Ethics requirement report

Copies of ethical approvals by the competent legal localnational Ethics BoardsBodiesadministrations must be submitted to the EASME prior to the commencement of the researchWhen submitting the application for scrutiny to the competent localnational ethical boardsbodies for authorization detailed information must be provided onThe procedures that will be used for the recruitment of participants eg number of participants inclusionexclusion criteria directindirect incentives for participation the risks and benefits for the participants etcThe applicant must confirm the procedures that will be implemented for data collection storage protection retention and destruction and confirmation that they comply with national and EU legislation including the specific provisions on such issue in accordance with the EU legal framework