited March 1, 2019); J. Platt et al., “Public Preferences Regarding Informed Consent Models for Participation in Population-Based Genomic Research,” Genetics in Medicine 16, no. 1 (2014): 11–18, available at <http://dx.doi.org/10.1038/gim.2013.59> (last visited March 1, 2019); J.M. Pulley, M.M. Brace, G.R. Bernard, and D.R. Masys, “Attitudes and Perceptions of Patients Towards Methods of Establishing a DNA Biobank,” Cell Tissue Banking 9, no. 1 (2008): 55–65, available at <http://dx.doi.org/10.1007/s10561-007-9051-2> (last visited March 1, 2019); N.A. Garrison et al., “A Systematic Literature Review of Individuals' Perspectives on Broad Consent and Data Sharing in the United States,” Genetics in Medicine 18, no. 7 (2016): 663–671, available at <http://dx.doi.org/10.1038/gim.2015.138> (last visited March 1, 2019).

10.

Abelson

et al ., “Deliberations about Deliberative Methods: Issues in the Design and Evaluation of Public Participation Processes,” Social Science & Medicine 57, no. 2 (2003): 239–251, available at <http://dx.doi.org/10.1016/S0277-9536(02)00343-X> (last visited March 1, 2019); S. Burkhalter, J. Gastil, and T. Kelshaw, “A Conceptual Definition and Theoretical Model of Public Deliberation in Small Face-to-Face Groups,” Communications Theory 12, no. 4 (2002): 398–422, available at <http://dx.doi.org/10.1111/j.1468-2885.2002.tb00276.x> (last visited March 1, 2019); K.L. Carman et al., “Effectiveness of Public Deliberation Methods for Gathering Input on Issues in Healthcare: Results from a Randomized Trial,” Social Science & Medicine 133 (2015): 11–20, available at <http://dx.doi.org/10.1016/j.socscimed.2015.03.024> (last visited March 1, 2019); M.X. Delli Carpini, F.L. Cook, and L.R. Jacobs, “Public Deliberation, Discursive Participation, and Citizen Engagement: A Review of the Empirical Literature,” Annual Review of Political Science 7, no. 1 (2004): 315–344, available at <http://dx.doi.org/10.1146/annurev.polisci.7.121003.091630> (last visited March 1, 2019); P.W. Hamlett, “Technology Theory and Deliberative Democracy,” Science, Technology, & Human Values 28, no. 1 (2003): 112–140, available at <http://dx.doi.org/10.1177/0162243902238498> (last visited March 1, 2019).

11.

A.A.

Lemke ,

Halverson , and

L.F.

Ross , “Biobank Participation and Returning Research Results: Perspectives from a Deliberative Engagement in South Side Chicago,” American Journal of Medical Genetics Part A 158A, no. 5 (2012): 1029–1037, available at <http://dx.doi.org/10.1002/ajmg.a.34414> (last visited March 1, 2019); C. Molster et al., “An Australian Approach to the Policy Translation of Deliberated Citizen Perspectives on Biobanking,” Public Health Genomics 15 (2012): 82–91, available at <http://dx.doi.org/10.1159/000334104> (last visited March 1, 2019); G. Haddow et al., “Generation Scotland: Consulting Publics and Specialists at an Early Stage in a Genetic Database's Development,” Critical Public Health 18, no. 2 (2008): 139–149, available at <http://dx.doi.org/10.1080/09581590701824086> (last visited March 1, 2019); A.A. Lemke et al., “Public and Biobank Participant Attitudes Toward Genetic Research Participation and Data Sharing,” Public Health Genomics 13, no. 6 (2010): 368–377, available at <http://dx.doi.org/10.1159/000276767> (last visited March 1, 2019); K.C. O'Doherty and M.M. Burgess, “Engaging the Public on Biobanks: Outcomes of the BC Biobank Deliberation,” Public Health Genomics 12, no. 4 (2009): 203–215, available at <http://dx.doi.org/10.1159/000167801> (last visited March 1, 2019); A. Hicks, J.H. Hellyers, and B. Koenig, “Involving the Public in Planning for the Genomics Revolution: An Experiment in Deliberative Democracy,” The Bioethics Examiner 11, no. 2 (2008): 1–3, available at <https://www.ahc.umn.edu/img/assets/26102/BTHX_Examiner_08.pdf> (last visited February 26, 2019); M.C. Gornick, A.M. Sherer, E.J. Sutton, K.A. Ryan, N.L. Exe, M. Li, W.R. Uhlmann, S.Y.H. Kim, J.S. Roberts, and R.G. DeVries, “Effect of Public Deliberation on Attitudes Toward Return of Secondary Results in Genomic Sequencing,” Journal of Genetic Counseling 26, no. 1 (2017): 122–132, available at <http://dx.doi.org/10.1007/s10897-016-9987-0> (last visited March 1, 2019); S.M. Dry et al., “Community Recommendations on Biobank Governance: Results from a Deliberative Community Engagement in California,” PLoS One 12, no. 2 (2017): e0172582, available at <http://dx.doi.org/10.1371/journal.pone.0172582> (last visited March 1, 2019); M. Burgess, K. O'Doherty, and D. Secko, “Biobanking in British Columbia: Discussions of the Future of Personalized Medicine Through Deliberative Public Engagement,” Personalized Medicine 5, no. 3 (2008): 285–296, available at <http://dx.doi.org/10.2217/17410541.5.3.285> (last visited March 1, 2019); D. Nicol et al., “Understanding Public Reactions to Commercialization of Biobanks and use of Biobank Resources,” Social Science & Medicine 162 (2016): 79–87, available at <http://dx.doi.org/10.1016/j.socscimed.2016.06.028> (last visited March 1, 2019).

