Page 17 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

1. Introduction

The primary purpose of research in medicine is to investigate and to understand the causes,
developments, and effects of health-related phenomena or events, and to improve the preventive,
diagnostic, and therapeutic interventions. In order to achieve this objective, the proposed research
or study must be thoroughly evaluated for its methodology, scientific validity, safety, quality,
effectiveness, efficiency, and accessibility.

Based on the set of principles as outlined by the Declaration of Helsinki, it is necessary for an
investigator to conduct research especially research that involves human subjects to contribute to the
knowledge of science and to improve the healthcare, health delivery systems while maintaining and
protecting the safety and wellbeing of the data and the subjects involved [4]. Furthermore, conducting
research from planning, grant funding as well as recruiting and collecting data needs to be performed
meticulously and monitored throughout the research period. Besides that, dissemination of research
findings and protection of intellectual properties are also important aspects of research that need to
be considered. This is to ensure that the investigators, key stakeholders, and most importantly society
will benefit from the research.

This guideline is compiled to help investigators from the MOH as well as others who are involved in
the conduct of any research involving the MOH facilities, subjects, samples or data. All requirements
and information in this document were adapted from both international and local guidelines and
regulations.

2. Definition of Research

Research is a systematic investigation involving the development of a hypothesis, testing, and
subsequent evaluation of the hypothesis on a particular subject(s) to establish and discover new
facts, principles or information [5,6,7]. In a general context, research could be a process to create
new generalisable knowledge or using existing knowledge to develop new findings and/or outcomes.
This process could be done using suitable methodologies that cover data collection, documentation
of critical information, synthesis, analysis, and interpretation of data or information set by specific
professional fields. From this point onwards, all acts of the abovementioned shall be referred to as
research.

3. Policy Statement

3.1. General Policy of Research Conduct in MOH Malaysia
3.2. Category of Investigator
3.3. The Conduct of Research
3.4. Roles and Responsibilities of the Institutional/Facility Director, Head of Department
(HOD), Clinical Research Centre (CRC) Unit and Research Review Committee (Panel/
Reviewers and Secretariats)
3.5. Ethical Review
3.6. MOH Research Grant Approval
3.7. Publication & Presentation Approval

NIH Guidelines for Conducting Research in MOH, 2021 01