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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 1437H - 2016 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. 5 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 6 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. 7 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 8 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.” 9 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 Lawandits Regulations. 10 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 11 research and monitors research ethics in accordance with provisions of the Law and its Regulations. Article (3.2) The establishment shall be responsible for any research conducted therein and shall, through local committees, ensure that the researcher and research staff comply with controls, procedures and provisions set forth in the Law and its Regulations as well as decisions of the National Committee. 12 Chapter Three: National Committee of Bioethics Article 4 1. A national committee of bioethics shall be formed at KACST comprising specialists nominated by the competent minister or head of an agency for a renewable term of 3 years, as follows: A representative of KACST Chairman A representative of the Ministry of National Guard Member A representative of the Ministry of Defense Member A representative of the Ministry of Interior Member A representative of the General Presidency of Religious Research and Ifta Member Two representatives from the Ministry of Higher Education (Universities) Members A representative of the Ministry of Health Member A representative of the Ministry of Education Member A representative of the Ministry of Agriculture Member A representative of the Saudi Wildlife Commission Member A representative of the Food and Drug General Authority Member A representative of King Faisal Specialist Hospital and Research Center Member A representative of Human Rights Commission Member The Director of Research Ethics Monitoring Office Member A representative of the private sector selected by the Chairman of the Council of the Chambers of Commerce and Industry Member A legal counselor selected by the President of KACST Member 2. The President of KACST shall issue the committee-formation decision, and said committee shall report to him. 13 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 14 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 15 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 16 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. 17 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. 18 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. 19 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. 20 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 21 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; 22 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 23 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. 24 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: 25 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. 26 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. 27 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 28 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 29 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 30 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. 31 اللجه الوطنيه للاخلاقيات الحويه National Committee of Bio Ethics 32 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 33 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. 34 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: 35 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: 36 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; 37 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 38 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 39 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; 40 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 41 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; 42 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. 43 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; 44 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 45 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. 46 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; 47 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 48 persons to participate as subjects of the research shall include the following data: a. Research title; b. Research obj …(85,412 more chars)