Description

National Committee of BioEthics

Implementing Regulations of
the Law of Ethics of Research
on Living Creatures

Version 3
2022

National Committee of BioEthics

Implementing Regulations of
the Law of Ethics of Research
on Living Creatures

Version 3
2022

Contents

Chapter One: Definitions and General Provisions ……………………………. 7
Chapter Two: Objectives of the Law …………………………………………….. 12
Chapter Three: National Committee of Bioethics ……………………………. 13
Chapter Four: Committee Revenues ……………………………………………. 20
Chapter Five: Research Ethics Monitoring Office …………………………… 21
Chapter Six: Local Committee for Research Ethics ………………………… 24
Chapter Seven: Informed Consent ………………………………………………. 41
Chapter Eight: Research on Humans …………………………………………… 45
Chapter Nine: Research on Inmates ……………………………………………. 52
Chapter Ten: Research on Special Cases …………………………………….. 53
Chapter Eleven: Dealing with Genetic Material and its Banks ………….. 57
Chapter Twelve: Use of Animals and Plants in Experiments …………….. 62
Chapter Thirteen: Violation Review Committee ……………………………… 72
Chapter Fourteen: Penalties ………………………………………………………. 78
Chapter Fifteen: Concluding Provisions ……………………………………….. 80

5

Chapter One

Definitions and General Provisions
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.
Law: Law of Ethics of Research on Living Creatures.
Regulations: Implementing Regulations of the Law of Ethics of Research on Living
Creatures.
KACST: King Abdul Aziz City for Science and Technology.
President of KACST: President of King Abdul Aziz City for Science and Technology.
National Committee: National Committee of Biomedical Ethics.
Monitoring Office: Research Ethics Monitoring Office.
Local Committee: Committee for licensing research formed at an establishment in
accordance with the provisions of this Law.
Establishment: A public or private corporate entity engaged in research activities on
Living Creatures.
Researcher: A person academically qualified in a subject related to research and has
completed a course on research ethics.
Research: A systematic experimental investigation aiming at improvement of biosciences
or enrichment or development of general knowledge by using a living creature or parts
thereof.
Living Creatures: Human beings, animals and plants.
Genetic Material: Chain of nitrogenous bases that exist within the cells or are extracted
therefrom and are responsible for carrying traits and characteristics from the mother cell to
the sub-cell and from one living creature to its offspring.
Legal Capacity: Reaching the age of eighteen, with mental ability to enter into legal
relation on his own.
Informed Consent: A person giving his consent with his free will, without exploitation or
coercion and upon full understanding of what is required from him and of the research
objectives and potential risks as well as of rights and obligations arising out of his
participation therein.
Minor: A person under eighteen years of age.
Fetus: Outcome of pregnancy from the beginning of nidation in the uterus to the time of
its delivery or removal.
Guardian: A person having the right of legal authority over another person.
Sperm: The product of fertilization up to forty days.
Zygotes: An egg fertilized by a male sperm; from the time of fertilization until the time of
division into eight cells.
Gamete: The product of fertilization; from the end of the zygote phase until the phase of
nidation where the zygote is implanted in the uterus.

7

Cloning: The process of producing a complete individual genetically identical to another
without sexual intercourse.
Product of Pregnancy: A fetus that comes out of or removed from the uterus.
Experimental Animals: Animals raised in cages or at certain places to be used in scientific
experiments.
Minimal Risk: Minor harm not exceeding potential risk encountered in daily life, which
cannot be avoided during ordinary clinical or psychological examination, including potential
discomfort and inconvenience.
Legally Incompetent: A person lacking full legal capacity due to being a minor, lacking
the ability of sound reasoning and judgment or being subject of a court ruling placing him
under custody or continuation thereof which bars him from entering into a legal relation
on his own.
Disabled: A person suffering from a permanent full or partial deficiency in his physical,
sensory, communicative, educational or psychological abilities to an extent that affects the
possibility of meeting his common needs compared to his non-disabled peers.
Child: A male or female not reaching the age of eighteen years which entails him to give
an informed consent.
Embryonic Stem Cells: Cells removed from the fertilized egg in its early phases; before
the differentiation phase.
Adult Stem Cells: Organically unspecialized cells that are removed from the cells of a
fully developed living being.

Article (1.1)
Without prejudice to the meanings of the terms and phrases specified in Article 1 of
the Law, the following terms and phrases – wherever used in the Law – shall have the
meanings assigned to them, unless otherwise required by context.
Human Subject (Participant): A person who consents or whose guardian consents to
conduct clinical, non-clinical or therapeutic research or experiments on him.
Principal Investigator: Lead researcher in charge of planning and conducting the research,
collecting and analyzing data, and directing interventions stated in the research plan.
Clinical Research: Any research related to collecting and analyzing data for volunteers
or patients for the purpose of obtaining general knowledge that can be applied to other
individuals with regard to mechanism of disease, its incidence, prevalence, transmission
or treatment of a disease.
Non-Clinical Research: Any research related to collecting and analyzing data not directly
related to people for the purpose of obtaining general knowledge or facts.
Clinical Trial: Experiments conducted on human volunteers to examine safety and
effectiveness of a medication or medical device.
Prisoner: A person deprived of liberty, whether serving a prison sentence, detained on
trial, or is a correction facility inmate.
Vulnerable groups: Groups of individuals in need of additional protection due to their
lack of legal capacity, their questionable or diminished capacity or their lack of freedom to
choose.

8

Stillborn: A fetus delivered, came out of, or removed from the uterus with no signs of life
such as heartbeat, natural breathing, movement, or pulsation of the umbilical cord if still
connected.
Diagnostic Procedure: A test aiming at finding a certain disorder or disease in a living
creature.
Medication: A chemical compound administered to a living creature to help diagnose,
treat, prevent, cure or alleviate the effects of a disease or organic disorder.
Periodic Assessment: Observation of research progress by safety assessment and
information monitoring committee to ascertain safety of the human subject on a continuous
basis and to ensure nonexistence of any reason for discontinuation or modification of the
research.
Periodic Follow-up: Review of the periodic report submitted by the principal investigator
to the local committee to evaluate research progress and conformity with the approved
research plan.
Expedited Review: An evaluation carried out by the local committee chairman, or by a
committee member designated by him, of a new research project or modifications of a
previously approved research where potential risk to the human subject does not exceed
minimal risk.
Genetic Therapy Research: Any research which includes insertion or deletion of genetic
material within body cells or targeting the same whether by modification or deactivation for
finding a treatment for hereditary or other diseases.
Confidentiality: Non-disclosure or passing of any data, information or results related to
the research or the human subject, to any third party not connected with the research.
Privacy: Observing common values, including traditions, thoughts and norms.
Safety Assessment and Information Monitoring Committee: A group of scientists,
physicians, and statisticians independent from researchers, whose task is to review
accumulated data during clinical experiments for prompt analysis and to observe any
significant likelihood towards a certain trend in the results or unacceptable side effects
requiring a recommendation for suspension of research or modification of its plan.
Genes: Molecular units of heredity data in all living organisms that encode the information
required for building and preserving cells and performing all vital functions, and hence
building bodies of Living Creatures and giving them their characteristic features.
Major Harm: Any harm leading to a participant›s death, jeopardy to his life, hospitalization
beyond expectation, permanent disability, or deformation of fetus. This harm is deemed
unexpected if not stated in the “informed consent”.
Contract Research Organization (CRO): A public or private organization with which the
beneficiary contracts to delegate to it the performance of one or more of the research
tasks.
Beneficiary: An entity with a personal or corporate structure, public or private, authorizing
the research organization (CRO) to carry out some or all of his responsibilities for research
based on a contract between them, whether in his capacity as researcher, sponsor or
financer of the research.
Contract: a signed contract between the beneficiary and the Contract Research
Organization (CRO) that specifies the obligations and rights of each of either party.

9

Adverse events: unwanted event, expected or unexpected, or deterioration in a preexisting condition, or any abnormal laboratory indicator during or after applying a treatment
or procedure under investigation, whether related to the investigational procedure or not.
Such event is considered unexpected if it is not listed in the informed consent.
Clinical Trial Agreement (CTA): it is a contract between the Contract Research
Organization (CRO) and the principal investigator, detailing both parties’ obligations and
rights related to conducting the clinical trial.
Animal: all vertebrate and non-vertebrate animals recognized for use in experiments.
Pain in animals: a response to an internal or external stimulus that the specialist can
recognize by observing the abnormal behavior of the animal.
Plant genetic resources: plant genetic resources for food and agriculture that contain any
genetic resource of plant origin and are of actual or potential value for food and agriculture,
including plant genetic material that contains functional units of heredity intended for
sexual or vegetative propagation.
Traditional knowledge: traditional and heritage practices, which have accumulated over
generations by the community and farmers for the use and preservation of plant genetic
resources.
Plant variety: A group of plants within the range of one of the lowest known botanical
classifications, defined by the ability of its distinctive and other genetic characteristics to
reproduce.
Natural site: The natural environment in which plant genetic resources are located.
Unnatural site: The place where plant genetic resources are kept outside their natural
environment.
Ecosystem: a natural space and its contents of living creatures plant, animal, and nonliving components.
In-situ conservation: the maintenance of ecosystems and natural habitats, and the
maintenance and restoration of populations of species that have viability constituents in
their natural environments.
Natural habitats: The natural environment in which the living creature exists or the
environment surrounding the species (which affects and is affected by this species).
Ex situ conservation: conservation of plant genetic resources outside their natural
habitats.
Terminator seeds: seeds that produce sterile plants, used in some genetically modified
crops, thus forcing farmers to buy seeds every year.
Microorganisms (Microbes): are minute living creatures that include bacteria, fungi, and
viruses.
Dual-use research (microorganism): Research on uses that can benefit or harm humans
or the environment.
Infectious microorganisms: are microscopic living creatures and include pathogenic
bacteria, fungi and viruses.

