The end of the mad professor?

Angiography of human abdominal aortic aneurysm (AAA). © Jean-Baptiste Michel
Angiography of human abdominal aortic aneurysm (AAA).© Jean-Baptiste Michel
Although stem cells, are vital to researchers, they elicit numerous ethical misgivings. This image shows the results of in vitro striatal differentiation of human embryonic stem cells after 68 days.© Inserm/Anselme Perrier
Although stem cells, are vital to researchers, they elicit numerous ethical misgivings. This image shows the results of in vitro striatal differentiation of human embryonic stem cells after 68 days.© Inserm/Anselme Perrier

Video surveillance, clinical trials, nuclear energy and embryonic stem cells are only the most highly publicised examples of ethically questionable scientific practices. The European Commission has decided to make research ethics a priority in evaluating European projects under the Seventh Framework Programme.

Though they are few and far between, explosive is the best way to describe the scandals surrounding scientific research practices. A very apt example was pharmaceutical giant Pfizer’s clinical trials of a meningitis drug in Nigeria. Although research holds out much hope because it can provide society with answers to issues and questions, at times it drifts perilously close to the borderline of ethics. So, even though freedom and independence are necessary to advance knowledge, it is crucial to set limits.

While the fundamental principles of research ethics seem obvious, their application depends on the context. Perceptions of the ethical and social impact of a given research subject are determined by a number of factors, such as the culture and period in question or the estimated risk/benefit ratio.

Safeguarding scientific excellence

The European Union has made research ethics a key concern of the Seventh Framework Programme for Research and Development (FP7). The very first draft of any project application for EU funding must contain a chapter on the ethical questions that the project raises and the means implemented to resolve them so as to comply with European and national ethical standards.

Why should ethics be integrated into EU-funded programmes? To guarantee to citizens and decision-makers compliance with the highest ethical standards and to promote quality research. In the words of François Hirsch, an expert seconded from the French National Institute for Health and Medical Research (INSERM), despite the reservations expressed by some researchers (see box), “ethical precaution is not an obstacle to scientific progress but rather a way to guarantee and safeguard research excellence. Even though it is rare for ethical principles to be flouted, one case in several thousand is enough to undermine the credibility and image of research across the board.”

The fundamental principle for deciding what is and what is not ethically acceptable is simple: respect for human dignity. It might be simple but the boundary is far too nebulous to be left to scientists to define. “Researchers can get carried away by a desire to advance knowledge in their specialist field and a thirst for answers, so they may underestimate the ethical implications of the research they undertake, or simply be unaware of them,” explains Isidoros Karatzas, head of the ethical evaluation section of the Governance and Ethics Unit at the European Commission’s Directorate-General for Research.

One of the cornerstones of ethical research is to obtain the informed consent of the participants in a survey or clinical trial. It is essential to inform the participants of the potential risks and benefits to themselves and to society as a whole, and for them to understand the issues well in advance of their decision whether or not to participate. The informed-consent principle covers a range of issues, including the protection and confidentiality of personal information and the participation of vulnerable groups. For instance, does the project involve children, disabled, sick or disadvantaged adults, or people from developing countries? “The latter is a particularly thorny issue,” says François Hirsch. “In many cases, developing-country nationals have no idea what informed consent means and fail to understand the potential risks of clinical trials, for example. They may believe that they are being offered a tried and tested treatment.” For such trials, researchers must obtain the approval of a local ethics committee in addition to having the research project validated by European Commission ethics experts.

Examining projects with a fine-tooth comb

Any project submitted to the Commission is first subjected to a scientific evaluation. If it is deemed satisfactory, experts automatically conduct ethical screening to rank the ethical approach as either ‘good’ or ‘inadequate’. If it is judged good, the proposal is sent to the national authorities of the country where the project will be carried out, as well as to the ethical review committee made up of experts from the Commission’s Governance and Ethics Unit, who then produce an ethical review report on the researchers’ ethical approach. If the proposal is judged inadequate, the ethical screening experts send the project back to the applicants to obtain additional information on its ethical approach. After this, the project is sent to an ethical review committee set up by the Directorate-General for Research, which then draws up its report.

So, even a project that has received a brilliant scientific evaluation is not guaranteed to receive EU funding if it has neglected the ethical considerations. Depending on the experts’ opinion, scientists are required to rework the ethical aspects of their proposal to ensure that it complies fully with European requirements. And once the project is accepted, it may still be subjected to a special audit. “An ethical audit is the final recourse to ensure that a project really does comply with fundamental ethical principles,” explains François Hirsch.

FP7, an educational framework programme

“By asking researchers to consider the ethical and social implications of their research right from the outset, the seventh framework programme is a sort of educational programme,” says Isidoros Karatzas. He believes that insufficient education is the main obstacle to integrating ethics into the scientific mindset. “Medicine is perhaps the only field where researchers are trained in ethical thinking, even though ethics is a common thread running through all research fields.”

So, improving research ethics is a real education and communication challenge. While scientists are the main target group, as they are responsible for doing research, many more people are affected. “It is important for ethical evaluators to be properly trained and informed. At the moment, information is available but you need time and determination to find it,” adds Isidoros Karatzas. Another target group for better ethical education is the general public. Raising public awareness of research ethics at the earliest possible age would make Europeans more open-minded and allow them to develop informed opinions on research practices and issues.

Audrey Binet


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Good ideas are not enough...

Jean-Baptiste Michel, director of the Hemostasis, Bio-engineering and Cardiovascular Remodelling Unit at INSERM (FR) has had first-hand experience of the European Commission’s ethical evaluation procedure. “I almost gave up altogether,” reveals the research director, who is now relieved to see his project Fighting Aneurismal Disease launched at last. The project aims to develop new diagnostic and therapeutic applications for aortic aneurysm and involves taking blood samples from patients. Although the application was submitted back in April 2007, the project did not actually start up until July 2008, following numerous exchanges with the Commission about its ethical implications.

Apart from providing further details on the involvement of children in the study and a few recommendations, the main snag with the application was the project’s European dimension. “In the proposal, we had integrated the statutory ethical documents of France and Sweden – such as the informed consent form – because we work with the Karolinska Institute in Stockholm,” explains Jean-Baptiste Michel. “The problem was that the documents failed to specify that the tissues collected could be used in other European countries.” After a number of exchanges with the Commission to amend his project’s ethical chapter, Jean-Baptiste Michel was so worried about the outcome that he travelled to Brussels to meet the European official in charge of the dossier. “In research, administrative constraints represent two thirds of the work, and that is what undermines Europe’s image,” he says. “Although ethical procedures for clinical trials need to be harsh because they may endanger lives, the constraints should be graduated in line with the ethical impacts.”