IIUM RESEARCH ETHICS COMMITTEE (IREC)

 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. 
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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.