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.

Submission

An application for ethical review should be accompanied by:

  1. Covering letter
  2. Completed application form or exemption form available online at http://nbcpakistan.org.pk/
  3. C.V of the Primary Investigator
  4. Research Protocol
  5. Budget to assess justification of funds

 

Timeline for the process:

  1. REC review will be sent to PI within six weeks after submission. In exceptional circumstances expedited review will be done within 2 weeks.
  2. Once the review by REC is sent to PI, it is expected that the PI must respond within 2-months, if no response from PI is received at the end of two months, a letter will be sent to PI stating ‘that if in the next 1-month the PI does not respond the study will be considered to be abandoned by PI’ and will be marked as ‘Null and Void’in the Submission Record.

 

 

 

NBC Secretariat, PHRC

Shahrah-e-Jamhuriat, G-5/2

Islamabad, Pakistan

Tel: +92-51-9224325, 9207386

Fax: +92-51-9216774

nbcpakistan.org@gmail.com