| The Ethics Policy on the Implementation and Use of the J-PDX Library |
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| Preamble |
| The usefulness of patient-derived xenograft (PDX) models, particularly those with individual patients’ detailed clinical information, for drug discovery and development as well as for medical research, has recently garnered attention domestically and internationally. On one hand, PDX samples can be proliferated by transplantation or passaging into experimental animals, enabling repeated use of the samples over a long period of time. On the other hand, these characteristics mean that PDX models always carry the risk of being provided to unspecified irresponsible third parties without controls or limits, and they inevitably carry a potential concern of abuse, thus impairing the patient’s dignity. In light of a recent series of scandals involving leaks and disclosures of personal information, there are strong calls by society to properly manage and protect privacy and personal information. In response to this social trend, the Act on Protection of Personal Information has been repeatedly reinforced through amendments, and penalties for infringement of personal information are becoming tougher each year. Moreover, researchers have now widely acknowledged that biomedical research involving human biospecimens and clinical information, as well as long-term research infrastructure such as biobanks that collect, store, provide, or distribute those specimens, and that information for other research projects and drug development purposes must establish an ethical research framework based on trust and social acceptance. Considering these circumstances, the National Cancer Center Japan (NCC) has established the Ethics Policy. In compliance with this policy, the NCC will ensure the promotion of the development and use of PDX models that are not just convenient but also scientific, easy to use, and ethically appropriate. |
| Policies |
| 1. Safeguarding the dignity of individual patients in relation to PDX models |
| PDX models and clinical information stored in the J-PDX Library are derived from individual patients who are to be treated with dignity. Thus, these samples and that information should not be treated as mere objects or data but as “human-derived” materials in compliance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects (MEXT, MHLW, and METI Notice no. 1 of 2021). The NCC and users of the Library must always be aware that their greatest responsibility is safeguarding the dignity of individual patients who contribute to the Library. |
| 2. Trust-based management and governance of PDX models |
| PDX models and clinical information stored in the J-PDX Library are a valuable resource for medical research and development of pharmaceutical products, and they are entrusted to the NCC by individuals who agree with the mission and purpose of the Library. Thus, the NCC will be responsible for operating the Library ethically and providing them only to trustworthy users, including academia and the medical industry, which will use them for the public good in accordance with the goals of the Library. |
| 3. Temporary lending of PDX models for limited purposes |
| The provision of PDX models and clinical information in the J-PDX Library to Library-users will be limited to temporary lending for limited purposes of proper use based on a contract between the users and the NCC to prevent unethical behavior by users such as the sale or subleasing of human-derived materials. The NCC will properly monitor and manage the use of PDX models by users with utmost attention. |
| 4. Ethical considerations in the care and use of laboratory animals |
| Laboratory animals are essential for the construction and implementation of the J-PDX Library. The NCC will take care of the welfare of laboratory animals used for PDX models, refining how PDX models are created to minimize potential pain and distress for the animals, using methods to minimize the number of animals used, and making efforts to find and use better alternatives when possible. Everyone involved in the Library must never forget to be grateful for the animals that make the Library possible. |
| 5. Compliance with relevant laws, ordinances, and regulations |
| In the implementation of J-PDX Library, the NCC will comply with relevant national and international laws, ordinances, and regulations, such as those concerning personal data protection, protection of human subjects, laboratory animal welfare, and intellectual property. |
