(P-PH-5) Ethical Considerations for Conducting Medical Devices' Clinical Trials and Scientific Research in Blood Banks

Background/Case Studies: In China, the public welfare nature of blood banks and their responsibility to ensure blood safety determine that they must adhere strict ethical review procedures when conducting clinical trials of medical devices and scientific research, to ensures that research activities comply with ethical standards and safeguard the rights and interests of participants.

Study

Design/Methods: Review the relevant laws and regulations on clinical trials and scientific research ethics both domestically and internationally, and establish an ethical review mechanism suitable for blood banks. The key points for ethical review include: protection of blood donors' rights and interests, scientificity and social value, privacy and information security, and management of conflicts of interest. Due to the unique nature of blood stations, it is necessary to pay particular attention to the ethical issues regarding the secondary use of voluntarily donated blood resources and the impact of medical devices on blood quality.

Results/Findings: At the Shenzhen Blood Center, we have established an independent ethics committee composed of members from multiple disciplines, have established an ethical review mechanism that covers the entire process from project initiation, process monitoring to project conclusion, have established a mechanism for protecting the rights and interests of blood donors that ensures their autonomous choice and the ability to withdraw at any time, have established a management system that ensures fair and impartial evaluation of the safety and effectiveness of medical devices.

Conclusions: Through standardized ethical review and supervision procedures, the legitimate rights and interests of blood donors are effectively protected, ensuring the scientific, true and reliable nature of research results, guaranteeing the safety of clinical blood use, that is, maintaining the public welfare nature of blood banks, and also providing ethical support for the development of the blood industry.