12.

Bomey

et al ., “Equifax data breach: What you need to know about hacking crisis,” USA Today, September 15, 2017, available at <https://www.usatoday.com/story/money/2017/09/15/equifax-data-breach-what-you-need-know-hacking-crisis/670166001> (last visited October 24, 2018); B. Fung, “Equifax's massive 2017 data breach keeps getting worse,” Washington Post, March 4, 2018, available at <https://www.washingtonpost.com/news/the-switch/wp/2018/03/01/equifax-keeps-finding-millions-more-people-who-were-affectedby-its-massive-data-breach/> (last visited October 24, 2018); N. Badshah, “Facebook to contact 87 million users affected by data breach,” Guardian (London), April 8, 2018, available at <https://www.theguardian.com/technology/2018/apr/08/facebook-to-contact-the-87-million-users-affected-by-data-breach> (last visited October 24, 2018); I. Moise, “Whole Foods Discloses Data Breach,” Wall Street Journal, September 28, 2017, available at <https://www.wsj.com/articles/whole-foods-discloses-data-breach-1506636659> (last visited October 24, 2018); B. Shoot, “Facebook Closes Loophole That Revealed Personal Data of People in ‘Closed’ Groups,” Fortune, July 12, 2018, available at <http://fortune.com/2018/07/12/facebook-chrome-extension-closed-group-loophole> (last visited October 24, 2018); E. Matloff, “Facebook Violates Trust of ‘Private’ Patient Groups,” Forbes, July 29, 2018, available at <https://www.forbes.com/sites/ellenmatloff/2018/07/29/facebook-violates-trust-of-private-patient-groups> (last visited October 24, 2018); R. Brandom, “Facebook Changes Privacy Settings after Outing Members of a Closed Medical Support Group,” The Verge, July 12, 2018, available at <https://www.theverge.com/2018/7/12/17565754/facebook-brca-private-group-breast-cancer> (last visited October 24, 2018); A. Hensel, “Marketers Could Harvest Member Data from Closed Facebook Groups as Recently as June, Report Says,” VentureBeat, July 12, 2018, available at <https://venturebeat.com/2018/07/12/marketers-could-harvest-member-data-from-closed-facebook-groups-as-recently-as-june-report-says> (last visited October 24, 2018); K. Fazzini, “Facebook Recently Closed a Loophole that Allowed Third Parties to Discover the Names of People in Private, ‘Closed’ Facebook Groups,” CNBC, July 12, 2018, available at <https://www.cnbc.com/2018/07/11/facebook-private-groups-breast-cancer-privacy-loophole.html> (last visited October 24, 2018); M. Allen, “Health Insurers Are Vacuuming Up Details About You — And It Could Raise Your Rates,” ProPublica, July 17, 2018, available at <https://www.propublica.org/article/health-insurers-are-vacuuming-up-details-about-you-and-it-could-raise-your-rates> (last visited October 24, 2018).

