Work package 8: Ethics requirements
Lead: University of Oslo
The objective of WP8 is to:
- Ensure compliance with the ethics requirements set out in this work package.
Description of work
This work package sets out the ethics requirements that the project must comply with. These include:
- Clarifying whether new blood samples will be collected from patients during this project. If new blood samples are to be collected, then the relevant approvals together with informed consent templates must be provided.
- Confirming that a Data Protection Officer (DPO) has been appointed and the contact details of the DPO are made available to all data subjects involved in the research. For host institutions not required to appoint a DPO under the GDPR a detailed data protection policy for the project must be submitted as a deliverable.
- Explaining how all of the data they intend to process is relevant and limited to the purposes of the research project (in accordance with the ‘data minimisation ‘principle). This must be submitted as a deliverable.
- Describing the security measures that will be implemented to prevent unauthorised access to personal data or the equipment used for processing must be submitted as a deliverable.
- Explicitly confirming, for case of further processing of previously collected personal data, that the beneficiary has lawful basis for the data processing and that the appropriate technical and organisational measures are in place to safeguard the rights of the data subjects must be submitted as a deliverable.
- As human samples will be obtained from another project, obtaining permission for their use from the co-ordinator of that project, together with confirmation that informed consent has been obtained for the re-use of the samples. This must be kept on file and submitted upon request.
- As human samples will be obtained from biobanks, keeping on file and submitting upon request details on the cell/tissue types, and on the biobank and on access to it.
- Keeping on file and submitting upon request details on the materials which will be imported to/exported from the EU.
- Submitting copies of import/export authorisations, as required by national/EU legislation as a deliverable.
Published Jan. 25, 2022 11:17 AM - Last modified Jan. 25, 2022 11:17 AM