When using tissue samples taken from human subjects, a number of guidelines that must be adhered to exist, such as human genome research guidelines, medical research guidelines, human stem cell research guidelines, human ES cell research guidelines, specified embryo research guidelines, and so on. According to these guidelines, research that requires the collection and use of human samples must be approved by a research ethics, obtain the consent of the subject/donor, and ensure that the subject/donor’s personal information is protected.
However, in today’s world where genetic analysis and sequencing technology is developing by leaps and bounds, researchers may want to use samples for new experiments that they did not anticipate or imagine at the time of obtaining consent from the donor. The primary goal of our work is to gather the latest material concerning the debate on using human-derived samples in research and to provide an overview of this complex and evolving subject.
The first purpose of information protection laws is to protect the privacy, rights, and wellbeing of individuals. The second purpose is to address the use and application of that information. In September 2015, the Personal Information Protection laws in Japan were amended and the debate concerning the protection and use of human genomic information has been evolving ever since. Internationally, similar efforts have been underway since 2013, bringing about great changes in the way information is shared between countries, and we can only assume that further changes are on the horizon.
The aim of our project is to provide a database of relevant information concerning this topic for researchers who use human samples and clinical information; for ethics committees of universities and other institutions; as well as for the general public, including individuals who are considering providing samples for this kind of research.
Since the spring of 2015, a heated international debate with a wide range of participants and stakeholders has been raging over the ethical status of genome editing in the human germline. In Japan, the Cabinet Office Committee on Bio-Ethics has recently shown approval towards genome editing research using human embryos.
One of our primary purposes is to collect all of the material available concerning genome editing (with a special focus on germline editing) and organize it so that it will be possible to easily survey the landscape of the debate and thus deepen the overall understanding of it.
With improvements in human genome sequencing technology, the potential of genome-based science and medicine to diagnosis and treat illness is becoming increasingly clear. Here, we would like to introduce some of the key initiatives and projects in the field of genome medicine, as well as the ethical policies and main issues for discussion in this field.
In addition to our other work, we would like to make all of the ethics committee documents and application forms required by researchers participating in the Platform for Advanced Genome Science available for download in one easy-to-access spot. We will also provide templates for consent forms and other such material, as well as links to relevant government resources.