Skip to main content Accessibility help

We use cookies to distinguish you from other users and to provide you with a better experience on our websites. Close this message to accept cookies or find out how to manage your cookie settings.

Close cookie message
×
Home
Hostname: page-component-7ccbd9845f-hcslb Total loading time: 0.408 Render date: 2023-01-29T07:06:31.682Z Has data issue: true Feature Flags: { "useRatesEcommerce": false } hasContentIssue true
  • English
Journal of Law, Medicine & Ethics Journal of Law, Medicine & Ethics

Article contents

The Role of Participants in a Medical Information Commons

Published online by Cambridge University Press:  01 January 2021

Mary A. Majumder ,
Juli M. Bollinger ,
Angela G. Villanueva ,
Patricia A. Deverka  and
Barbara A. Koenig
Get access Rights & Permissions[Opens in a new window]

Abstract

Meaningful participant engagement has been identified as a key contributor to the success of efforts to share data via a “Medical Information Commons” (MIC). We present findings from expert stakeholder interviews aimed at understanding barriers to engagement and the appropriate role of MIC participants. Although most interviewees supported engagement, they distinguished between individual versus collective forms. They also noted challenges including representation and perceived inefficiency, prompting reflection on political aspects of engagement and efficiency concerns.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 47 , Issue 1: Sharing Data in a Medical Information Commons , Spring 2019 , pp. 51 - 61
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Collins, F.S. and Varmus, H., “A New Initiative on Precision Medicine,” New England Journal of Medicine 372, no. 9 (2015): 793-795.CrossRefGoogle Scholar
Deverka, P.A., Majumder, M.A., Villanueva, A.G., and Anderson, M. 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://genome-medicine.biomedcentral.com/articles/10.1186/s13073-017-0476-3> (last visited January 9, 2019); A.L. McGuire, M.A. Majumder, A.G. Villanueva, and J. Bardill et al., “Importance of Participant-Centricity and Trust for a Sustainable Medical Information Commons,” Journal of Law, Medicine & Ethics 47, no. 1 (2019): 12-20; J.M. Bollinger, P.D. Zuk, M.A. Majumder, and E. Versalovic et al., “What Is a Medical Information Commons?” Journal of Law, Medicine & Ethics 47, no. 1 (2019): 41-50; A. Blassime and E. Vayena, “Becoming Partners, Retaining Autonomy: Ethical Considerations on the Development of Precision Medicine,” BMC Medical Ethics 17 (2016): 67.CrossRefGoogle Scholar
Hess, C. and Ostrom, E., “Introduction: An Overview of the Knowledge Commons,” In Hess, C. and Ostrom, E., Eds., Understanding Knowledge as a Commons: From Theory to Practice (Cambridge, MA: MIT Press 2007): 3-26, at 7. Hess and Ostrom note that “[c]ommons is an awkward word in the English language” because the “same word is used for both the singular and plural forms.” Id., at 21.Google Scholar
For more on MIC structure and characteristics, see Cook-Deegan, R. et al., “Introduction: Sharing Data in a Medical Information Commons,” Journal of Law, Medicine & Ethics 47, no. 1 (2019): 7-11; Bollinger, supra note 2; A.G. Villanueva, R. Cook-Deegan, B.A. Koenig, and P.A. Deverka et al., “Characterizing the Biomedical Data-Sharing Landscape,” Journal of Law, Medicine & Ethics 47, no. 1 (2019): 21-30; and M.A. Majumder, P.D. Zuk, and A.L. McGuire, “Medical Information Commons,” in B. Hudson, J. Rosenbloom, and D. Cole, eds., Routledge Handbook of the Study of the Commons (Routledge, Forthcoming 2019).CrossRefGoogle Scholar
