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Access to medical records for research purposes: varying perceptions across research ethics boards
  1. D J Willison1,
  2. C Emerson2,
  3. K V Szala-Meneok3,
  4. E Gibson4,
  5. L Schwartz5,
  6. K M Weisbaum6,
  7. F Fournier7,
  8. K Brazil8,
  9. M D Coughlin9
  1. 1
    Centre for Evaluation of Medicines, St Joseph’s Healthcare and Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada
  2. 2
    Department of Philosophy, McMaster University, Hamilton, Ontario, Canada
  3. 3
    School for Rehabilitation Sciences, McMaster University, Hamilton, Ontario, Canada
  4. 4
    Health Law Institute, Dalhousie University, Halifax, Nova Scotia, Canada
  5. 5
    McMaster University, Hamilton, Ontario, Canada
  6. 6
    Queen’s University, Kingston, Ontario, Canada
  7. 7
    Centre for Bioethics, Institut de Recherches Cliniques de Montréal, Montréal, Quebec, Canada
  8. 8
    St Joseph’s Health System Research Network, McMaster University, Hamilton, Ontario, Canada
  9. 9
    St Joseph’s Healthcare Hamilton and Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada
  1. D Willison, Centre for Evaluation of Medicines, St Joseph’s Healthcare, 105 Main Street East, P1, Hamilton, ON L8N 1G8, Canada; willison{at}mcmaster.ca

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.

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Footnotes

  • Funding: This research was funded by a grant from the Canadian Institutes of Health Research (grant number MOP-577484).

  • Competing interests: At the time of the study, KMW and MDC served on research ethics boards that participated in the study. In neither of these two cases did they attend the interview or attempt to coach or influence the response of the interviewee(s).

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