Ethics Board

A body with consultative functions, the Ethics Board (EB) is formed by independent experts external to the project, with the expertise and knowledge necessary to assist and advise the Project Scientific Committee on all ethical aspects of the conduct of each trial.

The Ethic Board’s task is also to make sure that the Convention on Human Rights and Biomedicine (Oviedo, 4.IV.1997), its Additional Protocol concerning Biomedical Research (Strasbourg 25.I.2005), the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (Strasbourg, 28.I.1981) and the principles laid out in “Ethical Considerations for Clinical Trials on medicinal products conducted with the Paediatric Population – Recommendations of the Ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use” (EC, 2008) are complied with.


Annagrazia Altavilla

Lawyer and Professor (P.A.S.T) at Aix-Marseille University (Espace Ethique Méditerranéen) specialised in Health Law and Biomedical Ethics. Former member of Paediatric Committee at the European Medicine Agency (2008-2011) and of the (EMA) Working Group for Third Countries Clinical Trials. Author of a book and more than 40 publications in national and international journals. Speaker invited in more than 50 conferences in 15 countries, she has also lectured in several training courses at European universities. Member of the Board of the international consortium TEDDY (Task-force in Europe for Drug Development for the Young) and expert/legal adviser in many EU-funded projects. Member of international and European scientific societies (WAML, EAHL, IIREB, UNESCO Geobs).

Anouk Nijenhuis

Anouk Nijenhuis has a Biomedical degree (2013) at the VU University Amsterdam. She has a master specialization in Management, Policy-analysis and Entrepreneurship in Health and Life Sciences. Her researched focused on palliative care for children and the organization of care for children with cancer. Since 2013 she assists the CCI International Office. Furthermore, she is a volunteer of the Dutch Childhood Cancer Parent Organization as childhood cancer survivor.

Helen Sammons

Dr Helen Sammons is Associate Professor of Child Health at the University of Nottingham and a Consultant Paediatrician at the Derbyshire Children’s Hospital. She was the first paediatrician formally trained in Paediatric Clinical Pharmacology in the UK, through the Royal College of Paediatrics in Child Health (RCPCH). Her research interests include clinical drug trials in children and neonates, safe and effective prescribing and the ethics of paediatric clinical trials. Dr Sammons is vice chair of the Derby Research Ethics Committee and the RCPCH/NPPG Joint Medicines Committee. Her published work includes the ethical issues surrounding clinical trials and the European Legislation, safety in clinical trials, sedation for diagnostic imaging and prescribing assessment.


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