Section 9: Assessing the Compatibility of Existing Ethics Assessment Frameworks with the SATORI Framework

In this section, we assess the compatibility of existing ethics assessment frameworks with the SATORI framework.

The SATORI framework does not have any clear areas of conflict with international regulations or guidelines. General human rights guidelines helped guide the development of formal EA, and SATORI draws heavily on the notion of human rights issues and principles as a basis for EA and guidance. Therefore, there is an obvious compatibility between them. Even though international regulations may operate in different fields, the procedures they offer for their own implementation affirm the type of approach that SATORI suggests. Regulations such as the Cartagena Protocol outline a process that includes reviews of decisions, simplified procedures, risk assessments and public education and awareness.1 There is an accepted importance of the need to train, monitor and follow through on initial recommendations.2 The organisational structures outlined in international regulations differ in subject matter from SATORI but show a shared approach, e.g. multiple international regulations mandate the creation of a national-level action plan or committee to ensure the regulations are properly implemented and monitored.3 The regulations also advocate for policy discussions to include all relevant stakeholders, including local actors, private industry, NGOs and diverse community members (in terms of race and gender).4 As with SATORI, several international regulations create specific bodies to organise this conversation between the public, private and government.

Nonetheless, national priorities may produce EA priority conflicts with the SATORI approach. For example, a desire to maintain historical (high) levels economic growth may conflict with present-day ethical considerations. Some developing countries argue that the necessity for growing the economy and opportunity outweigh the ethics principles and issues that govern sustainable environmental policy and that more developed countries benefited from a laxer environmental focus, so fairness dictates a right to develop using the same methods.

As regards the first of the two non-EU countries studied in the SATORI project, the SATORI framework is compatible with the U.S. approach to EA. This compatibility is due to the fact that many of the principles adopted by the SATORI framework are implicitly based in the ethical assessment framework of the U.S., such as the Belmont Report. The places where the SATORI framework differs from that in the U.S. arise from factors specific to the U.S., including the decentralised R&I system. They do not, however, suggest conflicts of the core values of the system. Research in the U.S. does not always face the level of EA desired by the SATORI framework, which has specific outlines for organising RECs and conducting uniform, transparent EAs.5

As far as China is concerned, even though currently it does not have a strongly developed infrastructure for EA, it is rapidly developing one. The major differences between the SATORI framework and Chinese approach to EA primarily arise from the China-specific factors including the political system or low engagement of CSOs. The Chinese and the SATORI frameworks align to some extent, particularly concerning the key issues and principles underlying EAs for research aimed at technological innovations, research involving human subjects and research involving possible environmental risks. Ethical review in relation to biomedical research involving human subjects in China is well covered by various national guidelines that adhere to international standards.6 However, the ethical review is limited to biomedical research.7

  1. The Cartagena Protocol on Biosafety to the Convention on Biological Diversity. Articles 12–15, 23.
  2. See, for example,
  3. See, for example,
  4. See, for example, SATORI 4.2 A Framework of Ethical Issues and Principles in R&I, pp. 64–127.
  5. SATORI Deliverable D3.2, Brey P. (et. al.), “International differences in ethical standards and in the interpretation of legal frameworks”, p. 127.
  6. Ibid.