See, e.g., Kaye, J. et al., “From Patients to Partners: Participant-centric Initiatives in Biomedical Research,” Nature Reviews Genetics 13, no. 5 (2012): 371–376, available at <https://doi.org/10.1038/nrg3218> (last visited January 10, 2019); S. Sheridan et al., “The PCORI Engagement Rubric: Promising Practices for Partnering in Research,” Annals of Family Medicine 15, no. 2 (2017): 165-170; L.E. Ellis and N.E. Kass, “How Are PCORI-funded Researchers Engaging Patients in Research and What Are the Ethical Implications?” American Journal of Bioethics Empirical Bioethics 8, no. 1 (2017): 1-10; E. Nelson et al., “Patient-Focused Registries Can Improve Health, Care, and Science,” BMJ 354 (2016); K. Ferryman and M. Pitcan, “Fairness in Precision Medicine,” Data & Society Research Institute (February 2, 2018) available at <https://datasociety.net/pubs/pm/DataSociety_Fairness_In_Precision_Medicine_Feb2018.pdf> (last visited January 10, 2019).Google Scholar
Aungst, H., Fishman, J.R., and McGowan, M.L., “Participatory Genomic Research: Ethical Issues from the Bottom Up to the Top Down,” Annual Review of Genomics and Human Genetics 18 (2017): 10.1-10.11; J.P. Woolley et al., “Citizen Science or Scientific Citizenship? Disentangling the Uses of Public Engagement Rhetoric in National Research Initiatives,” BMC Medical Ethics 17 (2016), available at <https://doi.org/10.1186/s12910-016-0117-1> (last visited January 10, 2019); G.N. Samuel and B. Farsides, “Genomics England's Implementation of Its Public Engagement Strategy: Blurred Boundaries Between Engagement for the United Kingdom's 100,000 Genomes Project and the Need for Public Support,” Public Understanding of Science (2017): 1-13. See also J. Reardon, The Post-Genomic Condition: Ethics, Justice, and Knowledge After the Genome (Chicago, IL: University of Chicago Press, 2017); B. Prainsack, Personalized Medicine: Empowered Patients in the 21st Century? (New York, NY: NYU Press, 2017).CrossRefGoogle Scholar
Sankar, P.L. and Parker, L.S., “The Precision Medicine Initiative's All of Us Research Program: An Agenda for Research on its Ethical, Legal, and Social Issues,” Genetics in Medicine 19, no. 7 (2017): 743-750; Samuel and Farsides, supra note 6; B. Kaplan et al., “A Culture of Understanding: Reflections and Suggestions from a Genomics Research Community Board,” Progress in Community Health Partnerships: Research, Education, and Action 11, no. 2 (2017): 161-165; S.H. Katsanis et al., “Participant-Partners in Genetic Research: An Exome Study with Families of Children with Unexplained Medical Conditions,” Journal of Participatory Medicine 10, no. 1 (2018): e2.CrossRefGoogle Scholar
The classic work on engagement as a continuum is Carman, K.L. et al., “Patient and Family Engagement: A Framework for Understanding the Elements and Developing Interventions and Policies,” Health Affairs 32, no. 2 (2013): 223-229 (focus on health care context). An engagement “roadmap” building on this framework is available at <https://patient-familyengagement.org> (last visited January 10, 2019). See also Ellis and Kass, supra note 5; Aungst, Fishman, and McGowan, supra note 6; M. Seid, P.A. Margolis, and L. Opipari-Arrigan, “Engagement, Peer Production, and the Learning Healthcare System,” JAMA Pediatrics 168, no. 3 (2014): 201-202; T. Nabatchi, “Putting the ‘Public’ Back in Public Values Research: Designing Participation to Identify and Respond to Values,” Public Administration Review 72, no. 5 (2012): 699-708. The continuum is critical to understanding the relationship between participant engagement and participant-centricity. While a project can employ limited participant engagement strategies without being participant-centric if these strategies in no way meaningfully empower participants, as one moves along the participant engagement continuum initiatives become increasingly participant-centric. It is hard to imagine an initiative that claims to be participant-centric having no participant engagement.CrossRefGoogle Scholar
