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Comparative Study
. 2011 Oct;57(10):1165-73.

Ethics and privacy issues of a practice-based surveillance system: need for a national-level institutional research ethics board and consent standards

Jyoti A Kotecha  1 , Donna Manca, Anita Lambert-Lanning, Karim Keshavjee, Neil Drummond, Marshall Godwin, Michelle Greiver, Wayne Putnam, Marie-Thérèse Lussier, Richard Birtwhistle
Affiliations
Comparative Study

Ethics and privacy issues of a practice-based surveillance system: need for a national-level institutional research ethics board and consent standards

Jyoti A Kotecha et al. Can Fam Physician. 2011 Oct.

Abstract
in English, French

Objective: To describe the challenges the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) experienced with institutional research ethics boards (IREBs) when seeking approvals across jurisdictions and to provide recommendations for overcoming challenges of ethical review for multisite and multijurisdictional surveillance and research.

Background: The CPCSSN project collects and validates longitudinal primary care health information (relating to hypertension, diabetes, depression, chronic obstructive lung disease, and osteoarthritis) from electronic medical records across Canada. Privacy and data storage security policies and processes have been developed to protect participants' privacy and confidentiality, and IREB approval is obtained in each participating jurisdiction. Inconsistent interpretation and application of privacy and ethical issues by IREBs delays and impedes research programs that could better inform us about chronic disease.

Results: The CPCSSN project's experience with gaining approval from IREBs highlights the difficulty of conducting pan-Canadian health surveillance and multicentre research. Inconsistent IREB approvals to waive explicit individual informed consent produced particular challenges for researchers.

Conclusion: The CPCSSN experience highlights the need to develop a better process for researchers to obtain timely and consistent IREB approvals for multicentre surveillance and research. We suggest developing a specialized, national, centralized IREB responsible for approving multisite studies related to population health research.

Objectif: Décrire les difficultés rencontrées par le Réseau canadien de surveillance sentinelle en soins primaires (RCSSSP) face aux bureaux institutionnels d’éthique en recherche (BIÉR) lors des demandes d’approbation aux diverses instances, et formuler des recommandations pour répondre aux défis que présente l’examen éthique dans les cas de surveillance et d’études multicentriques relevant de plusieurs juridictions.

Contexte: Le projet du RCSSSP recueille et valide des données longitudinales sur les soins de santé primaires (concernant l’hypertension, le diabète, la dépression, la maladie pulmonaire obstructive chronique et l’arthrose) à partir de dossiers médicaux électroniques d’un peu partout au Canada. On a élaboré des politiques et des processus relatifs à la protection de la confidentialité et au stockage sécuritaire des données afin de protéger la vie privée et la confidentialité des participants, tandis que l’approbation des BIÉR relève de chaque juridiction participante. Des différences entre les BIÉR quant à l’interprétation et l’application des questions de confidentialité et d’éthique retardent et gênent des programme de recherche qui pourraient mieux nous renseigner sur les maladies chroniques.

Résultats: Ce que le projet RCSSSP a constaté relativement à l’approbation des BIÉR illustre bien la difficulté d’effectuer une surveillance pan-canadienne de la santé et des recherches multicentriques. Des contradictions entre BIÉR dans les décisions concernant le fait de ne pas exiger des consentements éclairés individuels explicites ont occasionné des problèmes importants aux chercheurs.

Conclusion: L’expérience du RCSSSP fait bien voir la nécessité de mettre au point un processus plus adéquat permettant aux chercheurs d’obtenir de façon moins variable et en temps opportun des approbations pour des études de surveillance et de recherche multicentriques. Les auteurs suggèrent de créer un BIÉR national centralisé et spécialisé ayant la responsabilité d’approuver les études multicentriques sur la santé de la population.

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Figures

Figure 1.
Figure 1.
Map of regionally applicable privacy acts across Canada ATIPPA—Access to Information and Protection Privacy Act, FIPPA—Freedom of Information and Protection of Privacy Act, FOIP—Local Freedom of Information and Protection of Privacy Act, HIA—Health Information Act, HIPA—Health Information Protection Act, PHIA—Personal Health Information Act, PHIPA—Personal Health Information Protection Act, PIPA—Personal Information Protection Act, MFIPPA—Municipal Freedom of Information and Protection of Privacy Act. *Quebec acts: Respecting the Protection of Personal Information in the Private Sector, Respecting Access to documents Held by Public Bodies and the Protection of Personal Information, la loi sur services de santé et services sociaux due Québec.
Figure 2.
Figure 2.
The CPCSSN data elements CPCSSN—Canadian Primary Care Sentinel Surveillance Network, DIN—drug identification number, EMR—electronic medical record, FSA—forward sortation area, ID—identification, MD—medical degree.
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References

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