We are planning a registry study of a particular patient population to understand outcome of medical management. The study involves retrospective data collection from patient records from multiple hospitals. There is no further follow-up planned in the study and so informed consent is also not applicable.
Therefore, we would like to consider central ethics committee approach at one center as the study falls in low to minimal risk category.
Is this as per routine practice or guidelines & requirements says something different?
Do we need to get approval from all the institutional ethics committees for such registry studies?
Is there any guidelines or reference to support central EC approach and not requiring approvals from all data collection centers for such studies?
Thanking you in anticipation.
I do not think any committee is required for these things as good professionals are enough
I suspect each hospital's research ethics committee will want to see it if only to fast track it if they find it innocuous.
You do not mention the country that the study is conducted in as ethics review requirements will vary country by country. In South Africa the study would probably be rated as minimal risk and as such will require ethics review and approval by at least one registered research ethics committee, in addition to site/gatekeeper permission from each of the sites. Sites might also elect to conduct ethics review, but most might accept a single 'central' review. With regard to one answer above, professional permission to access records for clinical purposes is not the same as accessing them for research purposes.
I agree with Douglas Wassenaar, ethics review requirements will vary country by country. In Turkey ethics review will be required from Non-invasive clinical trials, Ethics Committee for such studies.
Thank you very much everyone.
The study was planned for India.
FYR: Indian regulators now allows a central ethics committee approach in-line with the ICMR guidelines and New Drug and Clinical trials Rules, 2019.
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