Ethics and Governance Council

The ESPOIR consortium will be assisted and advised by an independent Ethics and Governance Council (EGC), which has been established in addition to the safety and oversight requirements of Good Clinical Practice. The role of the EGC is to provide independent external supervision and advice regarding the ethical, legal and safety (including data safety) aspects concerning the clinical trial, in particular on all aspects concerning studies in children and donated human tissue. The Council will monitor the procedures in place for the clinical trial to ensure the application of the highest ethical standards, thus safeguarding patients’ interests and rights. A further important role of the EGC is to mediate between the prejudices against new methods of treatment provided by for-profit organisations and the need for charitable tissue donation. This will form an important pillar in the project’s dissemination strategy. 

The EGC will convene regularly as an independent forum and also be invited to take part in the project’s annual SC meetings. Reports of the EGC will also be included in the periodic reports and in the final reports to the EC.

During the project run-time, it is planned to hold a public meeting of the council at an international scientific meeting to further dialogue with both the scientific community and the general public. 

The EGC will focus on ethics and regulatory issues including but not limited to aspects of homograft procurement either by charitable tissue donation or domino-transplantation, inclusion/exclusion criteria of patients and a special emphasis will be placed on ethical concerns regarding studies involving children. Questions with ethical relevance concerning the research conducted in the project will also be communicated in a suitable and understandable way for the general public on the project website, helping to inform the public debate on tissue donation and new technologies. 

The ECG will also put emphasis on progress, safety data and critical efficacy endpoints of the clinical study. The EGC therefore will be integrated in the set-up up of the clinical trial including the implementation of the study data base which will be regularly updated by the Coordinator. All severe adverse events (SAE) will be reported immediately to the ECG in addition to regulatory requirements. In the case of accumulation of severe unexpected adverse events (SUSAR), the ECG will, if necessary, convey additional meetings to provide advice to the sponsor of the study, concerning the continuation, modification, or termination of the trial. 

Recommendations regarding modification of the design and conduction of the study may include: 

  • Modifications of the study protocol based upon the review of the safety data; 
  • Suspension or early termination of the study or of one or more study arms because of serious concerns about subjects’ safety, inadequate performance or rate of enrollment;  
  • Suspension or early termination of the study or of one or more study arms because study objectives have been obtained according to pre-established statistical guidelines; 
  • Optional approaches for sponsor and investigators to consider, when the ECG  determines that the incidence of primary study outcomes is substantially less than expected, such as recommendations to increase the number of trial centers or extend the recruitment period; and,  
  • Corrective actions regarding a study center whose performance appears unsatisfactory or suspicious.

A ECG meeting may be requested by ECG members, the Project Officer, the sponsor, institutional review boards or the Coordinator at any time to discuss safety concerns.

 

The following experts have agreed to join the ESPOIR EGC: 

Dr. Karen Melham, University of Oxford (UK), is a Researcher in Ethics at the Centre for Health, Law and Emerging Technologies (HeLEX) and will act as chair of the EGC. Her work focuses on the good practice of medical research and involves research, teaching, and ethics support. She is working with Dr Jane Kaye on “Aligning Excellence”; an initiative to identify, analyse, integrate and extend good practice in medical research and practice in Oxford. She coordinates the Oxford Bioethics Network and has experience in clinical ethics in Canada and the US and in research ethics in the UK. She is chair of Oxfordshire Research Ethics Committee A. Her research interests include models of enactment for ethics and the formative moral pedagogy of governance procedures and mentoring. 

Professor Sir Magdi Yacoub, Professor of Cardiothoracic Surgery at the National Heart and Lung Institute, Imperial College London and Founder and Director of Research at the Harefield Heart Science Centre (UK), will provide expertise as one of the world’s leading cardiac surgeons. Having retired from performing surgery for the National Health Service in 2001 at the age of 65, Sir Magdi Yacoub continues to act as a high profile consultant and ambassador for the benefits of transplant and congenital heart surgery, for example, through his charity organization for children suffering from life-threatening heart diseases, The Chain of Hope.

Dr. Nils Hoppe, Leibniz Universität Hannover (DE) is specialised in medical law and ethics, in particular questions of ownership and property in human tissue. He founded the Medical Law and Bioethics Research Group at the Leibniz Universität Hannover in 2007 and is now one of the directors of the Centre for Ethics and Law in the Life Sciences in the Institute for Philosophy (CELLS). He is co-coordinator of the project “Tiss.EU -Evaluation of Legislation and Related Guidelines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union." The project, funded by the European Commission under the 7th Framework Programme, addresses questions of ethical and legal regulation in relation to research using human tissue. 

Marte Jystad (NO) of the patient organisation “European Congential Heart Disease Organisation” has been working for the “Norwegian association for children with congenital heart disease” since 1989, when one of her daughters was born with a heart defect. Her responsibilities within the Norwegian organisation are to lobby politicians and health authorities, coordinate conferences and events for health personnel and parents, write articles for the organisations magazine, and provide counselling for members, health personnel and teachers. She is also a member of Corience, the independent European platform on congenital heart defects, funded within the Seventh Framework Programme (FP7). M. Jystad will be able to offer valuable insights and input for ESPOIR from a patient’s perspective and a two-way feedback channel between the project and patient organizations.  

Prof. Siegfried Kropf, University of Magdeburg (DE), is head of the Institute for Biometry and Medical Informatics and avails of extensive experience in multi-centre trials in congenital heart disease with special interest in parametrical and nonparametrical statistical analysis of clinical studies. He also has been involved in Data Safety Monitoring Boards for clinical studies.