National Committee of BioEthics (NCBE)

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N ational C

om m

ittee of BioEthics (N CBE)

Im plem

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

1437H – 2016

1437H – 2016

National Committee of BioEthics (NCBE)

Implementing Regulations of the

Law of Ethics of Research

on Living Creatures

Second Edition

Second Revised version

 

 

 

1437H – 2016

National Committee of BioEthics (NCBE)

Implementing Regulations of the

Law of Ethics of Research

on Living Creatures

Second Edition

Second Revised version

 

 

 

 

 

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.

 

 

6

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.

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

 

 

7

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.

 

 

8

Clinical Trial: Experiments conducted on human volunteers to examine

safety and effectiveness of a new 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.

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

 

 

9

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.”

 

 

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.

1. 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

 

 

12

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.

 

 

13

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.

 

 

14

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. 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.

2. 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.

3. 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.

4. Committee membership shall be a renewable term of three years,

provided half the members are replaced upon committee re-formation

 

 

15

for the third time. Membership may not be renewed for more than three

consecutive terms.

Article (4.2)

1. 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.

2. 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;

3. 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

 

 

16

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.

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)

1. The National Committee shall hold a monthly meeting upon a call by

its Chairman or designee;

2. 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

 

 

17

Committee Chairman or designee decides otherwise;

3. 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.

4. The National Committee shall convene at its headquarters or at any

other place set by the Committee Chairman or his designee if necessary.

5. 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.

6. 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.

7. 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)

1. National Committee meetings shall not be valid unless attended by

two-thirds of its members including the Chairman or his designee.

 

 

18

2. 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.

3. 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.

4. 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.

5. 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)

1. 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. Votes may be taken by a show of hands, secret ballot, electronically, or

by any other means decided by the Chairman.

3. 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.

 

 

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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.

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.

 

 

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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.

 

 

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Article (6.3)

1. The National Committee may, if necessary, form subcommittees

for conducting detailed studies on particular matters proposed for

discussion.

2. In forming said subcommittees referred to in Paragraph (1) above,

members shall be selected based on their academic qualification and

competence in conducting research.

3. Remuneration of subcommittee members shall be determined according

to applicable rules at KACST.

4. Remuneration of experts, associations, scientific centers or specialized

agencies whose consultancy services are sought shall be determined

according to applicable rules at KACST.

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

1. Samples transfer should be limited to international research agencies

known for their research experience in the relevant research fields.

2. 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.

3. If it turns out that a different Saudi investigator or entity is working

on the same subject, sending samples outside the Kingdom of Saudi

 

 

22

Arabia must not be carried out. Collaboration with the project running

inside the Kingdom must be done, unless there is a valid reason that

makes such collaboration impossible. Justification should be accepted

by the Local Ethics Committee.

4. Data accompanying the submitted samples or material must not reveal

the identity of the person whose sample is submitted. Material must

carry coded numbers only.

5. Notifying the National Committee on Bioethics in writing about the

Local Ethics Committee decision including the project’s purpose,

sponsor/s and collaborator/s. The National Committee on Bioethics

may stop the running or completion of the project if it carries no benefit

to the Saudi society or poses direct or indirect harm to the community.

Such rights of the National Committee on 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. 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.

2. The researcher must enclose a copy of the obtained Local Committee

approval with documents submitted to relevant agencies such as

customs and carriers;

3. Ensure security of leftover or genetic samples during storage and

transportation;

 

 

23

4. Disposal of excess genetic samples must be performed according to

standard scientific methods, and strict precaution must be observed to

ensure that the said samples are not stored in banks outside the Kingdom

once these samples have been analysed or studied for the consented

project.

 

Article (6.5)

1. The National Committee shall oversee local committees and monitor

compliance 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.

2. 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.

3. 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 safekeeping and retrieving information on

genetic material and provide said information for local genetic material

 

 

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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.

 

 

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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:

 

 

26

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.

 

 

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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.

 

 

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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.

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;

e. Signature of head of the establishment.

2. The establishment applying for registration of a local committee shall

 

 

29

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 Monitoring

Office shall notify the establishment of the reasons for rejection.

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

 

 

30

or by any member of the research team against local committee

decisions;

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

 

 

31

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.

 

 

32

 

 

33

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

 

 

34

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 or competent agency stating the names of committee

members, chairman and his deputy. The chairman and his deputy shall

have interest in biomedical ethics.

2. 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.

3. 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.

 

 

35

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:

 

 

36

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. Provide necessary equipment and ensure that such equipment is

adequate for the safety of the human subject participants.

4. Ensure especially that minors, legally incompetent or disabled persons,

or any other persons from (vulnerable groups) are never abused under

any circumstance.

5. The local committee will review the research project requests submitted

by researchers associated with the establishment where the committee

is affiliated. It also has the right to review the research project requests

submitted by researchers in vicinity of the establishment upon agreement

with the researcher, if there is no local committee in the establishment

where these researchers are affiliated, provided the absence of a local

committee is not the result of an administrative negligence to establish

such a committee.

6. In the case of researchers from multiple establishments participating

in a joint project, it is not necessary to obtain approval of the local

committee of every center participating in the research project. One

of the local registered committees shall in this case review the project,

and the principal investigator must be from the establishment where the

local committee which approves the project, and monitors it.

Article (10.6)

Committee membership shall be terminated for any of the following

reasons:

 

 

37

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;

 

 

38

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 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

 

 

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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

 

 

40

dismisses the complaint as unconvincing, the aggrieved party may have

recourse to the Monitoring Office to review the matter.

Article (10.13)

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 (10.14)

The research proposal shall comprise the following:

1. An abstract of the research within one page (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. Rationale for introducing any procedure, tool or device that has not

been used before;

5. 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. Plan for dealing with risky cases;

7. Plan for disposal of extra biological samples;

 

 

41

8. A clear description of duties and responsibilities of research team;

9. Time schedule of research and criteria of research suspension or

termination;

10. Case registration forms, daily cards, and questionnaires set for research

subjects, in case of clinical research;

11. 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.

12. 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;

13. A list of expected results and ways to benefit therefrom;

14. A list of references.

Article (10.15)

The principal investigator shall, if necessary, enclose the following

documents with his research proposal:

1. Any plans to stop or prevent administration of standard treatments

because of the research and justifications for preventing ordinary

standard treatments for conducting the research;

2. Medical care offered to human subjects during and after the research;

3. A description of the efficacy of social, psychological and medical

supervision for all human subjects;

4. A statement of the compensation or treatment that can be provided for

 

 

42

human subjects in case of injury, disability or death as a result of the

research;

5. Arrangements taken to provide compensation, if 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.

Article (10.16)

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.

2. The principal investigator shall submit the application for approval

according to the form referred to in the preceding paragraph 1 hereabove;

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

co- investigators;

c. Methods used for inviting human subjects, including advertisements;

d. “Informed Consent” form;

 

 

43

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.

 

 

44

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 (10.17)

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:

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;

 

 

45

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 (10.18)

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

 

 

46

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;

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 (10.19)

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.

