Access to Medical Records for Research Purposes: Varying Perceptions Across Research Ethics Boards

Authors

Donald Willison, McMaster University
Claudia Emerson
Karen Szala-Meneok, McMaster University
Elaine Gibson, Schulich School of Law, Health Law Institute, Dalhousie UniversityFollow
Lisa Schwartz, McMaster University
Karen Weisbaum, Queen's University
François Fournier, Institut de recherches cliniques de Montréal (IRCM)
Kevin Brazil, McMaster University - Department of Health Research Methods, Evidence, and Impact (HEI)Follow
Michael Coughlin, McMaster University

Document Type

Article

Publication Date

2008

Keywords

Medical Records, Access, Ethics, Consent, Privacy, Confidentiality, Health Research, Research Ethics Boards

Abstract

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.

Comments

2008 BMJ Publishing Group & Institute of Medical Ethics

Recommended Citation

Donald Wilson et al, "Access to Medical Records for Research Purposes: Varying Perceptions Across Research Ethics Boards" (2008) 34:4 J Med Ethics 308.