Page 29 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

6.9. Exemption from MREC Review

i. Applications for exemption from MREC review should be submitted as per the usual
procedure for ethical review if needed.
ii. Exemptions will be considered if:
a. Research utilises publicly available data or information that cannot be identified
directly or indirectly through identifiers linked to the subjects;
b. Taste and food quality evaluation and consumer acceptance research;
c. Audits that have obtained respective institutional authorisation;
d. Case reports with informed consent from patients; or
e. Public health surveillance activities that are deemed not for research. The
application needs to be supported with relevant documents authorised by a
public health authority [13]. The documents should be uploaded into the NMRR
system during research registration.

6.10. Additional information for Informed Consent Involving Biological Specimens Collection
and Genetic Testing

i. Please refer to the Malaysian Guidelines on The Use of Human Biological Samples for
Research [14].
ii. It is mandatory to have a separate informed consent for the conduct of genetic testing
in which the purpose of the testing is outside of the primary objective of the research.
The informed consent should not be combined with the routine informed consent form
of the original or main research proposal and this should be made optional for the
prospective subject
iii. If the investigator plans to store and use the excess biological samples or additional
collection of the samples for future research, separate informed consent forms (multiple
if applicable) are required for every additional consent needed such as:
a. Consent to the specific planned research or additional genetic tests;
b. Consent for storage and future use;
c. Consent for access to medical records and information for data relevant to the
bio-banking; and
d. Consent for re-contacting the subject for more data.

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