Panichkul Suthee, Mahaisavariya Punkae, Morakote Nimit, Condo Sumalee, Caengow Supak, Ketunpanya Aphronpirom
Office of Research Development, Phramongkutklao College of Medicine and Hospital, Bangkok, Thailand.
J Med Assoc Thai. 2011 Aug;94(8):1013-8.
Many research ethics committees (RECs) have been established to review biomedical research involving human subjects in many research institutes. The purpose is "To protect rights and welfare of human research participants". It is necessary to determine how many research ethics committees have been established in Thailand and whether they have a high enough standard toprotect the rights and welfare of human research subjects.
To determine the status of research ethics committees in Thailand.
One hundred thirty survey questionnaires were distributed by mail to medical schools of universities, public hospitals under the Ministry of Public Health, private hospitals, and research institutes.
Seventy-eight questionnaires were returned. Thirty respondents had standard Operating Procedures (SOP). Twenty-two RECs had their own office while 36 had to share the office with other departments or units. Board meeting frequency was once a month. The average number of committee members was 14 and the majority was scientific members. Absence of nonaffiliated members was found in RECs (20.6%). Thirty RECs had never provided training for REC members and investigators, the other 48 provided training at least once a year Decision are made by consensus in 51 and majority vote in 14 RECs. Twenty-two respondents managed conflicts of interest (COI) by asking those members to leave the meeting before a decision was finalized. Thirty-nine RECs required continuous review after approval of the protocols.
Strong support from the organization leader is a key factor to efficiency and high standards of REC operation. Developing a network of RECs will be useful for future development. REC members still need knowledge to better protect the rights, safety, and well-being of research participants.
许多研究机构已设立了众多研究伦理委员会（RECs），以审查涉及人类受试者的生物医学研究。其目的是“保护人类研究参与者的权利和福利”。有必要确定泰国已设立了多少个研究伦理委员会，以及它们是否具备足够高的标准来保护人类研究对象的权利和福利。
确定泰国研究伦理委员会的现状。
通过邮件向各大学医学院、公共卫生部下属公立医院、私立医院及研究机构发放了130份调查问卷。
共收回78份问卷。30个委员会有标准操作程序（SOP）。22个研究伦理委员会有自己的办公室，36个则需与其他部门或单位共用办公室。委员会会议频率为每月一次。委员会成员平均人数为14人，多数为科学成员。研究伦理委员会中未发现无关联成员（占20.6%）。30个研究伦理委员会从未为委员会成员和研究人员提供培训，其他48个委员会每年至少提供一次培训。51个委员会通过协商一致做出决策，14个委员会通过多数投票做出决策。22个受访者通过要求相关成员在最终决策前离开会议来处理利益冲突（COI）。39个研究伦理委员会要求在方案获批后进行持续审查。
组织领导的大力支持是研究伦理委员会高效运作和高标准的关键因素。建立研究伦理委员会网络对未来发展将有所帮助。研究伦理委员会成员仍需知识，以更好地保护研究参与者的权利、安全和福祉。
