Why are human genetic resources an indispensable condition in the construction of biobanks?

Biobank mainly refers to the standardized collection, processing, storage and application of healthy and disease organs, tissues, whole blood, plasma, serum, biological fluids or processed biological samples (DNA, RNA, protein, etc.) The clinical, pathological, treatment, follow-up, informed consent and other data related to these biological samples and their quality control, information management and application systems. It is an important guarantee for the rapid industrialization and application of many scientific research results to the clinic and the realization of "translational medicine".

The human genetic resources in the biobank are non-renewable resources, an important material and information basis for life science research, basic research data for in-depth excavation and mastery of the occurrence, development and distribution of diseases, and the promotion of disease prevention, intervention, It is an important guarantee for the development of control and diagnosis and treatment strategies, and has become a strategic resource related to public health, life safety, and national biosecurity and biosecurity.

However, in recent years, the illegal outflow of human genetic resources has continued to occur, the use of human genetic resources is not standardized, and the system for conducting international cooperative scientific research is not perfect. To this end, on May 28, 2019, Premier Li Keqiang signed the State Council Order No. , promulgated the "Regulations on the Administration of Human Genetic Resources" (hereinafter referred to as the "Regulations"), which came into force on July 1, 2019. The Regulations clearly stipulate that activities related to human genetic resources must be subject to corresponding administrative approval or filing. If approval or filing is not obtained, there will be risks such as fines, administrative penalties, and criminal liability. (Among them, the collection and preservation of organs, tissues, cells and other human substances and related activities for the needs of clinical diagnosis and treatment, blood collection and supply services, investigation and punishment of illegal crimes, doping testing, and funerals, etc., shall be implemented in accordance with relevant laws and administrative regulations.)

1 The Regulations clarify the relevant penalties

If you carry out relevant activities in violation of the "Regulations", you will face the following penalties:

Article 36 of the "Regulations" If anyone violates the provisions of this Regulation and falls under any of the following circumstances, the administrative department of science and technology under the State Council shall order to stop the illegal act, confiscate the illegally collected and preserved human genetic resources and illegal gains, and impose a fine of not less than 500,000 yuan and 500 yuan If the fine is less than 10,000 yuan, and the illegal income is more than 1 million yuan, a fine of more than 5 times but not more than 10 times of the illegal income shall be imposed:

(1) Without approval, collecting important genetic families in my country, human genetic resources in specific regions, or collecting human genetic resources of the type and quantity specified by the administrative department of science and technology under the State Council;

(2) Preserving my country's human genetic resources without approval;

(3) Using my country's human genetic resources to carry out international cooperative scientific research without approval;

(4) Failing to pass the security review, providing or opening for use of human genetic resources information that may affect my country's public health, national security and public interests to foreign organizations, individuals and institutions established or actually controlled by them;

(5) The type, quantity and use of human genetic resources to be used have not been filed with the science and technology administrative department of the State Council before conducting international cooperative clinical trials.

2 Requirements for obtaining approval/filing

Since the approval/filing of human genetic resources is an administrative license that must be obtained for biobanks to carry out related activities, what are the requirements for applying for administrative approval/recording of human genetic resources?

Taking the approval for the preservation of human genetic resources as an example, the Regulations put forward the following requirements on the conditions of declaration institutions:

Article 14 of the "Regulations" Preserving my country's human genetic resources and providing a basic platform for scientific research shall meet the following conditions and be approved by the science and technology administrative department of the State Council:

(1) It has the status of a legal person;

(2) The purpose of preservation is clear and legal;

(3) The preservation plan is reasonable;

(4) The source of the human genetic resources to be preserved is legal;

(5) Pass the ethics review;

(6) It has a department in charge of the management of human genetic resources and a preservation management system;

(7) Having sites, facilities, equipment and personnel that meet the national technical norms and requirements for the preservation of human genetic resources.

Among them, the platform for preserving my country's human genetic resources and providing the basis for scientific research refers to the biological sample bank.

