Between Scylla and Charybdis: Charting the Wicked Problem of Reusing Health Data for Clinical Research Informatics

Summary

Objectives: Recognising dilemmas posed by the sharing and reuse of health data as a classic wicked problem and uncover some current key challenges to clinical research informatics.

Methods: A modified thematic review process including identification of agreed critical research questions, appropriate query terms and search strategy, identification of relevant papers in accordance with inclusion criteria, and authors' co-review of full text papers.

Results: Queries returned 4,779 papers published between January 2014 and November 2017. A shortlist of 197 abstracts was analysed and 18 papers were finally selected for review. Thematic assessment of findings revealed four key challenges: (1) uncertain reliability of consent as a cornerstone of trust due to the limits to understanding and awareness of data sharing; (2) ethical challenges around equity and autonomy; (3) ambitious overly theoretical governance frameworks lacking practical validity; and (4) a clear desire for further public and individual engagement to achieve clearer and more nuanced knowledge dissemination around data sharing practice and governance frameworks.

Conclusions: Understanding the wicked problem of reusing clinically acquired health data for research purposes is essential if clinical research is to benefit from informatics advances. A lack of understanding around the context of data acquisition and sharing undermines the foundations of patient-professional trust. Efforts to protect privacy, where tailoring to specific contexts is a key driver, should support the development of solutions which more adequately honour privacy needs, justify access, and protect equity and autonomy.

Keywords

Clinical research - informatics - privacy - ethics - access and data sharing - trust - consent - public engagement and involvement

• References

• 1 Lea NC, Nicholls J. Are patient relationships the driver for information governance?. Br J Gen Pract 2016; 66 (648) 342-343
• 2 European Regulation (EU) 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation), art. 12
• 3 Thomas J, Harden A. Methods for the thematic synthesis of qualitative research in systematic reviews. BMC Med Res Methodol 2008; 8: 45
• 4 De Lusignan S, Liyanage H, Di Iorio CT, Chan T, Liaw ST. Using routinely collected health data for surveillance, quality improvement and research: Framework and key questions to assess ethics, privacy and data access. J Innov Health Inform 2016; 22 (04) 426-432
• 5 Willison DJ, Ondrusek N, Dawson A, Emerson C, Ferris LE, Saginur R. , et al. What makes public health studies ethical? Dissolving the boundary between research and practice. BMC Med Ethics 2014; 15: 61
• 6 Moore S, Tasse AM, Thorogood A, Winship I, Zawati M, Doerr M. Consent Processes for Mobile App Mediated Research: Systematic Review. JMIR MHealth UHealth 2017; 5 (08) e126
• 7 Nebeker C, Murray K, Holub C, Haughton J, Arredondo EM. Acceptance of Mobile Health in Communities Underrepresented in Biomedical Research: Barriers and Ethical Considerations for Scientists. JMIR MHealth UHealth 2017; 5 (06) e87
• 8 Arora S, Yttri J, Nilse W. Privacy and Security in Mobile Health (mHealth) Research. Alcohol Res 2014; 36 (01) 143-151
• 9 Spencer K, Sanders C, Whitley EA, Lund D, Kaye J, Dixon WG. Patient Perspectives on Sharing Anonymized Personal Health Data Using a Digital System for Dynamic Consent and Research Feedback: A Qualitative Study. J Med Internet Res 2016; 18 (04) e66
• 10 Williams H, Spencer K, Sanders C, Lund D, Whitley EA, Kaye J. , et al. Dynamic consent: a possible solution to improve patient confidence and trust in how electronic patient records are used in medical research. JMIR Med Inform 2015; 3 (01) e3
• 11 Audrey S, Brown L, Campbell R, Boyd A, Macleod J. Young people's views about consenting to data linkage: findings from the PEARL qualitative study. BMC Med Res Methodol 2016; 16: 34
• 12 Rothstein MA. Ethical Issues in Big Data Health Research: Currents in Contemporary Bioethics. J Law Med Ethics 2015; 43 (02) 425-429
• 13 Balas EA, Vernon M, Magrabi F, Gordon LT, Sexton J. Big Data Clinical Research: Validity, Ethics, and Regulation. Stud Health Technol Inform 2015; 216: 448-452
• 14 Aitken M, de St Jorre J, Pagliari C, Jepson R, Cunningham-Burley S. Public responses to the sharing and linkage ofhealth data for research purposes: a systematic review and thematic synthesis of qualitative studies. BMC Med Ethics 2016; 17 (01) 73
• 15 Grande D, Mitra N, Shah A, Wan F, Asch DA. The importance of purpose: moving beyond consent in the societal use of personal health information. Ann Intern Med 2014; 161 (12) 855-862
• 16 Eagleson R, Altamirano-Diaz L, McInnis A, Welisch E, De Jesus S, Prapavessis H. , et al. Implementation of clinical research trials using web-based and mobile devices: challenges and solutions. BMC Med Res Methodol 2017; 17 (01) 43
• 17 Shabani M, Thorogood A, Borry P. Who should have access to genomic data and how should they be held accountable? Perspectives of Data Access Committee members and experts. Eur J Hum Genet 2016; 24 (12) 1671-1675
• 18 Wang S, Jiang X, Singh S, Marmor R, Bonomi L, Fox D. , et al. Genome privacy: challenges, technical approaches to mitigate risk, and ethical considerations in the United States. Ann N Y Acad Sci 2017; 1387 (01) 73-83
• 19 Liyanage H, Liaw ST, Di Iorio CT, Kuziemsky C, Schreiber R, Terry AL. , et al. Building a Privacy, Ethics, and Data Access Framework for Real World Computerised Medical Record System Data: A Delphi Study. Contribution of the Primary Health Care Informatics Working Group. Yearb Med Inform 2016; [phone]
• 20 van Staa T-P, Goldacre B, Buchan I, Smeeth L. Big health data: the need to earn public trust. BMJ 2016;354