Hostname: page-component-78c5997874-dh8gc Total loading time: 0 Render date: 2024-11-19T17:04:11.289Z Has data issue: false hasContentIssue false

Electronic Informed Consent in Mobile Applications Research

Published online by Cambridge University Press:  01 January 2021

Abstract

The article covers electronic informed consent (eIC) from different dimensions so that practitioners might understand the history, regulation, and current status of eIC. It covers the transition of informed consent to electronic screens and the implications of that transition in terms of design, costs, and data analysis. The article explores the limits of regulation mandating eIC for mobile application research, and addresses some of the broader social context around eIC.

Type
Symposium Articles
Copyright
Copyright © American Society of Law, Medicine and Ethics 2020

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

The Electronic Signatures in Global and National Commerce Act (E-Sign Act), available at <https://www.fdic.gov/regulations/compliance/manual/10/x-3.1.pdf> (last visited February 14, 2020).+(last+visited+February+14,+2020).>Google Scholar
Reed, W., Carroll, J.A. S., and Agramonte, A., “The Etiology of Yellow Fever: An Additional Note,” Journal of the American Medical Association 36, no. 7 (1901): 431-440.CrossRefGoogle Scholar
21 C.F.R. § 11.1(a).Google Scholar
21 C.F.R. § 50.27(a).Google Scholar
21 C.F.R. § 50.27(a).Google Scholar
45 C.F.R. § 46.116 and 21 CFR § 50.25.Google Scholar
45 C.F.R. § 46.116(b)(5) and 21 CFR § 50.25(b)(5).Google Scholar
45 C.F.R. § 46.116 and 21 CFR § 50.20.Google Scholar
21 C.F.R. § 11.100(b).Google Scholar
Use of Electronic Informed Consent in Clinical Investigations — Questions and Answers, available at <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-electronic-informed-consent-clinical-investigations-questions-and-answers> (last visited February 14, 2020).+(last+visited+February+14,+2020).>Google Scholar
Clayton, E.W., “The Unbearable Requirement of Informed Consent” (2019), a comment on “Exploring Understanding of ‘Understanding’: The Paradigm Case of Biobank Consent Comprehension,” American Journal of Bioethics 19, no. 5 (2019): 6-18.Google Scholar
45 C.F.R. § 46.115; 21 C.F.R. § 56.115.Google Scholar
Collaborative Projects — EDM Forum, available at <https://www.edmforumresearchportal.org/edmhome/collaborate/collaborativeprojects> (last visited October 29, 2019).+(last+visited+October+29,+2019).>Google Scholar
Wilbanks, J., “Portable Approaches to Informed Consent and Open Data,” Privacy, Big Data, and the Public Good: Frameworks for Engagement 1 (2014): 234-252.CrossRefGoogle Scholar
Wilbanks, J., “Design Issues in E-Consent,” Journal of Law, Medicine & Ethics 46, no. 1 (2018): 110-18.CrossRefGoogle Scholar
Doerr, M., Suver, C., and Wilbanks, J., “Developing a Transparent, Participant-Navigated Electronic Informed Consent for Mobile-Mediated Research,” available at SSRN: https://ssrn.com/abstract=2769129> (last visited February 14, 2020).+(last+visited+February+14,+2020).>Google Scholar
GitHub —Sage-Bionetworks, “PCC-Toolkit,” available at <https://github.com/Sage-Bionetworks/PCC-Toolkit> (last visited February 14, 2020).+(last+visited+February+14,+2020).>Google Scholar
Elements of Informed Consent, available at <https://sage-bionetworks.org/tools_resources/elements-of-informed-consent/> (last visited February 14, 2020).+(last+visited+February+14,+2020).>Google Scholar
Bot, B.M. et al., “The mPower Study, Parkinson Disease Mobile Data Collected Using ResearchKit,” Scientific Data 3 (2016): 1-9.CrossRefGoogle Scholar
Developer Human Interface Guidelines, available at <https://developer.apple.com/design/human-interface-guidelines/researchkit/overview/introduction/> (last visited February 14, 2020).+(last+visited+February+14,+2020).>Google Scholar
ResearchStack, available at <http://researchstack.org/> (last visited February).+(last+visited+February).>Google Scholar
See Wilbanks, supra note 19.Google Scholar
Gray, C.M. et al., “The Dark (Patterns) Side of UX Design,” in Proceedings of the 2018 CHI Conference on Human Factors in Computing Systems, ACM (2018): 534.CrossRefGoogle Scholar
Senators Introduce Bipartisan Legislation to Ban Manipulative “Dark Patterns,” available at <https://www.fischer.senate.gov/public/index.cfm/2019/4/senators-introduce-bipartisan-legislation-to-ban-manipulative-dark-patterns> (last visited October 29, 2019).+(last+visited+October+29,+2019).>Google Scholar