 

 

47

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 (10.20)

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 (10.21)

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 (10.22)

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;

 

 

48

2. Addition of new medical equipment;

3. Addition of a new invasive or interventional procedure;

4. Increase or decrease of a medication dose, which may lead to increased

harms;

5. The research is conducted to identify new potential risks.

Article (10.23)

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 (10.24)

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

 

 

49

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 (10.25)

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;

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

 

 

50

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.

2. The principal investigator shall proceed with his supervision of the

research until the local committee has reviewed the application;

3. 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 (10.26)

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 (10.27)

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

 

 

51

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 follow-up process, and shall furnish the Monitoring office

with a copy of said procedures.

Article (10.28)

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 every six 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 (10.29)

If the principal investigator fails to submit the periodic report on time, the

local committee shall take the following measures:

1. Notify the researcher in writing that he must submit the periodic report

within the period set by the committee;

2. 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;

3. 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

 

 

52

whatever it deems fit;

4. 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;

5. 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 (10.30)

1. The principal investigator and the local committee must immediately

notify of any major harm 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 unexpected major

harm occurring during or after conducting the research, providing

the committee with all information pertaining to the harm related

incident, indicating whether this incident is definitely, probably or

by no means related to the research.

b. The local committee shall notify the Monitoring Office of the major

harm incident and all related details as soon as possible either in

writing or by telephone within a period of twenty-four hours at the

latest from the time of the harm related incident.

2. The principal investigator and the local committee must notify of any

minor harm occurring during or after conducting the research, according

to the following procedures:

a. The principal investigator shall notify the local committee of any

 

 

53

minor harm occurring during or after conducting the research within

seven days at the latest from the date of the incident, providing

the committee with all information pertaining to the harm related

incident, indicating whether this incident is definitely, probably or

by no means related to the research.

b. The local committee shall notify the Monitoring Office of the

incident of minor harm and all related details either in writing or

by telephone within two weeks at the latest from the date of the

incident, depending on the relevance of the incident.

3. The principal investigator shall include all expected or unexpected

harms in his periodic report submitted to the local committee.

Article (10.31)

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 (10.32)

The local committee may exempt the following research projects from the

periodic follow-up:

 

 

54

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 (10.33)

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

 

 

55

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.

Article (10.34)

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 (10.35)

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 (10.36)

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 (10.37)

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;

 

 

56

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 (10.38)

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.

Article (10.39)

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.

 

 

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Article (10.40)

In case of any disagreement with the local committee, the principal

investigator may file a complaint with the Monitoring Office.

 

 

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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;

 

 

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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 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

 

 

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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

 

 

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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.

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

 

 

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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.

 

 

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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.

 

 

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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)

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

 

 

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Kingdom is party.

Article (15.4)

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.

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

 

 

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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

 

 

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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.

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.

 

 

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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 collected for another

research purpose or for a purely medical care purpose and it is still possible

to relate the 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 collected for another

research or for a purely medical care purpose and it is no longer possible

to relate said samples to their source, permission of the local committee to

conduct the research may deem 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 of Sharia and standard medical principles, and

 

 

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the research shall be justified in terms of its contribution to medical

knowledge or technical applications;

2. The investigator shall obtain the “Informed Consent” from the person

donating zygotes or gametes in accordance with Article 11 of the Law.

3. 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 of the same for at least five

years from date of research completion, and shall submit periodic reports

on the research to the local committee.

Article (21.3)

No research may be conducted on human fetuses except for one of the

following purposes:

1. Find a treatment for reproductive problems, in which case the research

shall be conducted in an institution approved for treatment of such

problems;

2. Conduct a new experiment expected to benefit human fetuses;

3. Acquire new knowledge about the condition of fetuses if it is not

expected to achieve a direct benefit.

 

 

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Article (21.4)

The research proposal on human fetuses shall include the indication that

the expected benefit from the research would not be realized without using

such fetuses, and that a similar benefit has been previously obtained through

conducting research on animals, and that the research is justified in terms

of its contribution to improvement of treatment techniques or knowledge

of human diseases.

Article (21.5)

The investigator shall use the minimum number of fetuses to achieve

research purposes.

Article (21.6)

In cases of research conducted to acquire new knowledge, the researcher shall

submit to the local committee proof that potential risk for the fetus is minimal.

Article (21.7)

The investigator shall prepare and keep records of the source of each fetus

and the results of using said fetus in the research, and shall submit periodic

reports on the research to the local committee.

Article (21.8)

The investigator shall abide by the controls and procedures set by the

National Committee regarding research on stem cells, zygotes, gametes

and fetuses.

Article 22

No research may be conducted for the purpose of human cloning.

 

 

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Article (22.1)

No investigator shall be permitted to conduct research on human cloning

and any reproductive and research applications resulting therefrom due

to constraints determined by sharia, ethical principles and health-related

harms, where harms and dangers to humanity outweigh the expected

benefits.

Article 23

Research may be conducted on tissues, living cells and separated parts,

including stem cells extracted from the umbilical cord or adult stem

cells, upon obtaining the informed consent.

Article (23.1)

Subject to the provisions and principles set forth in the Law and Implementing

Regulations and directives issued by the National Committee, research may

be conducted on tissues, living cells and separated parts, including stem

cells extracted from the umbilical cord or adult stem cells, upon fulfilling

the following conditions:

1. Fetuses may not be cloned for the purpose of obtaining and using stem

cells in research.

2. Excess fertilized eggs from in vitro fertilization procedures or from

insemination using donor ovum and sperm, shall neither be used for

therapeutic purposes nor in stem cell research.

3. Male or female gametes taken from sperms or eggs may not be donated

to produce fertilized eggs that can grow into a fetus for the purpose of

generating stem cells therefrom.

4. Embryonic stem cells derived from aborted fetuses may be used for

therapeutic purposes. Likewise, miscarried fetuses without any signs

 

 

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of life yet may be used in research or in scientific and laboratory

experiments in accordance with observed Sharia rules in the Kingdom.

5. In case of stillborn fetuses, embryonic stem cells may be transferred

and used in research.

6. Stem cells of an adult human may be used, provided said human is not

subject to any harm, and such stem cells can be used to treat a patient,

and the expected benefit outweighs the possible harm.

7. Induced pluripotent stem cells, in which adult stem cells are induced to

obtain pluripotent cells which can be developed into other kinds of cells,

such as nerve cells and others, can be used solely at an experimental

and animal level, provided the following conditions are fulfilled:

a. The research is conducted at a research center affiliated with a

government agency, or with the participation of the said government

agency.

b. A written authorization is obtained from the local research ethics

committee.

c. It is pledged in writing not to use these induced pluripotent stem

cells on humans.

8. Embryonic cells and derivatives can be imported only from the sources

permitted by these regulations, once the authorization of the local

committee is obtained. Commercially available induced pluripotent

stem cells can also be imported from scientifically recognized sources.

Article (23.2)

It is prohibited to import the following stem cells:

1. Stem cells obtained from the insemination using a donor ovum and a

donor sperm, performed to extract stem cells.

2. Stem cells obtained from deliberately aborted fetuses.

 

 

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Article (23.3)

Cells can be used in clinical research (therapeutic research) under the

following conditions:

1. A written authorization is obtained from the local research ethics

committee.

