Thailand FDA periodically releases a list of institutional review boards (IRBs) / ethics committees (ECs) that it recognizes for acceptance of clinical trials. Under Thailand regulatory system, approved ethics committees serve as the main point of approvals for initiating clinical trials in the country.
This has been explained in our previous articles (see Part I and Part II), wherein we discussed a regulatory scenario, including regulatory approvals for the clinical trial in Thailand, ethics committee approval for the clinical trial in Thailand, documents required for regulatory submission, and ethics committee submission in Thailand.
We’d presented a list of ethics committees that are recognized for application to the Thailand FDA. Updates to this list were further reported in another article (see the previous update on Thailand’s approved IRBs).
The current article presents and discusses a list of IRBs as reported on the Thailand FDA website. This link provides details in the Thai language, but the below sections give this list in English for others to understand. [Note: Below the given list is an approx translation. You’re advised to use accredited translators before using the below information.]
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List of Ethics Committees recognized by FDA Thailand
|S# (Number as per the list on Thai FDA website)||Name of IRB, or name of institute / Hospital / University, where IRB is established||Recognition starts from||Recognition end on|
|1 (1/2016)||Bangkok Hospital, Bangkok||07 Oct 2016||06 Oct 2018|
|2 (2/2016)||Phramongkutklao Collage of Medicine, Bangkok||05 Oct 2016||04 Oct 2018|
|3 (3/2016)||IHRP, Bangkok||07 Oct 2016||06 Oct 2018|
|4 (4/2016)||Bumrungrad Hospital, Bangkok||07 Oct 2016||06 Oct 2018|
|5 (5/2016)||Khon Kaen University, Khon Kaen||11 Nov 2016||10 Nov 2018|
|6 (6/2016)||Siriraj Hospital, Mahidol University, Bangkok||24 Nov 2016||23 Nov 2018|
|7 (7/2016))||Mahidol University’s Center of Ethical Reinforcement for Human Research, Bangkok||29 Nov 2016||28 Nov 2018|
|8 (8/2016)||Ramathibodhi Hospital, Bangkok||07 Dec 2016||06 Dec 2018|
|9 (9/2016)||MOPH IRB, Bangkok||06 Dec 2016||05 Dec 2018|
|10 (10/2016)||CREC, Bangkok||07 Dec 2016||06 Dec 2018|
|11 (1/2017)||Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Bangkok||25 Jan 2017||24 Jan 2019|
|12 (2/2017)||Faculty of Medicine, Chulalongkorn University, Bangkok||20 Jan 2017||19 Jan 2019|
|13 (3/2017)||Faculty of Medicine, Prince of Songkla University, Hat Yai||25 Jan 2017||24 Jan 2019|
|14 (4/2017)||Faculty of Tropical Medicine, Mahidol University, Bangkok||20 Jan 2017||19 Jan 2019|
|15 (5/2017)||Faculty of Medicine, Chiang Mai University, Chiang Mai||25 Jan 2017||24 Jan 2019|
|16 (6/2017)||Faculty of Medicine, Thammasat University, Pathum Thani||17 Mar 2017||16 Mar 2019|
|17 (7/2017)||Research Institute of Health and Environment Sciences, Chiang Mai University, Chiang Mai||1 Jun 2017||31 May 2019|
|18 (8/2017)||Department of Thai Medicine and Alternative Medicine||5 Jul 2017||4 Jul 2019|
|19 (9/2017)||Bamrasnaradura Infectious Disease Institute, Nonthaburi||24 Aug 2017||23 Aug 2019|
|20 (10/2017)||Naresuan University, Phitsanulok||29 Aug 2017||28 Aug 2019|
Important updates in the new list
The current list has some important points to note.
- The first 10 ethics committees on the list are actually from the list approved earlier (reported here).
- Most of the ethics committees in the remaining list are currently out of their approval period. (Though, FDA may be coming out with a newly approved list with extended approval periods.)
- No more ethics committees (ECs) from private hospitals have been recognized by Thailand FDA. Earlier recognized private hospitals’ ECs were Bangkok Hospital and Bumrungrad Hospital.
- Ethics committees, which are still under their valid approval period are
- Research Institute of Health and Environment Sciences, Chiang Mai University, Chiang Mai
- EC of Department of Thai Medicine and Alternative Medicine
- Bamrasnaradura Infectious Disease Institute, Nonthaburi
- Naresuan University, Pitsanulok
- Govt. IECs/IRBs, including the MOPH ethics committee and, new ones on the bloc – CREC are continuing. Read more about CREC in our previous post.
- IHRP has been included this time as well. This EC is continuing to accept BE study applications.
- Naresuan University, which is continually being since the last two times, continues to be approved until 28 Aug 2019.
Impact of the new list of recognized ECs
Expired approval validity periods
Since most of the EC’s (including all traditional ones) are out of their validity period, further updates on the list from the Thai FDA will be keenly awaited. This list will help in providing validity to scores of clinical trials approved by such ethics committees.
Central Research Ethics Committees (CREC)
As discussed in our previous article, this new central ethics committee is one of the best things that happened to the Thailand clinical trial scene in the last few years. It’s recognized by FDA, affiliated to several sites in Thailand, and still not heavily loaded with clinical trial applications. This means shorter queues for submission, quicker approval times, and, best of all, flexibility to work at several excellent sites in Thailand.
Saving time…and cost!
If a site is not affiliated with an EC that has been recognized by Thailand FDA, then mostly the investigator needs to apply to two ECs for approval. Local EC and central EC (recognized by FDA). In such cases, there may be a delay in project approval due to the submission queue at the central EC office. It means that an additional time of 3-9 months may have to be factored in planning.
However, if a trial has been planned at a site that is affiliated with an FDA-recognized EC, then the trial team can save a lot of time in securing necessary EC approval, as well as the cost required for such planning, execution, and management.
Trial managers, do factor these sites in your project planning. 🙂
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