210523P - SAUDI RESEARCH ETHICS REGULATIONS

Presentation at a workshop on Week I: Bioethics Module - CRC Program held at King Fahad Medical City via Zoom on 23 May 2021 at 10:00-11:00 am by Professor Omar Hasan Kasule MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Professor of Epidemiology and Bioethics, King Fahad Medical City

 

 

1.0 HISTORICAL BACKGROUND:

1.1 Definitions of Research, ethics, and Bioethics.

1.2 Early experiments: Edward Jenner and smallpox, scurvy on ships.

1.3 Ethics violations in experiments on humans: Nazi unethical experiments in WW2, Tuskegee syphilis study.

1.4 International codes: Nuremberg code 1947, Helsinki, Belmont.

1.5 Main principle 1:  Respect for research participants (informed consent, privacy, confidentiality).

1.6 Main principle 2; Beneficence: study design, favorable risk/benefit, trained investigators.

 

2.0 SAUDI LAW OF ETHICS OF RESEARCH ON LIVING CREATURES (1475/2015):

2.1 Definitions.

2.2 Chapter 3: National Commission on Bioethics.

2.3 Chapter 5: Research monitoring office.

2.4 Chapter 6: Local Committee for Research Ethics (IRB).

2.5 Chapter 7: Informed Consent.

2.6 Chapter 8: Research on humans.

2.7 Chapter 9: Research on inmates.

2.8 Chapter 11: Genetic material.

2.9 Chapter 14: Penalties.

 

3.0 SAUDI FDA CLINICAL TRIAL GUIDELINES:

3.1 Glossary of terms.

3.2 Principles: protection of trial subjects.

3.3 Institutional Review Board: responsibilities, functions, procedures.

3.4 Investigator: qualifications, resources, responsibilities.

3.5 Sponsor: quality assurance, finance, safety.

3.6 Protocol: main elements.

3.7 Investigational product brochure.

3.8 Essential documents.

3.9 Adverse events reporting.