The ADITEC project has a special Ethical Review Board (ERB): an independent consultant body of the ethical issues of the project. This Board, which will report to the Steering Committee and EU about ethical issues within the ADITEC project, has recently been installed and consists of two members: Dr Cornelia D. Exner and Dr Zarifah Reed.
Cornelia Exner is currently Officer for animal welfare and ethics at the Philipps-University Marburg, Germany. Before she joined this university, she was Executive director of the senate commission for animal research and animal welfare of the German Research Foundation). Including her prior positions, she has an extensive experience in animal behaviour and animal welfare.
Zarifah Reed is clinical development and public health specialist and paediatrician. She has been working in clinical research and product development since 2000 (among others with WHO and Regional Emerging Diseases Interventions) and has a thorough understanding of clinical development of vaccines.
Cornelia Exners’ explaination about her role in the Ethical Review Board:
What exactly is your responsibility within the ADITEC project? I was asked to bring my experience as animal welfare specialist into the project. Additionally I will work as an advisor for ethical questions on human studies. As member of the ethical board I will keep an inventory of ethics approvals, conduce ethics monitoring tasks and prepare annual reports. As I was involved in the process of implementing the EU directive 2010/63/EU (Directive on the protection of animals used for scientific purposes) I got experience in the field of supranational legislation, which might be helpful for my work in the ADITEC project.
Why is an Ethical Review Board useful, besides all rules and conventions that already exist? The Ethics Review Board will act as an independent, consultant body for the ethical issues of the project and will report to the Steering Committee and the EU. The interest in animal welfare and in ethical issues of human studies of the European citizens is very high. An independent ethical board deals as a cutting point between the interests of the scientific group and the interests of the community members.
Why are clinical trials and animal experiments still necessary? I will answer this question for animal experiments: Modern medicine has benefited substantially from discoveries of basic biological research and their implementation in applied research. Animal experiments are a fundamental pillar of biomedical research. The use of animals in research must be in compliance with the EU Directive 63/2010/EU and the national animal welfare acts of the member stats. Major issues of the new EU Directive are transparency of the projects for the European public and an ethical review process, including a harm / benefit analysis. In this balancing process the concept of dignity in animal welfare must be regarded as quite distinct from the concept of human dignity, because the problems of differentiation established in legislation order.