Page 21 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

4. Research Registration and Submission

All research undertaken by MOH personnel or conducted in MOH institutions/facilities or using
MOH data/patient/sample/personnel as subject or funded by MRG must be registered with
NMRR prior to data collection and/or subject recruitment. Retrospective registration is only
applicable (although not advisable unless in unavoidable circumstances) for research that does not
require ethical review and approval by MREC, MOH (such as case study, systematic review, scoping
review, and research involving non-human subjects). Submissions for ethical review and grant
application should be made together during research registration. Submission for publication and
presentation approval can be made either together* or after research registration. Submission to other
regulatory authority or committee for specific research approval should be done either before, during
or after research registration in NMRR depending on the requirement by the respective authority or
committee. Any research led by non-MOH investigators involving any MOH personnel as part of
the research team is required to be registered as well.

Applications submitted for research approval will be subjected to a scientific review as well as an
ethical review. For Minimal Risk Research, the scientific review will be undertaken either by JPP-NIH
or HRRC ①. Recommendations following this review will be forwarded to MREC, MOH for further
consideration and ethical review. Meanwhile, the More than Minimal Risk Research and all Industry
Sponsored Research (ISR) will be forwarded directly to MREC for review and ethical consideration ②.
(①, ② refer to Diagram 1: Scientific and Ethical Review Processing Flowchart)

* Refer to Diagram 4: Publication and Presentation Review Processing Flowchart

Research applications submitted for MRG need to be submitted together with the application for
MREC ethical review. Submissions for MRG will be reviewed by the JPP-NIH ①. Recommendations
will be forwarded to the MREC, MOH for consideration and ethical review ②. Once ethical approval
has been obtained, the research submission will be forwarded to the MRG Review Panel for final
review and grant application approval ③. (①, ②, ③ refer to Diagram 2: MRG Processing Flowchart)

Research registration and submission for ethical approval, MRG application, Publication and
Presentation approval can be applied online via the National Medical Research Register (NMRR)
at nmrr.gov.my.

Registration of Clinical Trials in Malaysia involving investigational product(s) (including placebo) requires
the research to be registered (compulsory) in the NMRR and notified to the National Pharmaceutical
Regulatory Agency (NPRA).

4.1. National Medical Research Register (NMRR)

NMRR is a web-based tool developed in 2007 to support the implementation of the National
Institutes of Health (NIH) guidelines on the conduct of research in MOH. It enables online registration,
submission, review, and approval for research related to MOH. NMRR also serves as a publicly
accessible database of medical research conducted in the country (generally in MOH) and these
include clinical trials that are carried out in Malaysia.

The NMRR platform includes several modules namely research registration, submission for scientific
and ethical review and approval, submission for a grant application, and submission for presentation
and publication approval. The secretariat will coordinate and monitor the processes through this
platform.

NIH Guidelines for Conducting Research in MOH, 2021 05