RT Journal Article SR Electronic T1 Access to medical records for research purposes: varying perceptions across research ethics boards JF Journal of Medical Ethics JO J Med Ethics FD BMJ Publishing Group Ltd and Institute of Medical Ethics SP 308 OP 314 DO 10.1136/jme.2006.020032 VO 34 IS 4 A1 D J Willison A1 C Emerson A1 K V Szala-Meneok A1 E Gibson A1 L Schwartz A1 K M Weisbaum A1 F Fournier A1 K Brazil A1 M D Coughlin YR 2008 UL http://jme.bmj.com/content/34/4/308.abstract AB Introduction: 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 consent for the study to proceed as proposed. Three (10%) indicated that their response would depend on how potentially identifying variables would be managed. Eleven sites (38%) did not require consent. Two (7%) suggested a notification and opt-out process. Most stated that consent would be required if identifiable information was being abstracted from the record. Among those not requiring consent, there was substantial variation in recognising that the abstracted information could potentially indirectly re-identify individuals. Concern over access to medical records by an outside individual was also associated with requirement for consent. Eighteen sites (60%) required full committee review. Sixteen (53%) allowed an external research assistant to abstract information from the health record.Conclusions: Large variation was found across sites in the requirement for consent for research involving access to medical records. REBs need training in best practices for protecting privacy and confidentiality in health research. A forum for REB chairs to confidentially share concerns and decisions about specific studies could also reduce variation in decisions.