Page 31 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

For further questions and inquiries, investigator may contact the NRDHM Secretariat at:

Herbal Medicine Research Centre (HMRC),
Institute for Medical Research,
National Institutes of Health,
No.1, Jalan Setia Murni U13/52,
Seksyen U13, Setia Alam, 40170,
Shah Alam, Selangor
Phone: +603 -3362 8888 ext 7958
Email: jkkph_sec@moh.gov.my

7.3. Research involving Modern Biotechnology and Living Modified Organisms (LMOs):
Institutional Biosafety & Biosecurity Committee (IBBC) or Institutional Biosafety
Committee (IBC)

Research involving Modern Biotechnology and the use of LMOs requires an approval from
the Department of Biosafety, Ministry of Environment and Water prior to the commencement
of the research [3]. The application can be submitted through the IBBC/IBC of respective
facility and institution (if available). For NIH investigators and any collaborative research with
NIH, the submission should be sent to IBBC - IMR while for other MOH facility and institution,
submission is to be sent to the respective IBBC/IBC (if available).

IBBC and IBC is a committee established to advise investigators who are dealing with research
activities involving Modern Biotechnology and LMOs. Submission can be made concurrently to
IBBC/IBC during the research registration in NMRR. Research involving Modern Biotechnology
needs to submit Research Proposal Declaration Form (Appendix 7 – For NIH investigator)*
and Agree to Abide Form (Appendix 8 – For NIH investigator)*.

*Other IBBC/IBC might require different type of form to be submitted. Therefore, it is advisable
to refer to respective IBBC/IBC for the requirement of the submission.

The IBBC/IBC will review all submitted documents to determine research requirement status.
BSO and IBBC/IBC secretariat will then advise on either one of the following [16]:

a. If modern biotechnology is NOT USED, no further action is needed.

b. If modern biotechnology is USED, PI can either apply for;
- Exemption Activity or
- Notification for Contained Used Activity or
- Release Activity
In addition to that, investigator involves with LMOs need to submit E Form (Notification for
Contained Use and Import for Contained Use Activities Involving LMO for Biosafety Levels 1,
2, 3 and 4) and Annex 2 (IBC Assessment of Project Proposal Involving Modern Biotechnology
Activities) [17]. Both forms can be downloaded from the Department of Biosafety website.
(Diagram 5: Modern Biotechnology Research Notifications & Approval Flowcharts)

NIH Guidelines for Conducting Research in MOH, 2021 15