IIUM RESEARCH ETHICS COMMITTEE (IREC)

IIUM RESEARCH ETHICS COMMITTEE (IREC)

INITIAL REVIEW

INITIAL REVIEW


 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
  • 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)
  • 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
  • Any regulatory clearance (study site approval e.g. school)
  • Copy of Principal Investigator Good Clinical Practice (GCP) Certificates.
  • Case report form.
  • The 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 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.