8. Ethical aspects

Are there any ethical or legal issues that can have an impact on data sharing?

These can also be discussed in the context of the ethics review. If relevant, include references to ethics deliverables and ethics chapter in the Description of the Action (DoA). Is informed consent for data sharing and long-term preservation included in questionnaires dealing with personal data?

Guidance - Any ethical or legal issues that can have an impact on data sharing should be presented. Additionally, when the research uses personal data, aspects such as informed consent or long-term preservation should be referred to.

Sample:

There are no personal data, nor any other grounds for confidentiality.

• Sensitive personal data will be handled according to GDPR.
• IP rights will be managed in accordance with the contract drawn up with our industrial partner organization (specify).
• Survey and clinical data will be anonymized, i.e. all possibility to trace the data back to the study participant has been removed. The data is anonymized when the code key is destroyed and it is no longer possible to connect a person to the data.
• Data will be pseudonymized and a key will be kept separately from the data.
• Patient data is pseudonymized by the clinical collaborator and the code is not accessible to researchers in our research group. The material will arrive to research group coded, and the original code will be saved by the collaborators.
• Ethical approvals/amendments and informed consent forms for the project are registered in the diary.
• Consent has been acquired from human participants to process/share data.
• Data Transfer/Processing agreements will be signed prior to any data sharing.
• Results will only be presented on aggregated level without any possibility of backward identification.