13.

See K.L. Carman, supra note 10.

14.

A.G.

Villanueva ,

Cook-Deegan ,

B.A.

Koenig ,

P.A.

Deverka et al., “Characterizing the Biomedical Data-Sharing Landscape,” Journal of Law, Medicine & Ethics 47, no. 1 (2019): 21-30; M.A. Majumder, J.M. Bollinger, A.G. Villanueva, and P.A. Deverka et al., “The Role of Participants in a Medical Information Commons,” Journal of Law, Medicine & Ethics 47, no. 1 (2019): 51-61.

15.

Agency for Healthcare Research and Quality, The Purpose and Process of Cognitive Testing, Quality and Patient Safety, available at <http://www.ahrq.gov/professionals/quality-patient-safety/talkingquality/resources/cognitive/index.html> (last visited October 24, 2018).

16.

R.E.

Goodin and

J.S.

Dryzek , “Deliberative Impacts: The Macro-Political Uptake of Mini-Politics,” Politics & Society 34, no. 2 (2006): 219–244, available at <https://doi.org/10.1177/0032329206288152> (last visited March 1, 2019).

17.

The methods differed slightly by site as we learned by doing (e.g., Durham deliberants expressed the need for additional background information delivered in different formats. Therefore, we developed an educational video and made it available to Austin and Oakland deliberants both prior to and during the deliberations.)

18.

National Institutes of Health, Home Page, All of Us, available at <https://www.allofus.nih.gov> (last visited August 6, 2018).

19.

Involve, People & Participation: How to Put Citizens at the Heart of Decisions-Making, National Coalition for Dialogue & Deliberation, available at <http://www.ncdd.org/exchange/files/docs/People_Participation.pdf> (last visited August 2, 2018); National Coalition for Dialogue & Deliberation, Engagement Steams Framework, National Coalition for Dialogue & Deliberation, available at <http://www.ncdd.org/files/rc/2014_Engagement_Streams_Guide_Web.pdf> (last visited August 2, 2018);

Hofmaier

, “Open Space Technology,” Tools and instruments for a better societal engagement in “Horizon 2020,” Engage2020, 2014, available at <http://engage2020.eu/media/Fact-sheet-on-the-current-praxis-of-methods-tools-and-instruments.pdf> (last visited August 2, 2018); G. Rowe and L.J. Frewer, “Typology of Public Engagement Mechanisms,” Science, Technology, & Human Values 30, no. 2 (2005): 251–290, available at <http://dx.doi.org/10.1177/0162243904271724> (last visited March 1, 2019).

20.

K.L.

Carman ,

J.W.

Heeringa ,

S.K.R.

Heil ,

S.G.

Garfinkel ,

Windham ,

Gilmore ,

Ginsburg ,

Sofaer ,

Gold , and

Pathak-Sen , Public Deliberation To Elicit Input on Health Topics: Findings From a Literature Review, AHRQ, Publication No. 12-EHC070-EF (February 2013); H. Friberg-Fernros and J.K. Schaffer, “The Consensus Paradox: Does Deliberative Agreement Impede Rational Discourse?” Political Studies 62, no. 1 Supplement (2014): 99–116; S. Solomon and J. Abelson, “Why and When Should We Use Public Deliberation?” The Hastings Center Report 42, no. 2 (2012): 17–20.

21.

J.W.

Creswell and

Poth , Qualitative Inquiry and Research Design, 4th ed. (Thousand Oaks, CA: Sage, 2016); M.B. Miles, A. Huberman, and J. Saldana, Qualitative Data Analysis, 3rd ed. (Thousand Oaks, CA: Sage, 2014).

22.

NVivo qualitative analysis Software [Computer software], QSR International Pty Ltd., Version 10, 2012.

23.

See J.W. Creswell, supra note 21.

24.

Over the course of two days, four Oakland CAP deliberants left the deliberation early due to either family or work obligations; two left early because of perceived racial bias between deliberants.

25.

