9 September 2009
A consortium of European and Chinese bodies concerned with the ethical governance of biomedical research, BIONET, has called for more effective regulation of stem cell research and therapeutics across the world. Medical ‘stem cell tourists’ with incurable conditions are increasingly travelling to countries with clinics that offer novel stem cell novel therapies; however, most such treatments have not undergone clinical trials.
A BIONET expert group of scientists, clinicians, ethicists, lawyers and policy makers have looking at stem cell therapeutics have identified concerns in different countries that research was moving too rapidly into clinical practice, and called for proper clinical trials to investigate the safety and efficiency of new treatments before they are offered to patients. It was also found that treatments were often over-hyped to potential patients desperate for a cure. Professor Nicholas Rose of the London School of Economics, who co-chaired the group, said: "The key is informed consent. Doctors should be able to tell the patient about the short-term and long-term prognosis and the things we don't know about the risks" (see BBC news report).
The group also called for transparency over the source of germ cells, embryos and embryonic tissues used for treatments; for ethical safeguards to prevent coercion of potential donors or patients; and for quality standards for stem cells used in clinical practice to be established. Their recommendations follow on from guidance on issues surrounding the clinical translation of stem cells issued by the International Society for Stem Cell Research in 2008 (see previous news).
China introduced new regulations earlier this year that require clinical trials before new stem cell treatments can be offered to patients. BIONET Expert Group co-chair Professor Qiu Renzong of the Chinese Academy of Social Sciences commented: “Stem cell research is tremendously exciting and may lead to potential treatments. However its development must be governed in an ethical and responsible way if it is to fulfil its potential and not experience a backlash from public opinion. Many countries, including China and those in the EU, are now starting to regulate these therapies. However, if patients are to be properly protected, regulation needs to be enforceable and effective” (see press release).
The BIONET expert group has produced a series of additional recommendations for the ethical and structural development of European-Chinese collaborative research in the biological sciences, including stem cell and genomic research, launched at a conference last week. These include calls for improved regulation of clinical trials, international consensus on ethical issues related to biobanking, and the establishment of a permanent China-Europe partnership on research ethics.