200503P - SAUDI RESEARCH ETHICS REGULATIONS

Online presentation at a Clinical Research Program: Bioethics on 03 May 2020 at 1:00-3:00 in the afternoon by Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH (Harvard) Chairman of the Ethics Committee King Fahad Medical City.

1.0 HISTORICAL BACKGROUND

1.1 Definitions of Research, ethics, 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.