Sand, K., Stein, K., and Loge, J.H., “The Understanding of Informed Consent Information—Definitions and Measurements in Empirical Studies,” AJOB Primary Research 1, no. 2 (2010): 4-24.CrossRefGoogle Scholar
Beskow, L.M. and Weinfurt, K.P., “Exploring Understanding of ‘Understanding’: The Paradigm Case of Biobank Consent Comprehension,” American Journal of Bioethics 19, no. 5 (2019): 6-18.CrossRefGoogle Scholar
ResearchKit Apps and Studies Launched in 2016, available at <http://blog.appliedinformaticsinc.com/researchkit-appsand-studies-launched-in-2016/> (last visited October 29, 2019).+(last+visited+October+29,+2019).>Google Scholar
FocalView — Redefining Ophthamology Clinical Research, available at <http://researchkit.org/blog.html#article-32> (last visited October 29, 2019).+(last+visited+October+29,+2019).>Google Scholar
Obar, J.A. and Oeldorf-Hirsch, A., “The Biggest Lie on the Internet: Ignoring the Privacy Policies and Terms of Service Policies of Social Networking Services,” Information, Communication & Society (2018): 1-20.CrossRefGoogle Scholar
Steinfeld, N., “I Agree to the Terms and Conditions: (How) Do Users Read Privacy Policies Online? An Eye-tracking Experiment,” Computers in Human Behavior 55-Part B (2016): 992-1000.CrossRefGoogle Scholar
Moore, S. et al., “Consent Processes for Mobile App Mediated Research: Systematic Review,” JMIR mHealth and uHealth 5, no. 8 (2017): e126.CrossRefGoogle Scholar
See Doerr, supra note 21.Google Scholar
Benham-Hutchins, M. et al., “‘I Want to Know Everything’: A Qualitative Study Of Perspectives from Patients with Chronic Diseases on Sharing Health Information During Hospitalization,” BMC Health Services Research 17, no. 1 (2017): 529.CrossRefGoogle Scholar
A Big Step Towards Giving Patients Control Over Their Health Care Data, available at <https://hbr.org/2019/03/a-big-step-toward-giving-patients-control-over-their-health-care-data> (last visited February 14, 2020).+(last+visited+February+14,+2020).>Google Scholar
Wilkins, C. H. et al., “Understanding What Information Is Valued by Research Participants, and Why,” Health Affairs 38, no. 3 (2019): 399-407.CrossRefGoogle Scholar
See Clayton, supra note 15.Google Scholar
Wilkins et al., supra note 41.Google Scholar
Nebeker, C., Linares-Orozco, R., and Crist, K., “A Multi-Case Study of Research Using Mobile Imaging, Sensing and Tracking Technologies to Objectively Measure Behavior: Ethical Issues and Insights to Guide Responsible Research Practice,” Journal of Research Administration 46, no. 1 (2015): 118-137.Google Scholar
Schairer, C.E., Rubanovich, C.K., and Bloss, C.S., “How Could Commercial Terms of Use and Privacy Policies Undermine Informed Consent in the Age of Mobile Health?” AMA Journal of Ethics 20, no. 9 (2018): 864-872.Google Scholar
Greig, P. and Irvine, J., “Privacy Implications of Wearable Health Devices,” in Proceedings of the 7th International Conference on Security of Information and Networks, ACM (2014): at 117.Google Scholar
Reidenberg, J. R. et al., “Disagreeable Privacy Policies: Mismatches Between Meaning and Users’ Understanding,” Berkeley Technology Law Journal 30, no. 1 (2015): 39-88.Google Scholar
See Obar, supra note 35.Google Scholar
“Privacy Icons: Alpha Release,” available at <http://www.azarask.in/blog/post/privacy-icons/> (last visited October 29, 2019).+(last+visited+October+29,+2019).>Google Scholar
Gropper, A., “Patient Privacy Rights Information Governance Label,” August 19, 2019, available at <https://ssrn.com/abstract=3439701> (last visited February 14, 2020).CrossRef+(last+visited+February+14,+2020).>Google Scholar
“Privacy Toolkit,” available at <https://privacytoolkit.sagebio-networks.org/> (last visited February 14, 2020).+(last+visited+February+14,+2020).>Google Scholar
“AI-Powered Privacy Policies,” available at <https://pribot.org/> (last visited February 14, 2020).+(last+visited+February+14,+2020).>Google Scholar
Vaidhyanathan, S. and Bulock, C., “Knowledge and Dignity in the Era of ‘Big Data,’” The Serials Librarian 66, no. 1-4 (2014): 49-64.CrossRefGoogle Scholar
Greenberg, S. et al., “Dark Patterns in Proxemic Interactions: A Critical Perspective,” in Proceedings of the 2014 conference on Designing interactive systems, ACM (2014): 523-532.CrossRefGoogle Scholar
