Page 28 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

ii. Ethical approval - The duration of ethical approval from MREC is for one year. The
expiry date of the ethical approval is stated in the formal letter of approval. Application
for renewal of ethical approval must be submitted to MREC should it be anticipated that
the research cannot be completed within the original ethical approval time frame. This
is done by submitting a Continuing Review Form of at least 2 months (60 days) prior
to the expiry of the previous ethical approval.
iii. Closure/Termination/Suspension Notification - Any research that is closed/terminated/
suspended is required to be updated to the MREC
a. Upon research completion, the PI is required to submit the Closure Notification
to MREC.
b. In the event of early termination or suspension of research, the PI is required to
submit a termination or suspension Notification to MREC.
iv. Progress Report - As stated in the Malaysian GCP, the investigator is required to submit
written summaries of the research status to the IRB or IEC (MREC) annually, or more
frequently, if requested by the MREC based on the degree of the risk [10].
v. Protocol Deviations (PD) - Investigators should report to MREC on ANY deviation or
changes to the protocol in order to eliminate immediate hazards to the subjects of the
research. (Applicable for all interventional research)
vi. Serious Adverse Events (SAE) and Serious Adverse Device Effect (SADE) - All detected
SAEs and SADEs should be reported immediately to MREC, the sponsor, and other
regulatory authorities as required. (Applicable for all interventional research)
vii. Any research submission provided with an” Exemption from MREC Review” would not
be required to submit any post-approval application as stated above. However, the
research status or progress is still required to be submitted and updated in the NMRR.
viii. All Post Ethical Approval submissions should be made via the NMRR platform.

6.8. Waiver of informed consent

i. Applications for waiver of informed consent must be clearly justified with the reason
documented in the protocol.
ii. The decision for waiver of consent from MREC follows the CIOMS guidelines 10
that stated: - ‘Investigators must not initiate research involving humans without
obtaining each participant’s individual informed consent or that of a legally
authorised representative unless investigators have received an explicit approval
to do so from a research ethics committee’ [11].
iii. Prior to application for a waiver of informed consent, investigators should first seek to
establish whether informed consent could be modified in a way that would preserve the
participant’s ability to understand the general nature of the investigation and to decide
whether to participate [12].
iv. MREC may consider a modification or waiver of informed consent to research if ALL of
the following criteria are fulfilled:
a. The research would not be feasible or practicable to be conducted without the
waiver or modification;
b. The research has important social value;
c. The research poses no more than minimal risks to the participants; and
d. No personal identifying information is collected
v. Additional provisions may apply when waivers or modifications of informed consent are
approved in the context of specific research.

12 NIH Guidelines for Conducting Research in MOH, 2021