Ravitz

, “Henrietta Lacks: Her Cells, her Legacy,” CNN, April 28, 2018, available at <https://www.cnn.com/2017/04/21/health/henrietta-lacks-legacy/index.html> (last visited October 24, 2018).

26.

42 USC § 21F (2008).

27.

See C. Molster et al., supra note 11.

28.

See N.A. Garrison, supra note 9.

29.

See S.M. Dry et al., supra note 11.

30.

D.J.

Kaufman

et al ., “A Survey of U.S Adults' Opinions about Conduct of a Nationwide Precision Medicine Initiative Cohort Study of Genes and Environment,” PLoS One 11, no. 8 (2016): e0160461, available at <http://dx.doi.org/10.1371/journal.pone.0160461> (last visited March 1, 2019).

31.

See S.M. Dry, supra note 11.

32.

W.J.

Gordon and

Catalini , “Blockchain Technology for Healthcare: Facilitating the Transition to Patient-Driven Interoperability,” Computational and Structural Biotechnology Journal 16 (2018): 224-230, available at <http://dx.doi.org/10.1016/j.csbj.2018.06.003> (last visited March 1, 2019).

33.

National Institutes of Health, Achieving the Principles through a Prevision Medicine Initiative Data Security Policy Framework, All of Us, available at <https://www.allofus.nih.gov/about/program-overview/precision-medicine-initiative-data-security-policy-principles-and-framework-overview/achieving-principles-through-precision-medicine-initiative-data-security-policy-framework> (last visited August 6, 2018).

34.

See S.M. Dry, supra note 11; deCODE genetics, deCODE genetics, Home Page, available at <http://www.decode.com> (last visited August 6, 2018); University of Tartu Institutes of Genomics, Estonian Genome Center, Home Page, available at <https://www.geenivaramu.ee/en> (last visited August 6, 2018).

35.

See C. Molster and K.C. O'Doherty, supra note 11.

36.

Madden ,

Rainie ,

Zickuhr ,

Duggan , and

Smith , Public Perceptions of Privacy and Security in the Post-Snowden Era, Pew Research Center, available at <http://www.pewinternet.org/2014/11/12/public-privacy-perceptions/> (last visited August 6, 2018).

37.

Critchley ,

Nicol , and

Otlowski , “The Impact of Commercialisation and Genetic Data Sharing Arrangements on Public Trust and the Intention to Participate in Biobank Research,” Public Health Genomics 18, no. 3 (2015): 160–172, available at <http://dx.doi.org/10.1159/000375441> (last visited March 1, 2019).

38.

Platt and

Kardia , “Public Trust in Health Information Sharing: Implications for Biobanking and Electronic Health Record Systems,” Journal of Personalized Medicine 5, no. 1 (2015): 3–21, available at <http://dx.doi.org/10.3390/jpm5010003> (last visited March 1, 2019).

39.

Adjekum ,

Ienca , and

Vayena , “What Is Trust? Ethics and Risk Governance in Precision Medicine and Predictive Analytics,” OMICS: A Journal of Integrative Biology 21, no. 12 (2017): 704–710, available at <http://dx.doi.org/10.1089/omi.2017.0156>(last visited March 1, 2019).

40.

See A. Adjekum, supra note 39.

41.

See M.C. Gornick, supra note 11.

42.

Degeling ,

S.M.

Carter , and

Rychetnik , “Which Public and Why Deliberate? – A Scoping Review of Public Deliberation in Public Health and Health Policy Research,” Social Science & Medicine 131 (2015): 114–121.

43.

Longstaff and

M.M.

Burgess , “Recruiting for Representation in Public Deliberation on the Ethics of Biobanks,” Public Understanding of Science 19, no. 2 (2010): 212–224, available at <http://dx.doi.org/10.1177/0963662508097626> (last visited March 1, 2019).

44.

Pew Research Center, Social Media Fact Sheet, Pew Research Center, available at <http://www.pewinternet.org/fact-sheet/social-media/> (last visited August 17, 2018).

45.

Included are all deliberants who signed in at the start of the first day of deliberation.

46.

One deliberant from California did not respond to this question. Therefore, percentages for California for this question are calculated using N = 21. The totals for this characteristic are calculated using N = 74.

Hopeful and Concerned: Public Input on Building a Trustworthy Medical Information Commons

Abstract

Get full access to this article

References