Adopted by the 60th WMA General Assembly, New Delhi, India, October 2009
The field of stem cell research has been developing during the last decade and is now one of the fastest growing areas of biotechnology.
Stem cells can be harvested from an established tissue (adult stem cell) or from the blood of the umbilical cord and these sources, for many, create no specific ethical dilemma.
Stem cells can also be obtained from the embryo (embryonic stem cells). Obtaining and using these stem cells raises specific ethical questions and is, for some, problematic.
Some legislatures have prohibited obtaining and using embryonic stem cells. Others have allowed using so-called spare or excess embryos from assisted reproduction cycles for research purposes, but often the production of embryos solely for research purposes is prohibited. Many jurisdictions have no specific legislative provisions with respect to embryonic stem cells.
The basis of legal and ethical consideration is that human embryos have a specific and special ethical status. This has generated debate amongst ethicists, philosophers, clinicians, scientists, health workers, the public and legislators.
Some assisted reproductive technology, specifically in vitro fertilisation, involves the production of embryos outside of the human body. In many cases not all of these are needed to achieve pregnancies. Those not used, so called “spare or excess embryos”, may be donated for the treatment of others or for research or stored for some time and then destroyed.
The differing legislative approaches to the use of embryos for research, may be reflected in law prohibiting the public funding of such research.
Stem cells can be used to conduct research into human disease and basic developmental biology. There are many current research programs investigating the use of stem cells to treat human disease. Although clinical studies have not yet validated the use of stem cells in therapy, the potential for therapeutic use in the future has been widely acknowledged by members of the medical and scientific community.
It is too early to assess the likelihood of success in any specific therapy and the place of stem cells amongst a variety of forms of treatments.
Public views of stem cell research are at least as varied as those of doctors and scientists. Much public debate centres on concerns of abuse of the technology as well as specific concerns about the use of embryos.
Regulation according to established ethical principles is likely to alleviate concerns for many members of the public, especially if associated with careful and credible policing of the regulations.
Whenever possible research should be carried out using stem cells that are not of embryonic origin. However, there will be circumstances where only embryonic stem cells will be suitable for the research model.
All research on stem cells, regardless of their origin, must be carried out according to agreed ethical principles. Regulation and legislation must also accord with these principles to avoid confusion or conflicts between law and ethics.
The ethical principles should, where possible, follow international agreement. Recognising that different groups have widely varying views on the use, especially, of embryonic stem cells, these principles should be drafted to allow different jurisdictions to limit their allowed levels of research as locally appropriate.
All and any research using embryos must only occur when written informed consent has been obtained from both donors of the genetic material that created the embryo.