Table 1 Rationales offered by sites (n = 29) for their decisions regarding need for consent
Is consent required?Rationales provided
Principles/policies*Role of identifiability in influencing decisionAccess by outside research assistant
Yes (n = 14)Respect for individuals (14)REB policy (2)Consent is practicable (3)Concern over identifiability (10)No concern (3)Not raised (1)All 14 expressed concern. For 7, this was either the reason or an important factor for requiring consent
“It depends” (n = 3)Pivotal role (3). Consent required if needed full postal code, birth date, ethnic origin. Would drop requirement if reduced data specificity (eg, age instead of birth date)Not raised in the rationale
No (n = 10)Minimal risk (7)REB policy (4)Province allows (1)Consent impracticable (1)Identifiability is an important criterion, but not an issue here, because data are anonymous (6)Identifiability not relevant in consent decision (4)Not raised in the rationale
Notification and opt-out (n = 2)Precedent of other case (1)No rationale (1)Not raised in the rationale
  • NB One site was dropped from the analyses, as the opinion at that site was that the scenario did not represent research but quality assurance.

  • *Totals may add up to greater than the denominator, as more than one rationale may have been cited.