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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).

FAMILY involves human participants, including potentially vulnerable groups and individuals (children in families with intergenerational risk of mental illness).

The research involving human subjects will comply with the WMA Declaration of Helsinki, the CoE Oviedo Convention, and other international documents on human subject research. The non-EU countries being partners in tasks involving human subject research will comply with the EU regulations in addition to their country’s regulation. Both for medical and social sciences research involving human participants the ethics approval will be applied for and obtained from respective research ethics committees in advance in each country.

All consortium members and researchers in FAMILY are committed to the highest research ethics and integrity standards and will conform to the applicable international and EU law, Horizon Europe standards, and to national law in the countries where the project will be carried out. Consortium members will constantly seek advice from ethics experts involved in the consortium, external ethics experts (in the Scientific and Ethical Advisory Board [SEAB]), specialised ethics departments at their institutions and national ethics bodies, compliance managers, research ethics committees and DPOs. WP8 (work package 8: ethical aspects and social consequences of intergenerational transmission of risk and prediction of mental illness) will have the responsibility to coordinate handling previously identified, as well as any new ethical issues arising from the project. Given that ethical regulations are different between consortium member states and institutions, WP8 will also take responsibility for reviewing and advising on ethics issues if brought up by any one of the partners. The Steering Committee will evaluate ethical issues and decide upon actions at least bi-annually but more frequently when needed.

Is informed consent for data sharing and long term preservation included in questionnaires dealing with personal data?

In the process of recruitment, every potential participant will be informed about the planned research and receive an information sheet in their language. Potential research participants will have an opportunity to ask questions about the research project and get them answered. If potential participants will agree to participate in research, they will be asked to sign an informed consent form. Participation will be entirely voluntary, free, and fully informed consent will be obtained from all research participants. For children, parental consent and child’s assent will be obtained according to the legal regulations in each country.
In case of retraction of consent by a study participant, coupled with the wish to delete his/her personal data, all personal data of the participant will be deleted. This will be handled by the site hosting the cohort in which the participant participated, where data deleted within the DRE takes immediate effect for all partners with access.