10

General Provisions

Article (1.2)
Scope of Application
1- The provisions of the Law and its Regulations shall apply to any research establishment
conducting research on living creatures in the Kingdom of Saudi Arabia.
2- Research conducted on samples taken from within the Kingdom shall be subject to
the provisions of the Law and its Implementing Regulations as regards taking the
informed consent and sending genetic samples abroad.

Article (1.3)
Principles Governing Provisions of the Law and its Regulations
In interpretation and application, the provisions of the Law and its Regulations shall
be subject to Sharia provisions as adopted by official bodies in the Kingdom, laws and
controls set by the National Committee, and principles of human rights, without prejudice
to provisions of Sharia.

Article (1.4)
Banning Biological Research outside Licensed Establishments
Conducting biological research outside the premise and scope of supervision of licensed
establishments shall be deemed a violation of the provisions of the Law and its Regulations.

11

Chapter Two

Objectives of the Law
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 (2.1)
The Law aims to protect the rights of the human subject or part thereto, guarantee his
safety and dignity, and not harm animals or plants when conducting research.
Article (2.2)
Sharia dictates and professional ethics enforced in official bodies in the Kingdom as well
as rules and procedures set by the National Committee shall be observed in implementing
the provisions of the Law and its Regulations.

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 (3.1)
No establishment may conduct research on Living Creatures except after registration of a
local committee that grants licensing for conducting research and monitors research ethics
in accordance with provisions of the Law and its Regulations.
Article (3.2)
The establishment shall be responsible for any research conducted therein and shall,
through local committees, ensure that the researcher and research staff comply with
controls, procedures and provisions set forth in the Law and its Regulations as well as
decisions of the National Committee.

12

Chapter Three

National Committee of Bioethics
Article 4
1- 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, as follows:
A representative of KACST
Chairman
A representative of the Ministry of National Guard
Member
A representative of the Ministry of Defense
Member
A representative of the Ministry of Interior
Member
A representative of the General Presidency of Religious Research and Ifta’ Member
Two representatives from the Ministry of Higher Education (Universities)
Members
A representative of the Ministry of Health
Member
A representative of the Ministry of Education
Member
A representative of the Ministry of Agriculture
Member
A representative of the Saudi Wildlife Commission
Member
A representative of the Food and Drug General Authority
Member
A representative of King Faisal Specialist Hospital and Research Center
Member
A representative of Human Rights Commission
Member
The Director of Research Ethics Monitoring Office
Member
A representative of the private sector selected by the Chairman of the Council of the
Chambers of Commerce and Industry
Member
A legal counselor selected by the President of KACST
Member
2- The President of KACST shall issue the committee-formation decision, and said
committee shall report to him.
3- The President of KACST shall appoint a secretary for the committee.
4- Committee members shall elect from among themselves a vice president.
Article (4.1)
1-

2-

The President of KACST shall send a request for nomination to ministers and heads
of relevant agencies as specified in Article 4 of the Law not less than three months
before the formation or re-formation of the National Committee.
Each Minister or head of a relevant agency shall name a representative at the National
Committee in ample time prior to the date set for formation of the committee, taking
into consideration the following conditions:
a) Be a Saudi national;
b) Have academic qualification and experience necessary for contribution to
committee work;
c) Be known for integrity and competency;
d) Not be previously convicted of a crime impinging on religion or honor.

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3-

4-

If any member of the National Committee is unable to complete his term for any
reason, or if he expresses his desire to discontinue his membership in the committee,
or if he fails to attend three consecutive or seven non-consecutive meetings within the
same year without an excuse acceptable to KACST President, a replacement shall
be appointed in the same manner the replaced member was appointed to serve the
remainder of his term.
Committee membership shall be a renewable term of three years, provided half the
members are replaced upon committee re-formation for the third time. Membership
may not be renewed for more than three consecutive terms.

Article (4.2)
1-

2-

3-

The National Committee shall have a chairman in accordance with the Law. Said
chairman shall have a deputy to be elected by members of the National Committee
by secret ballot in the second committee meeting. The President of KACST shall be
notified of the ballot result.
The Chairman of the National Committee shall oversee its activities and all its
administrative, financial and technical matters, particularly the following:
a) Call for National Committee meetings and approve meeting agendas;
b) Preside over and manage National Committee meetings;
c) Ensure that National Committee decisions and recommendations are properly
reported and pursue implementation thereof;
d) Submit National Committee budget to KACST President;
e) Represent the National Committee before governmental, judicial and other
bodies within the Kingdom and abroad;
The Deputy Chairman of the National Committee shall assume the tasks of the
Committee Chairman in his absence or if so delegated.

Article (4.3)
A general secretariat for the National Committee shall be formed pursuant to a decision by
KACST President upon recommendation of the Chairman of the National Committee to be
in charge of the following:
1- Prepare for National Committee meetings, including preparing invitations and ensuring
their delivery, as well as meeting minutes and agendas;
2- Provide documents, research and studies related to items on National Committee
meeting agendas;
3- Prepare monthly reports on the activities of the National Committee;
4- Propose the annual budget of the National Committee and the Research Ethics
Monitoring Office;
5- File and organize documents related to National Committee work;
6- Maintain, file and make available to the public regulations, rules, directives and
controls issued by the National Committee in accordance with its jurisdiction as set
forth by the Law.

14

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 (5.1)
12-

3-

45-

6-

7-

The National Committee shall hold a monthly meeting upon a call by its Chairman or
designee;
The National Committee may hold extraordinary meetings if its Chairman or designee
deems it necessary. Said meetings shall only discuss items on the agenda without
adding any other items unless the Committee Chairman or designee decides otherwise;
If one or more members deem it necessary to hold an extraordinary meeting and this
is supported by at least one third of the members of the National Committee, they shall
submit a request in writing or by e-mail to the Committee Chairman or his designee,
naming the members in support of the meeting and the topic(s) to be discussed. In
this case, the Chairman or his designee shall call the committee to convene within a
period not exceeding ten days from the request submission date.
The National Committee shall convene at its headquarters or at any other place set
by the Committee Chairman or his designee if necessary.
Invitations for the meeting shall be sent to Committee members at least ten working
days prior to the meeting date. Invitations shall be delivered by hand or sent via
ordinary mail or e-mail.
Invitations shall include venue, date and time of meeting. Papers and documents
related to proposed items on the agenda shall be enclosed therein except for
classified documents. Members may have access to all documents at the meeting
place whether prior to or during the meeting.
The agenda of the National Committee meeting shall include the following items:
a) Minutes of the previous meeting for approval;
b) Topics proposed by the National Committee Chairman or members;
c) Monthly reports prepared by National Committee Secretariat, if any, upon
approval by Committee Chairman.

Article (5.2)
12-

National Committee meetings shall not be valid unless attended by two-thirds of its
members including the Chairman or his designee.
If the quorum provided for in Paragraph (1) above is not met within half an hour of
the designated time of the meeting, the Chairman shall adjourn the meeting and set a
new date within ten days. The call for said meeting shall be made at least five working
days prior to the meeting date.

15

34-

5-

If the National Committee Chairman or his deputy fails to attend the meeting within
half an hour of the meeting time, the Committee Secretary shall adjourn the meeting.
If the National Committee Chairman becomes aware that neither he nor his deputy
can attend the meeting, and it is necessary to hold the meeting, he may delegate
a Committee member to chair the meeting, and he shall have the powers of the
Committee Chairman with regards to managing the meeting.
If any of the National Committee members has an interest in a proposed item for
discussion that may affect his opinion or neutrality, he shall declare the same prior
to the meeting. In such case, the Committee Chairman may ask him to leave the
meeting or to remain without the right to participate in the discussion or voting. If the
Chairman leaves for such reason, his designee shall chair the meeting.

Article (5.3)
123-

Committee resolutions shall pass by simple majority vote of attending members. In
case of a tie, the meeting Chairman shall have the casting vote.
Votes may be taken by a show of hands, secret ballot, electronically, or by any other
means decided by the Chairman.
The National Committee may, if necessary, pass a resolution by circulation if approved
by two-thirds of its members. Committee approval of said resolution shall be included
in the subsequent meeting minutes.

