Projects for Ethical Review
1. The Research Ethics Committee (REC) reviews research on human subjects. All research (medical or social science) projects involving human subjects, whether as individuals or communities, including surveys, drug/device trial, the use of fetal material, embryos and tissues from alive or the recently dead done with
• International Funding specifically given for research done anywhere in Pakistan e.g. Research Advocacy Fund (RAF), DFID, USAID etc
• Funded or supported by the Government of Pakistan
• Any other research either done all over Pakistan or is a multi-province
• Drug trials for registration
shall be reviewed and approved by the NBC-REC before a study is started.
2. 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.
3. 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)
4. 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.
1. An application for ethical review should be accompanied by:
a. Covering letter
b. Completed application form or exemption form available online at http://nbcpakistan.org.pk/
c. C.V of the Primary Investigator
d. Research Protocol
e. 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 2-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-REC charges a fee which differs for multinational vs. national projects and for expeidited vs regular review. (Fee structure is avaiable at http://nbcpakistan.org.pk/guidelines.html)
For further detail contact please:
NBC Secretariat, PHRC
Tel: +92-51-9224325, 9207386