WP6 Regulatory and Ethical considerations

Lead participant: European Vaccine Initiative
This WP will ensure that materials utilised and conduct of activities meet with appropriate regulatory considerations for the level of development, and that materials utilised in all activities to generate the outcomes and deliverables of the project are collected according to accepted ethical guidelines. Additionally, this WP will also explore the formulation of informed consent forms in a standard way for clinical trials to enable the potential utilisation of leftover specimens for future immuno-assays that are later found to be useful for gathering further information on potentially important immune responses.
Key activities will include:
  • Identification of potential regulatory issues or questions by the work package teams
  • Identification of potential ethical issues by the work package teams
  • Compiling current informed consent templates from partners and considering the relevant issues in the process to enable and ensure the ability to plan for and ethically utilize leftover specimen samples for relevant analysis
  • Discussion with various IRB experts and ethics authorities on the issue of use of leftover blood specimens to clarify the issues and ensure that ethical and normative guidelines are adhered to in all OPTIMALVAC activities.