Article (5.4)
The National Committee may, upon a call of its Chairman or his designee, invite persons
with expertise in the item under discussion, whether from within or outside KACST, without
such persons having the right to vote.
Article (5.5)
Remuneration of the National Committee Chairman and members shall be determined in
accordance with laws and procedures applicable at KACST.

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:
1- Prepare bioethics research regulations and review them in accordance with recent
developments.
2- Propose amendment to the Law and its Regulations.
3- Form specialized subcommittees for conducting detailed studies on research fields
within the jurisdiction of the National Committee.
4- Set controls for sending biological samples to laboratories outside the Kingdom.
5- Oversee local committees and monitor compliance with Sharia and statutory rules
when dealing with biological material.

16

6-

Set ethical controls and monitor implementation thereof to safeguard rights of
human subjects during research and ensure confidentiality and security of research
information.
7- Establish a database for saving and retrieving national information on genetic material
of Saudi society.
8- Coordinate between the Kingdom and other countries as well as Arab and international
organizations with regard to its jurisdiction, in accordance with applicable legal
procedures.
9- Set bylaws for the National Committee.
10- Propose annual budget of both the National Committee and the Research Ethics
Monitoring Office.
11- Oversee and monitor the central information system for national genetic material
banks and set controls for documentation and retrieval thereof.
12- Set rules and principles for ethical recognition of research laboratories working in
biomedical fields.
13- Conduct periodic ethical evaluation and monitoring of national laboratories, and
monitor medical research and experiments conducted on Living Creatures to ensure
legitimacy.
The Committee may seek consultation from experts, associations, scientific centers or
specialized agencies within the Kingdom and abroad.
Article (6.1)
The National Committee Chairman or any of its members may propose amendment to
the Law or Regulations. Said proposal shall be submitted for review by the Committee in
accordance with its work procedures, and shall then be referred to the President of KACST
to address concerned authorities in this regard.
Article (6.2)
Approval of amendments to the Law or Regulations shall be by majority vote of National
Committee members.
Article (6.3)
12-

34-

The National Committee may, if necessary, form subcommittees for conducting
detailed studies on particular matters proposed for discussion.
In forming said subcommittees referred to in Paragraph (1) above, members shall
be selected based on their academic qualification and competence in conducting
research.
Remuneration of subcommittee members shall be determined according to applicable
rules at KACST.
Remuneration of experts, associations, scientific centers or specialized agencies
whose consultancy services are sought shall be determined according to applicable
rules at KACST.

17

Article (6.4)
Upon sending biological samples to laboratories outside the Kingdom for research
purposes, the researcher, his designee or the specialist involved shall comply with the
following principles:
First: Samples sent abroad for research purposes
12-

3-

4-

5-

Samples transfer should be limited to international research agencies known for their
research experience in the relevant research fields.
A Research Material Transfer Agreement shall be drafted to guarantee the rights of
human subjects, the rights of the researcher and national rights. The said agreement
shall take the form of a joint research to be agreed upon by the local committee in the
institution to which the researcher belongs and approved by the official in charge of
said institution.
If a different Saudi investigator or entity was/or is working on the same subject,
samples should not be sent outside the Kingdom of Saudi Arabia. Collaboration should
be made with the project running inside the Kingdom, unless such collaboration is
rendered impossible for a valid reason that is accepted by the local ethics committee.
Data accompanying the submitted samples or material must not reveal the identity
of the source person whose sample is submitted. Material may carry only coded
numbers.
Notifying the National Committee of Bioethics in writing about the Local Ethics
Committee decision including the project’s purpose, sponsor/s and collaborator/s.
The National Committee of Bioethics may decide to stop conducting or completing
the project if it appears to carry no benefit to the Saudi society or if it poses a direct
or indirect harm to the community. Such rights of the National Committee of Bioethics
must be clearly stated in any agreement drawn between the local entity intending to
send samples and any other institute outside the Kingdom of Saudi Arabia.

Second: In addition to the principles stated in sections «First», the researcher shall,
before sending biological samples outside the Kingdom for research purposes,
observe the following:
1-

234-

Obtain the Local Committee written authorization to send samples abroad, by
submitting an official letter indicating reasons for sending, quantity and type of
samples as well as identifying receiving agency, and notify the National Committee
of this authorization.
The researcher must enclose a copy of the obtained Local Committee approval with
documents submitted to competent agencies such as customs and carriers;
Ensure security of genetic samples during storage and transportation;
Disposal of excess genetic samples must be performed according to standard scientific
methods, and every precaution must be taken to ensure that the said samples are
not stored in banks outside the Kingdom once these samples have been analyzed or
studied.

Article (6.5)
1-

18

The National Committee shall oversee local committees and monitor compliance

23-

with Sharia and statutory rules when handling biological material in accordance with
the provisions of the Law and Regulations as well as guidelines set by the National
Committee in this regard.
The rules and principles related to handling of genetic samples apply to all samples,
whether the samples were taken in the Kingdom or imported from abroad.
Importing cells or other materials from commercial suppliers licensed in the country of
origin for research purposes does not require obtaining an ethical approval.

Article (6.6)
A database shall be established at KACST for saving and retrieving national information on
genetic material of the Saudi society. KACST shall supervise and monitor said database
as follows:
1- Provide facilities, human resources and equipment required for setting up databases;
2- Receive data of genetic material from local genetic material banks available in
research institutions;
3- Establish a central bank for saving and retrieving information on genetic material and
provide said information for local genetic material banks;
4- Set controls and procedures for saving, retrieving and ensuring confidentiality of
information on genetic material.
5- Set controls and procedures for requesting information on genetic material from the
central genetic information bank.
The procedures for saving and retrieving data and information on genetic material shall be
subject to provisions of the Law and Regulations.
Article (6.7)
Research laboratories operating in biomedical fields shall be ethically recognized upon
satisfying the following conditions:
1- Laboratories are supervised by a governmental institution or a private agency licensed
by competent authorities;
2- Laboratories are run by specialists qualified to perform their technical and
administrative duties and responsibilities;
3- Laboratories, if not affiliated with a governmental institution, satisfy conditions set
forth in the «Law of Private Laboratories»;
4- The institution is able to meet legal liability arising from damage caused by practices
conducted within its affiliated laboratories;
5- Laboratories meet safety conditions and preventive measures observed in establishing
biomedical research laboratories;
6- Laboratories observe confidentiality and privacy with regard to Living Creatures or
genetic material information available therein.
Article (6.8)
When coordinating between the Kingdom and other countries, or Arab or international
organizations, the National Committee, in the context of exercising its jurisdiction, shall
observe applicable legal procedures.

19

Chapter Four

Committee Revenues
Article 7
An annual financial allocation shall be set for the National Committee within the budget of
KACST along with endowments allocated therefor.
Article (7.1)
1- Committee revenues shall comprise the following:
a) Financial allocations set for it within KACST’s budget;
b) Endowments allocated for the Committee.
2- Upon setting allocations referred to in Paragraph (a) above, the following procedures
shall be observed:
a) The National Committee Chairman shall submit the allocations set for
the following fiscal year to be approved by the Committee 30 days before its
submission to KACST President;
b) Upon approval of allocations by the National Committee, the Committee
Chairman shall submit said allocations to KACST President.
c) The Committee Chairman shall coordinate with relevant departments at
KACST to incorporate said allocations in KACST budget. Upon discussing such
allocations, the Chairman may, if necessary, seek the assistance of any person
either from relevant departments at KACST or from the Ministry of Finance, as
he deems fit.
d) Upon approval of the budget and setting the financial allocations for the
National Committee, the Committee Chairman shall present to the Committee the
allocations and the proposed spending plan.
3- Upon allocating endowments for the National Committee, the following procedures
shall be observed:
a) If the National Committee receives a request to endow any property for its
activities, said request shall be presented to its members for discussion and
decision thereon.
b) Upon reviewing the endowment request, the National Committee shall observe
all relevant laws, decisions and directives.
c) If the endowment is accepted, the National Committee shall set necessary
controls and procedures for dealing therewith.
d) The National Committee Chairman shall submit annual reports to the Committee
regarding the endowments allocated for its activities. The Committee may take
any decision it deems necessary in this regard.
e) The National Committee may, if required, form from among its members or
others a subcommittee to manage endowments.

20

Chapter Five

Research Ethics Monitoring Office
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 (8.1)
The Monitoring Office shall report to the National Committee Chairman.
Article (8.2)
The President of KACST shall appoint, upon nomination by the National Committee
Chairman, a full-time director for the Monitoring Office; said director shall be experienced
in medical and scientific research and research ethics.
Article (8.3)
The Monitoring Office may establish branches in different areas of the Kingdom provided
the following conditions are satisfied:
1-

The need for opening a branch in the relevant area;

2-

Financial allocations required for establishing and operating the branch;

3-

Submission of a recommendation by the National Committee to KACST President
stating the need for opening a branch.

The branch may be located in any governmental agency in the relevant area.
Article (8.4)
The Monitoring Office shall have an adequate share of the financial allocations set for the
National Committee to pay for its activities.