2. A “Informed Consent” form is obtained from the human subject

participant before the research project is initiated.

3. A written authorization is obtained from the Saudi Food and Drug

Authority.

4. The expected benefit for the human subject and the extent to which

it outweighs the possible harm shall be evaluated through a clear and

thorough scientific assessment conducted by the investigator and

submitted to the local committee.

5. The investigator or research team conducting the research shall be

specialized and shall have sufficient scientific expertise and competence.

6. Research objectives shall be clearly and accurately defined, and

the research is preceded by sufficient experiments on animals if the

nature of the research so requires; subject to the discretion of the local

committee.

7. If the local committee finds that the potential harm for the human

subject outweighs the expected benefit, it must refrain from authorizing

the research project.

8. The local committee shall review periodic reports submitted by the

investigator to ensure that the expected benefit continues to outweigh

the possible harm.

9. The “Informed Consent” shall be obtained from the human subject prior

to conducting the research and the information provided shall contain a

full explanation of expected benefits and potential risks of the research.

 

 

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10. The investigator shall keep detailed records of the source of stem cells

and the results of their use in the research, and shall submit periodic

research reports to the local committee.

Article (23.4)

Stem Cell Banks may be established under the following conditions:

1. A written authorization from the National Committee is obtained.

2. The stem cell bank can only be established in a center affiliated with a

government agency.

3. It is prohibited to send any stem cells to be stored outside the Kingdom.

4. Stem cells stored in stem cell banks for therapeutic purposes may

not be used for research purposes without the permission of the local

committee and the stem cells’ owner’s consent;

5. An accurate and strict mechanism shall be set up to safeguard all

information and data with the utmost safety and confidentiality.

6. Each sample shall be given a permanent identification label specifying

its ownership. Information included in said label shall be updated by

the principal investigator under the supervision of the local committee.

 

 

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Chapter Nine: Research on Inmates

Article 24

Prisoners, including those sentenced to death, shall be treated like

other persons as regards conducting medical research on them. The

Regulations shall specify ethical controls for conducting research on

prisoners.

Article (24.1)

When serving as subjects in medical research, inmates, even if sentenced

to death, shall not be treated differently. Their confinement may not be

exploited to compel them to consent to be research subjects.

Article (24.2)

The local committee may not approve research on inmates unless said

research aims to achieve any of the following:

1. Study the criminal behavior of inmates, provided the research does not

expose them to more than the minimal potential risk;

2. Study conditions of prisons and inmates as well as prevailing diseases

and identify the circumstances leading to crime;

3. Study administrative rules and operational procedures applicable in

prisons, so as to improve health and living conditions of inmates;

4. Inmates may not be subject to clinical research whether by coercion or

inducement or for any purposes other than those set forth in this Article.

 

 

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Chapter Ten: Research on Special Cases

Article 25

Research may not be conducted on minors, incompetent or disabled

persons unless the interest of these categories so requires. The

Regulations shall specify ethical controls for conducting research on

said categories.

Article (25.1)

1. Research may not be conducted on minors, incompetent or mentally

disabled persons without obtaining the “Informed Consent” from

parents or the legal guardians in accordance with conditions set forth

in the Law and Regulations, provided they are informed of the level of

risk and its probability as well as the person’s assent.

2. Either parent or the legal guardian may grant the “Informed Consent”

on behalf of minors, incompetent or mentally disabled persons provided

his decision is based on the fact that the minor, incompetent or mentally

disabled person is subject to no harm and may benefit from the research.

3. After granting the “Informed Consent”, either parent or the guardian

may withdraw the consent at any phase of the research if he finds that

the research conflicts with the interests of the minor, incompetent or

mentally disabled person or if the research deviates from the objectives

upon which the consent was granted.

Article (25.2)

The local committee shall grant its approval for research on minors,

incompetent or mentally disabled persons subject to the following

conditions:

 

 

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1. It is not possible to conduct the research on a competent person;

2. The interest of the minor, incompetent or mentally disabled person

requires subjecting him to the research, provided he is not exposed to

more than the minimal potential risk;

3. The research protocol includes clear and appropriate measures to

minimize potential risk as much as possible;

4. Evaluation of potential risk and expected benefit from the research shall

indicate type, nature, degree and possibility of risk as well as the direct

benefit for the minor, incompetent or mentally disabled person subject

of the research and for similar persons;

5. The research shall be conducted in a school, camp, hospital, or institution

where the majority of occupants are incompetent or disabled, provided

the research subject belongs to this category.

Article (25.3)

If the local committee finds that the research in whole or in part

achieves a direct benefit for the minor, incompetent or mentally

disabled person but that its risk exceeds the minimal expected level,

it may grant its approval to conduct the research pursuant to the

following conditions:

1. The potential risk shall be within acceptable levels in accordance

with medical standards, if compared with expected benefits;

2. The ratio of the expected benefit shall exceed that of other methods

available outside the scope of the research;

3. The research shall lead to a better understanding of an important

problem that affects the minor, incompetent or mentally disabled

person or his interest, help reduce such problem, or prevent some

of its negative effects;

 

 

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4. Obtaining the “Informed Consent” from either parent or from the

legal guardian.

Article (25.4)

If the local committee finds that the research does not directly benefit the

minor, incompetent or mentally disabled person but does not expose him

to more than the minimal potential risk, it may approve the research in the

following cases:

1. If he had given the “Informed Consent” when he was competent or

before the disability occurred, and his legal guardian later gave the

“Informed Consent”;

2. If precautionary measures taken for his protection are adequate and

acceptable;

3. If there are sufficient reasons that make it possible to obtain significant

information through the research for understanding the case under study.

Article (25.5)

The local committee may, prior to giving its approval of conducting

research on the minor, incompetent or mentally disabled person, require

appointing a qualified lawyer experienced to handle such case. Said lawyer

shall have no relation with the researcher or the institution supervising and

funding the research and shall observe the interest of the minor subject of

the research, in coordination with his parents or guardian.

Article (25.6)

The physically, but not mentally, disabled person shall be treated as a normal

person, in terms of his responsibility for giving the “Informed Consent”

and his understanding of research potential risks and expected benefits.

 

 

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Article 26

Pregnant women, fetuses and the product of pregnancy may not be

used in research except in accordance with controls specified by the

Regulations.

Article (26.1)

An investigator may not initiate any research on a pregnant woman unless

the following conditions are satisfied:

1. Conduct appropriate studies, when possible, on animals and non-

pregnant women that confirm the safety of methods and means

of research, provided the results of such research are published in

internationally recognized scientific journals in accordance with the

provisions of the Law and Regulations;

2. The level of risk the research project poses to pregnant woman or her

fetus does not exceed the minimum risk level;

3. The investigator shall not have any role in deciding how and when the

pregnancy will be terminated or whether the fetus can survive after

termination of pregnancy;

4. The research shall not lead to a change in pregnancy termination

procedure if such change leads to more than the minimum level of risk

to the pregnant woman or her fetus;

5. The research project aims to provide health requirements for the

pregnant woman and her fetus and acquire information that cannot

otherwise be obtained;

6. The principal investigator shall comit not to offer any type of reward in

return for termination of pregnancy for research purposes;

7. Obtain the “Informed Consent” from both the pregnant woman and her

husband.

