Routine review process
The duration of approval for a study shall be valid to a maximum period of one (1) year after which a re-approval is required. This will be standard for any study submitted irrespective of its duration whether one (1), five (5) or more years. Any change in conditions that could affect the rights/autonomy/welfare of subjects or serious adverse event during a study must be informed for approval to continue the study. See More
In exceptional circumstance urgent/expedited review may be done by at least two or more members and the chairman for approval or disapproval. Such approvals shall be reported to the next meeting of REC. The response letter to the applicant should mention that the decision is through expedited review. (This would be in special circumstance and not for convince)
Studies that do not require direct human subject participants e.g. chart review, already collected data for routine public health reasons etc, case reports may be exempted for review. But these studies and NBC-REC exemption form would have to be submitted to the REC to issue an exemption certificate. Such exemptions shall be reported to the next meeting of REC.
An application for ethical review should be accompanied by:
Timeline for the process:
NBC Secretariat, PHRC
Tel: +92-51-9224325, 9207386