Article 9
The Monitoring Office shall be in charge of the following:
1-

Register and oversee local committees in accordance with the provisions of this Law;

2-

Monitor the implementation of research ethics subject to this Law through local
committees;

3-

Any other tasks assigned thereto by the National Committee.

The Regulations shall specify the office rules and procedures.

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Article (9.1)
The Monitoring Office shall register and oversee local committees and monitor their
compliance with the provisions of the Law and its Regulations and the as well as controls
and procedures set by the National Committee.
Article (9.2)
The following procedures shall apply upon registration of local committees:
1- The National committee shall prepare a registration form for the local committee to be
published on its website, including the following:
a) Name and address of establishment applying for registration;
b) Date of application;
c) Nature of research conducted therein;
d) Names and CVs of local committee chairman and members;
2- The establishment applying for registration of a local committee shall complete the
application form referred to in Paragraph (1) above, provide necessary data, and
submit the form along with necessary attachments, including the decision of forming
the local committee, to the Research Ethics Monitoring Office.
3- The Monitoring Office shall review each registration application submitted thereto by
the establishment. If the application data is incomplete, the establishment shall be
notified within 10 working days from the application submission date.
4- The Monitoring Office shall decide on the application within 15 working days from
the date of receipt of the complete application, render a decision to this effect, and
promptly notify the concerned establishment of said decision, provided the notification
includes registration number and date.
5- The Monitoring Office may not reject any application for registration except on legal
grounds. If the application is rejected, the Research Ethics Monitoring Office shall
notify the establishment of the reasons for rejection.
6- The registration period for the committee shall be in accordance with the period
specified in the decision to form it, and if a specific period is not specified in the
formation decision, the registration period shall be three years, subject to renewal.
7- The monitoring office may cancel the registration of the local committee if it does not
update its data or renew its registration.
Article (9.3)
In its supervision of registered local committees, the Monitoring Office may undertake the
following:
1- Assign any person it deems fit to conduct field visits to the registered establishment at
least once a year for examining committee documents and papers;
2- Assign any person it deems fit to attend local committee meetings, if required;
3- Ensure local committee compliance with relevant laws, regulations, rules and
directives and coordinate therewith for this purpose;
4- Review complaints or grievances submitted by the principal investigator or by any
member of the research team against local committee decisions;

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5- Review complaints submitted by the human subject in case he claims to have
been harmed as a result of the research.

Article (9.4)
In its monitoring of local committee compliance with the provisions of the Law and its
Regulations, the Monitoring Office may undertake the following:
1- Having access to all records and documents of research registered with the local
committee;
2- Contact the participating human subject, if required;
3- Cancel, suspend, terminate or prevent prompt evaluation, if necessary;
4- Record any violation committed by the local committee and take necessary actions in
accordance with the Law and Regulations;
5- The Monitoring Office shall conduct periodic ethical evaluation and monitoring of
national laboratories, and shall monitor medical research and experiments conducted
on Living Creatures to ensure legitimacy thereof.
6- Upon verification of occurrence of a violation or a reasonable possibility of a valid
claim of harm, the Monitoring Office may refer the matter to the Violation Committee
referred to in Article (42.1) of the Regulations to take appropriate action.
Article (9.5)
The Committee Chairman shall appoint office staff upon recommendation of the director of
the Monitoring Office in accordance with applicable procedures including office secretariat
to help carry out administrative and technical work.
Article (9.6)
The Office may, if necessary, seek the assistance of specialists, experts and consultants
as it deems fit; remuneration of said persons shall be according to KACST applicable
rules.

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Chapter Six

Local Committee for Research Ethics
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:
1- Verify that the research conforms to applicable laws in the Kingdom;
2- Verify the validity of the informed consent procedures;
3- Issue approval to conduct research from an ethical aspect;
4- Monitor research implementation on a periodic basis;
5- Monitor the health condition of the human subject during the experiment;
6- Coordinate with the monitoring office as regards its relevant activities.
Article (10.1)
The local committee shall be formed of at least five members in accordance with the
procedures set forth in Article (9.2) of the Regulations. Upon formation of said committee,
the following shall be observed:
First: The Committee chairman or his deputy shall be of Saudi nationality with experience
in the field of biological research.
Second: The number of members shall be determined according to volume and type of
research expected to be reviewed.
Third: Members shall be of different specializations, and when named the following shall
be observed:
1- One member at least shall have an interest in the main research field of the
establishment;
2- One member at least shall be from outside the establishment, and shall fulfill the
following conditions:
a) He shall have no business relation nor direct or indirect interest with the
establishment;
b) He shall be of an acceptable level of education;
3- One member at least shall have an interest in biomedical ethics;
4- One member at least shall have adequate knowledge in research design and
statistical analysis;
5- One member at least shall be adequately familiar with the customs, traditions and
values of the Saudi Society.
Article (10.2)
1- The local committee shall be formed by decision of the president of the establishment

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2-

3-

or competent agency stating the names of committee members, chairman and his
deputy. The chairman and his deputy shall have interest in biomedical ethics.
The relevant establishment or competent agency commits to providing the financial
support needed for the local committee as well as committee members remunerations
such as to ensure and preserve the independence of committee decisions and to
ensure its continued operation.
Committee members, employees and all persons invited to attend committee
meetings shall keep as confidential all information they come by and shall not disclose
any information included in research or research ideas and proposals.

Article (10.3)
Local committee members shall be appointed for a renewable term of 3 years, provided
half the members be replaced upon re-formation for the third time. Membership may not
be renewed for more than three consecutive terms.
Article (10.4)
The head of the establishment shall appoint a secretary for the local committee upon the
recommendation of its chairman, to undertake the following:
1- Receive applications submitted to the committee and verify that they meet all
conditions, and include all components and documents, and present the same to the
committee chairman;
2- Prepare agendas and minutes of committee meetings;
3- Coordinate local committee activities and communications with researchers and with
the National Committee;
4- Archive copies of committee meeting minutes, including names of attending
members, decisions issued, results of voting on such decisions, and a summary of
the discussions taking place during every meeting;
5- Prepare letters of notification of committee decisions and recommendations to be
signed by the committee chairman;
6- Any other work-related tasks assigned to him by the committee or its chairman;
7- Maintain confidentiality of information he is privy to and not disclose any information
in the research or research ideas and proposals.
Article (10.5)
The local committee shall seek to achieve the following:
1- Protect the human subject of the research, as well as protect and ensure the human
subject’s rights and safety;
2- Verify compliance with all requested and documented procedures in the research
project regarding the treatment of human subject participants and biological materials.
3- Ensure that the means by which advertisement, initial contact and selection, or
information provided to the participant, do not lead to revealing his personal information
or discovering his identity.
4- Ensure that necessary equipment and that such equipment is adequate for the safety
of the human subject participants.

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Ensure especially that minors, legally incompetent or disabled persons, or any other
persons from (vulnerable groups) are never abused under any circumstance.

Article (10.6)
Committee membership shall be terminated for any of the following reasons:
1- Resignation;
2- Death;
3- Chronic illness that prevents a member from attending local committee meetings;
4- If any member fails to attend three consecutive or five non-consecutive meetings
within the same year without an excuse acceptable to the local committee chairman;
5- Expiration and non-renewal of term of membership;
6- If a member is proved to have violated his commitment to keep information confidential
and the committee chairman has issued a decision to this effect based on proven
facts.
Article (10.7)
If the membership of any local committee member is terminated for any reason, committee
chairman shall instantly address the concerned party to appoint a replacement to fill in the
remainder of said member›s term, and shall notify the Monitoring Office thereof.
Article (10.8)
If the local committee chairman finds that one committee member does not effectively
take part in committee activities or that he has not appropriately accomplished the duties
assigned to him, he may notify the concerned party thereof and suggest whatever action
he deems fit, including dismissal of said member and appointment of a replacement.
Article (10.9)
1- The local committee shall convene upon a call by its chairman whenever required;
2- Local committee meeting shall not be valid unless attended by the majority of its
members including the chairman or his designee;
3- If the quorum is not reached within half an hour of the designated date of the meeting,
the meeting chairman shall adjourn the meeting to be held within fifteen days
thereafter;
4- Invitations for the meeting shall be delivered by hand or sent via ordinary mail or
e-mail at least ten work days before convention date. The meeting agenda and all
papers and documents related to topics proposed for discussion shall be attached to
the invitations;
5- Local committee secretary shall record the meeting minutes, and attending members
and committee secretary shall sign the minutes directly after the meeting or in the
next meeting.
Article (10.10)
If a local committee member finds that he or any other member has any sort of direct
or indirect interest related to any topic proposed for discussion by the committee, said

