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Access To Medical Records For Research Purposes: Varying Perceptions Across Research Ethics Boards, Donald Willison, Claudia Emerson, Karen Szala-Meneok, Elaine Gibson, Lisa Schwartz, Karen Weisbaum, François Fournier, Kevin Brazil, Michael Coughlin

Articles, Book Chapters, & Popular Press

Variation across research ethics boards (REBs) in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy. Aim: To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction. Methods: Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured questions around a case study with open-ended responses. Interviews were recorded, transcribed and coded manually. Results: Fourteen sites (47%) required individual patient …

Who's Minding The Shop? The Role Of Canadian Research Ethics Boards In The Creation And Uses Of Registries And Biobanks, Elaine Gibson, Kevin Brazil, Michael Coughlin, Claudia Emerson, François Fournier, Lisa Schwartz, Karen Szala-Meneok, Karen Weisbaum, Donald Willison

Articles, Book Chapters, & Popular Press

Background: The amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries and biobanks.

Methods: Chairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were …