Current status of the research ethics committees in Thailand.

BACKGROUND

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.

OBJECTIVE

To determine the status of research ethics committees in Thailand.

MATERIAL AND METHOD

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.

RESULTS

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.

CONCLUSION

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.