26

member shall disclose such interest at the beginning of the meeting. In that case, the
committee chairman shall ask the member who has declared such interest to withdraw
from the meeting during discussion of related topic and shall record this action in the
meeting minutes.
Article (10.11)
1- The local committee may invite experts and consultants to attend its meetings
whenever a proposed item on the committee meeting agenda requires so. These
expert guests do not have the right to vote.
2- If the research subject proposed for discussion by the local committee is related to any
category of the (vulnerable groups), the committee chairman shall invite a specialist
with experience in this field to take part in discussing said subject. Said specialist shall
have the right to take part in discussion and in voting. If said specialist fails to attend
the meeting, it shall be required to obtain a specialist›s written opinion of the matter.
3- If it deems it necessary, the local committee may invite the principal investigator to
attend one of its meetings, provided he does not attend the meeting during which the
final decision on the research project is made.
Article (10.12)
1- Local committee resolutions shall pass by simple majority vote of attending members.
In case of a tie, the meeting chairman shall have the casting vote.
2- Local committee chairman shall determine the voting method in committee meetings.
3- Issued resolution shall be printed on local committee or establishment official
stationary, and shall include a clear statement of resolution text. Committee chairman
shall notify the principal investigator of said resolution in writing.
4- In case the research application is rejected, the resolution shall state the reasons for
rejection.
5- Local committee may issue non-binding recommendations, if necessary, and attach
them to rejection resolution.
6- Local committee may issue a conditional approval, and the resolution shall determine
the necessary procedure to reconsider the application and any requirements or
suggestions for reassessment.
7- An aggrieved party may appeal local committee resolutions of rejection or provisional
approval before local committee. If the local committee dismisses the complaint as
unconvincing, the aggrieved party may have recourse to the Monitoring Office to
review the matter.
Article (10.13)
1- The local ethics committee reviews research project applications submitted by
employees of the facility to which it belongs. It has the right to consider research
applications submitted by investigators from nearby facilities after agreement with
the investigator if there is no local ethics committee in the facility with which these
investigators are affiliated.

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2-

3-

4-

5-

6-

If investigators from multiple establishments are collaborating on one common project
– the principal investigator (PI) must obtain the approval of the local ethics committee
in the establishment to which he/she affiliated with.
Collaborating investigators must submit the approval obtained by the principal
investigator (PI) to the local ethics committees in their respective local committees to
obtain their approval to conduct the research within the facility.
The local committee in the facility to which the collaborating investigator/s belong,
may approve research by expedited review method based on the approval obtained
by the principal investigator from his local committee.
The collaborating investigators shall submit periodic reports on the progress of the
research to their establishment›s local, in accordance with the procedures set forth in
Article (10/29) of these regulations.
The co-investigator/s shall inform the principal investigator and the local committee in
the facility to which he/she is affiliated about every harm (adverse event) – serious or
not – that occurs in the course of conducting the research project ,in accordance with
the procedures set forth in Article (M 10/31) of this Regulations.

Article (10.14)
The principal investigator, whether he belongs to the establishment or not, shall submit the
research approval to the local committee, including the research proposal. Upon setting of
research proposal, the researcher shall observe the following:
1- Design of study shall be appropriate to its objectives;
2- Expected benefits and possible harms to which the human subject may be subject
shall be in balance;
3- Research location shall be appropriate to the assistant group, including available
potentials and emergency measures.
Article (10.15)
The research proposal shall comprise the following:
1- One page research abstract (size: A4);
2- Research objectives;
3- Statistical methodology, including sample size calculations, taking into account
possibility of obtaining statistically significant results by using the minimum number of
research subjects;
4- Justification and rationale for introducing any procedure, tool or device that has not
been used before
5- Justification and rationale for using any substances that could be dangerous or
harmful to the human subject or his surroundings and methods of disposal of said
substances after research is completed;
6- Ethical considerations in research and how to deal with them;
7- Plan for dealing with risky cases;
8- Plan for disposal of extra biological samples;
9- A clear description of duties and responsibilities of research team;

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10- Time schedule of research and criteria of research suspension or termination;
11- Case registration forms, daily cards, and questionnaires set for research subjects, in
case of clinical research;
12- Research sample shall be determined according to the following considerations:
a) Characteristics of sample from which the subjects will be selected;
b) Criteria for inclusion and exclusion of the human subject;
c) Methods through which initial contact and selection are carried out;
d) Means of providing complete information to potential participants in the
research or their representatives.
13- In clinical research, the principal investigator shall present a description of the
individuals who will be given access to personal data of research subjects, including
medical records and biological samples;
14- A list of expected results and ways to benefit therefrom;
15- A list of references.
Article (10.16)
The principal investigator shall, as necessary, enclose the following documents with his
research proposal:
1- Any plans and justifications to stop, prevent or alter administration of standard
treatments because of the proposed research.
2- Medical care offered to human subjects during and after the research;
3- A description of proficient social, psychological and medical supervision for all human
subjects;
4- A statement of the compensation or treatment that can be provided for human subjects
in case of injury, disability or death as a result of the research;
5- Procedures taken to provide compensation, when required;
6- Indication of research funding methods and any research agreements related to the
research. The human subject shall not incur any financial expenses for conducting
the research on him.
7- Disclosure of potential conflict of interest that may occur in relation to conducting the
project and how to address it.
Article (10.17)
To approve the research proposals submitted to the local committee, the following
procedures shall be followed:
1- The local committee shall prepare a special approval application form and publish it
on its website, including the following:
a) Name of local committee and its postal address, electronic mail address and
contact numbers;
b) Name of principal investigator and his ordinary and electronic mail address and
contact numbers;
c) Title, duration and objectives of research project;
d) Date of submission of application.

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2-

The principal investigator shall submit the application for approval according to the
form referred to in the preceding paragraph 1 here above;
3- The principal investigator shall fill in the approval form, and shall append with it the
following documents:
a) The research proposal;
b) An updated, signed and dated CV of the principal investigator and coinvestigators;
c) Methods used for inviting human subjects, including advertisements;
d) “Informed Consent” form;
e) Proof of passing a valid research ethics course;
4- The local committee shall receive the application against a receipt given to the
applicant indicating reception thereof and including number and date of submission.
5- The local committee shall review the application in principle; if any requirements are
missing, the committee shall notify the applicant thereof within 10 work days of date
of submission of application. The investigator shall respond within 90 days of date
of notification. The application shall be deemed as rejected if the investigator fails to
respond to committee remarks and demands within the said period.
6- The local committee shall inform the applicant within 15 work days from completion
of request of the expected time period to provide the final response to his request.
7- The local committee shall evaluate the research proposal, provided it is complete and
it satisfies applicable scientific conditions in the establishment. The committee shall
consider the researchers› ethical efficiency and ability to conduct the research, and
shall verify that the «Informed Consent» form contains all basic requirements.
8- The local committee shall issue its decision indicating acceptance, rejection or
amendment of research proposal within the period referred to in Paragraph 6
hereabove.
9- The committee resolution shall include the following data:
a) Title of research project;
b) Date and number of research project;
c) Name of principal investigator and co- investigators;
d) Date of resolution.
e) Signature of local committee chairman or authorized person and date of
signature.
10- The following documents shall be attached to the decision: Research forms with their
appended documents including Informed Consent (the resolution number must be put
on the Informed Consent form).
Article (10.18)
Before consenting to conduct a research project, the local committee shall confirm the
following:
1- The research does not violate Sharia rules or laws or regulations observed in the
Kingdom;
2- Potential risk for the human subject is reduced to the minimum level through the
following:

30

a) Adopting standard operating procedures and scientific methods for research
design which do not expose research human subjects to risks;
b) Adopting standard and established procedures for therapeutic or diagnostic
purposes as much as possible.
3- Evaluating benefits and risks that might ensue from the research;
4- Ensuring that research subjects have been selected based on their understanding
of research objectives, place, time and method of conducting research, with special
additional attention in the cases in which the participation of persons requiring
additional protection is requested, such as (vulnerable groups)
5- Ensuring that the “Informed Consent” of the human subject contains all the required
elements;
6- Ensuring that the research plan includes a periodic monitoring of results to maintain
safety of the human subject;
7- Ensuring that the research plan includes management measures to protect the human
subject and the human subject’s rights;
8- Ensuring that sufficient measures are taken to protect privacy of the human subject
and maintain confidentiality of data.
9- In the case of clinical research involving testing drugs or equipment on humans, the
authorization of the Saudi Food and Drug Authority must be obtained according to
observed laws and regulations.
10- Every clinical research project must be registered first with the Saudi Food and Drug
Authority before human subjects are invited to participate.
11- The Saudi Food and Drug Authority clinical studies database must be checked first to
avoid conducting duplicate research.
Article (10.19)
The local committee may approve certain research by using the expedited review
procedure in the following cases:
1- If the risk that the human subject may be exposed to does not exceed the minimal
risk level;
2- If the research does not reveal the identity of the human subject;
3- If the research deals with clinical studies on drugs or medical equipment, provided:
a) The drug is used in accordance with its licensing and dosages approved by the
concerned party, and does not entail any increase in potential risk for the human
subject;
b) The medical equipment in use has originally been licensed by the concerned
party and has already been utilized accordingly.
4- If taking biological samples for research purposes is carried out via non-invasive
methods such as analysis of urine, saliva, nail or hair clippings, etc.
5- If research data is to be collected by using medical equipment approved by the
concerned party, such as:
a) Sensors which are directly applied on body surface or at a close distance
thereto and which do not expose the body to a significant amount of energy and
do not violate the privacy of the human subject;

