Dear all,
in our local ethical commetee we are trying to define some issues for reasearch submission.
One definition we find difficult to set is if a diagnostic accuracy study (tipical cross-over study with all patients who undergo both gold standard and new test) is an observational or sperimental design.
The cross-over design is a tipical observational study (i.e. prevalence study)
But if I decide (away from normal routine care) to execute two different tests (with some kind of risk - i.e. radiation) to all patients, this study does not sound like observational research
Any suggestion?
Readings?
We've found this document which gave us some hints:
National Ethics Advisory Committee. 2012. Ethical Guidelines for Observational Studies: Observational research, audits and related activities. Revised edition. Wellington: Ministry of Health.
https://neac.health.govt.nz/system/files/documents/publications/ethical-guidelines-for-observational-studies-2012.pdf
Best regards
Carlo
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