Ethics for Researchers aims primarily to facilitate “research excellence” in R&D projects supported by the Seventh Framework Programme, FP7 (the European Union uses ‘framework programmes’ as its main financial tool for supporting scientific R&D). However, the booklet is relevant to all clinical and experimental researchers.
For example, it notes that researchers need to ensure their studies meet the “common ground of shared values” encapsulated in The European Charter of Fundamental Rights. Article 8, for instance, protects personal information and gives everyone the right to access data about themselves.
Article 3 states that patients and volunteers in medical and biological research must provide “free and informed consent … according to the procedures laid down by law". This means, the report comments, that “only persons able to freely understand and question should give consent".
As a result, certain groups – such as prisoners, mentally-deficient people, severely injured patients and very young children – cannot give informed consent. In such cases, a “surrogate” legal or therapeutic representative, working within legal frameworks, should ensure that vulnerable people do not lose opportunities to participate in clinical studies.
As the report also observes, “numerous anthropological studies have pointed out that participants are rarely able to recall what they have agreed upon when signing an informed consent form”. It therefore suggests involving a “linguist” when preparing informed consent and using information technologies (such as video, PowerPoint and “play”) to present the research. Finally, the report advocates interviewing participants to ensure that they understand the issues.
It also addresses the contentious issue of research in developing countries. To stay on the right side of the ethical divide, the report suggests asking whether the research project benefits the local community, for example, in terms of their ability to access healthcare and modern technologies. The project should also respect the population’s choices and needs, and investigators should “understand what it means to be ill in contexts very different from those known to researchers”.
The report emphasises that researchers should not see ethics approval as another hurdle “hindering scientific progress”, but as central to their R&D success. As Janez Poto_nik, European Commissioner for Science and Research, notes in the report’s introduction: “Ethics permeates every area of research and it is only by getting the ethics right that research excellence can be achieved."
The European Commission's report can be found at http://ec.europa.eu/research/science-ociety/document_library/pdf_06/ethics-for-researchers-040707_en1.pdf