The IEC Secretary will schedule complete applications for an IEC meeting. Study documents will be circulated to IEC members before the scheduled meeting.
IEC members present at the meeting will decide on an individual study, and a decision will be communicated to the investigator. The decision may be:
In the event of a request for additional or amended documentation, updated study documents must be submitted by the investigator.
The Independent Ethics Committee
How to contact
The IEC Secretariat can be contacted at.
Phone
How to submit protocol amendments?
For clinical trials, the investigator should promptly report the following changes to the IEC:
Serious Adverse Event (SAE)/Serious Unexpected Adverse Event Reaction (SUSAR) Reporting:
In the occurrence of a serious adverse event, or serious unexpected adverse event reaction, the following processes must be strictly adhered to.
SAE/SUSAR -fatal/life threatening:
Initial report should be submitted as soon as possible, but no later than seven calendar days from awareness of the event by the investigator, followed by a complete report within 8 additional calendar days.
All other SUSARs/SAEs – non-fatal or non-life-threatening:
No later than 15 calendar days from awareness of event by the investigator. For more detailed information, please contact the IEC Secretariat.
Download Serious Adverse Events Reporting Form ( FORM - IEC SJMC Serious Adverse Event (SAE) report 2024_08))
IEC Submission Timelines
|
IEC Submission Type |
Timeline |
|
New applications |
IEC will review a new application and give initial feedback within 60 working days from date of receipt of a valid and complete application |
|
Resubmission of modifications |
To be submitted within 60 calendar days of IEC decision letter |
|
Amendments application |
For amendments which meet expedited criteria, IEC shall give an opinion within a maximum of 30 days of the date of receipt of the valid and complete proposed amendment submitted. For amendments affecting significantly, it will be tabled at the next scheduled IEC meeting |
|
Disapproved applications |
Timeline for appeal submission is within 40 days of the disapproval letter. |
|
SAE/SUSAR -fatal/life threatening |
Initial report should be submitted as soon as possible, but no later than seven calendar days from awareness of the event by the investigator, followed by a complete report within 8 additional calendar days. |
|
All other SUSARs/SAEs – non-fatal or non-life-threatening: |
No later than 15 calendar days from awareness of event by the investigator. For more detailed information, please contact the IEC Secretariat. |
|
Application for Renewal and Annual Progress Report |
The complete form must be submitted at least 30 calendar days before expiry of ethical approval. If a renewal application is submitted after the ethics approval expires but within three months, all study activities (except safety follow up) must be paused until the application receives a decision from the Ethics Committee. Please note that there is no specific review timeline for late-submitted renewal applications. The Ethics Committee will review them in due course. Approval letters for late submissions of ethics renewal applications will not be backdated. If no application is submitted within 90 calendar days after expiry of ethics approval, the study will be autoterminated without further notice. Please see section on autotermination. |
|
Research Study Closure Report |
To be submitted within 90 days after study completion/closure/termination. If a closure report is not submitted within 90 calendar days of the ethics approval expiration date, the study will be autoterminated without further notice. Please see section on autotermination. |
|
Autotermination |
Studies that are autoterminated cannot be reopened and appeals will not be considered. If the study is to be continued, it must be resubmitted as a new study. Studies that have been autoterminated are prohibited from conducting any further study activities including recruitment and/or data collection. Autotermination does not absolve investigators from their obligation to report serious adverse events, protocol deviations, and other mandatory reporting requirements. |
|
Protocol Deviation |
The complete reporting form, including Corrective and Preventive actions should be submitted as soon as possible, but no later than 30 calendar days from awareness of the event by investigator. |
Notification Process
Applicants will be notified by IEC SJMC of its decision in writing within 14 days from its review.
In cases of a full approval, a statement of responsibilities of the investigator is provided for Investigator to acknowledge. In cases of negative decisions (i.e rejected, termination), reasons are provided.
The Ethical approvals for new research projects are valid for 12 months from the date of issue of the IEC Decision Letter. An Annual Progress report application to IEC will have to be submitted 1 month before the Ethics approval expiry date.
When Modification Required decision is provided, the applicants must respond within 60 days from this notification to receive a full approval. The application will be closed if no response is received by IEC. A new application will need to be submitted if the applicant still would like to seek ethical approval.
