IIUM RESEARCH ETHICS COMMITTEE (IREC)

 INITIAL REVIEW APPLICATION
 
1. Online Form

• Applicants/Investigators are required to register online via the Submission Form link on the menus. Incomplete registration and file upload may result in a delay in getting IREC approval or termination of the application.

List of documents required:

Qualitative Study (Observation, interview, questionnaire, retrospective)

• Online Application Form
• Document that verifies the research have undergoes screening by any institution that ensure its validity e.g. Grant Approval, Proposal defense approval, Institution Approval. It is highly recommended to get Kulliyyah Research Committee approval.
• Any regulatory clearance (study site approval e.g. School) if any.
• CV of Principal Investigator
• Study Protocol (must include version and date)
• proforma, 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 (can be requested by Site PI to his/her respected Kulliyyah/Faculty/Institute)
• Any regulatory clearance (study site approval e.g., school) if any.
• CV of Principal Investigator
• Copy of Principal Investigator Good Clinical Practice (GCP) Certificates.(Other investigators involved are recommended to have GCP)
• Case report form.
• The study protocol. 
• 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 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).
• 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.