Research Ethics Board of Health: a seven year review of the only ethics review board in Bhutan

Abstract

Introduction: Research Ethics Board of Health (REBH), established in 2009, is the only ethics review board in Bhutan. The REBH was certified by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), Forum for Ethical Review Committees in the Asian and Western Pacific Regions (FERCAP) in 2010 and recertified in 2013, and it received the Federal Wide Assurance (FWA) from the Office for Human Research Protections (OHRP), USA, in 2010 and in 2013. All researchers conducting health related research in Bhutan have to seek prior ethical clearance from REBH under the requirements of the National Health Policy 2011. Objective: The article aims to describe the performance of REBH, its standard and review procedure.

Methods: A descriptive study of records and database of REBH from 2009 to 2015.

Results: As of December 2015, the REBH has received 227 protocols with an average of 32 protocols per year. The median number of days for the initial review was 21 days (Min 0 days; Max 85 days). The median duration for approval of protocols from the date of receiving the application was 48 days. The average number of times the protocols were reviewed before issuing the approval letter was 2.

Conclusions: There has been a progressive increase in the number of protocols submitted to REBH. This indicated an increasing research culture in Bhutan. It takes about one and half months to get an approval from REBH; therefore, researchers have to consider the time required for ethical clearance process while planning research projects.