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From “Informed” to “Engaged” Consent: Risks and Obligations in Consent for Participation in a Health Data Repository

Published online by Cambridge University Press:  01 January 2021

Elizabeth Bromley ,
Alexandra Mendoza-Graf ,
Sandra Berry ,
Camille Nebeker  and
Dmitry Khodyakov
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Abstract

The development and use of large and dynamic health data repositories designed to support research pose challenges to traditional informed consent models. We used semi-structured interviewing (n=44) to elicit diverse research stakeholders' views of a model of consent appropriate to participation in initiatives that entail collection, long-term storage, and undetermined future research use of multiple types of health data. We demonstrate that, when considering health data repositories, research stakeholders replace a concept of consent as informed with one in which consent is engaged. In engaged consent, a participant's ongoing relationship with a repository serves as a substitute or adjunct to information exchange at enrollment. We detail research stakeholders' views of the risks of engaged consent and suggest questions for further study about engagement and consent procedures in initiatives that aim to store data for future unspecified research purposes.

Type
Independent Articles
Information
Journal of Law, Medicine & Ethics , Volume 48 , Issue 1: LawSeq: Building a Sound Legal Foundation for Translating Genomics into Clinical Application , Spring 2020 , pp. 172 - 182
Copyright
Copyright © American Society of Law, Medicine and Ethics 2020

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References

McGuire, A.L. and Beskow, L.M., “Informed Consent in Genomics and Genetic Research,” Annual Review of Genomics and Human Genetics 11, no. 1 (2010): 361–381, at 362.CrossRefGoogle Scholar
45 CFR 46.116 (2018).CrossRefGoogle Scholar
Faden, R.R., Beauchamp, T.L., and Kass, N.E.. “Informed Consent, Comparative Effectiveness, and Learning Health Care,” New England Journal of Medicine 370, no. 8 (2014): 766–768.CrossRefGoogle Scholar
All of Us Research Program, National Institutes of Health, Department of Health and Human Services, 2018; 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.Google Scholar
See McGuire and Beskow, supra note 1, at 362.Google Scholar
Budin-Ljøsne, I., Teare, H.J., Kaye, J., et al. “Dynamic Consent: A Potential Solution to Some of the Challenges of Modern Biomedical Research.” BMC Medical Ethics 18, no. 1 (2017): 4; Burke, W., Beskow, L.M., Trinidad, S.B., Fullerton, S.M., and Brelsford, K., “Informed Consent in Translational Genomics: Insufficient Without Trustworthy Governance,” The Journal of Law, Medicine & Ethics 46, no. 1 (2018): 79–86; Sabatello, M. and Appelbaum, P.S., “The Precision Medicine Nation,” Hastings Center Report 47, no. 4 (2017): 19–29; Murphy, J., Scott, J., Kaufman, D., Geller, G., LeRoy, L., and Hudson, K.. “Public Perspectives on Informed Consent for Biobanking,” American Journal of Public Health 99, no. 12 (2009): 2128–2134; D'Abramo, F., “Biobank Research, Informed Consent and Society. Towards a New Alliance?” Journal of Epidemiolgical Community Health 69, no. 11(2015): 1125–1128; Sheehan, M., “Can Broad Consent be Informed Consent?” Public Health Ethics 4, no. 3 (2011): 226–235; Khodyakov, D., Mendoza-Graf, A., Berry, S., Nebecker, C., and Bromley, E.. “Return of Value in the New Era of Biomedical Research — One Size Will Not Fit All,” AJOB Empirical Bioethics 10, no. 4 (2019): 265–275.CrossRefGoogle Scholar
Beskow, L.M. and Weinfurt, K. P., “Exploring Understanding of ‘Understanding’: The Paradigm Case of Biobank Consent Comprehension,” The American Journal of Bioethics 19, no. 5 (2019): 6–18.CrossRefGoogle Scholar
