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Presentation at a Pediatric Program Lecture held at King Fahad Medical City, Riyadh on 22 April 2019. By Professor Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Chairman of the Ethics Committee King Fahad Medical City
PRINCIPLES:
} Clinical trials should be conducted in accordance
with the ethical principles that have their origin in the Declaration of
Helsinki, and that are consistent with GCP and the applicable regulatory
requirement(s).
} Before a trial is initiated, foreseeable risks and
inconveniences should be weighed against the anticipated benefit for the
individual trial subject and society. A trial should be initiated and continued
only if the anticipated benefits justify the risks.
} The rights, safety, and well-being of the trial
subjects are the most important considerations and should prevail over
interests of science and society.
Con’t… - 1:
} The available nonclinical and clinical information
on an investigational product should be adequate to support the proposed
clinical trial.
} Clinical trials should be scientifically sound, and
described in a clear, detailed protocol.
} A trial should be conducted in compliance with the
protocol that has received prior institutional review board (IRB)/independent
ethics committee (IEC) approval/favourable opinion.
Con’t… - 2:
} The medical care given to, and medical decisions
made on behalf of, subjects should always be the responsibility of a qualified
physician or, when appropriate, of a qualified dentist.
} Each individual involved in conducting a trial
should be qualified by education, training, and experience to perform his or
her respective task(s).
} Freely given informed consent should be obtained
from every subject prior to clinical trial participation.
Con’t… - 3:
} All clinical trial information should be recorded,
handled, and stored in a way that allows its accurate reporting, interpretation
and verification.
} The confidentiality of records that could identify
subjects should be protected, respecting the privacy and confidentiality rules
in accordance with the applicable regulatory requirement(s).
} Investigational products should be manufactured,
handled, and stored in accordance with applicable good manufacturing practice
(GMP). They should be used in accordance with the approved protocol.
} Systems with procedures that assure the quality of
every aspect of the trial should be implemented.