IIUM RESEARCH ETHICS COMMITTEE (IREC)

IIUM RESEARCH ETHICS COMMITTEE (IREC)

INITIAL REVIEW

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. 
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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.