NUS-IRB: References

References and Useful Links

 

Singapore

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
   
Organisations 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):

Hospitals 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)

 

International

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)
Council for International Organizations of  Medical Sciences (CIOMS) 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 International Compilation of Human Research Standards (2018)
CIOMS Epidemiological Studies 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)
- Helsinki - Statement of Clarification Nuremberg
Detailed Guidance on the European CT Database OIG-Globalization of Clinical Trials (2001)
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)
Human Biomedical Research Act (2015)