Ethics Committee for Research Using Human Specimen
In the process of new drug discovery, research using human specimen (blood, tissue, cells, genes, etc.) may be conducted as an effective means for predicting the efficacy and safety. It should be considered essential not only to obtain the donors’ understanding and consent about the necessity and usefulness of such research but to give ethical considerations including strict protection of privacy through proper management of personal information obtained in the course of research.
Especially, analytical research on human genome/gene sometimes reveals the genetic predisposition of donors as well as his or her relatives, depending on how the genetic information is handled, various ethical, legal or social issues may arise. We also recognize that the use of human embryonic stem cells (ES cells) for research purposes raises bioethical concerns because human ES cells are derived by destroying human embryos, which are the emerging potential of human life, and they have the potential to differentiate into any type of human cell. We believe that we should carefully consider the use of human ES cells for research purposes at an internal ethics committee based on relevant laws and regulations and guidelines.
In order to properly conduct the research using human specimen, we established internal rules based on the national Ethical Guidelines.
In addition, we set up “Ethics Committee for Research Using Human Specimen" as an advisory committee and the Committee scrutinizes and rules on the ethical and scientific appropriateness of each research plan.
The Committee comprises internal and external members including experts in the fields of humanities and social sciences, including ethics and law, experts in the field of natural science and person representing the ordinary public interest so that fair and independent review can be made based on an academic as well as multidisciplinary knowledge and viewpoints.
The committee rules, list of members, and summary of the committee’s minutes are made available to the public via “Ethical Review Committee Reporting System” of the Ministry of Health, Labor and Welfare. Please refer to their website for more information.