31

b) Weight taking or audiometry devices;
c) Magnetic resonance imaging (MRI) or ultrasonography imaging devices;
d) Electrography (ECG & EEG), Thermal Imaging, normal nuclear radiation rate
measuring, infra-red imaging, blood flow measurement with ultrasound imaging
(Doppler sonography), and echocardiography devices;
e) Moderate exercise, muscle strength, body ratios (such as body fat ratio) and
measurement of joint and muscle flexibility devices, provided these tests are
deemed appropriate after taking age, weight and health condition into account;
f) Search for information, records or samples that were previously collected or will
be collected in the future for non-research purposes;
g) Collect information via audio or video taping (static or moving) for the purpose
of looking for the attributes or behavior of an individual or group without violation
of privacy of the human subject.
However, excepted from these devices is the use of X-ray or electromagnetic microwave
devices.
Article (10.20)
1- Approval by expedited review shall be issued by local committee chairman or by one
or more members selected by committee chairman for their experience.
2- In case of expedited review, the research evaluator shall have all the powers given
to the local committee except for rejection of research, which shall be within the
jurisdiction of the local committee alone. If the evaluator decides to reject the research,
he shall refer it to the committee for reviewing it according to the provisions of this Law
and its Regulations.
3- In case approval of research is issued by using expedited review, the committee
chairman shall notify all committee members of the research projects that he has
approved via whatever notification means he deems appropriate.
Article (10.21)
The local committee chairman has the authority to approve any amendment of the
research previously approved by using expedited review. Exceptions include interviews
and surveys conducted on any of the (vulnerable groups), amendment of research project
or approval form, which shall be within the jurisdiction of the local committee.
Article (10.22)
Applications for approval using the expedited review procedure shall observe the terms
and requirements stipulated in the basic elements of the Informed Consent in accordance
with the provisions set forth in Chapter 5 of the Regulations.
Article (10.23)
The expedited review procedure may not be used for approving research if the objectives
of such research include the following:
1- Addition of a new medication;

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Addition of new medical equipment;
Addition of a new invasive or interventional procedure;
Increase or decrease of a medication dose, which may lead to increased harms;
The research is conducted to identify new potential risks.

Article (10.24)
1- If the principal investigator wishes to amend the research proposal approved by
the local committee, he shall submit the matter to the local committee to obtain its
approval prior to proceeding with the amendment.
2- The following may be exempted from local committee review:
a) Amendment of advertising material used for inviting human subjects, provided
said amendment does not disrupt the content of such material;
b) Amendments that only include providing administrative support to the study;
c) Enrolling samples or cases brought from outside the establishment with the
same terms.
3- In all cases, the principal investigator shall furnish the local committee with a detailed
report on the amendment he has carried out.
Article (10.25)
1- The principal investigator shall obtain the local committee approval of all types of
advertisements aiming to invite people to participate as volunteers in the research
project such as newspaper ads, posters, folders, etc. prior to distribution or publication
thereof;
2- Any advertisement proposed by the principal investigator to invite persons to
participate as subjects of the research shall include the following data:
a) Research title;
b) Research objective;
c) Attributes qualifying persons targeted to be the research subjects (participants
or volunteers);
d) Indication of all facilities to be provided to human subject;
e) Number of research project in the local committee and expected date of
completion;
f) Expected risks of the research, if any;
g) Name and address of principal investigator or his representative, his contact
numbers and his electronic mail address so that individuals aiming to join the
research group may call him for further information.
Article (10.26)
If the principal investigator decides to transfer research supervision responsibility to
a different investigator, he shall take the following measures:
1- Submit a written application to this effect to the local committee, including the following:
a) A written agreement for the replacement investigator to take responsibility for
the research;

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b) A written statement by the replacement investigator indicating his readiness to
fulfill all commitments and obligations made by the principal investigator;
c) CV of the replacement investigator;
d) A statement indicating that all samples and medical information related to the
research have been delivered to the replacement investigator;
e) A statement indicating that no part of research samples or results shall be
used in any future research unless a new approval is obtained from the local
committee.
The principal investigator shall proceed with his supervision of the research until the
local committee has reviewed the application;
The local committee shall decide the application within a period not exceeding one
month from date of submission thereof. In case of rejection, the decision shall be
furnished with reasons for rejection.

Article (10.27)
1- The investigator may publish the results of the research he is conducting, provided he
notifies and obtains approval of the local committee beforehand specifying the name
of periodical in which he will publish said results;
2- The local committee may refuse to grant permission if the published material is
inconsistent with the provisions of this Law and its Regulations or with the controls
and directives issued by the national committee.
Article (10.28)
The local committee shall conduct the periodic monitoring of the research as follows:
1- Review research progress regularly based on the periodic reports submitted by the
principal investigator, provided the periodic follow-up period does not exceed one
year;
2- Examine research records to ensure their consistency with the approved research
proposal and the submitted research reports or to guarantee documentation of
“Informed Consent” procedures. The local committee may assign specialists as it
deems fit to perform this task on its behalf.
3- The local committee shall set necessary procedures for carrying out the periodic followup process, and shall furnish the Monitoring office with a copy of said procedures.
Article (10.29)
1- The principal investigator shall provide the local committee with a periodic report of
the research every three months in case of conducting clinical research and not more
than 12 months in case of conducting other types of research.
2- The periodic report shall contain all the details of the research and its phases. The
investigator shall attach to this report proof of his commitment to the procedures and
controls set forth in this Law and its Regulations.
Article (10.30)
If the principal investigator fails to submit the periodic report on time, the local committee
shall take the following measures:

34

12-

3-

4-

5-

Notify the researcher in writing that he must submit the periodic report within the
period set by the committee;
If the principal investigator fails to submit the research within set period, the local
committee may suspend the research project until the report is submitted and shall
notify the principal investigator thereof;
In case the research project is suspended, the committee shall thoroughly review it and
examine all required documents to ensure that no violations have been committed;
otherwise, it shall carry out whatever it deems fit;
If the principal investigator submits the periodic report during local committee review
of research, the local committee may end the suspension the research project, and
notify the investigator not to be remiss in submitting reports in the future;
If the principal investigator persists in ignoring to submit the periodic report, the
local committee shall refer the whole matter to the Monitoring Office to submit it to
the Violations Committee to suspend the research project and decide appropriate
penalties.

Article (10.31)
1- The principal investigator and the local committee shall immediately report any major
harm (serious adverse event) occurring during or after conducting the research,
according to the following procedures:
a) The principal investigator shall immediately notify the local committee as well
as the research sponsor of any major harm (serious adverse event) occurring
during or after conducting the research, provide the committee with all information
pertaining to the harm related incident and indicate his assessment whether this
incident is definitely, probably or unrelated to the research.
b) The local committee shall notify the Monitoring Office of the major harm incident
(serious adverse event) and all related details as soon as possible either in writing
or by telephone within a period not exceeding twenty-four hours from the time of
the reported incident.
2- The principal investigator and the local committee shall report of any minor harm
(adverse event) occurring during or after conducting the research, according to the
following procedures:
a) The principal investigator shall notify the local committee of any minor harm
(adverse event) occurring during or after conducting the research, within a period
not exceeding seven days from the date of the incident, provide the committee
with all information pertaining to the harm (adverse event) incident and indicate
his assessment whether this incident is definitely, probably or unrelated to the
research.
b) The local committee shall notify the Monitoring Office of the incident of minor
harm (adverse event) and all related details either in writing or by telephone within
a period not exceeding two weeks from the date of the incident, depending on the
significance of the reported incident.
3- The principal investigator shall include all expected or unexpected harms (adverse
events) in his periodic report submitted to the local committee.

35

Article (10.32)
1- If the local committee finds, through periodic monitoring of the research, that an
unexpected harm has taken place as a direct result of the research but has not been
referred to in the research proposal, it may take appropriate measures to stop the
harm, including suspension of research project;
2- If the local committee finds that the investigator has not obtained required approvals,
it shall suspend the research project and refer the matter to the Monitoring Office
to submit it to the Violations Committee to decide appropriate penalties against the
investigator.
3- The local committee shall notify head of the establishment of any research that is
suspended or referred to the Monitoring Office.
Article (10.33)
The local committee may exempt the following research projects from the periodic followup:
1- Research involving study of information and data previously collected, provided one
of the two following terms is fulfilled:
a) If the information is generally and publicly available;
b) If the information is recorded in a manner that does not reveal the identity of
the source person.
2- Research including educational tests, surveys, interviews or public behavior
monitoring, except in the two following cases:
a) If the information is recorded in a manner that reveals the identity of the source
person.
b) If participation in the research should bring a person outside the scope of
research to be subject to criminal or civil liability or jeopardize his financial position
or career.
3- Research conducted for educational purposes.
Article (10.34)
1- Subject to the provisions of the following paragraph 2 hereunder, the local committee,
following Standard procedures, shall conduct the periodic monitoring of research
based on the periodic reports submitted by the principal investigator in accordance
with the procedures it sets up in this regard.
2- As an exception from the provision of the preceding paragraph 1 hereabove, the local
committee may exempt certain research projects that it has previously approved from
periodic evaluation in either of the following cases:
a) If the only objective of research continuation is a long-term monitoring of
persons who took part in the research and no additional risk emerged in the
research;
b) If the research is nearly finished and only analysis of data and conclusion of
results are remaining.
3- After the periodic assessment of the research is carried out, the local committee shall
issue a decision including its approval or rejection of continuation of the said research.

