National Bioethics Committee for Research
Health Research Institute
National Institutes of Health (NIH)
Routine Review Process
The National Bioethics Committee for Research 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-R before a study is started.
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 NBC-R. 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-R exemption form would have to be submitted to the NBC-R to issue an exemption certificate. Such exemptions shall be reported to the next meeting of NBC-R.
An application for ethical review should be accompanied by:
In case of Clinical trials additional requirements:
Time line for the process
National Bioethics Committee for Research (NBC-R), NIH (HRI),
Tel: +92-51-9224325, 9207386