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Canadian Family Physician Le Médecin de famille canadien|
VOL 60: JANUARY • JANVIER 2014Sentinel Eye | College
•Collège
Facilitating informed consent for EMR research in Quebec
Justin Gagnon
MAJannet Ann Leggett
JD CIPP/C CIPMClaude Richard
PhD MAMarie-Thérèse Lussier
MD MSc FCMFT
he Réseau de recherche en soins primaires de l’Université de Montréal (RRSPUM) is a primary care practice–based research network (PC-PBRN) partici- pating in the Canadian Primary Care Sentinel Surveillance Network (CPCSSN). It and 9 other PC-PBRNs comprise the first pan-Canadian public health surveillance and research project using patient data from providers’ (sen- tinels’) electronic medical records (EMRs). To collect and use anonymized1 electronic health data, each PC-PBRN works with research ethics boards (REBs) to establish procedures that comply with its province’s privacy laws.Among the provinces, Quebec’s privacy laws are the most stringent, which poses challenges for researchers. The handling of personal information is governed by the Civil Code of Quebec,2 and 2 acts pertaining to the public and private sectors.3,4 These mandate individuals’ right to control access to their health data and require explicit (opt-in) consent for the data’s use, even if the data do not directly identify them. Other privacy regimes across Canada permit implicit (opt-out) consent and apply only to identifying information.
The RRSPUM team had to develop distinct patient consent protocols to comply with distinct privacy laws for private and public sector institutions. For public sector institutions, Quebec’s An Act Respecting Health Services and Social Services5 governs the handling of health information. It permits the use of health data for research purposes without the individual’s explicit consent, provided researchers obtain permission from their health institution’s director of professional services after REB approval. The REB reviews research- ers’ proposed protocols and dictates required changes.
Patient notice protocols can differ among REBs. The REBs affliated with Quebec public institutions partici- pating in CPCSSN have determined that passive patient notifcation alone (CPCSSN brochures and posters in clinic waiting areas and consultation rooms) is insuff- cient. Instead, these REBs require a proactive approach, whereby each patient receives the brochure with a sep- arate opt-out form.
Working with clinic administrative staff and a soft- ware developer, RRSPUM researchers designed a proac- tive patient notifcation and consent protocol for public clinics. They added a check-box to the top administra- tive page of the patients’ EMRs, which the clinics’ recep- tion staff ticked when issuing the CPCSSN brochures and opt-out forms. In the year since implementation, the rate of opt-out for the public clinics’ notifed patients was 10%, which is well within an acceptable range for valid research.
The RRSPUM team used a different protocol for pri- vate clinics. The Central REB for the Ministère de la santé et des services sociaux requires that patients sign a consent form of several pages. The Central REB and RRSPUM developed a procedure for obtaining explicit (opt-in) consent: reception staff ticked a box on the EMR’s top page when the patient received the CPCSSN brochure and consent form, then ticked a second box when the patient returned the signed form. After several months, the opt-in rate is 40%, which is less than opti- mal for research.
While the proactive consent protocol satisfies pri- vacy demands, its implementation incurs costs, such as the printing of brochures and forms for the clinic’s total patient population, and the time reception staff spend notifying patients. However, these expenses diminish over time.
The RRSPUM proactive patient notification proto- col ensures patients are informed and respects their privacy rights to control access to their health data. It enables Quebec’s contribution to meaningful chronic disease surveillance and research, and provides valu- able feedback to health care providers about their patients and practices.
Mr Gagnon is Coordinator and Research Associate at RRSPUM in Quebec. Ms Leggett is Research Privacy and Ethics Offcer (CPCSSN Project) at CFPC. Dr Richard is Associate Researcher at the Centre de santé et des services sociaux de Laval in Quebec.
Dr Lussier is Director of RRSPUM and Associate Professor at the University of Montreal.
Competing interests None declared Acknowledgment
Funding for this publication was provided by the Public Health Agency of Canada. The views expressed do not necessarily represent the views of the Public Health Agency of Canada.
References
1. Tri-council policy statement. Ethical conduct for research involving humans.
Ottawa, ON: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada; 2010. p. 57. Available from: www.ethics.gc.ca/
pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf. Accessed 2013 Dec 9.
2. Civil Code of Québec, LRQ, c C-1991. Available from: http://canlii.
ca/t/5239b. Accessed 2013 Dec 9.
3. An Act respecting the protection of personal information in the private sector, CQLR c P-39.1. Available from: http://canlii.ca/t/l031. Accessed 2013 Dec 9.
4. An Act respecting Access to documents held by public bodies and the Protection of personal information, CQLR c A-2.1. Available from: http://
canlii.ca/t/lbd1. Accessed 2013 Dec 9.
5. An Act respecting health services and social services, CQLR c S-4.2.
Available from: http://canlii.ca/t/5243c. Accessed 2013 Dec 9.
Sentinel Eye is coordinated by CPCSSN, in partnership with the CFPC, to highlight surveillance and research initiatives related to chronic illness prevalence and management in Canada. Please send questions or comments to Anita Lambert Lanning, CPCSSN Project Manager, at all@cfpc.ca.
