IIUM RESEARCH ETHICS COMMITTEE (IREC)

IIUM RESEARCH ETHICS COMMITTEE (IREC)

INITIAL REVIEW

Contact Info

IIUM Research Ethics Committee,

Research Management Centre (Kuantan),

Level 1, Admin Building (OCD),

International Islamic University Malaysia,

Jalan Sultan Haji Ahmad Shah,

25200 Kuantan, Pahang

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.