Page 26 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

6. Ethical Review (Medical Research and Ethics Committee-MREC)

6.1. Introduction

MREC was established in 2002 to provide an independent ethical review on health research or
other research protocols that involve human subjects and are conducted in MOH facilities or
using data/patient/personnel from the MOH.

The constitution of MREC is in accordance with the ‘Malaysian Guidelines for Good Clinical
Practice (GCP)’ and complies with the ethical principles as outlined in the Declaration of
Helsinki, the International Ethical Guidelines for Biomedical Research Involving Human
Subjects (CIOMS), and ICH Guideline of Good Clinical Practice.
For further questions and inquiries, investigator may contact the MREC Secretariat at:

Sector for Ethics and Research Surveillance (MREC Secretariat),
Level 2, Block A,
National Institutes of Health,
No.1, Jalan Setia Murni U13/52,
Seksyen U13, Setia Alam, 40170,
Shah Alam, Selangor.
Phone: +603-3362 8798/8399/8398
Email: mrecsec@moh.gov.my / mreciir@moh.gov.my / mrecisr@moh.gov.my

6.2. Research application for ethical review by MREC

i. Ethical review and consideration for MREC approval is required in all research involving
human subjects that are conducted within or related to the MOH.*
ii. All applications forwarded to MREC for ethical review will undergo an initial screening
process.
iii. In the event of incomplete documentation or requirement of additional information, the
PI will be notified for corrective action/s before the application can be processed further
to the next step of ethical review.
iv. Sites with a signed IA-HOD-IA form are not mandated to obtain additional site approval
via the Site Approval Form (Appendix 2) unless required by the respective facilities or
institution’s SOP.

*The establishment of registries is under the purview of Pusat Informatik Kesihatan (PIK) and
Jawatankuasa Penilaian ICT (JPICT) or Jawatankuasa Teknikal ICT (JTICT) of MOH and does
not require ethical approval in the process of setting up. Ethical approval is only required when
secondary data is to be extracted from the registry for research purposes.

6.3. Essential documents

i. Essential documents are documents that are individually and collectively permit
evaluation of the conduct of a trial and the quality of the data produced. This serves to
demonstrate the compliance of the investigator, sponsor, and to monitor the standards
of Good Clinical Practice with all applicable regulatory requirements [9,10]. Please refer
to Appendix 3 (adapted from the Malaysian GCP, 4th edition).

10 NIH Guidelines for Conducting Research in MOH, 2021