Table 5 Illustrative verbatim explanations for the type of review required, by country: professional-cluster scenario
Country | Type of review | Explanation |
|---|---|---|
Canada | Full review | This study would require REB approval because there is an intervention, patient data is collected and consent is not planned. There is the onus to review fully given the lack of a consent process, regardless of the reason. |
| Â | Expedited | Meets all Tri-Council Policy Statement (TCPS) criteria for minimal risk. |
| Â | No review | This seems to be more akin to a Quality Improvement study of whether an educational intervention and reminders about an accepted Clinical Guideline leads to greater acceptance and adoption of these practices. Our REB does not review these, but there is a process of review and support for these studies through our Quality and Risk Management Dept. All interventions and practices are clinically indicated and data is only aggregate. |
United Kingdom | Full review | Because of the randomisation of practices. Otherwise could have been considered as a service evaluation and therefore not require review (potentially!) |
| Â | Expedited review | Minimal risk, using routinely collected data, assuming that patient data for outcome 2 are properly anonymised and secure, and do not require information that is outside normal clinical care. |
| Â | No review | This is classic improvement methodology and would not need review. |
United States | Full review | There is an issue of physicians being known to the researchers and the potential for data about their behavior that could be used to potentially harm the physician’s reputation due to information about his/her medical practices (x-rays). |
| Â | Expedited review | We would not consider an educational intervention as treatment. The educational intervention mailing established imaging guidelines is clearly minimal risk. Measuring radiology imaging by GP is not private information and routinely measured by many external entities. The outcome measures of number X-rays/thousand and anonymized medical records review would meet Expedited review categories. |
|  | No review | This seem to be primarily a trial to determine quality of care and use or misuse of diagnostic studies. No patient is harmed or helped by the study. It may help cost containment. It doesn’t need to come to the IRB. |