Links and References

Ethical Principles

• Nuremberg Code 
• WMA Declaration of Helsinki 
• Belmont Report 

Lebanese MOPH Regulations and CNRS Charter for Research

• Ministry of Public Health (Clinical Trials and IRB Authorization)
• Ministry of Public Health - Mental Health Program - Research in Mental Health and Psychosocial Support
• National Council for Scientific Research (CNRS)  - Charter of Ethics of Scientific Research in Lebanon

Registering your Clinical Trial

• MOPH Lebanese Clinical Trial Registry (LCTR) Platform
• Clinical Trials .Gov

European Union Clinical Trial Directive

• Clinical Trials

International Conference on Harmonization

• Good Clinical Practice – Efficacy Guidelines (E6)

International Committee of Medical Journal Editors (ICMJE)

• Requirements for ICMJE

UNESCO

• Ethics in Science and Technology

U.S Office for Human Research Protection

• Office of Human Subject Protection website 
• Human Subject Protection – 45CFR46
• International Requirements for Human Subject Protection

U.S. Food and Drug Administration (FDA)

• Food and Drug Administration
• 21CFR 50 (Human Subjects)
• 21CFR 56 (IRB)
• 21 CFR 312 (IND)
• 21CFR 812 (IDE)
• Information Sheet Guidance for IRBs, Clinical Investigators and Sponsors
• A Guide to Informed Consent – Information Sheet

World Health Organization

• Standards and operational guidance for the ethics review of health-related research within human participants