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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 1: Definitions:
} The following terms and phrases – wherever used in this Law – shall
have the meanings assigned to them, unless otherwise required by context.
ARTICLE 2:
} This Law aims at setting the general principles and controls necessary
for dealing with Living Creatures, parts thereof or their genetic material in
research in light of applicable professional ethics not conflicting with Sharia.
ARTICLE 3:
} No establishment may conduct research on a living creature except upon
fulfilling procedures required under this Law. Research shall be subject to
periodic inspection by the National Committee in accordance with the
Regulations.
ARTICLE 4:
} A national committee of bioethics shall be formed at KACST comprising
specialists nominated by the competent minister or head of an agency for a
renewable term of 3 years.
ARTICLE 5:
} The National Committee shall convene periodically upon the Chairman’s
call or as necessary. The committee shall convene upon a call by its Chairman
or upon a written request by one third of its members. Committee meetings shall
not be valid unless attended by two thirds of its members. Committee
resolutions shall pass by majority vote of attending members. In case of a tie,
the Chairman shall have the casting vote.
The Regulations shall determine committee’s work procedures and meetings
as well as remuneration of members in accordance with applicable laws,
resolutions and directives.
ARTICLE 6:
} The National Committee shall set standards for biological research
ethics and oversee enforcement thereof. It shall be the authority regarding
overseeing research ethics and monitoring implementation thereof. It shall
particularly undertake the following.
ARTICLE 7:
} An annual financial allocation shall be set for the National Committee
within the budget of KACST along with endowments allocated therefor.
ARTICLE 8:
} Pursuant to this Law, an office for monitoring research ethics shall be
established, and it shall report to the National Committee. Said office shall
be located at KACST in Riyadh, and it may establish branches in the Kingdom’s
provinces pursuant to a decision by KACST President upon recommendation by the
National Committee. The office shall be headed by a specialist with experience
in medical and scientific research and research ethics.
ARTICLE 9:
The Monitoring Office shall be in charge of the following:
} Register and oversee
local committees in
accordance with the provisions of
this Law;
} Monitor the implementation of research ethics subject to this Law
through local committees;
} Any other tasks assigned thereto by the National Committee. The
Regulations shall specify the office rules and procedures.
ARTICLE 10:
Each establishment shall form a local committee consisting of at least
five members. The Regulations shall determine the manner of forming said
committee as well as the provisions and rules governing its activities. The
committee shall especially, but not exclusively, undertake the following:
} Verify that the research conforms to applicable laws in the Kingdom;
} Verify the validity of the informed consent procedures;
} Issue approval to conduct research from an ethical aspect;
ARTICLE 10: Con’t.:
} Monitor research implementation on a periodic basis;
} Monitor the health condition of the human subject during the
experiment;
} Coordinate with the monitoring office as regards its relevant
activities.
ARTICLE 11:
} No investigator may conduct research on any human subject prior to
obtaining an informed consent from him or from his guardian in accordance with
procedures specified by the Regulations.
ARTICLE 12:
} Upon obtaining the informed consent, the investigator shall clearly
explain to the human subject or his guardian all potential outcomes of the
research including harmful ones, if any, which result from withdrawal of the
informed consent.
ARTICLE 13:
} The informed consent shall be documented in accordance with conditions and
procedures specified by the Regulations.
ARTICLE 14:
} Subject to the provisions of Article 11 of this Law, the local
committee may approve conducting the research without obtaining the informed
consent if it is not possible to relate the information obtained by the
researcher from the records or pathological samples to the source person or if
the results related to individuals are available to the public.
ARTICLE 15:
} Research conducted on humans shall be for clear scientific objectives,
and shall be preceded by sufficient laboratory experiments on animals if the
nature of the research so requires.
ARTICLE 16:
} The expected benefit from the experiment or research to the human
subject shall be greater than the possible harm.
ARTICLE 17:
} The researcher may not in any way exploit the conditions of the human
subject and shall not expose him to any type of coercion or exploitation.
ARTICLE 18:
} Approval to conduct research on humans shall take into consideration
their right to normal life and their safety from all types of harm in
accordance with the provisions of Sharia.
ARTICLE 19:
} The investigator may not exploit the human subject for the purpose of
trading in gametes, zygotes, organs, tissues, cells or any parts thereof or
genetic data related to human derivatives or products.
ARTICLE 20:
} An organ removed for a purely medical purpose may be used in
scientific research upon
obtaining the informed
consent.
ARTICLE 21:
} No research may be conducted on human zygotes, gametes or fetuses
except under controls specified by the Regulations.
ARTICLE 22:
} No research may be conducted for the purpose of human cloning.
ARTICLE 23:
} Research may be conducted on tissues, living cells and separated parts,
including stem cells extracted from the umbilical cord or adult stem cells,
upon obtaining the informed consent.
