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 modification prior to approval required (Major or Minor), it must specify whether the changes will require a full board review or only primary reviewers.
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
CEA is valid for one (1) 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), Serious Adverse Reactions (SUSARs), Protocol Amendments, or other unanticipated problems.
For reporting local SAE which are fatal or life threatening the PI must report to EC immediately, no later than twenty four (24) hours after the PI becomes aware of the event while for the local SAE which is non-fatal or non lifethreatening the PI must report to EC immediately, no later than seven (7) calendar days after the PI becomes aware of the event.
For reporting any non-local Serious Adverse Reactions sponsor must report non-local serious adverse reaction including SUSARs to EC at least every six (6) months accompanied by a brief report highlighting the main point of concern. Other adverse reactions that may increase risks to subjects, the sponsor must report to EC as soon as possible but no later than fifteen (15) calendar days. Other type of reports, the sponsor must report to EC at least every year or periodically or on request.
In case of the SAEs occurring in different countries of a multicenter project, the Investigator can report to the FTM EC in one (1) month of the event notification to PI.
For reporting local SUSARs which are fatal or life threatening sponsor must report to EC as soon as possible using CIOMS form, no later than seven (7) calendar days after the sponsor becomes aware of the event. If the initial report is incomplete, the sponsor must report to EC relevant follow-up information and complete report as soon as possible, within additional eight (8) calendar days. Sponsor must report any significant new information as a follow up report within fifteen (15) calendar days.
Local SUSARs which are non-fatal or non life threatening sponsor must report to EC as soon as possible using CIOMS form, no later than fifteen (15) calendar days after the sponsor becomes aware of the event. Further relevant follow-up information should be given as soon as possible.
The EC will require that PI report all Adverse Events related and not related to the study to the EC Chairperson. This must be accomplished in writing in one (1) year of the event notification to PI. The FTM EC will require that PI report all any unexpected situation affect serious to research project while the research participant is participating in a research study to the EC Chairperson (e.g., medication errors, unexpected complications, protocol violations). This must be accomplished in writing within five (5) working days of the event notification to PI, while the protocol deviations must be submitted in one (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), 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.