If your project involves human subjects, you require ethics committee approval. This is to ensure the safety of the subjects, protection of confidential information, and appropriate ethical treatment of those involved in your research. There are three routes to EC approval, full board review, expedited review, and exemption from review. To learn more about each route, please click the links below.
Full Board Review is the standard review conducted by the EC. These reviews are conducted once a month. The schedule for the meetings can be found here
If you have further questions, please do not hesitate to contact the EC via email (email@example.com) or visit our office on the 4th floor, of the 60th Anniversary of His Majesty the King's Accession to the Throne Building.
Once the research proposal and all appropriate submission forms have been submitted, the EC assistant secretary will distribute the materials to assigned reviewers seven working days before the scheduled meeting. The EC chairperson will assign three primary reviewers and one Lay member for each proposal. The assigned reviewers will complete a Reviewer's Assessment Form for Initial Review, while EC members who are not assigned reviewer of the review panel will read research proposal and be ready to submit their comments at the scheduled EC meeting. During the meeting, the following points must be discussed:
After discussing the project according to the points above, members must reach a consensus to decide the outcome of each proposal. If there is no consensus, there will be a vote:
If the EC decides on approval with conditions and/or suggestions, it must specify whether the changes will require a full board review or only primary reviewers.
The EC will also provide a summary of the discussion to the researcher.
Expedited review is a speedier approval process available for certain projects which have specific characteristics:
Expedited review allows certain kinds of research to be reviewed and approved without convening a meeting of the EC. The EC will review certain categories of research through an expedited procedure only
Expedited review applies to research with the following characteristics
Projects can be exempt from Ethics Committee review if they involve minimal risk to participants, do not include identifiers, or if the topic is deemed non-sensitive.
An exempt review applies to research that involves
Below is a brief overview of the post-review process. For full details, please read the EC SOP documents, or get in touch with the EC directly via email (firstname.lastname@example.org) or by visiting our office on the 4th floor, 60th Anniversary of His Majesty the King's Accession to the Throne Building.
CEA is valid for one year. Therefore, PI must extend the certificate using Progress Report Form/Certificate of Ethical Approval Extension Request Form (FTM ECF-008-RR) two (2) months prior to the expiry date if the study is not finished, and submit progress reports as stipulated by EC requirements related to the identified risk. In addition to these scheduled reports, PIs must submit reports in case of Serious Adverse Events (SAE), Adverse Events (AE), Protocol Amendments , or other unanticipated problems. SAE and unanticipated problems must be reported to the EC within 5 working days of eventnotification to PI. The protocol deviations must be submitted in 1 month of the event notification to PI.
These reports are reviewed by the EC Chairperson or by the primary reviewers (unless an amended protocol is considered to contain major revisions, in which case a full board review is necessary), while AE and SAE reports are reviewed by SAE Subcommittee, and once a decision has been made, the PI and the other EC members are notified.