IIUM RESEARCH ETHICS COMMITTEE

IIUM RESEARCH ETHICS COMMITTEE

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

Email: irec@iium.edu.my

Tel: Br. Aimullah - technical and guideline

      Sr. Azaidatul - application status

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 
  • 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.