Governing emerging biotechnologies

The appropriate creation and application of biotechnology raises numerous challenges: scientific, environmental, social, ethical and legal. Human stem cell research (SCR), as an evolving exemplar of biotech innovation, is a nexus for many of these challenges. Although there is a growing body of work relating to human stem cells, there is very little on the interaction of social values and law, particularly in developing countries. This Project is intended to encourage
consideration about how socio-ethical values are or could be translated into legal rules (themselves deployed as social shaping tools insofar as they guide/promote socially significant research and actions). In doing so, it generates new/unique data and contributes to governance which promotes socially useful progress balanced by equitable and ethical considerations. This
Project examines the conduct and motivating values of Argentine stakeholders as they struggle with the moral and other controversies surrounding SCR, and endeavour to formulate socially acceptable regulatory structures. Argentina is a useful case study because it is an emerging economy actively pursuing biotech research as a developmental tool, and is therefore intending to integrate its innovation into the global science setting. As such, it has to grapple with both
international and uniquely domestic controversies/issues. In pursuing this course, the Project (1) maps the Argentine scientific and regulatory setting, (2) reveals the multiple goals envisioned for regulation and uncovers moral values held by stakeholders, including scientists and regulators, (3) theorises how science regulation and science communication could be improved in Argentina,
and (4) contributes to debates surrounding and formulation of value-sensitive regulatory models in Argentina and beyond by engaging with stakeholders on an ongoing basis.

Within the context of a case study on the regulation of biotechnology in Argentina, with special emphasis on the governance of stem cells from sourcing to storing to commercialising research outputs, this Project examines how social and ethical values are, and can be, translated into legal rules (themselves deployed as social shaping tools insofar as they guide/promote socially significant research). It will examine the conduct and motivating values of Argentine stakeholders as they struggle with the moral and other controversies surrounding these regulatory subjects and endeavour to formulate socially acceptable regulatory structures applicable thereto. Objectives include mapping the most salient features of the social/moral/legal debates, developing dialogues with stakeholders to reveal the multiple goals envisioned for regulation, and contributing to the debate surrounding and formulation of value-sensitive regulatory models. It is expected that the Project will (1) highlight the importance of values to the legitimacy and quality of regulation, (2) explore those values with individuals operating in this arena, and (3) identify opportunities to translate values into effective regulation within this developing economy. However, given that Argentina has ambitions to become a regional leader, both scientifically and regulatorily, findings and benefits may not be limited to Argentina.

This project was designed to gather qualitative data around stem cell research governance in Argentina (discover stakeholder values relevant to, and objectives for, SCR and its governance). Participants were chosen from medical, scientific, academic, policy, legislative and regulatory communities (ie, those viewed as likely to influence the nature/content of SCR regulation given the Argentine socio-cultural context). Concepts and their relationship to theory are still being explored. The following conclusions/observations are offered:
Existing Science Setting: Most respondents took a positive view of research capacities and trends in Argentina, though there was concern around three issues: an inability to get a clear picture of the research environment due to lack of oversight/reporting; unethical and/or unauthorised research that was known to be undertaken; the sustainability of quality research given a training environment that was persistently shuttered and undemocratic.
Existing Regulatory Setting: Respondents felt there was very little in the way of regulatory architecture. Most felt this was sub-optimal despite the dangers of trying to democratically create a new framework.
Perceived Social Costs/Benefits of SCR: Everyone conceded the financial costs associated with SCR. Most felt it was a cost worth bearing despite Argentina’s other pressing social and health conditions. Some identified social disruption as a cost, but felt that potential benefits outweighed them.
Past/Existing Public Debates/Understanding: Most respondents had little knowledge of any public debates on SCR beyond their own activities, which were mostly restricted to professional circles. They felt that public understanding of SCR practices and (realistic) objectives was very low. They did not equate these low science literacy rates with resistance to science, and indeed generally felt that people were positive about science and research.
Hurdles to Achieving Regulation: The primary hurdles to achieving (moral) regulation were identified as: low science literacy amongst legislators and the public; an absence of opportunities to engage with the broader public (and develop science democratically); and the dogmatic position of the church toward science and its undue political influence.
Necessity of Government Regulation: All respondents felt that the current regulatory situation was far from ideal, and all felt that something should be done to improve it, but there was no consensus on the best way forward.
Appropriate Regulatory Purposes/Objectives: While opinions on appropriate objectives varied, all respondents felt that law had an important role to play in directing the new and powerful biosciences. The most commonly cited objective for regulation was to create a positive science environment, ensure professional (and international) standards, and protect patients.
Source of Values: It was felt that religions (and formal religious positions) were not an appropriate source of moral values. Sources cited as valuable and legitimate were international legal and bioethics instruments, the community, and the individual properly informed about the scientific possibilities and competing ethical issues.
Regulatory Values: Most respondents felt that broad social/moral values must be reflected (if not explicitly identified and defined) in regulation. Values considered to be important include human wellbeing, solidarity, justice, democracy, knowledge, autonomy, dignity, honesty, safety, scientific freedom, professionalism, transparency, and population health.