Page 27 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

ii. Administrative requirements documents to be submitted to MREC for initial ethical
review (Please refer to Appendix 4).
iii. Investigators may also be required to provide additional documents necessary for
ethical review.

6.4. Risk assessment and type of MREC review

i. During risk assessment, research is categorised as:
a. Minimal risk (low risk);
b. Minor increase over the minimal risk (medium risk); or
c. More than a minor increase over the minimal risk (high risk).
ii. The type of review will be based on the risk assessment:
a. Low risk - expedited review by MREC Chairperson/Deputy Chairperson/
Secretary;
b. Medium risk - expedited review by MREC Primary Reviewers; or
c. High risk - MREC Full Board Review.

6.5. MREC Full Board meetings

i. MREC Full Board meetings are held as per scheduled or ad hoc if needed according
to the SOP.
ii. Members of the committee are appointed by the Director-General of Health and consist
of members from diverse backgrounds to ensure an adequate and thorough review of
research documents. The committee consists of:
a. Medical reviewers
b. Scientific reviewers
c. Layperson reviewers

6.6. Requirement for consent

i. Requirements for subjects’ consent are as per the Malaysian GCP [10].
ii. Parental consent is required for minors below the age of 18 years old [10]. Assent is required
for respondents between 7 years old to 18 years old. The language and terminology used in
assent forms should be appropriate according to the age and more than one assent form
may be required depending on the age range involved in any research.
iii. Investigators must first obtain permission from the parents or guardians for the
participation of the minor in the research before soliciting assent from the minor [10].
iv. Dissent of the minor must be respected even if the parent or guardian has agreed to the
participation of the minor.
v. Administrative requirements of the consent documents are listed in Appendix 4.

6.7. Post Ethical Approval

i. Amendment - Prior to the implementation of any amendments or changes to the
research documents/sites/research team/procedure, the investigators must obtain
prior approval for amendment from MREC. MREC reserves the right to withdraw
previous ethical approval if changes are not completely declared when applying for
approval of amendment/s.

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