Page 5 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

6. Ethical Review (Medical Research and Ethics Committee-MREC) 10
6.1. Introduction 10

6.2. Research application for ethical review by MREC 10

6.3. Essential documents 10
6.4. Risk assessment and type of MREC review 11

6.5. MREC Full Board meetings 11
6.6. Requirement for consent 11

6.7. Post Ethical Approval 11
6.8. Waiver of informed consent 12

6.9. Exemption from MREC Review 13

6.10. Additional information for Informed Consent Involving Biological 13
Specimens Collection and Genetic Testing

7. Specific Requirements 14
7.1. Research involving use of stem cell on human subjects: National Stem 14
Cell Research and Ethics Subcommittee (NSCERT)
7.2. Research involving use of herbal products and preparations on human 14
subject: National Committee for Research and Development of Herbal
Medicine (NRDHM)

7.3. Research involving Modern Biotechnology and Living Modified 15
Organisms (LMOs): Institutional Biosafety & Biosecurity Committee
(IBBC) or Institutional Biosafety Committee (IBC)

7.4. Phase 1 Clinical Trial: Scientific Review Panel for Phase 1 Clinical 16
Trial(FIH)

7.5. Research involving animal: Animal Care and Use Committee (ACUC) 16
7.6. Research involving Orang Asli (Aborigines): Jabatan Kemajuan Orang 17
Asli (JAKOA)
7.7. Research involving Ministry of Education (MOE) facilities 17

7.8. International Investigators (Malaysian and non-Malaysian residing 18
overseas from foreign universities or entities)

7.9. Clinical Trial Research including Industrial Sponsored Research (ISR) 18
and Bioavailability/Bioequivalence (BA/BE)

NIH Guidelines for Conducting Research in MOH, 2021 iii