36

Article (10.35)
If, after the periodic assessment, the local committee disapproves of research continuation,
it shall suspend the research project without prejudice to its right of extending the treatment
period in case its sudden suspension may cause harm to the human subject.
Article (10.36)
1- If the research project is suspended, the investigator may request the local committee
to reconsider the suspension decision, by appending reasons for his request;
2- The local committee shall consider said request in a meeting held for this purpose or
in the nearest meeting.
Article (10.37)
Upon completion of the research project, the principal investigator shall prepare his final
report and shall deliver a copy thereof to the local committee along with related scientific
publications, if any.
Article (10.38)
The local committee shall keep the records of its contributions in the field of research
follow-up and evaluation, including the following:
1- A copy of all research proposals evaluated by the committee, along with evaluation
results;
2- A copy of the «Informed Consent» form approved by the committee and periodic
reports on research progress;
3- A copy of the reports detailing harm to the research subjects, if any;
4- A statement of the reasons that led the local committee to reject the proposal or
request modification of research proposal;
5- Copies of periodic follow-up and evaluation proceedings;
6- Copies of all correspondences between the committee and the principal investigator;
7- A declaration of all new and important data provided to the human subject, including
all necessary details of the method used to obtain his consent to take part in the
research.
Article (10.39)
The local committee shall submit an annual report to the Monitoring Office, subsidiary to
the National Committee, including:
1- Any changes in its formation;
2- A list of the research projects that it has studied and its decision in each case (rejection,
approval or suspension), indicating reasons therefor;
3- Any scientific activities carried out by the committee, including scientific publications,
workshops, colloquia and symposia;
4- Any other information deemed by the Monitoring Office as necessary to be included
in the report.

37

Article (10.40)
1. Any member of the research team may file a complaint with the local committee;
2. The local committee shall consider said complaint in its next meeting or in a special
meeting called for by the committee chairman.
Article (10.41)
In case of any disagreement with the local committee, the principal investigator may file a
complaint with the Monitoring Office.
Article (10.42)
The research assignments carried out by the Contract Research Organization (CRO) for
the beneficiary are subject to the stipulations of the law and regulations.
Article (10.43)
1- The beneficiary may authorize Contract Research Organization (CRO) to carry
out some or all of his responsibilities for research based on the contract, such as
developing the research project, selecting clinical auditors, following up on the course
of the study, reviewing adverse events, or analyzing data. . This does not prejudice
the responsibility of the principal investigator.
2- The beneficiary, when delegating some of his responsibilities for conducting the
research to the Contract Research Organization (CRO), must specify in the contract
what are the delegated responsibilities and obligations, the rights of each party and
the details of the duties and responsibilities, and shall identify all the obligations that
the Contract Research Organization (CRO) will bear.
3- It is permissible – by agreement of the beneficiary and the Contract Research
Organization (CRO) to amend the contract by adding obligations or cancelling some
previous obligations, provided that the amended contract indicates the status of the
previous assignments that were not covered by the amendment. And, in all cases
in which the assignments are transferred, suspended or amended, either by the
beneficiary or the Contract Research Organization (CRO), the two parties must inform
the principal investigator and the local ethics committee. In the event that the contract
relates to performing assignments of a clinical trial, the Saudi Food and Drug Authority
shall be notify of the changes as well.
4- Each party of the contract shall bear full responsibility for violations that may occur
while performing his assignments.
5- In the event that the contract includes performing a clinical trial by an investigator
unaffiliated with either party to the contract, the Contract Research Organization
(CRO) shall sign with him a clinical trial agreement.
6- The quality and integrity of the final research data is the responsibility of the
beneficiary.

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Article (10.44)
1-

The Contract Research Organization (CRO) conducting clinical trials must register
a local ethics committee with the National Committee of Bioethics.

2-

The Contract Research Organization (CRO) performing exclusively the roles of
mediation and coordination – and in the absence of a local ethics committee at any
of the contracting parties – must have an agreement with the nearest registered
local ethics committee to carry out the tasks of reviewing the research proposal and
following it up as stipulated in the law and regulations.

Article (10.45)
In addition to the conditions for the formation of local ethics committees stipulated in
the law and regulations, when forming a local ethics committee in a Contract Research
Organization (CRO) the chair of the ethics committee the absolute majority of the members
or all of them must be from outside the (CRO).
Article (10.46)
Considering the provisions of Article (10/45) of the Regulations, the conditions for
establishing and function of local ethics committees in Contract Research Organization
(CRO) are subject to the same conditions stipulated in the law and regulation.
Article (10.47)
The Contract Research Organization (CRO) shall ensure that the beneficiary obtains
ethical approval for his research; In accordance with the stipulations of the law and
regulations.
Article (10.48)
In the event that the principal investigator delegates some of his research responsibilities
to a Contract Research Organization (CRO), he must include a statement in his research
proposal specifying the name of the (CRO), the type of tasks he delegated to it, attach a
copy of the contract, the address of the institution and the means of contact with it.
Article (10.49)
The local ethics committee that granted approval for research project may request from
the Contract Research Organization (CRO) any information or document related to the
project, and may conduct field visits to the (CRO) to ensure that there are no violations in
conducting research.
Article (10.50)
In the event that the Contract Research Organization (CRO) fails to provide the local
committee with the requested information and documents related to research conducted
within the (CRO) – the local ethics committee – may raise the matter to the Research
Ethics Monitoring Office for presentation to the Violation Review Committee.

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Article (10.51)
The Contract Research Organization (CRO) may, transfer all or some of its obligations to
another (CRO), under two conditions:
1- To obtain the prior written consent of the beneficiary.
2- The transfer shall be in accordance with the provisions of Article (10/43).
Article (10.52)
If the Contract Research Organization (CRO) is unable to fulfill its obligations as stipulated
in the contract it shall immediately inform the beneficiary, and it must deliver to him all the
previous works that have been accomplish AS well.
Article (10.53)
It is not permissible for an institute to collect from the investigators employed by it any
fees in exchange for reviewing their research to be conduct within that institute, unless the
research sponsored by an outside body or for the benefit of that body.
Article (10.54)
The Results of the accomplished contract tasks considers confidential, and they are the
right of the beneficiary. The Contract Research Organization (CRO) may not use them or
dispose of them without consent of the beneficiary.
Article (10.55)
Both the beneficiary and the Contract Research Organization (CRO) shall abide by the
relevant laws and regulations issued by the Saudi Food and Drug Authority in this regard.
Article (10.56)
Both the beneficiary and the Contract Research Organization (CRO) shall abide by the laws
and regulations governing intellectual property rights, including the rights of investigators
who carry out the obligations of both parties.
Article (10.57)
Specimens used in the research or left over after its completion shall be handle according
to what stipulated in the law and regulation.
Article (10.58)
The beneficiary, the Contract Research Organization (CRO), the local Ethics Committee
and all employees thereof, shall comply with the confidentiality of information, data and
results related to the research, including the information pertaining to each party.
Article (10.59)
The Contract Research Organization (CRO) shall guarantee the security of personal
information and data pertaining to the research that include those stored by electronic
means, and shall take all necessary measures and means for electronic protection to
prevent illegal access to the data or tampering with it by alteration or destruction.

40

Chapter Seven

Informed Consent
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 (11.1)
The local committee shall approve the «Informed Consent» form which will be appended
to the research proposal submitted by the principal investigator to the local committee. The
researcher may not use any other document or form other than the approved one to obtain
the «Informed Consent». The researcher shall provide all research-related information to
the human subject. Such information shall include research objective, potential risk and
expected benefit, if any.
Article (11.2)
The “Informed Consent” form shall include the following:
1- A clear statement at the top of the first page that reads «You are invited by (Name of
principal investigator) to participate in a scientific research».
2- Research title.
3- Name of institution approving the research.
4- Research objectives.
5- A description of any expected benefit for the human subject.
6- A description of any expected risk or harm that may affect the human subject or
society.
7- A description of alternative treatments available outside the scope of the research, if
any.
8- A statement of the level of respect accorded to the confidentiality of information that
may reveal the identity of the subject, along with a commitment by the investigator to
secure such confidentiality.
9- A description of all medical procedures and treatments related to the research or
carried out only as a result of conducting the research, if any.
10- Duration of the research project.
11- A description of requirements to be fulfilled by the human subject.
12- A description of type, quantity and method of use of samples taken from the human
subject, if any, with commitment to dispose with excess or leftover samples through
recognized scientific methods.
13- A statement which explicitly reads as follows: «Participation in the research is
voluntary. Refusal to participate shall not entail penalty or loss of benefits to which the

41

human subject would otherwise be entitled. The human subject may withdraw from
the research at any phase without loss of benefits to which he is otherwise entitled».
14- Indication of risks or harms, if any, that might ensue due to withdrawal from research.
15- The investigator’s pledge that the human subject (participant or volunteer) shall be
notified of all information that may emerge during the research period, the knowledge
of which may affect his decision for continued participation in the research, such as
harms or complications not stated in the «Informed Consent».
16- Contact numbers and addresses to enable the human subject to obtain information
related to the research or to his rights, or to report any harm sustained. Said numbers
and addresses shall include the contact numbers and e-mail addresses of the local
committee and researcher.
17- Signature of the human subject (male or female) or guardian, the researcher, and
any other person whose signature on the form is required in accordance with the
provisions of the Law and Regulations.
18- Date and place of the «Informed Consent».
19- Method of compensating of the human subject in case he sustains any harm resulting
from the research.