E.g., Blassime and Vayena, supra note 2.Google Scholar
E.g., Evans, B., “Barbarians at the Gate: Consumer-Driven Health Data Commons and the Transformation of Citizen Science,” American Journal of Law & Medicine 42, no. 4 (2016): 651-685.CrossRefGoogle Scholar
See Bollinger, supra note 2.Google Scholar
See, e.g., Jongsma, K., Spaeth, E., and Schicktanz, S., “Epistemic Injustice in Dementia and Autism Patient Organizations – An Empirical Analysis,” American Journal of Bioethics Empirical Bioethics 8, no. 4 (2017): 221-233. (Drawing on the work of Miranda Fricker, the authors define epistemic injustice as “a wrong done to someone in their capacity as a knower.” It includes testimonial injustice, “the devaluation of the credibility of persons or groups by a hearer due to negative and culpable prejudices,” and hermeneutical injustice, deprivation “of opportunities to contribute…social experiences to the collective understanding on an event or condition.”). See also D.M. Wenner, “Barriers to Effective Deliberation in Clinical Research Oversight,” HCE Committee Forum 28, no. 3 (2015): 245-259.CrossRefGoogle Scholar
Kaye et al., supra note 5; Feeney, O. et al., “Genuine Participation in Participation-Centred Research Initiatives: The Rhetoric and the Potential Reality,” Journal of Community Genetics 9, no. 2 (2018): 133-142; D.M. Walker et al., “Information Technology to Support Patient Engagement: Where Do We Stand and Where Can We Go?” Journal of the American Medical Informatics Association 24, no. 6 (2017): 1088-1094; D.E. Winickoff, L. Jamal, and N.R. Anderson, “New Modes of Engagement for Big Data Research,” Journal of Responsible Innovation 3, no. 2 (2016): 169-177; for a balanced overview of technology-enabled (“high-tech”) and in-person (“high-touch”) approaches to engagement, see D.C. Lavallee et al., “Stakeholder Engagement in Patient-Centered Outcomes Research: High-Touch or High-Tech?” Expert Reviews in Pharmacoeconomic Outcomes Research 14, no. 3 (2014): 335-344.CrossRefGoogle Scholar
Walker et al. and Lavallee et al., supra note 13.Google Scholar
Blassime and Vayena, supra note 2. Other recent work that is attentive to the political dimensions of large assemblages of genomic and other data includes Kraft, S.A., Cho, M.K., Gillespie, K. et al., “Beyond Consent: Building Trusting Relationships With Diverse Populations in Precision Medicine Research,” American Journal of Bioethics 18, no. 4 (2018): 3-20; L.A. Mamo, D.K. Browe, H.C. Logan, and K.K. Kim, “Patient Informed Governance of Distributed Research Networks: Results and Discussion from Six Patient Focus Groups,” AMIA Annual Symposium Proceedings Archive (2013): 920-929; K.C. O'Doherty et al., “From Consent to Institutions: Designing Adaptive Governance for Genomic Biobanks,” Social Science and Medicine 73, no. 3 (2011): 367-374; Woolley et al, Reardon, and Prainsack, supra note 6.CrossRefGoogle Scholar
Sankar and Parker, supra note 7.Google Scholar
Ellis and Kass, supra note 5.Google Scholar
Katsansis, supra note 7; see also Prainsack, supra note 6, especially pp. 198-201.Google Scholar
Regarding the general need to attend to intersectionality, including the interaction of race and gender in the experience of discrimination, see the work of Kimberlé Crenshaw, e.g., Crenshaw, K., “Demarginalizing the Intersection of Race and Sex: A Black Feminist Critique of Antidiscrimination Doctrine, Feminist Theory and Antiracist Politics” University of Chicago Legal Forum 1989, no. 1 (1989), Article 8, available at <http://chicagounbound.uchicago.edu/uclf/vol1989/iss1/8> (last visited January 10, 2019). Regarding intragroup differences and tensions in the context of research in particular, see Reardon, p. 195, Jongsma, Spaeth, and Schicktanz, supra note 12, Kaplan et al., supra note 7.Google Scholar
