Main title

You need IBEC approval if your research and/or teaching involves:

• Animals (via notification from the Institutional Animal Care and Use Committee (IACUC) of approved animal study proposals and through periodic reports from IACUC)
• Biological materials, including biohazardous agents (Risk Group 2; Risk Group 1 agents must be registered with the Biosafety Officer; they are not reviewed by IBEC unless increased risk is identified); biologically derived toxins; genetically modified organisms; plants, especially invasive species or noxious weeds; potentially infectious environmental samples and corresponding cultures; human-derived materials (e.g., blood, tissues, embryonic stem cells, primary cell lines, etc.); recombinant or synthetic nucleic acids; and viral vectors
• Gene-editing techniques such as CRISPR/Cas9
• Human subjects
• Nanotechnology and other developing, biologically relevant technologies Potential risk to living organisms and the environment

An application form for IBEC review must be completed, submitted and approved by IBEC before any such research or teaching activity can begin.

Material transfer agreements (MTA) need IBEC approval if the material falls into any of the categories listed above.

Informed consent must be obtained from the human subject or their guarding prior to conducting research on any human subject unless the research qualifies for a Waiver of Informed Consent.
Forms:

• Informed Consent Template
• Waiver of Informed Consent

To be attached in Section 15 of the protocol

A research project may be approved without obtaining the Informed Consent if the below conditions are satisfied:
1. Research involves the study of data, records or pathological samples previously collected, provided one of the two following terms is fulfilled:

• The information is generally and publicly available;
• The information is recorded in a manner that does not reveal the identity of the source person.

2. Research involves any of the following categories:

• educational tests
• surveys
• interviews
• public behavior monitoring

And both of the following conditions apply:

• The information is recorded in a manner that does not reveal the identity of the source person.
• Research should not expose the participant to criminal or civil liability or jeopardize their financial position or career.

OR
3. Research conducted for educational purposes.

OR
4. When obtaining consent would jeopardize the integrity of the research.

Forms:

• Informed Consent Template
• Waiver of Informed Consent

To be attached in Section 15 of the protocol

Article 6.4 of the NCBE Living Creatures Act requires that before sending biological samples to laboratories outside the Kingdom for research purposes, the researcher must comply with the following:

• Obtain IBEC written authorization to send samples abroad. This might need a new IBEC application or the amendment of an existing IBEC protocol.
• Samples transfer should be limited to international research agencies known for their research experience in the relevant research fields. If a different Saudi investigator or entity was or is working on the same subject, samples should not be sent outside the Kingdom. Collaboration should be made with the project running inside the Kingdom, unless such collaboration is rendered impossible for a valid reason that is accepted by the IBEC.
• A Research Material Transfer Agreement (MTA) must be drafted to guarantee the rights of human subjects, the rights of the researcher and national rights.
• The researcher must enclose a copy of the IBEC Letter of Approval (LOA) with documents submitted to competent agencies such as customs and carriers.
• Ensure security of genetic samples during storage and transportation;
• Data accompanying the submitted samples or material must not reveal the identity of the source person whose sample is submitted. Material may carry only coded numbers.
• Notifying the National Committee of Bioethics in writing about the IBEC’s decision including the project’s purpose, sponsor/s and collaborator/s.
• Disposal of excess genetic samples must be performed according to standard scientific methods, and every precaution must be taken to ensure that the said samples are not stored in banks outside the Kingdom once these samples have been analyzed or studied.

The National Committee of Bioethics may decide to stop conducting or completing the project if it appears to carry no benefit to the Saudi society or if it poses a direct or indirect harm to the community. Such rights of the National Committee of Bioethics must be clearly stated in any agreement drawn between the local entity intending to send samples and any other institute outside the Kingdom of Saudi Arabia.

For further information on this process, please contact the Research Compliance Team

IBEC must approve all types of advertisements to invite people to participate as volunteers in the research project, such as newspaper ads, posters, folders, etc., before distribution or publication. Your proposed advertisement to invite persons to participate must include:

• Research Title;
• Research Objective;
• Attributes qualifying people targeted to be the participants;
• Indication of all facilities to be provided to the human subject;
• IBEC Reference Number;
• Expected date of completion;
• Expected risks of the research (if any);
• Details of the principal investigator/representative: name, address, contact number, and electronic mail address; so that individuals aiming to join the research group may contact them for further information.

The approval process can vary from a couple of weeks to several months depending on the type of research, the completeness of the application, and the responsiveness of the investigator. It is best to contact IBEC in advance to discuss research plans so that the application can be submitted in time for review and approval before the planned date to start the research project.

IBEC will do their best to review and approve projects promptly. However, it is important to plan far enough in advance and have time allocated for approval to occur.

Please recognize that the members of the committee are faculty members with busy schedules, that they have volunteered to serve on the committee, and that there is no time guarantee.

Moreover, the review process may take longer because it may require approval by additional KAUST Committees, such as IACUC or IRSC.

Submitting applications in advance of funding deadlines or fixed project start dates is strongly encouraged.

After submission of an application to IBEC, Research Compliance will ensure that all necessary information has been provided and that all required training for all researchers on the team has been completed.

The application will be sent to the full committee. IBEC is given two weeks to issue comments or concerns regarding the protocol. At that point, Research Compliance will email you the comments from the committee. Once you address the comments, the application will be placed on the agenda for approval at the next regular meeting. The committee may approve low-risk applications via email without convening a meeting.

Principal Investigator(s) planning to conduct research involving human subjects or human-derived materials in collaboration with an external institution must provide documentation of approval from the collaborators ethics committee (or IBEC equivalent) as part of their IBEC applications. The IBEC may at its discretion defer review of the external components of the study to the collaborators ethics committee.

After an application is approved, IBEC will monitor research activities for compliance.

The Principal Investigator is responsible for informing IBEC immediately of any biosafety and/or bioethics concerns related to an approved application. Biosafety concerns include, but are not limited to, unanticipated adverse events.

Applications are approved for a maximum of three consecutive years, after which they must be renewed. As well, if an approved application requires amendment, IBEC must review and approve the amendment.

If an application has been approved, but research was not conducted or will not be conducted, the Principal Investigator must inform IBEC by email.

If an approved application is regulated by the Saudi National Committee of Bio-Ethics (NCBE), then a yearly progress report must be submitted to IBEC.

Yes, research and/or activities associated with an approved IBEC application can be suspended due to significant biosafety, bioethics or non-compliance concerns.

IBEC applications involving the use of animals must be approved by the Institutional Animal Care and Use Committee IACUC@kaust.edu.sa.

IBEC applications involving the use of radiation must be approved by the Institutional Radiation Safety Committee IRSC@kaust.edu.sa.

Please be aware that any modification to an already approved IBEC application must be reviewed and approved by the IBEC BEFORE it can be implemented. Application modifications include, but are not limited to, changes in collaborators, species or strain of organism used, biohazardous agents, location, or personnel.