Page 18 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

Policy Statements
3.1 General Policy of Research Conduct in MOH

All research conducted in MOH institutions and facilities must comply with the Declaration
of Helsinki, International Ethical Guidelines for Biomedical Research Involving Human
Subjects (CIOMS), ICH Guideline of Good Clinical Practice, Malaysian Good Clinical
Practice, and other local regulatory requirements and guidelines.
3.2 Category of Investigator

All research related to MOH (undertaken by MOH personnel OR conducted in MOH
institutions/facilities OR using MOH data/patient/sample/personnel as subject OR funded
by MOH Research Grant) shall require registration and approval* by the relevant authorities
according to the following categories:

i. MOH & NIH Investigator **
ii. Non - MOH Investigator
iii. Investigator applying for MOH Research Grant (MRG)

* Refer to policy statement 3.5
** MOH and NIH investigator is considered as MOH personnel. The differentiation between
the types of investigators is required due to different process flow during both scientific
and ethical reviews and the approval of the submission.
3.3 The Conduct of Research

i. Prior Approval by the MOH.
a. All research must be registered with the National Medical Research Register
(NMRR);
b. Principal Investigator (PI), PI at the site, and at least 1 Sub-Investigator (Sub-I) (for
each research site without PI at the site) must sign an Investigator Agreement and
obtain approval from his or her HOD and Institutional/Organisational Director by
using the IA-HOD-IA Form. (Appendix 1);
c. Investigator is advised to engage with relevant stakeholders prior to selecting the
research sites; and
d. For collaborative research with any external organisation or entity outside of MOH,
a Memorandum of Understanding (MoU) or Memorandum of Agreement (MoA) and
Research Agreement (RA) between the related MOH division, institution or facility,
and the external party must be obtained.

ii. After obtaining ethical approval, and before the recruitment of subjects and/or data
collection,
a. Sites without a signed IA-HOD-IA form should obtain approval to conduct research
at each site via the Site Approval Form (Appendix 2). An investigator is required to
fulfil any other site’s requirements depending on the respective facilities/institution’s
SOP.

02 NIH Guidelines for Conducting Research in MOH, 2021