Wieten, S., Blythe, J., and Magnus, D., “Informed Consent: A Matter of Aspiration Since 1966 (At Least),” The American Journal of Bioethics 19, no. 5 (2019): 3–5.CrossRefGoogle Scholar
Clayton, E.W., “The Unbearable Requirement of Informed Consent,” The American Journal of Bioethics 19, no. 5 (2019): 19–20, at 19.CrossRefGoogle Scholar
Capron, A. M., “Where Did Informed Consent for Research Come From?” The Journal of Law, Medicine & Ethics 46, no. 1 (2018): 12–29.CrossRefGoogle Scholar
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report, (Department of Health, Education, and Welfare: 1979).Google Scholar
Sugarman, J. and Paasche-Orlow, M., “Confirming Comprehension of Informed Consent as a Protection of Human Subjects,” The Journal of General Internal Medicine 21, no. 8 (2006): 898–899; Flory, J. and Emanuel, E., “Interventions to Improve Research Participants’ Understanding in Informed Consent for Research: A Systematic Review,” JAMA 292, no. 13 (2004): 1593–1601.CrossRefGoogle Scholar
Del Carmen, M. G. and Joffe, S., “Informed Consent for Medical Treatment and Research: A Review,” The Oncologist 10, no. 8 (2005): 636–641; Goldberger, J.J., Kruse, J., Kadish, A., H., Passman, R., and Bergner, D.W., “Effect of Informed Consent Format on Patient Anxiety, Knowledge, and Satisfaction,” American Heart Journal 162, no. 4 (2011): 780–785, e781; Palmer, B.W., Cassidy, E., L., Dunn, L., B., Spira, A.P., and Sheikh, J.I., “Effective Use of Consent Forms and Interactive Questions in the Consent Process,” IRB: Ethics & Human Research 30, no. 2 (2008): 8–12.CrossRefGoogle Scholar
Patil, S., Majumdar, B., and Awan, K.H., et al., “Cancer Oriented Biobanks: A Comprehensive Review,” Oncology Reviews 12, no. 1 (2018); De Souza, Y.G. and Greenspan, J.S., “Biobanking Past, Present and Future: Responsibilities and Benefits,” AIDS 27, no. 3 (2013): 303–312.Google Scholar
Kaufman, D. J., Baker, R., Milner, L. C., Devaney, S., and Hudson, K. L., “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.CrossRefGoogle Scholar
Lemke, A.A., Halverson, C., and Ross, L.F., “Biobank Participation and Returning Research Results: Perspectives from a Deliberative Engagement in South Side Chicago,” American Journal of Medical Genetics Part a 158A (2012): 1029-1037; Burke, W., Antommaria, A.H., and Bennett, R., et al. “Recommendations for Returning Genomic Incidental Findings? We Need to Talk!” Genetics in Medicine 15, no. 11 (2013): 854–859; Sanderson, S.C., Brothers, K.B., and Mercaldo, N.D., et al., “Public Attitudes Toward Consent and Data Sharing in Bio-bank Research: A Large Multi-Site Experimental Survey in the US,” The American Journal of Human Genetics 100, no. 3 (2017): 414–427; Beskow, L.M., Dombeck, C.B., Thompson, C.P., Watson-Ormond, J.K., and Weinfurt, K.P., “Informed Consent for Biobanking: Consensus-Based Guidelines for Adequate Comprehension,” Genetics in Medicine 17, no. 3 (2015): 226.Google Scholar
45 CFR §§ 46, subparts A-D (2017).Google Scholar
Grady, C., Eckstein, L., and Berkman, B., et al., “Broad Consent for Research with Biological Samples: Workshop Conclusions, The American Journal of Bioethics 15, no. 9 (2015): 34–42, at 35.CrossRefGoogle Scholar
Guidance on Broad Consent Under the Revised Common Rule, Attachment C - Recommendations for Broad Consent Guidance, Secretary's Advisory Committee on Human Research Protections, Department of Health and Human Services, July 26, 2017, np.Google Scholar
Guidance on Broad Consent Under the Revised Common Rule, Attachment D - Recommendations for a Broad Consent Template, Secretary's Advisory Committee on Human Research Protections, Department of Health and Human Services, July 26, 2017, np.Google Scholar