 

 

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Article (26.2)

No research on fetuses may be initiated unless the following conditions are

satisfied:

1. The research shall not harm or endanger the life of the fetus;

2. The research project shall aim to provide health requirements for the

fetus and to acquire information that cannot otherwise be obtained;

3. No research may be conducted on a living fetus unless it is nearly

certain that its life is threatened or that the level of risk the fetus may

face in case it remains in the uterus could be lessened, provided there is

no safer means to achieve the same.

Article 27

Cells, tissues and derivatives of human sperms, gametes and zygotes

may not be transported or exploited for the purpose of research

except in accordance with conditions and restrictions laid down by the

National Committee.

Article (27.1)

The National Committee shall set controls required for transfer and use

of cells, tissues and derivatives constituents of human sperms, gametes

and zygotes for research purposes. Said controls shall be reported to the

Research Ethics Monitoring Office and local committees to abide by.

Article 28

Fetuses may not be cloned for the purpose of obtaining embryonic stem

cells, nor may male or female gametes taken from sperms or eggs be

donated to produce fertilized eggs that can grow into a fetus for the purpose

of generating stem cells therefrom and conducting research thereon.

 

 

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Article (28.1)

The National Committee shall monitor institutions where fertilized eggs

are produced to ensure their compliance with the provisions of the Law

and Implementing Regulations and instructions issued by the National

Committee.

Article 29

Banks for preserving reproductive male or female cells with the intent

of conducting research thereon may not be established.

Article 30

Organs and tissues of fetuses aborted before reaching one hundred

twenty days may be used in research and experiments in accordance

with controls and conditions set forth in the Regulations.

Article (30.1)

Research may be conducted on a pre-quickening stillborn fetus, if deemed

necessary by the local committee, provided the research project is beneficial

and contributes to the progress of applied sciences.

Article (30.2)

Samples may be taken from a stillborn fetus upon obtaining approval of

the local committee, provided said samples are legally stored at approved

gene banks.

Article (30.3)

1. Research may be conducted on products of conception if the two

following conditions are satisfied:

 

 

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a. It is established through a medical report signed by two consultant

physicians, upon medical examination of products of conception,

that it has no chance for survival;

b. The conditions set forth in the Law and Regulations regarding

research on the minor, incompetent or mentally disabled person

shall be applied.

2. Research may be conducted on products of conception if said research

aims to improve fetus chances of survival and obtain important

information that may not be otherwise obtained, unless there is

additional risk to the products of pregnancy.

Article (30.4)

If the research is conducted on an aborted or miscarried fetus, the following

controls shall be observed:

1. Obtain the “Informed Consent” from the woman and her husband in

accordance with the provisions of the Law and Regulations as well as

controls and procedures set by the National Committee in this regard;

2. The woman and her husband shall be informed of the methodology

used in the research on the aborted or miscarried fetus and whether

there is an intention to store tissues taken therefrom to be used later for

research;

3. Only miscarried and lawfully aborted fetuses according to the Law of

Practicing Healthcare Professions may be used in research.

 

 

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Chapter Eleven: Dealing with Genetic Material and its Banks

Article 31

A central data bank shall be established within KACST for the

purpose of maintaining information related to genetic material and

regulating use thereof in accordance with procedures specified by the

Regulations. Said bank shall provide information for research using

genetic material in the Kingdom.

Article (31.1)

The Central Data Bank and the local gene banks shall provide parties

concerned with information available on different diseases affecting

individuals, families or the community, subject to maintaining the privacy

of the genetic material source and barring the possibility to identify the

source of the sample.

Article (31.2)

The investigator shall maintain the confidentiality of research conclusions,

and not identify their source.

Article (31.3)

When conducting research on genetic material, the following shall be

observed:

1. Islamic values, local culture and environmental safety;

2. Applicable and internationally recognized practices relating to

conducting research on genetic material.

 

 

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Article (31.4)

Results of the research on genetic material shall be the property of the State.

Neither the researcher nor the institution may provide said results to any

internal or foreign body without permission from the National Committee,

provided the material and scientific rights of the researcher or research

team and the research subject are preserved.

Article (31.5)

The local genetic material biobank shall provide the Central Data Bank

with an annual report including the following data:

1. A classified list of genetic material available at the local bank, indicating

date of acquisition and use;

2. A list of genetic materials withdrawn from the local bank, indicating

date of withdrawal and investigator or institution using it;

3. A summary of research conducted on samples withdrawn from the local

bank and used.

Article 32

When setting up local data banks for the preservation of genetic

material, establishments conducting research on such genetic

material shall comply with conditions and procedures specified by the

Regulations.

Article (32.1)

Prior to initiating research on genetic samples, the investigator or research

team shall observe the following procedures:

1. Set a detailed plan including, but not limited to, research objectives,

study approach, expected results and risks, and submit the same to the

 

 

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local committee;

2. Explain to the donor, if known, the subject and nature of the research,

expected results, and potential risks, particularly if the research has an

unclear genetic therapeutic nature provided that the research plan is

accompanied with proof thereof;

3. Obtain the “Informed Consent” according to the Law and Regulations.

Article (32.2)

The National Committee shall specify the data to be included in the

“Informed Consent” form for research conducted on the sample of genetic

material.

Article (32.3)

Prior to approval of the research on genetic material, the local committee

shall take the following measures:

1. Carefully review and verify the research protocol and ensure that it

contains appropriate laboratory tools and techniques as well as all

prevention and sterilization measures required in such cases;

2. Ensure that the investigator or research team has the necessary expertise

to conduct the research;

3. Ensure that the research project contributes to knowledge on genes

relating to the community and adds new scientific contribution to

previous research, and that it seeks to develop and improve scientific

standards and health conditions of different categories of the community;

4. Verify that the investigator or research team applies adequate scientific

methods and precautions to prevent escape of living organisms from

research laboratories if research includes conducting experiments on

microbes such as genetically modified bacteria or bacteria that will be

 

 

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genetically modified for the purpose of research.

Article (32.4)

1. In case of conducting therapeutic research on the genetic material of

animals or humans, the research objective shall be limited to finding

treatment for genetic defects or diseases, provided the research is

conducted on somatic and stem cells only;

2. In all cases, no research may be conducted on reproductive cells for the

purpose of modifying natural human characteristics;

3. Except for the provisions set forth in paragraphs 1 and 2 above, the

genetic treatment research shall be subject to controls and rules applied

to clinical research as well as laws and controls issued by the National

Committee.

Article 33

The same genetic sample may not be subject to multiple use in research

projects of different purposes without obtaining an informed consent

for each purpose except if such use is not related to the source person,

provided this is approved by the local committee.

Article (33.1)

The same genetic sample may not be used in multiple research projects

of different purposes without obtaining an “Informed Consent” for each

purpose, unless the following two conditions are satisfied:

1. The sample was previously obtained for diagnostic purposes and was

retained for a time sufficient to preclude identification of the source by

the investigator;

2. Obtain the approval of the local committee.

 

 

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Article 34

The researcher shall observe the privacy and confidentiality of

information related to those from whom the research samples have

been collected.

