IIUM RESEARCH ETHICS COMMITTEE (IREC)
INITIAL REVIEW
Contact Info
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INITIAL REVIEW
INITIAL REVIEW APPLICATION
1. Online Form
- Applicant/Investigator are required to register online via the Submission Form link on the menus. Incomplete registration may result in delay on getting IREC approval.
2. Documentation (hardcopy)
- Applicant/Investigator are required to submit the following copy of documents package to IREC Secretariat. Form can be downloaded from:
List of document required:
Qualitative Study (Observation, interview, questionnaire, retrospective)
- 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 (must include version and date)
- proformae, case report forms, questionnaires, follow - up cards, etc.(must include version and date)
- Informed Consent for Qualitative Study (Information Sheet & Consent Form) Template Link: Resources (must include version and date)
- Additional Document
Clinical Trial
- Investigator's Brochure
- Online Application Form
- Approval Letter from Kulliyyah Research Committee/ Institution
- Any regulatory clearance (study site approval e.g. school)
- Copy of Principle Investigator Good Clinical Practice (GCP) Certificates.
- Case report form.
- Study protocol (Should comply with Protocol Checklist).
- Protocol Checklist. Link: Resources
- Informed Consent for Clinical Trial (Information Sheet & Consent Form) Template Link: Resources
- 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 previous Trial done by others in Malaysia or outside of Malaysia. (if applicable)
- Copy of Insurance Certificate (IREC will hold Approval Letter until Investigator have submitted the Insurance Certificate copy).
- 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.