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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
ARTICLE
25
} Research may not
be conducted on minors, incompetent or disabled persons unless the interest of
these categories so requires. The Regulations shall specify ethical controls
for conducting research on said categories.
ARTICLE
25.1
} Research may not
be conducted on minors, incompetent or mentally disabled persons without
obtaining “Informed Consent” from parents or the legal guardians in accordance
with conditions set forth in the Law and Regulations, provided they are
informed of the level of risk and its probability as well as the person’s
assent.
} Either parent or
the legal guardian may grant the “Informed Consent” on behalf of minors,
incompetent or mentally disabled persons provided his decision is based on the
fact that the minor, incompetent or mentally disabled person is subject to no
harm and may benefit from the research.
} After granting the
“Informed Consent”, either parent or the guardian may withdraw the consent at
any phase of the research if he finds that the research conflicts with the
interests of the minor, incompetent or mentally disabled person or if the
research deviates from the objectives upon which the consent was granted.
ARTICLE
25.2
The
local committee shall grant its approval for research on minors, incompetent or
mentally disabled persons subject to the following conditions:
} It is not possible
to conduct the research on a competent person;
} The interest of
the minor, incompetent or mentally disabled person requires subjecting him to
the research, provided he is not exposed to more than the minimal potential
risk.
ARTICLE
25.2 con’t.
} The research
protocol includes clear and appropriate measures to minimize potential
risk as
much as possible;
} Evaluation of
potential risk and expected benefit from the research shall indicate type,
nature, degree and possibility of risk as well as the direct benefit for the
minor, incompetent or mentally disabled person subject of the research and for
similar persons;
} The research shall
be conducted in a school, camp, hospital, or institution where the majority of
occupants are incompetent or disabled, provided the research subject belongs to
this category.
ARTICLE
25.3
If
the local committee finds that the research in whole or in part achieves a
direct benefit for the minor, incompetent or mentally disabled person but that
its risk exceeds the minimal expected level, it may grant its approval to
conduct the research pursuant to the following conditions:
} The potential risk shall be within acceptable levels in accordance with medical standards,
if compared with expected benefits;
} The ratio of the
expected benefit shall exceed that of other methods available outside the scope
of the research;
ARTICLE
25.3 con’t.
} The research shall lead to a better understanding of
an important problem that affects the minor, incompetent or
mentally disabled person or his
interest, help reduce such problem, or prevent some of its negative effects;
} Obtaining the “Informed
Consent” from either parent or from the legal guardian.
ARTICLE
25.4
If
the local committee finds that the research does not directly benefit the
minor, incompetent or mentally disabled person but does not expose him to more
than the minimal potential risk, it may approve the research in the following
cases:
} If he had given
the “Informed Consent” when he was competent or before the disability occurred,
and his legal guardian later gave the “Informed
Consent”;
} If precautionary
measures taken for his protection are adequate and acceptable;
} If there are
sufficient reasons that make it possible to obtain significant information
through the research for understanding the case under study.
ARTICLE
25.5
} The local
committee may, prior to giving its approval of conducting research on the
minor, incompetent or mentally disabled person, require appointing a qualified
lawyer experienced to handle such case. Said lawyer shall have no relation with
the researcher or the institution supervising and funding the research and
shall observe the interest of the minor subject of the research, in coordination
with his parents or guardian.
ARTICLE
25.6
} The physically,
but not mentally, disabled person shall be treated as a normal person, in terms
of his responsibility for giving the “Informed Consent” and his understanding
of research potential risks.