June 2, 2017 Policies & Guidelines
The major role of the IMU Joint Committee on Research and Ethics (IMU-JC) is to receive and evaluate research proposals, including those for consultancy services, and make appropriate recommendations. It also evaluates ethical issues relating to human and animal experimentation. In addition, the IMU-JC serves as the Institutional Review Board, accredited by the Malaysian Pharmaceutical Bureau to evaluate clinical trials conducted not only by researchers from IMU but also external parties. In discharging its duties, the IMU-JC is guided by the codes of good practice as set in the guidelines for “Good Clinical Practice” (GCP), “Good Laboratory Practice” (GLP) and “International Guiding Principles for Animal Research”. Please refer to the SOP and other documents as well as the application forms for details on submission of proposals to IMU-JC:
- Introduction
- IMU IBC Member
- Act & Guidelines
a. Biosafety Act 2007
b. Biosafety Regulations 2010
- Forms
a. Biosafety Approval - Form A
b. Biosafety Approval - Form B
c. Biosafety Approval - Form C
d. Biosafety Approval - Form D
e. Biosafety Approval - Form E (Refer to Sample)
f. Biosafety Approval - Form F
- Training
- Activities
- FAQ
Overview
The major role of the IMU Joint Committee on Research and Ethics (IMU-JC) is to receive and evaluate research proposals, including those for consultancy services, and make appropriate recommendations. It also evaluates ethical issues relating to human and animal experimentation. In addition, the IMU-JC serves as the Institutional Review Board, accredited by the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia to evaluate clinical trials conducted not only by researchers from IMU but also external parties. In discharging its duties, the IMU-JC is guided by the codes of good practice as set in the guidelines for “Good Clinical Practice” (GCP), “Good Laboratory Practice” (GLP) and “International Guiding Principles for Animal Research”.
The IMU-JC is given the authority to
- evaluate proposals on all types of research, including biomedical and clinical research
- approve, disapprove or modify the proposed studies
- endorse progress reports from the investigators
- suspend or terminate approved studies, and
- place restrictions on a study
Composition of the IMU-JC
The IMU-JC has a total of 17 staff members from various schools, 2 non-IMU affiliated members (lay- persons) and 5 scientists/clinician who are not affiliated with IMU. Every IMU-JC review meeting shall have a quorum of 5 members, with varying backgrounds to promote complete and adequate review of the research. The current IMU-JC members are as follows:
No. | Member (Title and Name) | Occupation (Designation) |
1 | Professor Abdul Aziz Baba | President, IMU Health; Vice Chancellor & CEO IMU Education |
2 |
Professor Datuk Dr Lokman Hakim Bin Sulaiman |
Director, Institute for Research, Development and Innovation/Professor of Public Health, School of Medicine IMU |
3 |
Professor Leong Chee Onn |
Deputy Director of IRDI/ Professor, Pharmacy Dept, School of Pharmacy IMU |
4 |
A/Prof Dr Tan Eng Lai |
Dean, School of Postgraduate Studies, IMU / Assoc. Prof, Life Sciences Department, School of Pharmacy, IMU |
5 | Tan Sri Dato’ Dr Abu Bakar Suleiman | President, IMU Health |
6 | Professor Datuk Dr Maimunah A Hamid | Associate Dean, School of Medicine, IMU |
7 | Professor Allan Pau Kah Heng | Dean, School of Dentistry, IMU |
8 | Professor Vishna Devi Nadarajah | Vice Chancellor, Education IMU |
9 | Professor Dato’ Dr Sivalingam Nalliah | Head - Division of Surgery, School of Medicine, IMU Clinical Campus, Seremban |
10 | Professor Dr. Taufik Teng Cheong Lieng | Head, Department of Family Medicine, IMU Clinical Campus, Seremban |
11 | Professor Dr. Mallikarjuna P. Rao | Assoc. Dean – Research & Consultancy, School of Pharmacy, IMU |
12 | Assoc. Prof Dr Chen Yu Sui | Associate Professor – Student Experience Coordinator, Med. Sciences, School of Medicine, IMU |
13 | Professor Dr Chin Beek Yoke | Associate Dean for Research & External Affairs, School of Health |
14 | Professor Dr James Koh Kwee Choy | Head of Academic, School of Medicine |
15 | Professor Dr Seow Liang Lin | Associate Dean, Clinical Oral Sciences |
16 | Associate Professor Dr Wong Shew Fung | Department of Pathology, School of Medicine, IMU |
17 | Professor Dr Adlina Suleiman | Department of Community of Medicine, School of Medicine, IMU |
18 | Emiretus Professor Mak Joon Wah | Emeritus Professor, IMU |
19 | Professor Dr Stephen Ambu | Professor |
20 | Professor Khor Geok Lin | Adjunct Professor, IMU |
21 | Dr Sia Juo Yiing | Unit Head, Laboratory Animal Resources, The Medical Research Resource Centre (MRRC) |
22 | Dr Rozaihan Mansor | Dept. of Veterinary Medicine, UPM |
23 | Madam Lena Goh Lee Geok | Part-Time Lecturer, Nilai University |
24 | Mr Daniel Low Fock Sing | Manager of Esplanad Residents Association |
Forms, Policies and Guidelines
Research forms and policies can change over time as regulations and requirements adjust, so it’s essential to have the most accurate information. This is the place to find the most up-to-date forms and policies.
- SOP-Management of Research Projects
- Flowchart of Management of Research
- Checklist I - Lab-Based Research
- Checklist II - FieldSurvey-Based Research
- Checklist III - Clinical Trial Research
- FAQ IMU-JC
- Appendix A - Sample of Itemised Budget Form
- Appendix 1 - Application Form
- Appendix 1(a) - Study Information Sheet
- Appendix 1(b) - Consent Form
- Appendix 1(c) - Study Information Sheet (BM)
- Appendix 1(d) - Consent Form (BM)
- Appendix 1(e) - Information on Animail Use Research
- Appendix 2(a) - Application Form for Laboratory Space Requirement
- Appendix 2(b) - Application Form for Protected Time
- Appendix 3 - Remit of IMU-JC
- Appendix 4 - IMUJC IRB-EC Approval Form
- Appendix 5 - Letter to Finance Dept on ID & COA Number
- Appendix 6 - Confirmation Letter to PI on Project ID&COA Numbers
- Appendix 7 - Lab Space Approval Letter
- Appendix 8 - Tracking Form
- Appendix 9 - Request for Employment of Temporary Research Assistant (RA) for Approved Research Project
- Appendix 10 - 6th Monthly Progress & Financial Report Form
- Appendix 11 - Decision by IMU-JC on 6th MthlyProg & Financial Report
- Appendix 12 - End of Project Report Form
- Appendix 13 - Recommendations on End-of-Project Report
- Appendix 14 - Evaluation Form for Research Project Proposal
- Appendix 15 - Summary and Feedback Form (Response to IMUJC Review Panel)
IMU-JC Proposal Submission
All applications to IMU-JC must be submitted through the web-based research management system
(IMU-JC Research Proposal Submission Form).
Research that does not involve human subjects or animals |
Required Optional |
Research involving recombinant DNA, infectious agents, and other potentially hazardous biologics carries inherent safety risks |
Required
Optional |
Research that involve human subjects (Lab-Based Research) |
Required
Optional |
Research that involve human subjects (Field/Survey-Based Research) |
Required
Optional |
Research that involve animals |
Required Optional |
Clinical trials |
Required
Optional
|