ARISE touches on important and possibly controversial ethical issues. This is a natural result of research and development in an innovative biomedical context, which has the potential to significantly improve individuals' lives. The ARISE consortium is acutely aware of the ethical issues involved in the proposed research and has, additional to the safeguards required by Good Clinical Practice, as well as generally accepted best practices, included further ethics monitoring and advice mechanisms in this proposal. An overview of the consortium’s ethics strategy will be given below.

National Legal and Ethical Requirements

The ARISE consortium’s membership is multinational and standards and mechanisms for procurement and allocation of tissue differ across regions. It is beyond the scope of ARISE’s accompanying ethics advice and monitoring to attempt to standardise local statutes and practice. WP2 will undertake survey-based research to ascertain the status quo for each of the partners and will share and discuss the outcomes of these surveys with the EGC. Further, WP2 will query data collection and processing and insurance arrangements and create an overview of all pertinent aspects of ARISE’s work in order to guide participants and inform the EGC. Additionally, the WP leader for WP2 (LUH) is a beneficiary in two other current EU-funded research undertakings - EUCELLEX (FP7) and EBiSC (IMI-JU). In both of these projects, LUH will generate signficant knowledge in relation to the ethical and legal status quo in relation to human tissue research and therapy in all EU member states. This knowledge will be actively made available to ARISE and provided as background. The expected outcome of this information sharing between EU projects, with LUH being the nexus, is that a near-complete awareness of the heterogeneus ethical and legal standards across the EU will lead to the establishment of a highest-common-denominator set of standards within ARISE. Additional collection, analysis and dissemination of current regulation and practice will afford the consortium a view of possible inequities and inducements occurring as a result of different health systems, provide all members with a better sense of current norms and, through greater familiarity, aim to lift standards across the consortium.

Research Objectives

ARISE's research objectives are to ascertain the safety and feasibility of the DAH and to establish it as the intervention of choice for a range of diseases and conditions requiring aortic valve replacement. When these objectives are achieved, they will give rise to a significant benefit outweighing the current conventional interventions in these circumstances. This may give rise to a situation where there is a moral imperative to make the superior intervention available to patients, whilst at the same time operating in an environment of scarcity. This is a problem underlying vast parts of health care provision. The ARISE consortium is not in a position to solve these problems, but the addition of the DAH to the treatment portfolio is an augmentation of the available treatment options, significantly to the benefit of patients.

Ethics and Governance Framework

"The ARISE project's Ethics and Governance Council's (EGC) first task was to begin the development of an appropriate governance framework for the project. As the decellularised heart valve was granted a marketing authorisation early on in the project's life, a significant number of ethically challenging aspects of the project ceased to take place in an experimental setting, but became part of the various centres' conventional clinical ethics remit. It would have been inappropriate for the ARISE EGC to second-guess the centres' individual review bodies and work on the framework therefore ceased, with the EGC focusing on more specific downstream issues of DHV deployment. In the interest of transparency and in the spirit of open science, the first working draft of the framework is made available here."