Article (34.1)

The principal investigator shall be responsible for maintaining the privacy

and confidentiality of information related to donors and shall be liable for

any damage sustained by the donors or the community.

Article (34.2)

If local or international researchers are invited to conduct joint research on

genetic material, the institution and principal investigator shall emphasize

the necessity of observing the privacy and confidentiality of information

related to donors in accordance with the provisions of the Law and

Regulations.

Article 35

The local committee may restrict the researcher’s use of research

results on genetic material if said results harm public interest, provided

the National Committee approves the same.

Article (35.1)

The local committee may restrict the principal investigator’s use of research

results on genetic material if publishing said results would harm public

interest, subject to the approval of the National Committee.

 

 

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Article (35.2)

If prevented from using results of his research, the investigator may claim

indemnification for research expenses from the institution.

Article 36

Research with negative impacts on society may not be conducted,

especially research reinforcing racial discrimination.

Article (36.1)

Conducting research on diseases that are particular among a certain

group for the purpose of treatment and understanding of mechanisms of

transmission of said diseases may not be construed as promoting racial

discrimination.

Article (36.2)

Scientific results shall not be leaked to the media if this could lead to

promoting discrimination on the basis of race or family or tribal affiliation.

Article 37

The Regulations shall specify the ethical controls and criteria of genetic

treatment research.

Article (37.1)

The following ethical controls and criteria shall be complied with when

conducting genetic treatment research:

1. A written approval shall be obtained from the National Committee in

all matters related to gene therapy research;

2. Gene therapy research shall be subject to controls and provisions set

 

 

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forth in the Law and Regulations and provisions set by the National

Committee;

3. The research shall be consistent with the provisions of Shari’a, and

the research plan shall include proof of taking such provisions into

consideration;

4. The research shall comply with the controls and criteria set forth in

international agreements related to gene therapy and amendments

thereto, without prejudice to Shari’a rules and provisions;

5. Said research shall be limited to incurable diseases affecting human

life, which have not yet been successfully treated by conventional

medical methods;

6. Prior to approval of research, it shall be ascertained that all available

treatment options have been exhausted;

7. The local committee evaluating this type of research shall comprise at

least two persons with scientific competence to evaluate gene therapy

research. The local committee may invite experienced consultants to

attend its meetings to help evaluate the research project;

8. Gene therapy research shall be conducted in qualified hospitals and

research centers with required medical specializations, as well as

experienced and qualified staff;

9. The research plan shall include a detailed description of research

objectives, methodology, expected benefits, difficulties, risks and

health complications for the human subject;

10. The research shall be based on scientific principles, and preceded by

sufficient laboratory experiments and animal testing;

11. The expected benefit from the research shall outweigh any potential

risks;

12. The research shall be conducted by a qualified investigator specialized

 

 

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in genetic medicine and assisted by a highly efficient medical team.

Said investigator shall be well versed in genetic and scientific material

related to the subject of the research;

13. Gene therapy may not be carried out for research purposes on gametes

(sperms and ova) or experimental research on stem cells obtained from

fertilized zygotes or related to reproductive cloning;

14. Handling of genetic material in research, storage and disposal thereof,

as well as collaborative research with centers abroad shall be in

accordance with the controls set forth in the Law and Regulations.

 

 

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Chapter Twelve: Use of Animals and Plants in Experiments

Article 38

1. Animals may be used for research employing all experimental or

scientific means not causing unusual pain to the animals.

2. Use of animals shall be restricted to research whose objectives

cannot be realized without such use.

3. Endangered animal species may not be subject to negative use.

The Regulations shall specify ethical conditions and procedures for use

of animals in research.

Article (38.1)

Animals may be used in scientific experiments where research objectives

cannot be otherwise realized.

Article (38.2)

When conducting research on animals, the investigator shall comply with

the following:

1. Sharia provisions related to humane treatment of animals.

2. Scientific principles and conventions governing experimental practices

on animals.

3. A license must be obtained from the local committee to conduct research

on animals according to the licensing procedures of the National

Committee.

4. The approval of the local committee to commence the research must

be obtained.

5. It must be verified that previous cell research was conducted before

conducting research on animals when needed.

 

 

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6. Usage must be limited to the minimum number of animals required to

achieve research objectives.

7. Potential harm to and suffering of animals must be minimized as much

as possible.

8. Observing that the expected results and desired benefits from the

research outweigh any risks and harms to the animal subject of the

research or the environment in general;

9. The appropriate animal must be selected to provide credible information

and results.

10. Practice shall be subject to appropriate and acceptable scientific and

experimental principles.

Article (38.3)

To obtain approval to conduct research on animals, any of the following

shall be satisfied:

1- To Prevent, diagnose or treat a disease or a deformity that must

be rectified or whose effects must be removed;

2- To explore animal physiology;

3- Protection of the natural environment as well as general health

of humans or animals;

4- Achievement of scientific advancement in biological sciences;

5- Contribution to forensic research;

6- Improvement of animal breeding methods and management;

7- Conduct preliminary research on pharmaceutical substances,

toxins and radioactive effects.

Article (38.4)

When reviewing research proposals involving animal and plant experiments,

 

 

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the local committee must verify that the research proposal includes the

following mandatory elements:

1. Principal investigator and research team credentials,

2. Animal/plant species used for the experiment, source and quantity.

3. Any agreements with other parties related to the experiment, or to the

experiment’s results.

4. A detailed account of the locations where the experiment will be carried

out to conduct field visits when necessary.

5. The system of identification used to distinguish the animals and plants

used in the experiment, and the system used to save the information and

data related to every animal or plant in the experiment’s records.

6. Emergency and hazards management plans.

7. Means and mechanism for the disposal of the experiment’s components.

8. System used to save all data and information resulting from the

experiment in dedicated databases.

9. The authorizations of relevant authorities when needed.

Article (38.5)

When reviewing research proposals resulting in pain and suffering of

animals, the local committee must thoroughly assess the proposal, and

confirm that:

1. The experiment is not prohibited or restricted by international or

regional conventions or rulings where the Kingdom of Saudi Arabia is

a party or a signatory.

2. There are no other possible alternatives to achieve the same required results.

3. The research team is fully competent and qualified, and the tools ,

materials and laboratory environment of the experiment are perfectly

adequate.

 

 

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Article (38.6)

The research protocol shall take all measures necessary to prevent animal

suffering, using the minimum number of research animals which have a

low level of neurological or physiological sensation.

Article (38.7)

Artificial hybridization may not be conducted except between animals of

the same species, even if breeds are different, provided that the expected

benefit outweighs the risks and that such risks can be prevented or controlled.

Article (38.8)

Animals may not be cloned unless medically proven safe as per a medical

report approved by at least two specialists.

Article (38.9)

Transplant of animal fetuses shall be subject to the same conditions

governing the process of artificial insemination set forth in Article (38.7).

Article (38.10)

Banks for preserving animal sperms or eggs for production or research

purposes may be established, without prejudice to rules of artificial

insemination.

