iPS Cell Research & Challenges It Faces

iPS Cells Seen From ELSI Viewpoint

   While iPS cells bask in the public limelight following Yamanaka's winning of the Nobel Prize, they are still in the laboratory stage. It may take at least years before they can be put to practical applications. However, as long as the discovery involves a praiseworthy technology at all, it is imperative for clear-cut rules to be stipulated on how to properly treat and utilize it. There seems to have been little debate on this point. But sooner or later, a broad range of issues inherent in the promising technology will have to be sorted out in preparation for necessary legislation. We look into some of the problems posed by iPS cells at the present stage.

 

 A 2010 announcement of the Cabinet Office’s Bioethical Inquiry Board focusing on the debate at a closed workshop in Spain broadly classifies ethical, legal and social issues (generally known as ELSI) concerning iPS cells into six categories.

 The first concerns "protection of privacy" which is seen as the biggest issue to be addressed in establishing and utilizing human iPS cells. Such cells carry a cell donor's all genetic information and can grow proliferously without limitation. When genetic codes flow out in an inappropriate manner, the donor's privacy can be invaded, possibly giving him or her a lot of social, economic and other disadvantages. First of all, a solid security system must be put in place to prevent that happening. Furthermore, there can be "incidental findings" in the research process of human iPS cells. For example, a genetic variation with high possibilities of causing a disease may be found. What researchers should do with such finding? Should they tell the donor about it? This is a subject common to researches based on use of human tissue specimens. But a particularly cautious approach will have to be made in the case of human iPS cells that can be grown infinitely. This issue needs to be addressed especially when procedures for informed consent are defined.

 The second point is about the donor’s "consent and withdrawal of consent." Those who undertake a research are required to explain its details and get the donor’s voluntary consent (informed consent). However, in a research on iPS cells that can be grown infinitely and may be used for unscheduled purposes, it will be difficult to obtain a perfect informed consent in the conventional sense of the word. When researchers use donated sample tissues in a way that may worry some donors (such as creation of human-animal chimeras, a research on production of genital cells, etc.), they should explain that in writing and get their prior consent. Principles of research ethics allow the donors to withdraw their consent any time after the start of the research. But can they withdraw their consent even after the establishment of human iPS cells? Probably, depending on how the cells are used, such withdrawal may be difficult. But their revocatory intention may have to be respected when there are prior arrangements for linkable anonymizing. Important is to make the research policy clear beforehand to avoid confusion that may come along the way.

 The third issue is about "how far can the donor's rights go?" In connection with an informed consent, the extent of the donor’s rights can be a subject of jurisprudence in a broader sense. For example, can the donor assert the rights to get at least a part of the economic gains derived from the established iPS cells? Or how far can his or her rights go to control future utilization of the iPS cells? In the United States, there are a number of judicial precedents concerning the donors’ proprietary rights to the cells and tissues they provided. They do not permit such rights. However, confusion and uncertainty persist as there is no established legal system in this field even now.

 The fourth concerns "intellectual property rights." An effective application of intellectual property rights is imperative in order to promote innovations in the research of iPS cells. However, registration procedures for patent rights in this field remain complicated because the technologies used to create iPS cells can be varied and it is often hard to tell the differences between the established cells. Many questions remain to be answered, such as whether each of the newly invented production methods is worth being patented or whether each of the created iPS cells deserves a patent. Presence of too many segmented patents can lead to so-called "patent thickets," making negotiations on socially useful basic research and technological development complicated, costly and time-consuming.

 The fifth issue pertains to "ethical use of iPS cells." The debut of human iPS cells was greeted with much fanfare for having done away with the ethical question posed by use of fertilized eggs in the creation of human ES cells. However, a host of challenges must be cleared before iPS cells can be put to practical use. First comes the transplant of a human cell to an animal (for the creation of human-animal chimeras). In order to expedite the progress of research on human iPS cells, they need to be transplanted into animals to check their functions and safety. However, some of those experiments can pose ethical and policy issues (such as a case where human cells form nerve tissues in the body of an animal). Production of genital cells can be most ethically serious. Such production may be important as basic research. However, use of genital cells for auxiliary reproductive medicine in the future can give rise to many problems, such as the possibility of childbirth irrespective of informed consent, safety and the cell donor's intention. In the course of basic research, it will become eventually necessary to fertilize an ovum and trace how it will grow. (While ovum fertilization for study purposes is allowed in Britain and Singapore, it is forbidden in most other countries. Some states in Canada and the U.S. permit study of genital cell production itself.) General recognition at the moment is that all those problems should be thoroughly examined.

The sixth issue involves "challenges toward clinical applications." As to application technology using iPS cells, there are growing expectations for regeneration medicine that may cure diseases by way of their transplant. But various hurdles must be cleared before clinical tests can be conducted. Those include prevention of cell canceration, evaluation of safety, etc. Can clinical applications using iPS cells be treated in the same as a product based on other cells? Or should they be evaluated by a special method? This will also become an important issue. If iPS cells are evaluated in the conventional way, the process can be complicated and time-consuming. This issue is being studied in many countries but general recognition is that much more is needed. (For example, it was pointed out at the Spanish workshop that the U.S. Food and Drug Administration sees iPS cells as "the most artificially treated cell.”)

 As we have seen, there are many issues that must be discussed and resolved before iPS cells can be put to practical applications. An intensive interdisciplinary approach is needed so that medical progress can bring comfort to human life.

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