See S.A. Kraft, M.K. Cho, K. Gillespie et al., supra note 15.Google Scholar
See, e.g., Garrison, N.A., “Cases of How Tribes are Relating to Genetic Research,” available at <http://genetics.ncai.org/what-do-tribes-think-about-genetics-research.cfm> (last visited January 10, 2019); L.L. Bitsóí (Diné), “Enhancing Genomic Research Through a Native Lens,” available at <http://genetics.ncai.org/enhancing_genomic_research.cfm> (last visited January 10, 2019); H. Washington, Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present (New York: Doubleday, 2006); Reardon, supra note 6.+(last+visited+January+10,+2019);+L.L.+Bitsóí+(Diné),+“Enhancing+Genomic+Research+Through+a+Native+Lens,”+available+at++(last+visited+January+10,+2019);+H.+Washington,+Medical+Apartheid:+The+Dark+History+of+Medical+Experimentation+on+Black+Americans+from+Colonial+Times+to+the+Present+(New+York:+Doubleday,+2006);+Reardon,+supra+note+6.>Google Scholar
Nabatchi, supra note 8.Google Scholar
See Wenner, supra note 12, at 253.Google Scholar
Ellis and Kass, supra note 5.Google Scholar
Related to PCORI, see Kim, K.K. and Helfand, M., “Engagement in PCORnet Research Networks,” Medical Care 56, no. 10, Suppl 1, (2018): S1-S2; J.V. Selby, C. Grossman, M. Zirkle, and S. Barbash, “Multistakeholder Engagement in PCOR-net, the National Patient-Centered Clinical Research Network,” Medical Care 56, no. 10, Suppl 1 (2018): S4-S5; C.H. Wilkins, “Effective Engagement Requires Trust and Being Trustworthy,” Medical Care 56, no. S6-S8 (2018); A. Fagerlin, “Learning from Others: Lessons for Improving Collaborations Between Stakeholders and Researchers,” Medical Care 56, no. 10, Suppl 1 (2018): S9-S10; M. Faulkner et al., “Exploring Meaningful Patient Engagement in ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness),” Medical Care 56, no. 10, Suppl 1 (2018): S11-S15; W.B. Nowell, J.R. Curtis, and R. Crow-Hercher, “Patient Governance in a Patient-Powered Research Network for Adult Rheumatologic Conditions,” Medical Care 56, no. 10, Suppl 1, (2018): S16-S21; A. P. Boyer et al., “A Multilevel Approach to Stakeholder Engagement in the Formulation of a Clinical Data Research Network,” Medical Care 56, no. 10, Suppl 1 (2018): S22-S26; S.C. Haynes et al., “Engaging Stake-holders to Develop a Patient-centered Research Agenda: Lessons Learned from the Research Action for Health Network (REACHnet),” Medical Care 56, no. 10, Suppl 1 (2018): S27-S32; A.E. Chung et al., “Crohn's and Colitis Foundation of America Partners Patient-Powered Research Network: Patient Perspectives on Facilitators and Barriers to Building on Impactful Patient-Powered Research Network,” Medical Care 56, no. 10, Suppl 1 (2018): S33-S40; K.K. Kim et al., “A Novel Stakeholder Engagement Approach for Patient-centered Outcomes Research,” Medical Care 56, no. 10, Suppl 1 (2018): S41-S47; K.S. Kimminau et al., “Patient vs. Community Engagement: Emerging Issues,” Medical Care 56, no. 10, Suppl 1 (2018): S53-S57; N.T. Warren et al., “Building Meaningful Patient Engagement in Research: Case Study form ADVANCE Clinical Data Research Network,” Medical Care 56, no. 10, Suppl 1 (2018): S58-S63; J. Arkind et al., “Lessons Learned from Developing a Patient Engagement Panel: An OCHIN Report,” Journal of the American Board of Family Medicine 28, no. 5 (2015): 632-638; Ellis and Kass, supra note 5; Lavalee, supra note 13; PCORnet Engagement Assessment Project: Findings and Recommendations, September 28, 2018, available at <https://pcornetcommons.org/resource_item/pcornet-engagement-assessment-project-findings-and-recommendations> (last visited January 10, 2019). Related to the HCSRN, see S. Madrid and, L. Wright, Patient Engagement Workbook, October 2, 2014, available at <http://www.hcsrn.org/en/Tools%20&%20Materials/Plan_Field/HCSRNPatientEngagementWorkbook.pdf> (last visited January 10, 2019). For guidance developed for a different but related context, clinical trials, see National Health Council, Tackling Representativeness: A Roadmap and Rubric, available at <https://www.nationalhealthcouncil.org/sites/default/files/Representativeness%20in%20Patient%20Engagement.pdf> (last visited January 10, 2019); National Health Council, Lessons Learned and Pathways Forward: Practical Experiences in Patient Engagement, A Portfolio of Case Examples, September 19, 2017, available at <http://www.national-healthcouncil.org/sites/default/files/CM-SOAbstracts.pdf> (last visited January 10, 2019).CrossRefGoogle Scholar
For example, an analysis carried out in the context of the Clinical Trials Transformation Initiative captures impacts of patient engagement in clinical trials such as avoiding protocol amendments and/or improving enrollment, adherence, and retention, and potential financial impact. Levitan, B. et al., “Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI's Patient Groups and Clinical Trials Project,” Therapeutic Innovation & Regulatory Science 52, no. 20 (2017): 220-229, available at <http://journals.sagepub.com/doi/full/10.1177/2168479017716715> (last visited January 10, 2019).CrossRefGoogle Scholar
Kelty, C. and Panofsky, A., “Disentangling Public Participation in Science and Medicine,” Genome Medicine 6, no. 1 (2014): 8.Google Scholar
For information on one model that has been extensively tested, see Joosten, Y.A. et al., “Community Engagement Studios: A Structured Approach to Obtaining Meaningful Input from Stakeholders to Inform Research,” Academic Medicine 90, no. 12 (2015): 1646-1650; A. P. Boyer et al., supra note 25.CrossRefGoogle Scholar
Reardon, supra note 6, at 196.Google Scholar
E.g., Ball, M.P. et al., “Harvard Personal Genome Project: lessons from participatory public research,” Genome Medicine 6, no. 10 (2014), available at <https://doi.org/10.1186/gm527> (last visited January 10, 2019); S. Daugherty, S. Wahba, and R. Fleurence, “Patient-Powered Research Networks: Building Capacity for Conducting Patient-centered Clinical Outcomes Research,” Journal of the American Medical Informatics Association 21, no. 4 (2014): 583–586.CrossRefGoogle Scholar
Chen, F., Anguiano, B., Koenig, B.A., and Harris-Wai, J., “Methods for the Evaluation of Deliberative Community Engagement Events: Mapping the Terrain” [Poster] ELSI Congress. Farmington, CT, June 5-7, 2017.Google Scholar
5
Cited by

Save article to Kindle

To save this article to your Kindle, first ensure coreplatform@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about saving to your Kindle.

Note you can select to save to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

The Role of Participants in a Medical Information Commons
Available formats
×

Save article to Dropbox

To save this article to your Dropbox account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you used this feature, you will be asked to authorise Cambridge Core to connect with your Dropbox account. Find out more about saving content to Dropbox.

The Role of Participants in a Medical Information Commons
Available formats
×

Save article to Google Drive

To save this article to your Google Drive account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you used this feature, you will be asked to authorise Cambridge Core to connect with your Google Drive account. Find out more about saving content to Google Drive.

The Role of Participants in a Medical Information Commons
Available formats
×
×

Reply to: Submit a response

Please enter your response.

Your details

Please enter a valid email address.

Conflicting interests

Do you have any conflicting interests? *