Article (38.11)

Research and experiments causing pain to animals may not be conducted

unless the following two conditions are satisfied:

1. The investigator is well versed in physiology, and the research or

experiment is beneficial to science, such as leading to the discovery

 

 

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of disease or treatment that can help combat diseases and ailments,

protecting health and the environment.

2. The investigator shall obtain local committee approval.

Article (38.12)

Pain-causing research and experiments on animals must be conducted under

anesthesia unless this undermines research objectives, at the discretion of

the investigator.

Article (38.13)

In all cases, upon completion, the animal subject of research shall be

disposed of while under anesthesia, in accordance with the provisions of

Shari’a.

Article (38.14)

Animals earmarked for experimentation shall be disposed of if they contract

an infectious disease other than the one under study. However, if it is possible

to treat such animals, this shall be carried out in isolated places, and all

procedures of epidemic quarantine shall be enforced under the supervision

of the veterinarian in charge. The disease and the measures taken for its

control or treatment shall be reported to the competent authorities.

Article (38.15)

1. No research or experiment may be conducted on animals for the purpose

of acquiring skills or practical training without using anesthetics except

in cases where the animal is not subject to severe pain or torture;

2. Research and experiments may be conducted on animals for the purpose

of demonstration and explanation to students, provided it is undertaken

 

 

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by a qualified person and the said research or experiment is necessary

to explain theoretical information and furnish students with useful

scientific knowledge.

Article (38.16)

Endangered animal species may not be used in research or experiments

unless said research or experiments are required for breeding or preservation

of species. The approval of the Monitoring Office shall be obtained before

conducting the research.

Article (38.17)

Painful or harmful methods may not be used in hunting wild animals for

the purpose of research.

Article (38.18)

Captured animals shall be subject to quarantine in their natural habitat

before being moved to the research unit wherein they are to be quarantined

once again before conducting the research. The National Committee shall

set conditions for the quarantine and its duration.

Article (38.19)

Wild animals may not be used in scientific research except in the following

cases:

1. If it is impossible to achieve study objectives by using other alternatives;

2. Increase the number of animals subject of the research and protect them

from extinction without affecting their genetic nature;

3. Detect whether the animal subject carries any zoonotic or epidemic

diseases or immunize said animal to prevent spread of such diseases.

 

 

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Article (38.20)

Upon completion of the research and ascertaining the well-being of the

research animal, it shall be released and returned to its original habitat,

whenever possible.

Article (38.21)

1. Wild animals foreign to the Kingdom’s wildlife may not be introduced

thereto for the purposes of research;

2. Wild animals may not be returned to their habitat after being genetically

modified;

3. No research may be conducted to increase the population of certain

species of wild animals at the expense of other species unless said

species is in danger of extinction.

Article (38.22)

For capturing terrestrial and marine animals for the purposes of research,

a permit from the relevant authority indicating the term of the license, and

type of animal shall be obtained, without prejudice to the hunting laws in

the Kingdom.

Article (38.23)

Animals or products thereof exposed to chemical, biological or genetic

substances for the purposes of research may not be consumed, sold or given

away. Said animals as well as wastes and products thereof shall be disposed

of through established scientific practices under veterinary supervision.

Article (38.24)

The institution licensed to conduct research on animals shall have facilities

 

 

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for the care of experimental animals, comprising the following:

1. Enclosures for the care of experimental animals appropriately equipped

for animal living conditions;

2. A person qualified to monitor animal safety and health and care for

animals prior to commencement of research;

3. Fully equipped laboratories appropriate for conducting experiments

and reaching sound scientific results.

Article (38.25)

The institution licensed to conduct research on animals shall submit an annual

report to the Monitoring Office, including: activities, experiments conducted,

numbers, types and sources of animals used, results of each experiment, and

destruction procedures, pursuant to forms prepared for this purpose.

Article (38.26)

Persons licensed to conduct experiments on animals as well as institutions,

places and experiments shall be monitored by the Monitoring Office.

Article (38.27)

The National Committee shall set up rules and controls governing use

of animals in research experiments in matters not provided for in these

Regulations.

Article 39

Plants may not be used in research that upsets environmental balance

and distribution of vegetation. Endangered plant species may not be

subject to negative use. The Regulations shall specify ethical terms and

procedures of research on plants.

 

 

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Article (39.1)

No research may be conducted on endangered plants unless it is necessary

for reproduction or preservation of plants. The approval of the Monitoring

Office shall be obtained prior to conducting the research.

Article (39.2)

Persons licensed to conduct experiments on plants as well as institutions,

places and experiments shall be subject to auditing by the Monitoring

Office, without prejudice to laws pertaining to food, drugs, and agriculture

as well as Wildlife Reserves Law and the Law of Fishing, Investment and

Protection of Marine Life in Territorial Waters and all relevant laws and

regulations in the Kingdom

Article (39.3)

Penalties set forth in the Law and Regulations shall be imposed on any

person violating controls and provisions therein according to the jurisdiction

of the National Committee.

Article 40

If research includes conducting genetic modification experiments on

Living Creatures, the investigator shall take all necessary measures to

prevent their escape from research laboratories.

Article (40.1)

Genetic modification research on animals and plants shall be conducted in

laboratories designated for this purpose, provided all measures are taken to

prevent escape of genetically modified creatures.

 

 

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Article (40.2)

Microorganisms subject to the research and their outcome shall be disposed

of through standard scientific procedures.

 

 

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Chapter Thirteen: Violation Review Committee

Article 41

KACST President shall designate inspection employees in charge of

detecting violations of the provisions of this Law and its Regulations in

accordance with procedures specified by the Regulations.

Article (41.1)

Inspection employees, named pursuant to a decision by KACST President,

shall be in charge of detecting violations of the provisions of the Law and

Regulations, without prejudice to the authority of the Monitoring Office

and the local committee with regard to detection of such violations.

Article (41.2)

For the purpose of detecting violations of the provisions of the Law and

Regulations, the inspection employees may enter and inspect institutions

licensed under the Law, examine records and documents, request necessary

data, and question employees therein. Institution owners and officials shall

facilitate the work of the inspection employees.

Article (41.3)

Inspection employees shall record every violation in an official report

including name of violator or violating institution as the case may be, a

description of the violation, time of detection, recording of any relevant

sample, paper, or document seized therein. The report shall be signed by

the relevant inspection employee and the violator. If the violator refuses to

sign, such incident shall be recorded in the report.

 

 

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Article (41.4)

The violator shall be notified of the detected violation in writing.

Article 42

a- A committee shall be formed pursuant to a decision by KACST

president to review violations of the provisions of this Law and decide

appropriate penalties, except for imprisonment, according to this Law.

Said committee shall determine amount of damages for private claims.

