Areas of NCBE interests

A standard set of mandatory ethical and research conditions for research in the Kingdom is crucial to the protection of the rights of patients, families, society as well as the various medical and health research establishments operating such labs. NCBE hence works on setting ethical standards and principles for medical and biological research, and oversees compliance with such standards in the following framework:

Procedural guidelines

NCBE will:

  • Form expert medical and biological research ethics committees at hospitals and research centers in the Kingdom- these committees will review submitted research and studies, and evaluate adherence to national medical and biological ethics standards and principles, for either approval or rejection, providing researchers with guidance and advice
  • Prioritize the interests and wellbeing of patients and society
  • Confirm the need to send samples abroad when it is determined that tests cannot be conducted in the Kingdom, to avoid duplicate work, and minimize the cost of genetic disease diagnosis. Genetic samples will be sent to reference diagnostic centers outside the Kingdom when such tests cannot be performed in the Kingdom, after signing an agreement protecting the rights of both the patient and society.

National guidelines

NCBE seeks to:

  • Utilize national qualified professionals at universities, colleges, research institutes and coordinate among them to outline a comprehensive plan, and produce a database of national qualified professionals in the bio/medical ethics field
  • Support related training and development programs for technology transfer and localization
  • Avoid duplicate efforts, and repetitive testing upon the establishment of expert genetic diagnosis centers, in addition to adopting an integrated referral system to ensure early, fast and accurate diagnosis of certain genetic diseases
  • Detection of mutant gene carriers, and communication of a preventive hereditary disease guide to limit chronic genetic diseases
  • Protection of information confidentiality and security.

Research guidelines

  • Observe Sharia and societal laws concerning the manipulation of genetic material
  • Written consent of the patient or his legal guardian (for a minor) must be obtained
  • Maintain the absolute confidentiality of patient genetic/social information

Medical practice guidelines

  • Procedures and policies guiding and controlling medical research on patients, such as drug trials or the use of equipment for patient examination, surgery or clinical testing, must be developed, informing the concerned parties of the potential medical and scientific advantages and side effects. In addition, the written consent of the patient or his legal guardian (for a minor) must be obtained
  • The ethical aspects must be taken into consideration when performing any surgery, which must always conform to prevalent legal and social rules, to which the person involved must adhere.

Genetic material database and banks

Stored genetic samples can serve as a genetic reference for local genes. They can also enhance our scientific understanding of genetic factors related to the environment and diseases. Questions may arise in the near or distant future, which could remain unanswered in the absence of genetic material samples, and genetic changes leading to diseases differ from one society to another. In other words, preserving genetic samples until genetic mutations are identifiable may allow doctors in the future to achieve early diagnosis before symptoms appear, thus limiting diagnosis and treatment and exercising prevention and protection in medical practice. The existence of a national genetic bank will provide sufficient information regarding the transfer of genetic matter among generations, as well as the impact of age, chemicals and other factors on genetic matter. The NCBE will establish genetic material banks through:

  • Financial and technical support for existing genetic material and human tissue repositories in the Kingdom’s hospitals and research centers
  • The establishment of at least one bank per administrative region in the Kingdom
  • The development of a standard process for the extraction and preservation of genetic matter, as well as related data recording, and rules guiding access/retrieval of such information
  • Various genetic material and tissue repositories will electronically link their systems to KACST databases.
  • Educating health sectors professionals on the national value of genetic material banks, once these genetic banks are established.

Animal research

In the spirit of mercy and compassion towards animals embodied by Islam, and given the importance of animal testing in universities and research centers, it was necessary to draw rules related to animal lab testing, through:

  • Identifying research warranting animal testing
  • Identifying researchers and individuals having the right to conduct research on animals, and animal handling methods before and during experiments
  • Research monitoring, ensuring that animals are not harmed when conducting experiments
  • Post-testing disposal techniques

Cooperation with stakeholders

The NCBE seeks to collaborate with relevant stakeholders to achieve the following:

  • Help promote health culture and awareness among doctors, health sector professionals and society in general of the role and importance of genetic research
  • Record and document all genetic cases in the Kingdom to help organize and provide health care in the Kingdom, preserving genetic materials and human tissues in a specialized bank
  • Maintain the integrity and confidentiality of information for storage in a specialized database, and prohibit the disclosure or utilization of such information to create problems in society
  • Cooperation with relevant parties in the Kingdom and international bodies to set common objectives and facilitate research according to the NCBE related guidelines.

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