MEDICAL ETHICS APPROVAL APPLICATION, FACULTY OF DENTISTRY

1)     NEW APPLICATION

Applicant (main investigator/academic staff) are required to submit:-

i) Checklist  (Appendix 1)
ii) Presentation proposal (for Postgraduate onlyAppendix 2)
iii) Application Form (Appendix 3):The application form must be typed. Handwritten forms will not be processed.
iv) Brief CV of Main Investigator
v) Patient Information Sheet and Consent Form (Appendix 4)– For research involving human as a subjects and questionnaire survey/ interviews.
vi) Questionnaires (if applicable)

The forms are attached.

If your research involving human subjects, please send 11 copies (including original copy) of the completed forms (i-vi). If your research is not involving human subjects, please send original form and soft copy only. Completed form should be sent to:

Pn Junaida @ Maimunah Hassan Basari
Level 7, Research Laboratory,
Dental Specialist and Research Tower,
Faculty of Dentistry
University of Malaya

2)     AMENDMENT/ CLOSURE OF THE APPROVED PROJECT

In accordance with ICH-GCP guidelines, any changes to the approved protocol must be promptly reported to the Ethics Committee by submitting an Amendment Form (Appendix 5).

Ethics approval by the Medical Ethics Committee is valid during the research period as written in the ethics approval letter. If the period of project is extended, the applicant need to renew the approval by submitting an Amendment Form (Appendix 5) to Medical Ethics Committee, Faculty of Dentistry,UM.

Completed project should be updated by submitting  Annual Study Report/ Study Closure Report  Form  (Appendix 6) to Medical Ethics Committee, Faculty of Dentistry, UM.

All applicants for research projects involving human subjects must attend the meeting to present their research project to all the committees. Please do not hesitate to call Pn Junaida 03-7967 6461 if you have further enquiries.

Regards,
Pn Junaida @ Maimunah Hassan Basari
Secretary
Medical Ethics Committee
Faculty of Dentistry

On behalf,

PROF. DR. NOOR HAYATY ABU KASIM
Chairperson
Medical Ethics Committee
Faculty of Dentistry
UM

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