ARTICLE 24:
} Prisoners, including those sentenced to death, shall be treated like
other persons as regards conducting medical research on them. The Regulations
shall specify ethical controls for conducting research on prisoners.
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 26:
} Pregnant women, fetuses and the product of pregnancy may not be used in
research except in accordance with controls specified by the Regulations.
ARTICLE 27:
} Cells, tissues and derivatives of human sperms, gametes and zygotes
may not
be transported or
exploited for the
purpose of research except in accordance with conditions
and restrictions laid down by the National
Committee.
ARTICLE 28:
} Fetuses may not be cloned for the purpose of obtaining embryonic stem
cells, nor may male or female gametes taken from sperms or eggs be donated to
produce fertilized eggs that can grow into a fetus for the purpose of
generating stem cells therefrom and conducting research thereon.
ARTICLE 29:
} Banks for preserving reproductive male or female cells with the intent
of conducting research thereon may not be established.
ARTICLE 30:
} Organs and tissues of fetuses aborted before reaching one hundred
twenty days may be used in research and experiments in accordance with controls
and conditions set forth in the Regulations.
ARTICLE 31:
} A central data bank shall be established within KACST for the purpose
of maintaining information related to genetic material and regulating use
thereof in accordance with procedures specified by the Regulations. Said bank
shall provide information for research using genetic material in the Kingdom.
ARTICLE 32:
} When setting up local data banks for the preservation of genetic
material, establishments conducting
research on such
genetic material shall comply with conditions and procedures specified
by the Regulations.
ARTICLE 33:
} The same genetic sample may not be subject to multiple use in research
projects of different purposes without obtaining an informed consent for each
purpose except if such use is not related to the source person, provided this
is approved by the local committee.
ARTICLE 34:
} The researcher shall observe the privacy and confidentiality of
information related to those from whom the research samples have been collected.
ARTICLE 35:
} The local committee may restrict the researcher’s use of research
results on genetic material if said results harm public interest, provided the
National Committee approves the same.
ARTICLE 36:
} Research with negative impacts on society may not be conducted, especially
research reinforcing racial discrimination.
ARTICLE 37:
} The Regulations shall specify the ethical controls and criteria of
genetic treatment research.
ARTICLE 38:
} Animals may be used for research employing all experimental or
scientific means not causing unusual pain to the animals.
} Use of animals shall be restricted to research whose objectives cannot
be realized without such use.
} Endangered animal species may not be subject to negative use.
} The Regulations shall specify ethical conditions and procedures for use
of animals in research.
ARTICLE 39:
} Plants may not be used in research that upsets environmental balance
and distribution of vegetation. Endangered plant species may not be subject to
negative use. The Regulations shall specify ethical terms and procedures of
research on plants.
ARTICLE 40:
} If research includes conducting genetic modification experiments on
Living Creatures, the investigator shall take all necessary measures to prevent
their escape from research laboratories.
ARTICLE 41:
} KACST President shall designate inspection employees in charge of
detecting violations of the provisions of this Law and its Regulations in
accordance with procedures specified by the Regulations.
ARTICLE 42:
} A committee shall be formed pursuant to a decision by KACST president
to review violations of the provisions of this Law and decide appropriate
penalties, except for imprisonment, according to this Law. Said committee shall
determine amount of damages for private claims.
ARTICLE 43:
} Public prosecution before the committee shall be carried out by
competent personnel designated
by KACST President.
ARTICLE 44:
Without prejudice
to any severer penalty prescribed by other laws, a person violating any
provision of this Law shall be subject to one or more of the following
penalties:
} Warning;
} Suspension of research until the effects of the violation are
rectified;
} Barring the researcher from conducting the research subject of the violation;
} A fine not exceeding two hundred thousand (200,000) riyals;
} Imprisonment for a period not exceeding six months.
ARTICLE 45:
} If the committee decides to impose a penalty including imprisonment, a
recommendation to this effect shall be submitted to KACST President for
referral to the competent court.
ARTICLE 46:
} The committee may include in the final penalty decision publication of
the decision text at the expense of the violator in not more than three local
newspapers, one of which at least is published in the region where he resides.
If no such newspaper is published in the region, the decision shall be
published in the newspaper published in the nearest region.
ARTICLE 47:
} An aggrieved party may appeal the penalty decision before the Board of
Grievances within sixty days from date of notification.
ARTICLE 48:
} KACST President shall issue the Implementing Regulations of this Law
within ninety days from date of publication of this Law.
ARTICLE 49:
} This law shall enter into force ninety days from the date of its
publication in the Official Gazette.
ARTICLE 50:
} Existing establishments shall fulfill necessary conditions and
requirements and adjust their status within ninety days from the effective date
of this Law.
ARTICLE 51:
} This Law shall supersede all other provisions conflicting therewith.