The BICRC maintains a full Bumrungrad International Institutional Review Board (BI/IRB), which reviews all investigational protocols involving human and animal experimentation. When a new protocol is submitted for IRB review by the first Monday of each month, the BI/ IRB usually convenes its monthly meeting on every fourth Monday to review new protocols, amendments, adverse events, etc. The BI/IRB is registered as IRB00005009 with US Federal Wide Assurance number FWA00009042 for biomedical and behavioral studies (BI is listed as IORG0004223). Clinical trial protocols that require importation permits and material transfer agreements for investigational products are processed first by the BI/IRB, with final approval from the Royal Thai Government IRB of record endorsed by the Thai Food and Drug Administration (FDA). Currently,
a Memorandum of Understanding (MOU) signed between the Ministry of Public Health (MOPH) and Bumrungrad International establishes the Ethical Review Committee for Research in Human Subjects of the MOPH as the IRB of record for studies requiring importation permits for investigational products.
  When a research study is proposed by BI physicians, its appropriateness to be conducted in BI is reviewed by the Director of the BICRC; in other departments, it is reviewed by the respective administrator (e.g. Nursing, for nurses’ studies, etc.). If deemed appropriate, the proposal is forwarded to BI/IRB, to determine whether it requires BI/IRB approval (Figure 1). Before formal protocol submission to the IRB for review and approval, all necessary documentation undergoes meticulous preliminary review, with consultation and advice to the PI, and document editing, to ensure the submission conforms to the relevant rules and regulations, ICH/GCP Guidelines, and BI institutional culture. The well-trained Senior Coor dinator for Research Review, in consultation with the CRC Director, performs these tasks. The English and Thai versions of the protocol, informed-consent documents in applicable and appropriate languages for laypersons, etc. undergo particular examination. Once deemed compliant and presentable, the complete protocol is submitted to the IRB for consideration on the first Monday of each month (Figure 2). It is then sent to two scientific reviewers, who assess its scientific value and validity; their reviews are presented to the Full Board of the IRB for review on the fourth Monday of the month. Given current limitations in IRB members’ availability, the BI/IRB can process a maximum of two good-quality reviews at its monthly meeting. Studies can only commence once approval has been granted by the respective administrator and the BI/IRB.
  Figure 1.
  Figure 2.
  At the end of 2012, 173 research projects had been submitted to BICRC and reviewed by the BI/IRB (Figure 3). Of these, 36% were clinical trials originating in the private sector, 38% private-sector or in-house observational studies/projects, 24% social-science studies by staff (mostly nurses), and 1% non-human studies needing BI/IRB clearance; 1% of all studies was disapproved (Figure 3). At the end of 2012,
55 studies were considered as active/ongoing. While the trend for industry-sponsored clinical trials has decreased over time (Figure 4), in-house studies by physicians and staff have increased. These trends correlate well with BI’s objective to become a learning institute. The possible explanations for the decrease in industry-sponsored trials include, e.g., difficulty recruiting private patients of high socioeconomic status, unclear policy of the Thai Food and Drug Administration (TFDA) regarding the accreditation of private-sector IRBs, which impedes the approval process, political unrest, coups d’├ętat, compulsory licensing, flooding, etc.
  Figure 3.
  Figure 4.