title: Access to medical records for research purposes: varying perceptions across research ethics boards.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
authors: Centre for Evaluation of Medicines, St Joseph's Healthcare, McMaster University, 105 Main Street East, P1, Hamilton, ON L8N 1G8, Canada. willison@mcmaster.ca
authors: D J
authors: DJ
authors: Willison
authors: C
authors: C
authors: Emerson
authors: K V
authors: KV
authors: Szala-Meneok
authors: E
authors: E
authors: Gibson
authors: L
authors: L
authors: Schwartz
authors: K M
authors: KM
authors: Weisbaum
authors: F
authors: F
authors: Fournier
authors: K
authors: K
authors: Brazil
authors: M D
authors: MD
authors: Coughlin
mesh_terms: D035843:Biomedical Research / Q000941:ethics* / Q000592:standards; D002170:Canada; D003219:Confidentiality / Q000331:legislation & jurisprudence* / Q000523:psychology / Q000592:standards; D028744:Ethics Committees, Research / Q000941:ethics* / Q000592:standards; D006801:Humans; D008499:Medical Records / Q000331:legislation & jurisprudence*; D018907:Privacy / Q000331:legislation & jurisprudence* / Q000523:psychology; D035842:Research Subjects / Q000331:legislation & jurisprudence* / Q000523:psychology