Jun 2010

Applying the Stem Cell Charter: Protecting Ourselves

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Charter Principle #2: We support the “Protection of citizens from harm and the safeguarding of the public trust and values.”

Persons are treated ethically by respecting their autonomy and protecting them from harm, but also by making efforts to secure their well-being. The Charter’s principle of “protection” encompasses two other principles related to biomedical guides for ethical action: “non-malfeasance” and “beneficence”.

It sounds a little complicated, so what do these mean? “Non-malfeasance” simply means not intentionally causing harm or injury to people.  “Beneficence” means acting in the best interests of others, whether that is an individual or society as a whole. This latter principle encompasses two ethical (and sometimes legal) rules:

  1. Do not harm
  2. Maximize possible benefits and minimize possible harms

Since the Nuremberg Code and the 1964 Helsinki Declaration first framed research ethics, other historical precedents have emphasized the importance of scientists taking responsibility for their own work.   The 1975 Summary Statement of the Asilomar Conference outlines this idea of self-regulation. The conference focused on research on recombinant DNA molecules that introduced techniques for the combination of genetic information from different organisms. Of particular concern was the need to define this new science so 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 the consensus that research should have safeguards; that measures of protection should be high at first, and then, once new knowledge, technical improvements and risk assessment changed over time, they could be lowered. It was also decided that research activities should not proceed in the presence of serious risk.

This approach has been adopted by organizations around the world such as the Human Genome Organization, International Society for Stem Cell Research and the International Stem Cell Forum.

Adhering to international norms of human rights implies respect for values, traditions, culture and integrity of individuals; it requires accepting and upholding their dignity and freedom. Moreover, ethical probity means respecting and promoting the health and rights of patients. The principle of “protection” encompasses respect for persons. It implies both a requirement to respect individual’s decisions with respect to their bodies, and the protection of individuals with diminished autonomy, who, for whatever reason, do not have the ability to speak for themselves.

How are these principles related to real-world issues? Well, a good example is stem cell tourism – when people travel abroad to receive stem cell-based treatments and therapies.  Over the past decade, clinical trials for stem cell-based treatments have been carried out using umbilical cord blood stem cells and blood stem cells from bone marrow to treat diseases like leukemia, lymphoma and several inherited blood disorders. The safety and efficacy of these interventions has been well established.

Treatments using human embryonic stem cells and fetal tissue, however, are still in early experimental stages. But controversial clinical trials using these cells are being conducted and advertised in several countries as if they were established therapies. Some of them are being carried out with little scientific evidence and oversight (legal, ethical), and with no evaluation of clinical outcomes and safety.

This is why it’s important to become informed about stem cell science, and the issues surrounding its applications. The Stem Cell Charter acts as a springboard. Start by learning about each of the principles and why they are important in the context of stem cell science. In the upcoming weeks, we’ll explore the principles of “intellectual freedom,” “transparency,” and “integrity.”

Rosario Isasi is a Research Associate at the Centre of Genomics and Policy at McGill University. Her hobbies include bioethics, bioethics and bioethics. (And stem cells and policy.)

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