From the point of view of application requirements, the qualifications and qualifications required for biobanks of medical institutions are not complicated, and the "Regulations" make the organizational structure, management system, information management system, environment, equipment, facilities and other aspects of biological sample banks. If there are clear requirements, medical institutions only need to prepare according to the relevant requirements. However, judging from the application situation in 2019 and 2020, a total of 17 companies have passed through the country, and there are not many passed. Even the first application of some large hospitals was rejected, such as Wuhan Union Medical College Hospital, which was more difficult to declare. If the first application is rejected, subsequent applications will be affected.

Dashu Huachuang has summarized the experience of previous projects, and the difficulty of application is mainly reflected in: ensuring that the preservation plan is reasonable, the preservation management system is complete, the preservation technical documents are fully standardized, and the preservation site, facilities, equipment and personnel meet the requirements of relevant technical specifications, etc. It is recommended that medical institutions fully interpret the "Regulations" during the construction of biological sample banks, and refer to ISO 20387 (GB/T37864) "Guidelines for Accreditation of Biological Samples Quality and Capability" to prepare relevant materials. (ISO 20387 is the first international standard for biobanks. Most countries agree to use ISO 20387 as a unified evaluation standard in the future, and adopt an accredited method to carry out the evaluation of biobanks.)

3 Laws and regulations related to the construction of biological sample banks

In addition, the construction and development of biobanks involve more than the Regulations and ISO 20387 accreditation criteria. The construction of biobanks also needs to comply with other relevant laws and regulations. like:

• GB38736 Ethical Requirements for the Preservation of Human Biological Specimens

• GB39766 Management Specification for Human Biobanks

• GB39767 Specification for the Management of Human Biological Samples

• GB39768 Classification and coding of human biological samples

• GB38735 Human Urine Sample Collection and Processing

• GB38576 Human blood sample collection and processing

• "Biosafety Law of the People's Republic of China"

• "Measures for Ethical Review of Biomedical Research Involving Humans"

• "Notice on the Application of Pilot Units for Clinical Application of High-throughput Genetic Testing Technology"

• "Guiding Opinions on Promoting and Regulating the Application and Development of Health and Medical Big Data"

• "Theoretical Guidelines for Human Embryonic Stem Cell Research"

• "Measures for Ethical Review of Biomedical Research Involving Humans"

• "Information Security Technology Personal Information Security Specification"

• "Measures for Ethical Review of Life Sciences and Medical Research Involving Humans"

4 How to quickly improve biobank compliance

To sum up, it can be seen that the construction of biobanks is a process of compliance and standardization. Compliance is the most basic requirement for biobanks, and the standardization of biobanks is the only way to improve the quality and capacity of biobanks. At present, many institutions plan to build a biological sample bank to help the transformation of scientific research results and enhance the overall competitiveness of the institution. However, many biobank personnel are unfamiliar with this part of the work and do not have a thorough research on laws and regulations. They need to explore in many aspects, which consumes a lot of manpower and material resources, affects the normal work of the hospital, and is inefficient. Therefore, it is a more professional solution to introduce professional consulting institutions to improve the compliance, standardization and standardization of biobanks in medical institutions.

As an experienced third-party consulting agency in the biobank industry, Dashu Huachuang has thoroughly studied relevant laws and regulations. With its professional advantages, it has accumulated many industry users, and has cooperated with dozens of large-scale tertiary hospitals such as Beijing Fuwai Hospital, Peking Union Medical College Hospital, 309 Hospital (The Eighth Medical Center of the People's Liberation Army), and the Second People's Hospital of Shandong Province, with rich project experience. , can provide users with an overall solution for the standardization of sample library construction, including sample library planning/design, personnel construction, quality management system construction, equipment consumables, information systems, management specifications, personnel training and other comprehensive services.

In terms of team, Dashu Huachuang has a professional R&D team with rich industry experience. Each project sets up an expert consulting group of more than 5 people, and invites industry experts to help the project operate with high quality and efficiency.

Provide unique external training courses on human genetic resources approval/filing and ISO20387 biobank quality and capability pre-accreditation consulting services. By inviting the staff of the sample bank to observe and study in the representative high-standard biological sample bank in the industry, the professional quality and management skills of the staff of the sample bank will be comprehensively improved.

Dashu Huachuang is committed to the compliance and standardization of biological sample banks, and improves the intelligence level of laboratories in the field of life sciences. increase steadily.