Stem Cell Charter

All of humankind has a vested interest in the progression of stem cell science for the treatment of debilitating conditions. With the hope that is generated by this progress, there is also concern regarding questionable practices. The September 22, 2009 release of the Stem Cell Charter [101] brings these issues into sharper focus. The Charter identifies and affirms five principles for responsible stem cell science:

• ▪ Responsibility to maintain the highest level of scientific quality, safety and ethical probity;

• ▪ Protection of citizens from harm and the safeguarding of the public trust and values;

• ▪ Intellectual freedom to exchange ideas in the spirit of international collaboration;

• ▪  Transparency through the disclosure of results and of possible conflicts of interest, in order to ensure integrity in the promotion and advancement of stem cell research and therapy for the betterment of the welfare of all human beings.

The principles and intent of the Stem Cell Charter draw from previous instruments for the protection of human rights. Central to the Stem Cell Charter is the 1946 WHO’s Constitution, which affirms that the “[e]njoyment of the highest attainable state of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.”

Since the Nuremberg Code and the 1964 Helsinki Declaration first framed research ethics, other historical precedents underscore the importance of researchers themselves taking responsibility for their work. Indeed, the 1975 Summary Statement of the Asilomar Conference illustrates this self-regulatory approach [1]. The conference focused particularly on research on recombinant DNA molecules that introduced techniques for the combination of genetic information from different organisms. Of particular concern to the Asilomar scientists was the need to define the parameters of this new science such that it would have “minimal risks to workers in laboratories, to the public at large and to the animal and plant species sharing our ecosystems.” Most importantly, the Asilomar conference reached consensus that research should proceed with appropriate safeguards; that protection should be greater at the outset; should be modified as new knowledge, technical improvements and risk assessment change; and that research activities should not proceed in the presence of serious risk.

While the Asilomar Statement specifically addressed genetics and predates subsequent discoveries such as animal cloning, gene therapy and stem cell research, it began to articulate shared ethics and the interpretation of human dignity within the context of human rights and research. This approach has been further advanced by organizations such as the Human Genome Organization [102] and more specifically in the field of stem cell research, by the guidelines of the International Society for Stem Cell Research [103,104] and the International Stem Cell Forum [105].

A model of interest in the development of bioethical guidelines specific to the practice of stem cell research at the national level is the Singapore Bioethics Advisory Committee. Since 2001, it has published government-endorsed recommendations that guide research in that region. The stated aim of its first report Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and Therapeutic Cloning is “to protect human life and the rights and welfare of the individual, and to advance human life by curing disease” [106].

Most national legislation in the stem cell arena is more concerned with prohibiting human reproductive cloning [2] and regulating such research or limiting it to surplus embryos [3]. By contrast, California’s Constitution establishes “a right to conduct stem cell research derived from somatic nuclear transfer research on stem cells” [107].

To further the advancement of responsible stem cell research, the Canadian Stem Cell Foundation [108] released the Stem Cell Charter in September 2009 [101]. The promulgation and promotion of this Charter aims to prospectively frame stem cell research and to serve as a benchmark for the guidance of international and national initiatives in both scientific research and policymaking.