Nanibaa'A, G., Sathe, N.A., and Antommaria, A.H.M., 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; Garrett, S.B., Dohan, D., and Koenig, B.A., “Linking Broad Consent to Biobank Governance: Support From a Deliberative Public Engagement in California,” The American Journal of Bioethics 15, no. 9 (2015): 56–57.Google Scholar
Bunnik, E.M., Janssens, A.C.J.W., and Schermer, M.H.N., “A Tiered-Layered-Staged Model for Informed Consent in Personal Genome Testing,” European Journal of Human Genetics 21, no. 6 (2013): 596–601.CrossRefGoogle Scholar
Lentz, J., Kennett, M., Perlmutter, J., and Forrest, A., “Paving the Way to a More Effective Informed Consent Process: Recommendations from the Clinical Trials Transformation Initiative,” Contemporary Clinical Trials 49 (2016): 65–69.CrossRefGoogle Scholar
Kaye, J., Whitley, E.A., Lund, D., Morrison, M., Teare, H., and Melham, K., “Dynamic Consent: A Patient Interface for Twenty-First Century Research Networks,” European Journal of Human Genetics 23, no. 2 (2015): 141–146; Wee, R., Henaghan, M., and Winship, I., “Ethics: Dynamic Consent in the Digital Age of Biology: Online Initiatives and Regulatory Considerations,” Journal of Primary Health Care 5, no. 4 (2013): 341–347.CrossRefGoogle Scholar
See McGuire and Beskow, supra note 1.Google Scholar
Wendler, D., Broad versus Blanket Consent for Research with Human Biological Samples,” Hastings Center Report 43, no. 5 (2013): 3–4.CrossRefGoogle Scholar
Caulfield, T., “Biobanks and Blanket Consent: The Proper Place of the Public Good and Public Perception Rationales,” King's Law Journal 18, no. 2 (2007): 209–226.CrossRefGoogle Scholar
Greely, H.T., “The Uneasy Ethical and Legal Underpinnings of Large-Scale Genomic Biobanks,” Annual Review of Genomics and Human Genetics 8 (2007): 343–364.CrossRefGoogle Scholar
See supra note 19, np.Google Scholar
Klima, J., Fitzgerald-Butt, S.M., and Kelleher, K.J., et al., “Understanding of Informed Consent by Parents of Children Enrolled in a Genetic Biobank,” Genetics in Medicine 16 (2014): 141–148; Barr, M. “‘I’m not Really Read up on Genetics’: Biobanks and the Social Context of Informed Consent,” Biosocieties 1, no. 2 (2006): 251–262; McCarty, C.A., Nair, A., Austin, D.M., and Giampietro, P.F., “Informed Consent and Subject Motivation to Participate in a Large, Population-Based Genomics Study: The Marshfield Clinic Personalized Medicine Research Project,” Community Genetics 10 (2007): 2–9; Ormond, K.E., Cirino, A.L., Helenowski, I.B., Chisholm, R.L., and Wolf, W.A., “Assessing the Understanding of Biobank Participants,” American Journal of Medical Genetics 149A (2009): 188-198.CrossRefGoogle Scholar
Dickert, N.W., Fehr, A.E., Llanos, A., Scicluna, V.M., and Samady, H., “Patients’ Views of Consent for Research Enrollment During Acute Myocardial Infarction,” Acute Cardiac Care 17, no. 1 (2015): 1–4; Mandava, A., Pace, C., Campbell, B., Emanuel, E., and Grady, C., “The Quality of Informed Consent: Mapping the Landscape, A Review of Empirical Data from Developing and Developed Countries,” Journal of Medical Ethics 38, no. 6 (2012): 356–365.CrossRefGoogle Scholar
Dickert, N.W., Eyal, N., and Goldkind, S.F., et al, “Reframing Consent for Clinical Research: A Function-Based Approach,” The American Journal of Bioethics 17, no. 12 (2017): 3–11, at 4.CrossRefGoogle Scholar
Brudney, D., “Choosing for Another: Beyond Autonomy and Best Interests,” Hastings Center Report 39, no. 2 (2009): 31–37.CrossRefGoogle Scholar
See Faden et al., supra note 3.Google Scholar
See Beskow and Weinfurt, supra note 7.Google Scholar
See Beskow and Weinfurt, supra note 7, at 16.Google Scholar