The committee shall comprise the following:

1. A Sharia counselor named by Minister of Justice Chairman

2. A faculty member of a Saudi medical college, of a rank not

lower than associate professor, named by the Minister of Higher

Education Member

3. A researcher specialized in genetic material, of a rank not

lower than associate professor or equivalent, selected by

KACST President Member

4. A qualified and experienced researcher specialized in bioethics,

selected by KACST President Member

5. A legal counselor selected by KACST President Member

6. A faculty member of a Saudi university specialized in zoology, of

a rank not lower than associate professor, named by the Minister

of Higher Education Member

7. A faculty member of a Saudi university specialized in botany, of

a rank not lower than associate professor, named by the Minister

of Higher Education Member

Said committee may seek the assistance of one or more experts as

regards the issue in question.

b- The committee seat shall be at KACST in the city of Riyadh. Similar

 

 

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committees may be established the Kingdom’s provinces pursuant to a

decision by KACST President.

c- Remuneration of committee chairman and members shall be

determined in the Regulations according to applicable laws, decisions

and directives.

d- The Regulations shall determine committee rules, procedures and

meetings.

e- Committee term of membership shall be three renewable years. If a

member is unable to complete his term for any reason, a replacement

shall be appointed in the same manner the replaced member was

appointed.

f- The committee shall convene if attended by two-thirds of its members

upon a call by the Chairman as needed. Committee resolutions shall

pass by majority vote of attending members. In case of a tie, the

Chairman shall have the casting vote.

Article (42.1)

One or more committees shall be formed pursuant to a decision by KACST

President to review violations of the provisions of the Law and Regulations,

upon nomination of members of said committee(s) by competent bodies in

accordance with Article 42 of the Law.

Article (42.2)

Violation Review Committee term of membership shall be three renewable

years. If any member is unable to complete his term for any reason, or if he

declares his wish to discontinue his committee membership, 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

 

 

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shall be appointed in the same manner the replaced member was appointed

to fill out the remainder of his term.

Article (42.3)

The Violation Review Committee chairman shall manage its affairs and

head its meetings, and committee members shall deliberate in camera.

Article (42.4)

The Violation Review Committee shall particularly perform the following

tasks:

1. Review claims submitted thereto by KACST representative of public

prosecution against violators of the provisions of the Law and Regulations;

2. Decide appropriate penalty from among the penalties set forth in

Article 44 of the Law, except for imprisonment, against the violator

after hearing his statements and reviewing his defense;

3. Submit a recommendation to KACST President for referral of violators

to the competent court if the committee finds that the violation detected

requires a penalty including imprisonment. KACST President shall

refer the case to the Bureau of Investigation and Prosecution to submit

it to the competent court;

4. Review compensation claims filed therewith by civil suit claimants

and estimate the appropriate compensation if deemed justifiable, after

hearing the defendant;

5. Compel the violator to publish the decision text at his expense in at least

three local newspapers, one of which at least is published in the region

where he resides. If no such newspaper is published in the region, the

decision shall be published in the newspaper published in the nearest

region.

 

 

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Article (42.5)

The Violation Review Committee shall hold its meetings at KACST upon

a call by its Chairman as needed, and may, if necessary, hold its meetings

at any other place with the approval of KACST President. Committee

meetings shall not be valid unless attended by two thirds of its members,

including the chairman. Committee resolutions shall pass by majority vote

of attending members. In case of a tie, the Chairman shall have the casting

vote.

Article (42.6)

Violation Review Committee members shall be notified of each meeting

date at least ten days prior to the meeting, and meeting proceedings shall

be recorded in special minutes set for such purpose.

Article (42.7)

The Violation Review Committee may seek technical assistance from

specialists or experts with regard to an issue before it, provided the letter

sent to said specialists or experts specifies the remuneration.

 

Article (42.8)

In a compensation claim, if the claimant requests technical assistance from

any agency with experience, the Violation Review Committee may, at its

discretion, approve his request and refer the claim papers to said agency.

Article (42.9)

The Violation Review Committee may summon any of KACST personnel

whose presence it deems necessary to seek advice on matters filed therewith.

 

 

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Article (42.10)

The Violation Review Committee may, if necessary, approach public and

private agencies as regards any of its affairs.

Article (42.11)

The Violation Review Committee may take any measures necessary to

proceed with claims filed with it. It may itself conduct the inspection or

delegate a member for this purpose, provided said member submits an

inspection report.

Article (42.12)

The Violation Review Committee shall have a secretary appointed pursuant

to a decision by KACST President.

Article (42.13)

The secretary shall manage the technical and administrative affairs of

the Violation Review Committee, and shall particularly undertake the

following duties:

1. Prepare committee minutes and arrange its meetings;

2. Coordinate between the committee and parties concerned from within

and outside KACST, including meeting dates and notification of notices

and decisions;

3. Perform typing, copying, and archiving tasks and save and retrieve

files;

4. Keep a file for violations which includes the following:

a. Violations with serial numbers;

b. Name of violator;

c. Date of receipt of violation report;

 

 

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d. Description of violation;

e. Penalty imposed by the committee, and penalty decision and date

thereof;

f. Decision of the Board of Grievances with regard to the violation in

case of an appeal.

Article (42.14)

1. The Violation Review Committee shall consider public suits and notify

the violator of the date of hearing at least ten days in advance. The

notification shall include a description of the violation; date, time and

place of scheduled hearing, summoning the violator or his representative

to appear before the committee and present his defense.

2. The Violation Review Committee may not consider public suits for a

violation after the elapse of more than one year after detection without

taking any action.

Article (42.15)

The Violation Review Committee shall consider civil suits and notify the

defendant of the date of hearing at least ten days in advance. The notification

shall include a copy of the petition and any other documents submitted by

the claimant; date, time and place of the hearing, summoning the defendant

or his representative to appear before the committee and present his defense.

Article (42.16)

If the defendant or his legal representative fails to attend the first hearing,

the Violation Review Committee shall adjourn the hearing and notify

the defendant of the new hearing date. If the defendant fails to attend a

second time, though properly notified, the Violation Review Committee

 

 

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may proceed with the consideration of the case as if he was present. The

defendant shall be deemed present if he attends one hearing and fails to

attend the rest of the hearings.

Article (42.17)

The secretary of the Violation Review Committee shall draft the hearing

minutes under the supervision of the hearing chairman, provided the

minutes include names of attending members, place and time of the hearing,

names of attending parties to the suit or their representatives, all hearing

proceedings, as well as statements and defenses of parties. The minutes

shall be signed by the committee chairman, members, secretary and parties

to the suit or their representatives.

Article (42.18)

If the Violation Review Committee finds that the violation considered

includes a crime punishable by other laws, it shall refer the criminal case to

the competent agencies to take legal action, in accordance with said laws,

and shall decide the violation under consideration unless it finds that either

violation cannot be decided separately from the other.

Article (42.19)

Decisions of the Violation Review Committee shall be reasoned and shall

include a rebuttal of all defenses raised by parties to the suit. A committee

member (or the chairman) adopting a different opinion shall include said

opinion in the minutes with the reasons thereof.

Article (42.20)

The Violation Review Committee secretariat shall notify the parties

 

 

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concerned of committee resolutions by official letters delivered to them

or their legal representatives, provided that the notification letter includes

the following text: “A party against whom a committee decision has been

issued may appeal before the Board of Grievances within sixty days from

date of notification.”

