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 two panels, one for clinical studies, and one for non-clinical (biomedical and observational) studies, and 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: Panel 1 (clinical studies), Panel 2 (non-clinical studies).
If you have further questions, please do not hesitate to contact the EC via email (firstname.lastname@example.org) 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 each EC member seven working days before the scheduled meeting. The EC chairperson will assign two primary reviewers for each proposal. All EC members will complete a Reviewer's Assessment Form for Initial Review, while primary reviewers and non-scientist members will also complete additional forms that take further details into considerations. 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 conditional approval, 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 (email@example.com) 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 submit annual progress reports requesting CEA extension. 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 event. The protocol deviations must be submitted in 1 month.
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), and once a decision has been made, the PI and the other EC members are notified.