Page 32 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

For further questions and inquiries, NIH investigator may contact IBBC Secretariat at:

IBBC Secretariat,
IMR – Institutional Biosafety and Biosecurity Committee,
Infectious Diseases Research Centre,
Level 3, Blok C,
Institute for Medical Research,
National Institutes of Health,
No.1, Jalan Setia Murni U13/52,
Seksyen U13, Setia Alam, 40170,
Shah Alam, Selangor
Phone: +603- 3362 8888 ext 8995
Email: ibbcsecretariat@moh.gov.my

For other facility and institution, please contact the respective IBBC/IBC for more information.

7.4. Phase 1 Clinical Trial: Scientific Review Panel for Phase 1 Clinical Trial (FIH)

The Scientific Review Panel (SRP) for Phase 1 Clinical Trials is established to support the
MREC, MOH in performing the scientific evaluation of First-In-Human (FIH) or First Dose in
Human Trials on new drugs undertaken by and/or conducted in clinical trial sites in Malaysia
[18].

SRP for Phase 1 Clinical Trials is under the Governance of the National Committee for Clinical
Research (NCCR).

Submission to SRP for Phase 1 Clinical Trials should be done in parallel with the submission
for ethical review to MREC and also notification to NPRA.
Documents submitted to SRP for Phase 1 Clinical Trials will be evaluated scientifically and
recommendations will be then forwarded to MREC, MOH for further ethical evaluation. The list
of documents required is listed in Appendix 9.
For further questions and inquiries, investigator may contact the SRP for Phase 1 Clinical Trial
Secretariat at:

Secretariat,
Scientific Review Panel (SRP) for Phase 1 Clinical Trial
D-26-06, Menara Suezcap 1,
KL Gateway, No. 2 Jalan Kerinchi,
Gerbang Kerinchi Lestari,
59200 Kuala Lumpur, Malaysia
Phone: +603 7931 5566
Email: contact@clinicalresearch.my
7.5. Research involving animal: Animal Care and Use Committee (ACUC)

The Animal Care and Use Committee (ACUC) is a scientific and ethical committee consisting
of veterinary officers, medical officers, research officers, and various categories of identified
officers from IMR, external panels from local universities, and the Department of Veterinary
Services.

16 NIH Guidelines for Conducting Research in MOH, 2021