Article (42.21)

Procedures of the Board of Grievances shall apply to matters not provided

for in the Violation Review Committee Procedures.

Article (42.22)

An aggrieved party may appeal Violation Review Committee decision

before the Board of Grievances within sixty days from date of notification

thereof.

Article (42.23)

Remuneration of Violation Review Committee’s chairman and members

shall be determined according to Regulations of Joint Governmental

Committees and their Work Procedures issued pursuant to Civil Service

Council Decision No. (1/1270) dated 21/11/1428 H approved by wired

High Order under No. (3759/MB) dated 12/6/1432 H.

Article 43

Public prosecution before the committee shall be carried out by

competent personnel designated by KACST President.

Article (43.1)

One or more public prosecution representatives shall be appointed pursuant

 

 

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to a decision by KACST President to file suit and litigate before the

Violation Review Committee against violators of the Law and Regulations.

Article (43.2)

Based upon the contents of the violation detection report, the public

prosecution representative shall file the public suit before the Violation

Review Committee.

Article (43.3)

The Violation Review Committee shall consider the suit without delay,

and if it is necessary to consider the suit in more than one hearing, the

committee shall notify the parties concerned of the date, time and location

of each hearing.

 

 

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Chapter Fourteen: Penalties

Article 44

Without prejudice to any severer penalty prescribed by other laws, a

person violating any provision of this Law shall be subject to one or

more of the following penalties:

1. Warning,

2. Suspension of research until the effects of the violation are rectified;

3. Barring the researcher from conducting the research subject of the

violation;

4. A fine not exceeding two hundred thousand (200,000) riyals;

5. Imprisonment for a period not exceeding six months.

Article (44.1)

The National Committee may warn the researcher, the institution, or both

if it finds that the violation committed does not require a severer penalty,

taking into consideration that repeating the violation may require additional

penalties at the discretion of the committee.

Article (44.2)

If the penalty is a suspension of research, the suspension period shall not

exceed two years. If the violation is not rectified, the research shall be

cancelled.

Article (44.3)

The National Committee may bar the principal investigator from conducting

the research subject of the violation, or from practicing any other activity

that may affect the research.

 

 

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Article (44.4)

The National Committee may impose a fine not exceeding two hundred

thousand (200,000) riyals on the researcher, the institution, or both if

violation is established.

 

Article (44.5)

If the National Committee finds that the violation committed requires

imprisonment, it shall take Article (45.1) into consideration.

Article 45

If the committee decides to impose a penalty including imprisonment, a

recommendation to this effect shall be submitted to KACST President

for referral to the competent court.

Article (45.1)

The Committee shall recommend an imprisonment term appropriate to the

violation committed and state reasons for not imposing a lesser penalty.

Article 46

The committee may include in the final penalty decision publication of

the decision text at the expense of the violator in not more than three

local newspapers, one of which at least is published in the region where

he resides. If no such newspaper is published in the region, the decision

shall be published in the newspaper published in the nearest region.

Article (46.1)

A copy of the decision shall be delivered in person or through registered

mail to the person against whom the penalty decision was issued.

 

 

117

Article (46.2)

If it is decided to publish the violation text in newspapers, it shall be noted

that the researcher deliberately committed the violation or insisted on

committing it.

Article 47

An aggrieved party may appeal the penalty decision before the Board

of Grievances within sixty days from date of notification.

Article (47.1)

Provisions of Article (42.22) of these Regulations shall be taken into

consideration.

 

 

118

 

 

119

Chapter Fifteen: Concluding Provisions

Article 48

KACST President shall issue the Implementing Regulations of this

Law within ninety days from date of publication of this Law.

Article (48.1)

These Regulations shall be published in the Official Gazette, and shall enter

into force as of its publication date.

Article (48.2)

No amendments to these Regulations may be made except in the same

manner they were issued.

Article 49

This law shall enter into force ninety days from the date of its publication

in the Official Gazette.

Article 50

Existing establishments shall fulfill necessary conditions and

requirements and adjust their status within ninety days from the

effective date of this Law.

Article (50.1)

If the institution fails to rectify its status in accordance with the conditions

and requirements stipulated in the Law and Regulations within the ninety-

day period set forth in Article 50 of this Law, it shall be barred from

conducting research.

 

 

120

Article 51

This Law shall supersede all other provisions conflicting therewith.

….. The End …..

 

 

121

National Committee of BioEthics (NCBE)

King Abdulaziz City for Science and Technology

T :+966 11 4813805

F: +966 11 4813860

P.O.Box 6086

Riyadh 11442

E-mail: bioethics@kacst.edu.sa Website: http://bioethics.kacst.edu.sa

 

 

 

 

N ational C

om m

ittee of BioEthics (N CBE)

Im plem

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

1437H – 2016

King Abdulaziz City for Science and Technology Tel : 011 4883555 – 011 4883444 Fax : 011 4883765 P. O. Box 6086 Riyadh 11442 Kingdom of Saudi Arabia

KACST Publications : publications.kacst.edu.sa Email: awareness@kacst.edu.sa KACST Printing Press NO: 330201

www.kacst.edu.sa

Composition of the Committee Enforcement of the royal decree. No. 7 / B / 9512 on 18/05/1422 H, under the title of 🙁 National Committee of Bio and Medical Ethics), which later changed to (the National committee of Bioethics), by the Royal Decree No. (M / 59) on 14/09/1431 H, mandating to approve the law of research ethics on living creatures, which aims to monitor the implementation of the bioethics research standards, for im- provement establish health, preventive, diagnostic, therapeutic and psychological aspects with respect for human dignity, justice, and beneficence, and maintaining individuals rights, communities as consistent with the Islamic law, traditions and customs of the kingdom. Its mandates include bioethics research ethics and it applications that take place in hospitals, universities, and research institutes, as well as to related public and private entities.

Law and Regulation Royal Decree No. (M / 59) on 14/09/1431 H, was issued approving the law of research ethics on living creatures, which was prepared by the National Commit- tee of Bioethics. It aims to develop general principles and necessary regulations to deal with living creatures, or parts, or there of genetic material in the field of research, in the light of professional ethics and in a manner compatible with the Sharia. It consists of fifteen chapters organized by topics and situations that are governed by the law. It issued after approval of the President of the King Abdulaziz City for Science and Technology (KACST), upon perusal of Article Forty-eighth of the implementing Regulations of the law, and detailed explanation of the regulations and proce- dures under the law.

National Committee of BioEthics (NCBE) King Abdulaziz City for Science and Technology T :+966 11 4813805 F: +966 11 4813860 P.O.Box 6086 Riyadh 11442 E-mail: bioethics@kacst.edu.sa Website: http://bioethics.kacst.edu.sa

N ational C

om m

ittee of BioEthics (N CBE)

Im plem

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

1437H – 2016

1437H – 2016

National Committee of BioEthics (NCBE)

Implementing Regulations of the

Law of Ethics of Research

on Living Creatures

Second Edition

Second Revised version

King Abdulaziz City for Science and Technology carries out a number of tasks being assigned to it to establish an ecosystem for supporting and promoting science, technology and innovation, which places Saudi Arabia in the ranks of developed, knowledge-based countries

 

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