Appendix 4

International Medical University

No. 126, Jalan Jalil Perkasa 19, Bukit Jalil, 57000 Kuala Lumpur

Tel: 603-8656 7228 Fax: 603-8656 7299

NAME OF ETHICS COMMITTEE/IRB:
IMU Joint-Committee on Research & Ethics, International Medical University
ADDRESS:
No. 126, Jalan Jalil Perkasa 19, Bukit Jalil, 57000 Kuala Lumpur
Tel: 603-8656 7228 Fax: 603-8656 7299 / ETHICS COMMITTEE/IRB REF NO:
PROTOCOL NO:
TITLE:
PRINCIPAL INVESTIGATOR:
TELEPHONE:
H/PHONE NO:
FAX NO.:
EMAIL: / SPONSOR:
The following items (√) have been reviewed and received in connection with the above study to be conducted by the above investigator.
No. / (√) / Documents Received /

Date Received

1. / Application Form for Research Grant (Appendix 1)/Protocol /Protocol Amendments
2. / IMU Biosafety Approval Forms A; B; C; D; Others (where necessary)
3. / IMU Biosafety Notification Forms: E; F; Others (where necessary)
4. / Study Information Sheet: (where applicable)
English / Bahasa Melayu / Chinese / Tamil
5. / Consent Form:(where applicable)
English / Bahasa Melayu / Chinese / Tamil
6. / Investigator’s Brochure
7. / Advertisement (if any)
8. / Insurance Coverage
9. / Indemnity Agreement
10. / Investigator’s Curriculum Vitae /Qualifications (GCP certification)
11. / Payment and Compensation
12. / Recruitment Procedure
13. / Form for Animal Use in Research Laboratory (Appendix 1e)
14. / Application for Laboratory Space Requirement (Appendix 2a)
15. / Application for Protected Time Requirement (Appendix 2b)
16. / Questionnaires (if any)
17. / Any Other Documents (if necessary)
All the documents have been:
(√) Checked and Approved.
( ) Conditionally Approved (Identify item and specify modificationbelow or in accompanying letter).
( ) Rejected (Identify item and specify reasons below or in accompanying letter).
( ) Notified to IMU Joint-Committee on Research & Ethics Members: Accepted / Not Accepted
( ) Recommendation
( ) Suggestion(If any)
Comments:
The IMU Joint-Committee on Research and Ethics operates in accordance to the International Conference of Harmonization /Good Clinical Practice Guidelines (ICH-GCP) Guidelines; the Declaration of Helsinki 2000; Malaysian GCP and any applicable laws and regulations.
Date of Approval:
______
Signature:
Name:
IMU-Joint Committee on Research & Ethics (IMU-JC)

IMU/SOP/PGSR/02 [Appendix 4]

PGSR/Management of Research Projects

Revised as at 1 October 2015 (16th Edition)

International Medical University

No. 126, Jalan Jalil Perkasa 19, Bukit Jalil, 57000 Kuala Lumpur

Tel: 603-8656 7228 Fax: 603-8656 7299

IMU JOINT-COMMITTEE ON RESEARCH & ETHICS COMPOSITION

INTERNATIONAL MEDICAL UNIVERSITY

Date:

No. / Member
(Title and Name) / Occupation
(Designation) / Gender
(Male/Female) / Tick (√) if present when above items were reviewed
1 / Chairman:
Tan Sri Dato’ Dr Abu Bakar Suleiman / President, IMU / M
2 / Co-Chairman:
Professor Dr Mak Joon Wah / Vice President, Research, IMU / M
3 / Secretary:
Assoc. Prof. Dr Tan Eng Lai / Head, Centre of Biomolecules & Drug Discovery (IRDI) / Assoc. Prof, Life Sciences Department, School of Pharmacy, IMU / M
Members:
4 / Professor Abdul Aziz Baba / Vice President, School of Medicine and Dentistry, IMU / M
5 / Professor Dr Chu Wan Loy / Deputy Director of IRDI /
Dean, School of Postgraduate Studies, IMU / M
6 / Professor Dr Stephen Ambu / Head, Centre of Environmental and Population Health (IRDI) / Assoc. Dean, School of Postgraduate Studies, IMU / M
7 / Prof Yeoh Peng Nam / Dean, School of Pharmacy, IMU / F
8 / Professor Dato’ Dr Abu Bakar Abdul Majeed / Asst. Vice Chancellor
Sg Buloh Medical Campus, UiTM. / M
No. / Member
(Title and Name) / Occupation
(Designation) / Gender
(Male/Female) / Tick (√) if present when above items were reviewed
9 / Professor Datin Paduka Dr Aini Ideris / Professor
Dept. of Veterinary Clinical
Studies, Faculty of Veterinary Medicine
Universiti Putra Malaysia
(UPM) / F
10 / Director, Hospital Tuanku Ja’afar, Seremban, Negeri Sembilan / M
11 / Dr. Mahadevan Deva Tata / Medical Specialist
Surgery Department
Hospital Tuanku Ja’afar
Seremban, Negeri Sembilan / M
12 / Professor Dato’ Dr. Sivalingam Nalliah / Head of Division of Human Development and Population Health, IMU Clinical School, Seremban / M
13 / Professor Dr. Taufik Teng Cheong Lieng / Head, Department of Family Medicine, IMU Clinical School, Seremban / M
14 / Mr Dhinesh Bhaskaran / Lawyer – Shearn Delamore & Co / M
15 / Professor Dr Leong Chee Onn / Head, Centre of Cancer and Stem Cell Research (IRDI) / Professor, Pharmacy Dept, Division of Pharmacy, IMU / M
16 / Assoc. Prof Dr Tony Ng Kock Wai / Associate Professor - Division of Nutrition & Dietetics, IMU / M
17 / Assoc. Prof Dr Chen Yu Sui / Associate Professor - Human Biology Department, IMU / F
18 / Pastor Dr Paul Chen Chieh Yee / Pastor / M
19 / Professor Dr Hematram Yadav / Professor, Department of
Community Medicine and Behavioural Sciences, IMU / M
No. / Member
(Title and Name) / Occupation
(Designation) / Gender
(Male/Female) / Tick (√) if present when above items were reviewed
20 / Professor Dr Vishna Devi Nadarajah / Head, Centre of Health Professional Education Research, IMU / F
21 / Professor Dr Ammu Radhakrishnan / Professor, Pathology Dept, IMU / F
22 / Professor Dr Lim Pek Hong / Head of Nursing Dept, IMU / F
23 / Professor Allan Pau Kah Heng / Director, Oral Health / Professor, School of Dentistry, IMU / M
24 / Professor Khor Geok Lin / Adjunct Professor, IMU / F
25 / Assoc. Prof Dr Tony Ng Kock Wai / Assoc. Professor - Division of Nutrition & Dietetics, IMU / M
26 / Assoc. Prof Dr Chen Yu Sui / Assoc. Professor - Human Biology Department, IMU / F
27 / Madam Tan Keat Hoon / Lecturer (IMU) – Malaysian Studies – LayPerson / F

Comments:

The IMU Joint-Committee on Research and Ethics operates in accordance to the International Conference of Harmonization /Good Clinical Practice Guidelines (ICH-GCP) Guidelines; the Declaration of Helsinki 2000; Malaysian GCP and any applicable laws and regulations.

______

Signature:

Full Name:

IMU Joint-Committee on Research and Ethics (IMU-JC)