References and Useful Links


Legislation and MOH Resources
Human Biomedical Research Act 2015
MOH HBRA Decision Tools
- Is my study Human Biomedical Research?
Am I handling human tissue and conducting tissue banking activities regulated under the Human Tissue Framework?
Related Offices and Sites in NUS

Office of Deputy President (Research & Technology)
NUS Life Sciences Institute
Office of Safety, Health & Environment
NUS Institutional Animal Care & Use Committee

Bioethics Advisory Committee (BAC)
Health Sciences Authority (HSA)
Ministry of Health (MOH)
***MOH guidelines on the Human Biomedical Research Act
Singapore Medical Association (SMA)
NHG Domain Specific Review Boards (NHG DSRBs)
Singhealth Centralized Institutional REview Board (CIRB)
Research Institutes
National Medical Research Council (NMRC)

Agency for Science, Technology and Research (A*STAR):


Alexandra Hospital (AH)
Changi General Hospital (CGH)
Institute of Mental Health (IMH)
KK Women's & Children's Hospital (KKH)
National University Hospital (NUH)
Singapore General Hospital (SGH)
Tan Tock Seng Hospital (TTSH)

Khoo Teck Puat Hospital (KTPH)



The American Journal of Bioethics Online Listing of Social-Behavioral Research Standards
Australian National Health and Medical Research Council U.S. Office of Human Research Protections (OHRP)
CIOMS - International Ethical Guidelines For Epidemiological Studies (2008) U.S. National Bioethics Advisory Committee (NBAC)
European Forum for Good Clinical Practice (EFGCP) U.S. National Institute of Health (NIH)

Food and Drug Administration (FDA)
-Information Sheet Guidances -Guidance for Institutional Review Boards,
Clinical Investigators, and Sponsors

World Health Organization (WHO)
Global Forum for Health Research World Medical Association (WMA)
International Bioethics Centre, UNESCO
Johns Hopkins University Bioethics Institute, USA

Useful Articles

AAHRPP-Accreditation Procedures IBC-Universal Declaration on the Human Genome
Belmont Report ICMJE-Sponsorship, Authorship, and Accountability (2002)
Biomedical Ethics in U.S. Public Policy IOM-Preserving the Public Trust
BMJ-Clinical Guidelines-Benefits and Limits 2019-International-Compilation-of-Human-Research-Standards
CIOMS - International Ethical Guidelines For Epidemiological Studies (2008) Medicines Act [Chap. 176]
Code of Federal Regulations Title 21 Part 56 (CFR 21-56) Medicines (Clinical Trial Regulations), 2016
Code of Federal Regulations Title 45 Part 46 (CFR 45-46) NIAID-DSMB Guideline
Declaration of Helsinki NMEC: Guidelines on Research Involving Human Subjects (Sep 1997)
Declaration of Helsinki Nuremberg
Detailed Guidance on the European CT Database OIG-Globalization of Clinical Trials
EFGCP-Guidelines and Recommendations 1997 OIG-Tissue Banking (Jan 2001)
Ethical Considerations in HIV Preventive Vaccine Research (UNAIDS-Guidance Document 2000) Personal Data Protection Act (2012)
European Directive 2001 Terms of the FWA
FDA Acceptance of Foreign Clinical Studies Tuskegee Syphilis Study
FDA-Computerized Systems Used in Clinical Trials (2007) WHO Declaration of Interests for WHO Experts
FDA-Draft Guidance on CT DMCs (2006) WHO-Defining Policy through Action
FDA-Testing Drugs in People 1995 WHO GCP 1995
Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance 1996 (ICH-GCP E6) WHO-Operational Guidelines (2000)