Initial Review categories, workflow and timeline

Timeline for Initial review process

Expedited Review:

The Expedited review will take within twenty (20) working days , from the date of completed submission package have been verified by IREC secretariat and application queue.

Full-board Review:

Full review will take within sixty (60) working days, from the date of completed submission package have been verified by IREC Secretariat subjected to the date of the next IREC Meeting

*any study involving the use of Stem Cell will require additional 4 Weeks for recommendation by NSCERT.


INITIAL REVIEW APPLICATION

Attention! You need to complete step 1 (Register your project) and 2 (Upload required document) prior your application accepted for review.

Update! The form is temporarily closed until 14th April 2024. Kindly submit your application starting on 15th April onwards.

1.     Register your project

Visit IREC Application form (using the link below) and register you application.

After completion you will be provided with IREC ID (IREC 20xx-xxx) via thank you page and email response (kindly check your email SPAM if it not in INBOX).

Attention!: If you are applying for Clinical Trial, Registration must provide National Medical Research Register (NMRR) Registration ID. User can go to  National Medical Research Register (nmrr.gov.my) for registration. This is according to Arahan Pengarah Perkhidmatan Farmasi CT1-2009, whereas IEC cannot provide approval if the clinical trial is not registered with NMRR.

Kindly be informed that IREC approval could only be obtained prior the date of data collection of the research. Any request for backdated approval will not be entertained.

* Please clear your browsers “COOKIES” every time prior submitting a new application to avoid rejected submission due to duplicate cookies.


2.     Upload required document -General Individual application only

After registration, user will be provided with upload link via email, or you can visit the upload page using the link below.

After completion, user will get email response that the upload was successful.

User are given 5 working days to upload the document or the application will be terminated.

The processing timeline are initiated once the complete submission was done or any resubmission was done.

*For Clinical Trial Application with large file and unable to upload via the upload form above, kindly upload it via the one drive folder link below under one (1) folder labelled with IREC ID generated by the registration. Please attach together list of document submitted (must be in excel format)!

*Both step 1 and 2 are required prior your application to be accepted for review.

Undergraduates Submission

Individual undergraduate application kind use the link below. This is only for BULK application by representative of Department for undergraduate. For individual undergraduate application kindly use the Undergraduate Individual Form.

BULK undergraduate application kind use the link below. This is only for BULK application by representative of Department for undergraduate. For individual undergraduate application kindly use the Undergraduate Individual Form.

List of Document to be uploaded:

Non-clinical Trial study
  • Online Application Form
  • Approval Letter from Kulliyyah Research Committee / Head of Institution
  • Any regulatory clearance (study site approval e.g., School)
  • CV of Principal Investigator
  • Study Protocol/Proposal (must include version and date) –
  • Proforma, case report forms, questionnaires, follow-up cards, etc.(must include version and date).  This document must apply de-identification techniques, such as removing or altering direct identifiers (names, addresses) and modifying indirect identifiers (age, gender) to further protect participant privacy. Collect only the minimum amount of data necessary for your research objectives. Avoid gathering excessive or irrelevant information.  more details
  • Informed Consent for Study using human (Information Sheet & Consent Form) (must include version and date) if any
  • List of documents submitted to IREC in excel format. This will appear in approval letter.
  • Additional Document if any


Clinical Trial Study
  • Investigator’s Brochure
  • Online Application Form
  • CV of Principal Investigator
  • Approval Letter from Kulliyyah Research Committee/ Institution
  • Any regulatory clearance (study site approval e.g., school) if any
  • Copy of Principal Investigator Good Clinical Practice (GCP) Certificates.
  • Case report form.
  • The study protocol.
  • Informed Consent for Clinical Trial (Information Sheet & Consent Form)
  • Source of funding and financial requirements for the project.
  • A list of Involved staff the trial and their function. (e.g., Nurses, Medical Doctor)
  • Any information of the previous Trials done by others in Malaysia or outside of Malaysia. (If applicable)
  • Copy of Insurance Certificate (IREC will hold Approval Letter until Investigator has submitted the Insurance Certificate copy).
  • List of documents submitted to IREC in EXCEL format. This list will appear in IREC Approval letter.
  • A statement describing any compensation for study participation (including expenses and access to medical care) to be given to research participants; a description of the arrangements for indemnity, if applicable (in study-related injuries); a description of the arrangements for insurance coverage for research participants.
  • NSCERT Checklist form. (for study involving Stem Cell) Download Link


Fee structure

Please note on the fee structure above and follow the below step to make payment: 

 a)     local order/ bank draft/cheque to “Research Management Centre IIUM” and send to the IREC’s Office; OR

b)     invoice; OR

c)     Online Banking/Direct Bank Transfer/Cash Deposit Machine (CDM)/ Telegraphic Transfer should be routed to: –

           Account Name:    IIUM Operating

           Account Number: 1407-000000-4716

           Bank Name: BANK MUAMALAT MALAYSIA BERHAD                  

Please e-mail a copy of your transaction (with reference no.) to  irec@live.iium.edu.my as proof of payment. Receipt/Tax Invoice will be emailed to you once we have received it from Finance Division.

Should you have any questions or clarifications regarding the above, please do not hesitate to contact IREC Secretariat at (09) 570 4733/4227 or  irec@live.iium.edu.my