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 (12.1)
1- When obtaining the “Informed Consent”, the investigator shall in all cases observe
the following:
a) He shall, in a clear and simple manner, explain in person the information stated
in the “Informed Consent” form to the human subject (or his guardian if the subject
is incompetent);
b) The explanation shall be appropriate to the educational level, culture and
understanding of the human subject (or guardian if the subject is incompetent);
c) He shall, if required, explain any additional information not stated in the
“Informed Consent” form;
d) He shall answer any question raised by the human subject (or guardian if the
subject is incompetent);
e) He shall not obtain the consent in haste or use coercion or undue inducement
to obtain it.
f) He shall ensure via suitable methods that the human subject (or guardian if the
subject is incompetent) has understood all the information provided to him prior to
signing the “Informed Consent” form;
2- If the human subject is a patient, a person other than his attending physician shall
obtain his “Informed Consent”, provided said person is well-informed about the
research and able to answer all the patient›s questions.

42

Article (12.2)
The “Informed Consent” form or the explanation presented by the investigator to obtain the
consent may not include any statement absolving the investigator (or the institution) from
liability against any unexpected error or harm that may occur during the research.

Article 13
The informed consent shall be documented in accordance with conditions and procedures
specified by the Regulations.
Article (13.1)
The local committee may assign a qualified person to attend the interview in which the
“Informed Consent” form is explained, if necessary, in order to verify compliance with the
provisions of the Law and Regulations. In such case, said person shall cosign the consent
form upon completion.
Article (13.2)
The local committee shall ensure the validity of the procedures used for obtaining the
“Informed Consent” and shall assign a person to monitor the obtaining of such consent. It
shall also ensure that the human subject is competent without prejudice to the provisions
of research on minors and incompetent persons.
Article (13.3)
1- The principal investigator shall be responsible for obtaining the “Informed Consent”
but he may delegate one of his assistants to obtain such consent provided said
assistant is fully aware of the research project and able to answer questions raised
by the human subject.
2- If the principal investigator or one of his assistants fails to carry out the procedures
required for obtaining the “Informed Consent”, the principal investigator may submit
a request to the local committee to delegate another research team member or any
other person fully aware of the research project to undertake such procedures. The
local committee may or may not approve this request based on the justifications
provided by the principal investigator. In case of acceptance, the committee shall
ensure that the person assigned to obtain the consent is well-informed about all
aspects of the research and the items of the “Informed Consent” form referred to in
Article (11.2) of the Regulations.
Article (13.4)
1- The principal investigator or his duly appointed designee shall issue the “Informed
Consent” form in three copies, one for the principal investigator, one for the human
subject of the research to be conducted, and the third for the local committee or in the
patient’s file in the case of a clinical research.
2- If the human subject of the research is a patient, the researcher must document
obtaining the “Informed Consent” in the patient’s medical file.

43

Article (13.5)
1- The local Committee may waive the condition of documenting informed consent and
accept a verbal consent in the following situations:
a) If the risk of research does not exceed minimal risk.
b) If the participant’s signature on the (Informed Consent Form) ICF reveals the
participant’s identity and information.
2- The exemption from documentation does not apply to research that requires collecting
biological samples, or research involving mentally incompetent participants.

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 (14.1)
The local committee may approve conducting the research project without obtaining the
“Informed Consent” if the conditions set forth in Article (10.32) of the Regulations are
satisfied.

44

Chapter Eight

Research on Humans
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 (15.1)
1-

Each research proposal shall be subject to the approval of the local committee;

2-

The local committee shall verify the scientific objectives of the research proposal;

3-

The researcher shall obtain the “Informed Consent” from the human subject according
to the provisions of the Law and Regulations.

Article (15.2)
Prior to conducting clinical research on humans, the following shall be observed:
1-

The investigator shall clearly and accurately specify his objectives and methodology;

2-

The research shall be preceded by sufficient experiments on animals if the nature of
the research so requires.

3-

Potential risks shall not be greater than expected benefits.

Article (15.3)
When conducting interventional human clinical trials that carry a risk to the participants
– a data safety monitoring committee (DSMC/DSMB) should be appointed to monitor
accumulating data and evaluate safety.
Article (15.4)
Unprecedented experimental surgeries and medical research shall be consistent with
controls and criteria set forth in laws and regulations applicable in the Kingdom as well as
the relevant agreements to which the Kingdom is party.
Article (15.5)
The investigator or research team conducting the experimental surgeries and medical
research shall be specialized and shall have adequate scientific qualification, expertise
and competence.

Article 16
The expected benefit from the experiment or research to the human subject shall be
greater than the possible harm.

45

Article (16.1)
1- The investigator shall evaluate the expected benefit to the human subject and the
extent to which it is greater than the potential risk according to a scientific evaluation
carried out by the researcher and submitted to the local committee.
2- If the local committee finds that the potential risk to the human subject is greater than
the expected benefit, it must deny permission to conduct the research.
3- The local committee shall verify, through periodic reports submitted by the investigator,
that the expected benefit is still greater than the potential risk.
Article (16.2)
1- Prior to approving research on humans, the local committee shall verify that the
investigator takes into consideration the right of human subject to normal life and
safety from all types of physical and psychological harm, and shall not affect him
wholly or partially except with his consent and in accordance with the provisions of
Sharia and applicable laws. This shall include all body organs and their components,
such as living tissues and cells whether connected or otherwise.
2- The investigator or research team may not conduct any medical intervention on the
human subject for research purposes that do not entail any expected benefit.
3- Approval of all competent government bodies shall be obtained in cases related
thereto.
4- The local committee or the Research Ethics Monitoring Office may impose additional
restrictions on any research on humans if conducting said research would endanger
the human subject.
Article (16.3)
The human subject may seek indemnification for any harm resulting from conducting the
research on him by filing a complaint with the local committee. If the local committee fails
to respond, the human subject may submit the complaint directly to the Monitoring Office.

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 (17.1)
The provisions of Articles (24.1), (24.2), (25.1) and (25.2) of the Regulations shall be
observed.

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 (18.1)
The provisions and controls of the “Informed Consent” referred to in Article 11 of the Law
and Articles (10.17), (11.1), and (11.2) of the Regulations shall be observed.

46

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 (19.1)
The investigator may not exploit the human subject or any part thereof, including gametes,
zygotes, organs, tissues, cells or parts thereof or genetic data related to human derivatives
or products or human images for the purpose of trading therein.
Article (19.2)
In case the investigator is found guilty of violating Article (19.1) of the Regulations, he shall
be subject to the appropriate penalties set forth in the Law and Regulations as well as laws
prohibiting trade in human organs and not in conflict with Sharia.

Article 20
An organ removed for a purely medical purpose may be used in scientific research upon
obtaining the informed consent.
Article (20.1)
Subject to the provisions of the Law and Regulations regarding obtaining the “Informed
Consent”, human organs removed for medical purposes may be used in scientific research
in a way not conflicting with the provisions of the Law and Regulations.
Article (20.2)
When conducting research on samples previously extracted for another research purpose
or a purely medical purpose and it is still possible to relate said samples to their source,
consent of the person from whom the samples have been collected is required prior to
conducting research thereon.
Article (20.3)
When conducting research on samples previously extracted for another research or
a purely medical purpose and it is no longer possible to relate said samples to their source,
the local committee permission to conduct the research may be deemed sufficient.

Article 21
No research may be conducted on human zygotes, gametes or fetuses except under
controls specified by the Regulations.
Article (21.1)
No research may be conducted on human zygotes or gametes except under the following
controls:
1- The practices indicated in the research proposal shall be consistent with the provisions

47

23-

of Sharia and standard medical principles, and the research shall be justified in terms
of its contribution to medical knowledge or technical applications;
The investigator shall obtain the “Informed Consent” from the person donating zygotes
or gametes in accordance with Article 11 of the Law.
The investigator shall provide all research-related information to the persons donating
zygotes or gametes, and their spouses, if any. Said information shall include a full
explanation of the research potential risk and expected benefit.

Article (21.2)
When conducting research on human zygotes or gametes, the researcher shall accurately
record all required data and information about the human subject and each person related
to the zygotes or gametes under research, and all research findings. He shall keep records
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