oa Ethical, Legal, and Social Issues on the Recruit Process of Healthy Volunteers for Induced Pluripotent Stem Cell bank at Kyoto University

Banking of biomedical tissues or information related to them has been conducted around the world for clinical, research and/or commercial purposes. In addition to stem cells in the differentiated tissues such as cord blood and bone marrow, pluripotent stem cells are also subjects of banking. Human embryonic stem cells (hES cells) are one type of these cells, but induced pluripotent stem cells (iPS cells) are now also subjects of banking for various purposes.

In Japan, the Center for iPS Cell Research and Application (CiRA), led by Dr Shinya Yamanaka, was established in 2010 to conduct research on iPS cells. In order to realize iPS cell based therapies, CiRA is now working to establish a new iPS cell bank. The bank aims to establish clinical-grade, HLA-matched iPS cell lines from healthy volunteers and store them to provide for therapeutic or research use. Although some iPS cell banks in Japan or in other countries, including the one in CiRA, are already established, these banks store and provide basically disease-specific iPS cell lines. Therefore, the planned iPS cell bank at CiRA is unique in that it is going to store and provide clinical-grade iPS cells derived from healthy volunteers.

We have been collaborating with researchers at CiRA to establish appropriate procedures for the recruitment of healthy volunteers. We have found that there are a variety of ethical, legal, and social issues (ELSI) that need to be addressed. Since iPS cells are pluripotent stem cells, some ELSI are similar to those already identified in hES cell banks. However, there are other issues that are relatively novel and specific to iPS cells, especially when the donor is a healthy volunteer, not a patient. These ELSI identified arise because: 1. these cells are derived from healthy volunteers; 2. these cells expand infinitely; and 3. the bank deals not only with information such as genome sequence but also with other aspects of the cells.

In this presentation, we will summarize and discuss the ELSI we encountered while establishing the process of healthy-volunteer recruitment for the iPS cell bank.