Group 3 - Public perspective & expectations; Political & regulatory landscape

Chair: Professor Megan Munsie

There is no doubt that stem cell science has captured public imagination—attracting both excitement about potential curative treatments for intractable conditions, and concern about the source of cells and technologies used by researchers. While community debate in Australia initially focused on whether it was ‘ethical’ to use human embryos in research, the last decade has seen mounting public frustration about the perceived lack of progress in delivering on the promise of stem cell science. This has resulted in the establishment of a thriving ‘stem cell’ industry—abroad  and in Australia. The doctors and clinics involved are prepared to meet demand for treatment for a fee, despite the lack of reputable evidence on whether the interventions are effective or even safe.

If the Australian stem cell research sector is to remain viable, and importantly maintain community support and credibility, it is essential that researchers continue to engage with the broader community. Such engagement needs to accurately inform the public about research progress; identify, acknowledge and address ethical, regulatory and societal issues related to current and emerging technologies; and facilitate responsible clinical translation. Failure to do so will not only compromise the viability of the field, but in the case of unproven ‘stem cell’ interventions, place the health and wellbeing of patients at risk.

The task for Group 3 is to discuss public perspectives and expectation in stem cell science and determine whether current Australian regulations, guidelines and educational initiatives are adequate in light of current research practices and emerging technologies, as well as international standards. Members will be asked to develop recommendations to address any identified shortfalls.

Questions to get you thinking:

  1. Do current regulations and guidelines strike the right balance between allowing research and addressing community concern about potential ethical issues? For many years Australia has had permissive legislation in place to allow the use of human embryos (from donated excess in vitro fertilisation and those created via somatic cell nuclear transfer) in research, but are there additional research applications involving pluripotent stem cells that are likely to raise ethical concerns in the community? Consider the creation of human gametes; modification of human germline via CRISPR technology; research into mitochondrial disease, and the possibility of recapitulating early gastrulation in a dish.  Do current legislation and guidelines address such issues? Are there any other emerging technologies or applications that may require refinement of current regulations or guidelines with respect to the use of pluripotent or indeed other types of stem cells? Relevance of current legislation and licensing requirements pertaining to the use of human embryos in research and prohibition of human cloning should also be considered.

  2. When should patients be able to access stem cell treatment? Under what circumstances, if any, is it acceptable to apply experimental stem cell-based interventions in Australia? Should more be done to address medical travel abroad for putative stem cell treatments? Given this is happening, and will probably continue to happen, would it be informative to collate the experience of individual travellers and, if so, how could this be achieved?

  3. Who should have oversight of stem cell clinical translation in Australia? Is the current exclusion of all autologous cellular therapies from TGA oversight acceptable? If not, what should be done? Should medical boards or the Australian Competition and Consumer Commission have a greater role in policy around sale of unproven treatments?

  4. Is there more that could be done to foster clinical translation of stem cell research in Australia? What long-term strategy could be developed to enhance the number of clinical trials?

  5. Should more be done to engage the community about Australian stem cell science and if so, how? In particular, how could patients be better informed of developments in the field and potential risks in pursuing unproven treatment (if this is acknowledged as an issue)? What role should scientists and regulators play in such engagement and who else should be involved? Should the stem cell research community do more to engage with media, politicians and policy makers, and if warranted how could this be achieved?

References and reading material:

Biotechnology public attitude research – visit 2012 Community Awareness Survey [Department of Industry and Science website]

Stem cells, cloning and related issues [NHMRC website]

Review of relevant chapters of the National Statement on Ethical Conduct in Human Research [NHMRC website]

Research ethics and stem cells: Is it time to re-think current approaches to oversight? [ Caulfield et al. EMBO Reports, 2015]

CRISPR germline engineering – the community speaks [Bosley et al. Nature Biotechnology, 2015] and DNA editing in mouse embryos prevents disease [Reardon Nature, 2015]

Rudimentary egg and sperm cells made from stem cells [Cyranoski Nature, 2014]

Cloning debate: stem cell researchers must stay engaged [Pera & Trounson Nature, 2013]

ISSCR Guidelines for the clinical translation of stem cells [2008; note draft of revised Guidelines to be released in June and will be distributed to Think Tank delegates] plus ISSCR 2013 Statement on Delivery of unproven autologous cell-based interventions to patients

Untested, unproven, and unethical: the promotion and provision of autologous stem cell therapies in Australia [McLean et al. Stem Cell Research & Therapy (2015)]

Therapeutic Goods Administration 2015 discussion paper on Regulation of autologous stem cell therapies and the Australian Academy of Science’s submission to the public consultation. Other submissions can be accessed here.

Therapeutic journeys: the hopeful travails of stem cell tourists. [Petersen et al. Sociology of Health & Illness (2014)]

Stem cell tourism and public education: the missing elements. [Master et al. Cell Stem Cell (2014)]

Some examples of current educational material: ISSCR Closer Look at Stem Cells website; NHMRC Stem cell treatments info; Australian Stem Cell Handbook; ASSCR Stem Cell Essentials; EuroStemCell fact sheets; CIRM–For Patients website.

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