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International guidance

1. Nuremberg Code, 1947

2. Belmont Report, 1979

3. Declaration of Helsinki, 2024

4. Declaration of Taipei (pending update by the end of 2026, first edition 2016)

5. ICH-GCP E6 (R3), 2025

6. CIOMS

6.1 International ethical guidelines for health-related research involving humans, 2016

6.2 Clinical research in resource-limited settings, 2021

6.3 Patient involvement in the development, regulation and safe use of medicines, 2022

6.4 International guidelines on good governance practice for research institutions, 2023

1. WHO Guidance for Best Practices for Clinical Trials, 2024

2. US “Common Rule” 45 CFR 46, 2018

3. US FDA 21 CFR 50 (Protection of Human Subjects)

4. US FDA 21 CFR 56 (Institutional Review Boards)

5. OHRP International Compilation of Human Research Standards, 2024

6. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2022) (Canada)

7. UK Policy Framework for Health and Social Care Research, 11 March 2020 (UK)

8. The National Statement on Ethical Conduct in Human Research 2025 (Australia)

9. WHO tool for benchmarking ethics oversight of health-related research involving human participants, 2023

10. WHO tool for benchmarking ethics oversight of health-related research involving human participants: user guide, 2023

11. Emanuel, E. J., Wendler, D., & Grady, C. (2000). What makes clinical research ethical?. JAMA, 283(20), 2701–2711. https://doi.org/10.1001/jama.283.20.2701

12. Emanuel, E. J., Wendler, D., Killen, J., & Grady, C. (2004). What makes clinical research in developing countries ethical? The benchmarks of ethical research. The Journal of Infectious Diseases, 189(5), 930–937. https://doi.org/10.1086/381709

 

Local guidance

Professional Bodies

1. MMC Clinical Trial & Biomedical Research, 2006

2. MMC Medical Genetics and Genetic Services, 2006

3. MMC Stem Cell Research & Stem Cell Therapy, 2009

4. MMA Code of Ethics 2023 edition

5. A Guide to Conducting Clinical Trials in Malaysia, 2nd Edition, 2024 (SCRPM)

6. Malaysian Phase I Clinical Trial Guidelines, 2017 (CRM)

7. Malaysian Decentralised Clinical Trial (DCT) Guidance Document, 2023 (CRM)

8. The Malaysian Code of Responsible Conduct in Research 2nd Edition, 2021 (ASM)

 

KKM / NPRA

1. Malaysian Guidelines for Good Clinical Practice 5th Edition (2026)

2. Malaysian Guidelines for Good Clinical Practice (GCP) Inspection, Third Edition (2026)

3. Malaysian Guideline for Application of CTIL and CTX 8.1th Ed (Effective on 30 April 2025)

4. NIH Guidelines for Conducting Research in Ministry of Health Institutions & Facilities 3rd Edition (2021)

5. Malaysian Guidelines on The Use of Human Biological Samples for Research 2nd Edition, 2025

6. Guidelines on Stem Cell and Cell-Based Research and Therapy 3rd Edition, 2024

7. Guideline for Herbal Medicine Research, 2023

8. Malaysian Guideline for Bioequivalence Inspection 2nd Edition, 2024

9. Malaysian Guideline for Independent Ethics Committee Registration and Inspection, First Edition, 2014

10. Guideline on Good Distribution Practice 3rd Edition, 2018

11. The National Standards for Stem Cell Transplantation: Collection, Processing, Storage and Infusion of Haemopoietic Stem Cells and Therapeutic Cells (2nd Ed., 2018)

12. The National Guidelines for Haemopoietic Stem Cell Therapy 2nd Edition, 2023

13. Guidelines on Ethical Issues in the Provision of Medical Genetics Services in Malaysia, 2019

14. Guidelines for the Safe Transport of Clinical Specimens and Infectious Substances in Malaysia, 2023 (replacing Standard Operating Procedure for Transport of Biological Specimens)

15. Guidance Document for Biological Lot Release in Malaysia, 2025 (Guidance Document and Guidelines for Vaccines Lot Release in Malaysia has been included in this guidance since 2019)

 

MOSTI

1. The National Guidelines on AI Governance & Ethics, 2024

2. Garis Panduan Etika Bioteknologi di Malaysia, 2025

 

Specialty

Stem cell research

• ISSCR Guidelines for Stem Cell Research and Clinical Translation, v1.2, 2025 August

 

Genomic Research / Data-intensive Research

• GA4GH’s standards:

1. Consent Policy (v2.0, 2019);

2. Data Privacy and Security Policy (v2.0, 2019);

3. Framework for Involving and Engaging Participants, Patients, and Publics in Genomics Research and Health Implementation (v1.0, 2021);

4. Ethics Review Recognition Policy (v2.0, 2020);

5. Framework for responsible sharing of genomic and health-related data sharing (v1.0, 2019)

6. Machine-Readable Consent Guidance (v1.0, 2023)

7. Policy on Clinically Actionable Genomic Research Results (v1.0, 2021)

 

Public Health Emergencies (including human-controlled infection)

1. WHO Key criteria for the ethical acceptability of controlled human infection studies during public health emergencies, 2025

2. WHO Emergency use of unproven clinical interventions outside clinical trials: ethical considerations, 2025

3. WHO guidance on the ethical conduct of controlled human infection studies, 2021

4. WHO Guidance for research ethics committees for rapid review of research during public health emergencies, 2020

 

Artificial Intelligence

1. WHO Ethics and governance of artificial intelligence for health, 2021

2. WHO Ethics and governance of artificial intelligence for health: Guidance on large multi-modal models, 2024

3. WHO Benefits and risks of using artificial intelligence for pharmaceutical development and delivery, 2024

 

Other type of research

1. WHO Guidance on ethical considerations in planning and reviewing research studies on sexual and reproductive health in adolescents, 2018

2. WHO Ethics in implementation research: facilitator's guide, 2019

3. WHO Ethics in implementation research: participant's guide, 2019

The Ottawa Statement on the ethical design and conduct of cluster randomized trials (2013, may be updated this year) https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001346