Nielsen Kåre Nolde, Fredriksen Børge Nilsen, Myhr Anne Ingeborg
Nanoethics. 2011 Apr;5(1):57-71. doi: 10.1007/s11569-011-0111-5. Epub 2011 Mar 29.
The diversity of nanotechnologies and of the governance challenges that their applications raise calls for exploration and learning across different cases. We present an Upstream Oversight Assessment (UOA) of expected benefits and potential harms of nanoparticles made of a synthetic polymer (PLGA) to improve vaccines for farmed salmon. Suggested by Jennifer Kuzma and colleagues, an UOA may help identify and prioritise research needs, and it may support evaluations of the adequacy of relevant existing regulatory frameworks. In this work, the UOA approach is modified and supported with elements from the uncertainty analysis framework developed by Warren Walker and colleagues. Empirically, we draw on relevant available published literature and insights generated in an ongoing nanoparticle salmon vaccine project, in which one of the authors participates. Nanotechnologies have not previously been encountered in the regulatory context of fish vaccines, which in part raises unique challenges due to prospective large scale vaccine use in semi-open aquatic systems. Strengthened through cooperation between ELSA and technology researchers we found the UOA useful for an early mapping of benefits and concerns, and for identifying areas in need of further research prior to a nanoparticle based salmon vaccine is developed and taken into use. We consider our approach to represent one among several complementing initiatives that seek to contribute to early stage evaluations of possible negative side effects, broadly conceived, in order to facilitate a more robust nanotechnology development.
纳米技术的多样性以及其应用所带来的治理挑战，需要对不同案例进行探索和研究。我们对用于改良养殖三文鱼疫苗的由合成聚合物（聚乳酸 - 羟基乙酸共聚物，PLGA）制成的纳米颗粒的预期益处和潜在危害进行了上游监督评估（UOA）。由詹妮弗·库兹马及其同事提出的上游监督评估，有助于确定研究需求的优先级，并支持对现有相关监管框架的充分性进行评估。在这项工作中，上游监督评估方法进行了修改，并融入了沃伦·沃克及其同事开发的不确定性分析框架中的元素。在实证方面，我们借鉴了相关已发表的文献以及一位作者参与的正在进行的纳米颗粒三文鱼疫苗项目中产生的见解。在鱼类疫苗的监管背景下，此前尚未遇到过纳米技术，部分原因是由于未来将在半开放水生系统中大规模使用疫苗，这带来了独特的挑战。通过ELSA与技术研究人员之间的合作得到加强，我们发现上游监督评估有助于对益处和问题进行早期梳理，并在基于纳米颗粒的三文鱼疫苗开发和投入使用之前，确定需要进一步研究的领域。我们认为我们的方法是旨在为广义上可能的负面副作用的早期评估做出贡献的若干补充举措之一，以便促进更稳健的纳米技术发展。
