In pharmaceutical R&D , pursuing new life sciences and knowledge is not all that matters, ethical consideration is also essential. At Nippon Shinyaku, we have a system in place to ensure that we conduct ethical R&D in view of human rights and animal welfare at every stage of drug discovery.
Ethical consideration in basic research using human-derived samples
In basic research conducted to assess the safety and efficacy of drugs for human users, human-derived samples, such as cells, tissues, and blood, and information on human health are sometimes used. To treat those who provide such samples or information in an ethically responsible and considerate manner, we at Nippon Shinyaku have taken necessary measures, notably the establishment of in-house regulations based on the research ethics guidelines set by the Japanese Government (including the Ethical Guidelines for Medical and Health Research Involving Human Subjects), and the formation of a research ethics committee comprising members from both within and outside the company to conduct a fair, neutral, and rigorous examination of the ethical validity and scientific rationality of the company’s R&D.*1
Information disclosure based on the research ethics guidelines
While using human-derived samples and information on human health in research, Nippon Shinyaku obtains prior consent from those who provide such samples and information (research participants), in compliance with the related laws, regulations, and research ethics guidelines. In cases of sample/information use for purposes not anticipated at the time the consent is first obtained (i.e., use beyond the scope of consent) or sample/information transfer from Nippon Shinyaku to a third party for such purposes as joint research, in accordance with the research ethics guidelines, the company is required to publicly disclose information on the research projects in which such sample/information use has occurred.
Nippon Shinyaku acquires human-derived samples and information in the anonymized form, and they can never be traced to the individual names, addresses, or other such information. Those who have provided their samples or information to be used for research purposes and wish to have the use discontinued or have questions about this matter are invited to consult the point of contact designated for the concerned research project.
Ethical Considerations in Clinical Trials
When conducting clinical trials to assess the efficacy and safety of medications in humans, we place the highest priority on protecting the human rights and personal information of participating patients, ensuring their safety, and giving consideration to their welfare. We are committed to conducting high-quality clinical trials through compliance with laws and regulations, such as the Pharmaceuticals and Medical Devices Act and GCP (Good Clinical Practice), and through review of the ethical and scientific validity of clinical trials by our internal institutional review board, which is composed of members in various positions.
Ethical Considerations in Animal Research
Research using animals is also essential to confirm the safety and efficacy of medications. From the perspective of animal welfare, Nippon Shinyaku has established internal regulations in accordance with relevant laws, regulations, guidance and guidelines, and it has set up an animal research committee to examine if all animal research is carried out with appropriate consideration based on the principles of the 3Rs*2 pursuant to the internal regulations. As for our animal research implementation system, we periodically conduct a self-inspection to ensure its conformance with relevant laws and regulations, and we have also been accredited by a third-party organization, the Japan Health Sciences Foundation (the Center for Accreditation of Laboratory Animal Care and Use).
- *1: Published in the Ethical Review Committee Reporting System of the Japan Agency for Medical Research and Development.
- *2: Replacement (to consider alternative methods), Reduction (to minimize the number of animals used), and Refinement (to reduce pain and discomfort suffered by animals)