Page 30 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

7. Specific Requirements

For the following research types, additional approval from the respective committees should be
obtained together or prior to the submission of the research application. The committees are as follows:
7.1. Research involving use of stem cell on human subjects: National Stem Cell Research
and Ethics Subcommittee (NSCERT)

All research involving the use of stem cell or cell-based therapies on human subjects must
adhere to the Malaysian Guidelines for Stem Cell Research and Therapy [15].

All applications for research involving the use of stem cell or cell-based therapies must fulfil the
criteria listed in the Checklist for Research on Stem Cell and Cell-Based Therapies and provide
the necessary supporting documents together with the checklist during the submission to
NMRR. (Appendix 5)
For further questions and inquiries, investigator may contact the NSCERT Secretariat at:
Secretariat,
National Stem Cell Research and Ethics Subcommittee (NSCERT),
Medical Development Division,
Ministry of Health,
Level 5, Block E1, Parcel E,
Kompleks Kerajaan Persekutuan,
62590, Putrajaya
Phone: +603 - 8883 1153/1161
Fax: +603 - 8883 1155

7.2. Research involving use of herbal products and preparations on human subject: National
Committee for Research and Development of Herbal Medicine (NRDHM)

NRDHM was initially established in the MOH in 2002 after approval by the Cabinet to spearhead
the research and development (R&D) of herbal products. The Committee was restructured in
2011 in conjunction with the Economic Transformation Programs to develop herbal products
as a new economic source.

The functions of NRDHM are to coordinate the R&D of herbal medicine (herbal products and
standardised extracts) in the pre-clinical and clinical stages. The committee plays a role in
assisting MREC as SMEs in reviewing the fitness and suitability of the herbal products intended
to be used as an intervention in clinical trials.

NRDHM assists MREC by providing SME opinions in the review of the submitted research
involving herbal medicine. The committee acts to provide a separate and independent review
of the scientific merits, standardisation, safety, and possible risks of the herbal products that
are intended to be used as an intervention in the submitted research proposals.
The proposals of clinical trials involving herbal products will be evaluated by reviewing the
standardisation, quality, efficacy, and data safety. The details are usually obtained from the
research protocol, investigator’s brochure, Certificate of Analysis of the herbal item, and
Certificate of Good Manufacturing Practice (GMP) from the manufacturer and other relevant
supporting documents. The list of documents required is listed in Appendix 6.

14 NIH Guidelines for Conducting Research in MOH, 2021