Kim, S.Y. and Miller, F.G., “Waivers and Alterations to Consent in Pragmatic Clinical Trials: Respecting the P:rinciple of Respect for Persons,” IRB: Ethics and Human Research 38, no. 1 (2016): 1–5; McKinney, R.E. Jr., Beskow, L.M., and Ford, D.E., et al., “Use of Altered Informed Consent in Pragmatic Clinical Research,” Clinical Trials 12, no. 5 (2015): 494-502; Kraft, S.A., Garrison, N.A., and Wilfond, B.S., “Understanding as an Ethical Aspiration in an Era of Digital Technology-Based Communication: An Analysis of Informed Consent Functions,” The American Journal of Bioethics 19, no. 5 (2019): 34–36; Solberg, B. and Ursin, L., “Being Polite: Why Biobank Consent Comprehension Is Neither a Requirement nor an Aspiration,” The American Journal of Bioethics 19, no. 5 (2019): 31–33.Google Scholar
Cargill, S. Solomon, “Rejecting ‘Understanding’: An Ethical Proposal Whose Time Has Come,” The American Journal of Bioethics 19, no. 5 (2019): 41–42, at 41.CrossRefGoogle Scholar
Parens, E., “Drifting Away from Informed Consent in the Era of Personalized Medicine,” Hastings Center Report 45, no. 4 (2015): 16–20.CrossRefGoogle Scholar
Lakes, K.D., Vaughan, E., Jones, M., Burke, W., Baker, D., and Swanson, J.M., “Diverse Perceptions of the Informed Consent Process: Implications for the Recruitment and Participation of Diverse Communities in the National Children's Study,” American Journal of Community Psychology 49, no. 1-2 (2012): 215–232.CrossRefGoogle Scholar
See Parens, supra note 39, at 17.Google Scholar
See Parens, supra note 39, at 17.Google Scholar
See Parens, supra note 39, at 19.Google Scholar
Appelbaum, P.S., “Ignorance Isn't Bliss: Retaining a Meaningful Comprehension Requirement for Consent to Research,” The American Journal of Bioethics 19, no. 5 (2019): 22–24.CrossRefGoogle Scholar
Zawati, M. and Knoppers, B.M., “Reciprocity and the Quest for Meaningful Disclosure,” The American Journal of Bioethics 19, no. 5 (2019): 36–38.CrossRefGoogle Scholar
Dickert, N.W., “The Value of Consent for Clinical Research Does Not Always Hinge on Understanding,” The American Journal of Bioethics 19, no. 5 (2019): 20–22, at 21.CrossRefGoogle Scholar
Henderson, G.E., Edwards, T.P., and Cadigan, R.J., et al., “Stew-ardship Practices of U.S. Biobanks,” Science Translational Medicine 5 (2013): np.CrossRefGoogle Scholar
Jeffers, B.R., “Human Biological Materials in Research: Ethical Issues and the Role of Stewardship in Minimizing Research Risks,” Advances in Nursing Science 24, no. 3 (2001): 32–46; Laurie, G.T., Dove, E.S., and Ganguli-Mitra, A., et al., “Charting Regulatory Stewardship in Health Research: Making the Invisible Visible,” Cambridge Quarterly of Healthcare Ethics 27, no. 2 (2018): np.CrossRefGoogle Scholar
Kraft, S.A., Cho, M.K., and Gillespie, K., et al., “Beyond Consent: Building Trusting Relationships with Diverse Populations in Precision Medicine Research,” The American Journal of Bioethics 18, no. 4 (2018): 3–20; Khodyakov, D., Mikesell, L., and Bromley, E., “Trust and the Ethical Conduct of Community-Engaged Research,” European Journal of Person-Centered Healthcare 5, no. 4 (2017): 522–526; Yarborough, M., Fryer-Edwards, K., Geller, G., and Sharp, R., “Transforming the Culture of Biomedical Research from Compliance to Trustworthiness: Insights from Non-Medical Sectors,” Academic Medicine 48 (2009): 472-477; Moreno-John, G., Fleming, C., and Ford, M.E., et al., “Mentoring in Community-Based Participatory Research: The RCMAR Experience,” Ethnicity & Disease 17, no. 1 (2007): 33–43.CrossRefGoogle Scholar
Kraft, S.A., Cho, M.K., and Gillespie, K., et al., “Beyond Consent: Building Trusting Relationships with Diverse Populations in Precision Medicine Research,” The American Journal of Bioethics 18, no. 4 (2018): 3–20; Burgess, M.M. and O’Doherty, K.C., “Moving From Understanding of Consent Conditions to Heuristics of Trust,” The American Journal of Bioethics 19, no. 5 (2019): 24–26.Google Scholar