Ethics framework
PoCCardio has issued a Statement of Ethics which includes an ethics monitoring and data privacy framework with four defining Ethical Principles: Respect for Persons, Beneficence, Justice, and Confidentiality & Data Protection which are relevant particularly for the clinical trials.
The ethics monitoring and data privacy framework consists of several internal procedures, protocols, and tools which will facilitate the project management of implementing and monitoring compliance with ethical and legal frameworks. Together, this ensures a uniform approach for the management of the ethical dimensions of the project across all work packages and clinical trial sites.
Ethics Board
PoCCardio has also established an Ethics Board which will have a key role in advising and supporting the project in taking the appropriate action to resolve ethical issues reported by project partners, trial participants or other stakeholders. In additional to members affiliated with the project partners, two external experts have been appointed who will bring an external perspective and better objectivity on the issues at hand. While the Ethics Board is not a decision-making body, the project is committed to take their advice seriously.