“CRF Health: eConsent Adoption to Reach 82% by 2020,” available at <https://www.outsourcing-pharma.com/Article/2017/03/16/eConsent-adoption-to-reach-82-by-2020-CRF-Health> (last visited February 14, 2020).+(last+visited+February+14,+2020).>Google Scholar
“About the Framingham Heart Study Participants,” available at <https://www.framinghamheartstudy.org/about-the-fhs-participants/> (last visited February 14, 2020).+(last+visited+February+14,+2020).>Google Scholar
The Director of the NIH Lays Out His Vision of the Future of Medical Science,” available at <https://time.com/5709207/medical-science-age-of-discovery/> (last visited February 14, 2020).+(last+visited+February+14,+2020).>Google Scholar
“Data — AllofUs Research Hub,” available at <https://www.researchallofus.org/data/> (last visited February 14, 2020).+(last+visited+February+14,+2020).>Google Scholar
McConnell, M.V. et al., “Feasibility of Obtaining Measures of Lifestyle From a Smartphone App: The MyHeart Counts Cardiovascular Health Study,” JAMA Cardiology 2, no. 1 (2017): 67-76.CrossRefGoogle Scholar
Pratap, A. et al., “Indicators of Retention in Remote Digital Health Studies: A Cross-Study Evaluation of 100,000 Participants,” available at <https://arxiv.org/pdf/1910.01165> (last visited February 14, 2020).CrossRef+(last+visited+February+14,+2020).>Google Scholar
Meyer, M.N., “Ethical Considerations When Companies Study — and Fail to Study — Their Customers,” The Cambridge Handbook of Consumer Privacy (2018): 207.CrossRefGoogle Scholar
Metcalf, J. and Crawford, K., “Where Are Human Subjects in Big Data Research? The Emerging Ethics Divide,” Big Data & Society 3, no. 1 (2016): 1-14.CrossRefGoogle Scholar
Heck, P.R. et al., “Sometimes People Dislike Experiments More than They Dislike Their Worst Conditions: Within-Subjects Evidence for ‘Experiment Aversion’ and the A/B Effect,” PsyArXiv (2019), available at <https://psyarxiv.com/jmxgc> (last visited February 14, 2020).+(last+visited+February+14,+2020).>Google Scholar
Cadwalladr, C. and Graham-Harrison, E., “Revealed: 50 Million Facebook Profiles Harvested for Cambridge Analytica in Major Data Breach,” The Guardian (March 17, 2018).Google Scholar
González, F. et al., “Global Reactions to the Cambridge Analytica Scandal: An Inter-Language Social Media Study,” WWW ’19 Companion, available at <https://faculty.washington.edu/aragon/pubs/LA_WEB_Paper.pdf> (last visited February 14, 2020).CrossRef+(last+visited+February+14,+2020).>Google Scholar
Ajunwa, I., Crawford, K., and Schultz, J., “Limitless Worker Surveillance,” California Law Review 105, no. 3 (2017): 735-776.Google Scholar
Funk, M., “How ICE Picks Its Targets in the Surveillance Age,” The New York Times Magazine, available at <https://www.nytimes.com/2019/10/02/magazine/ice-surveillance-deportation.html> (last visited February 14, 2020).+(last+visited+February+14,+2020).>Google Scholar
Dickerson, C., “U.S. Government Plans to Collect DNA From Detained Immigrants,” New York Times, available at <https://www.nytimes.com/2019/10/02/us/dna-testing-immigrants.html> (last visited February 14, 2020).+(last+visited+February+14,+2020).>Google Scholar
Geekwire, “FTC Files First-Ever Charges Against Company Accused of Paying for Fake Amazon Reviews,” available at <https://www.geekwire.com/2019/ftc-files-first-ever-charges-company-accused-paying-fake-amazon-reviews/> (last visited February 14, 2020).+(last+visited+February+14,+2020).>Google Scholar
“New York Arm-wrestling Legend and His Mom Arrested for Selling ‘Apricots From God’ as Bogus Cancer Cure,” The Washington Post, available at <https://www.washingtonpost.com/nation/2019/10/24/jason-vale-apricot-seeds-cancer-cure-arrest-arm-wrestling/> (last visited February 14, 2020).+(last+visited+February+14,+2020).>Google Scholar
Boyd, D. and Crawford, K., “Critical Questions for Big Data: Provocations for a Cultural, Technological, and Scholarly Phenomenon,” Information, Communication & Society 15, no. 5 (2012): 662-679.CrossRefGoogle Scholar
See Clayton, supra note 15.Google Scholar
Fiske, S.T. and Hauser, R.M., “Protecting Human Research Participants in the Age of Big Data,” Proceedings of the National Academy of Sciences of the United States of America 111, no. 38 (2014): 13675-13676.CrossRefGoogle Scholar