Table 2 Legal and regulatory risks faced by biobanks and our solution using the Integrated Information Management System

Civil Code of the People’s Republic of China

Strengthening the management and supervision of the collection, preservation, utilisation and external provision of human genetic resources and biological resources in China.

The collection, preservation, utilisation and external provision of China’s human genetic resources shall be in accordance with ethical principles and shall not endanger public health, national security or the public interest.

A Project Management function module is set up in the system to manage human specimens according to projects.

Before using the biobank, the researcher will be assigned an account, fill in the project’s research plan, research content, research purpose, collaborators, the source, type, quantity and purpose of the human genetic resources to be collected online, and then initiate the online approval, which will be reviewed and approved by the administrator of the biobank, the ethical committee of the hospital, the director of the hospital’s science and education department and the dean in charge of the project before carrying out the human genetic resources collection.

When human genetic resources are deposited into the repository for preservation, the researcher has to sign an informed consent form with the sample donor, and after uploading it to the system, the staff of the biobank will register and process the information of the donor and the human specimen before depositing them into the repository for preservation.

When human genetic resources are released for use or destruction, the researcher fills in the information of the partner online, signs the declaration of compliance with ethical and legal requirements, and then initiates online approval. After review and approval by the administrator of the biobank, the ethical committee of the hospital, the director of the department of science and education of the hospital and the director in charge of the hospital, the staff of the biobank distributes the human genetic resources out of the bank.

A Specimen Information Management function module is set up to connect with the HIS system and use the registration number or hospitalization number as the unique identification information to capture the basic information and diagnostic information with one key. Simplifying the process of enrolment recruitment and follow-up, reducing their waiting time, increasing their motivation to enrol, and avoiding lost visits and loss of human specimen information and manual entry errors.

A Quality Management function module has been set up in the system to monitor the entire process of human genetic resources from collection to use or destruction, facilitating risk and quality management. According to the project’s research programme, pre-storage handling parameters, processing and dispensing parameters are tied to the appropriate specimen type, prompting staff to reduce manual errors and specimen damage.

The biosafety law of the People’s Republic of China

The collection of China’s important genetic lineage, specific areas of human genetic resources or the collection of the types and quantities of human genetic resources specified by the competent department of science and technology under the State Council shall be approved by the competent department of science and technology under the State Council.

The preservation of China’s human genetic resources; the use of China’s human genetic resources to carry out international scientific research and cooperation; the transport, mailing and carrying of China’s human genetic resources materials out of the country shall be subject to approval.

Overseas organisations, individuals and the institutions they set up or actually control to acquire and utilise China’s biological resources shall obtain approval in accordance with the law.

Implementing Rules of the Regulations on Human Genetic Resources Management

Human genetic resource material means genetic material such as organs, tissues, cells, etc. that contain genetic material such as human genomes and genes.

Detailed regulations on the types, quantities and uses of human genetic resources, or on collaborators, research programmes, research content, research objectives, etc.

Accreditation Criteria for Biobank Quality and Capacity CNAS-CL10:2020

Quality risk control in the collection, preservation, utilisation and destruction of human genetic resources.

The main common quality risks in cohort construction include: Loss of donors eligible for enrolment, loss of follow-up, missing sociological information on donors, missing clinical information on human specimens, incorrect storage location in the refrigerator, inappropriate collection and processing methods for human specimens, damage to human specimens

General Requirements for Biobank Quality and Capacity GB/T37864-2019/ISO20387:2018

Best Practices for Repositories:Collection, Storage, Retrieval and Distribution of Biological Materials for Research(ISBER)

Technical Specifications for Collection, Preservation and International Cooperation of Human Genetic Resources