Introduction to AREB
The Advisory Regulatory Ethics Board (AREB) has been established to provide EJP RD with the proper strategy to address ethical and regulatory issues. The mandate of the AREB is to provide project partners with advice on the regulatory procedures to be followed and ethical provisions to be taken in every EJP RD activity for the whole duration of the project. The main aim is to provide the best guidance for ethically-sound and regulatory-compliant multi-national research and therewith to contribute to the protection of patients’ rights.
The Advisory Regulatory Ethics Board:
- collaborates with the Funding of collaborative research, through the ethics monitoring of the Joint Transnational Calls in order to ensure that all ethics requirements are fulfilled before the start of the funded research projects and to perform periodic monitoring activities to confirm that all the activities are performed in line with the applicable ethics and regulatory provisions
- collaborates with the Networking Support Scheme, the Rare Disease Research Challenges, the ERN Research Mobility Fellowship & Research Training Workshop calls, and the Demonstration projects on existing statistical methodologies to improve RD clinical trials, through the ethical evaluation of the proposals submitted to those calls to contribute that all ethics requirements are fulfilled.
- collaborates with the Virtual Platform of Data and Resources in the framework of Use Cases activities with particular reference to the Use Case on Informed Consent and Data Access
- provides guidance on ethical and regulatory issues to the EJP RD partners upon request
- has representatives participating in Global Alliance for Genomics and Health (GA4GH) Regulatory & Ethics workstream (REWS) activities on behalf of EJP RD
- advises pilot project/proof of concept foreseen in the Virtual Platform of Data and Resourcers and the Research Translation and Clinical Studies support Office activities on their regulatory- and ethical compliance and that they will properly address patient rights and the necessary regulatory procedures
- ensures that the ethics management activities are carried out within the H2020 framework in collaboration with the Ethics Advisor and with WP21 Ethics
- advises for data handling carried out in the Virtual Platform of Data and Resources and the Research Translation and Clinical Studies support Office and the projects funded in compliance with GDPR and national laws, including requirement for special declarations or authorisations
- updates the EJP RD consortium partners on the advancements, changes and news from the regulatory, ethical and legal framework on regular basis through internal newsletters and channels and during the yearly Consortium meeting
The Ethics and Regulatory support is provided to EJP RD partners only.