Page 11 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

NDA : Non-Disclosure Agreement: It is the legal contract that establishes
a confidential relationship between 2 or more parties which shall
be ready upon entering negotiations
NIH : National Institutes of Health. NIH comprises of 6 institutes:-
i. Institute for Medical Research (IMR)
ii. Institute for Public Health (IPH)
iii. Institute for Health System Research (IHSR)
iv. Institute for Clinical Research (ICR)
v. Institute for Health Management (IHM)
vi. Institute for Health Behavioural Research (IHBR)
NIH Investigator : Investigator from NIH facilities
NMRR : National Medical Research Register
NPRA : National Pharmaceutical Regulatory Agency
NRDHM : National Committee for Research and Development of Herbal
Medicine
NSCERT : National Stem Cell Research and Ethics Subcommittee
PD : Protocol Deviation
PI : Principal Investigator
PUU : Penasihat Undang-Undang
RA : Research Agreement
Release Activity (in : Refers to any intentional introduction of living modi-fied organisms
Modern Biotechnology) or products of such organisms into environment through activities
or for purposes specified in the Second Schedule.
SAE : Serious Adverse Event
SADE : Serious Adverse Device Effect
Scientific Merit : The quality of the research with sound methodology and obligation
to provide new information and evidence. [2]
Second Schedule : A list of microorganisms that can cause severe/lethal disease, high
risk to individual and community and potential to be weaponized
[3].
SME : Subject Matter Expert
SOP : Standard Operating Procedure
SRP : Scientific Review Panel
Sub-I : Sub Investigator. Any individual member of the research team
designated and supervised by Principal Investigator at a research
site to perform research related procedures and/or to make
important research-related decisions (such as clinicians, medical
personnel, associates, residents, research fellows)
Surveillance : A systematic collection and analysis of health- related data
designed to help in organisation, implementation and health
service delivery (for example in situation such as managing an
outbreak). It helps the authority and public by identifying and
understanding the risks associated. Personal data and samples
may be collected with the intent to manage the incident. This may
involve a systematic, statistical methods to allow timely public
health action. Normally it does not involve an intervention. [1]

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