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Online presentation at a Clinical Research Program: Bioethics on 03 May 2020 at 10:00-12:00 in the morning by Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH (Harvard) Chairman of the Ethics Committee King Fahad Medical City.
1.0 NUREMBERG CODE
1.1 Voluntary consent that can be withdrawn any time.
1.2 Benefits not achievable otherwise.
1.3 Animal experiments first.
1.4 Qualified researchers.
1.5 Experiment to stop if there is harm.
2.0 HELSINKI DECLARATION
2.1 Protection of patient safety and welfare, informed consent, privacy, confidentiality, full disclosure.
2.2 Conform to scientific principles.
2.3 Protect the environment.
2.4 Research must be described in a protocol approved by an ethics committee.
2.5 Qualified investigators.
2.6 Risk benefit consideration.
2.7 Obligation to publish.
3.0 BELMONT
3.1 Respect for the person.
3.2 Benefit.
3.3 Justice.
4.0 WHO PRINCIPLES
4.1 Ethical conduct, review by independent ethical committee,
continuing review.
4.2 Protocol, protocol compliance.
4.3 Risk identification, benefit/risk assessment.
4.4 Informed consent, confidentiality, privacy.
4.5 Investigator and staff qualifications.
4.6 Records.
4.7 Good manufacturing practice, quality systems.
5.0 CIOMS GUIDELINES
5.1 Ethical justification, ethical review, and scientific validity.
5.2 Informed consent, the vulnerable s, confidentiality, compensation
for injury, equity.
5.3 Obligations of the sponsor to provide health care services.
6.0 JCI STANDARDS
6.1 Protect of human research subjects.
6.2 Establish scope of research activities.
6.3 Requirements for sponsors.
6.4 Review of human research.
6.5 Manage conflicts of interest.
6.6 Integrate research in quality and safety programs.
6.7 Inform and protect patients during subject selection and execution of research.