HBM4EU will comply with all relevant ethics requirements, both at the level of the European Union and at national level.
A webinar on ethics and data management requirements under HBM4EU will be held on 12 June 2017. For details, please see our training page.
Ethics requirements that apply to the types of work that may be undertaken in the context of HBM4EU are summarised below.
When working with humans:
1. Information must be provided on whether adults unable to give informed consent will be involved and, if so, justification for their participation must be provided.
2. Information must be provided on how consent/assent will be ensured with respect to the participation of children and -if applicable- adults unable to give informed consent
3. If vulnerable individuals/groups will be involved, details must be provided about the measures taken to prevent the risk of enhancing vulnerability and/or stigmatization of individuals/groups.
4. With respect to participants, who have indicated on the consent form that they want to receive their individual results, the applicants must take into consideration potential detrimental socioeconomic disadvantages such information can have for participants when they want to apply for private health insurance, life insurance or occupational disablement insurance, and inform the participants on such issue accordingly in the informed consent forms.
When working with human cells and/or tissues:
1. In case human cells/tissues are obtained within the project, details on cells/tissues type and ethics approval must be provided.
2. In case human cells/tissues are obtained within another project, details on cells/tissues type and authorisation by primary owner of data (including references to ethics approval) must be provided.
3. In case of human cells/tissues stored in a biobank, details on cells/tissues type must be provided, as well as details on the biobank and access to it.
With respect to data protection:
1. A number of identifiers, related to the environment in which the data was collected could, if merged, open the way to re-identification. These aspects must be considered and adequately documented by the applicants, in particular with respect to enabling data access to tier groups of data users at different levels of aggregation.
2. A document must be provided stating that all planned measures for data management comply with national and EU legislation, in particular with Regulation EU 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data.
3. Copies of the notifications/approvals/opinions/authorisations from the relevant data protection authorities for the proposed data collection and processing as well as re-use must be provided prior to any data treatment, this being electronic or other.
4. Detailed information on the informed consent procedures that will be implemented with regard to the collection, storage and protection of personal data must be submitted on request.
5. Detailed information must be provided on the procedures that will be implemented for data collection, storage, protection, retention and destruction and confirmation that they comply with national and EU legislation.
6. Templates of the informed consent forms and information sheets must be submitted on request.
When performing research on animals:
1. Copies of relevant authorisations (for breeders, suppliers, users, and facilities) for animal experiments must be submitted.
2. Copies of project authorisation (covering also the work with genetically-modified animals, if applicable) must be submitted.
3. In case research protocols are not defined, general information must be kept by the beneficiary in the project files on the nature of the experiments, the procedures to ensure the welfare of the animals, and how the Principle of the Three Rs will be applied. This information must be provided upon request.
4. Detailed information must be provided on why living animals have to be used as well as on which species and why that species has been chosen. In addition, information should be given on the numbers of animals to be used in experiments, the nature of the experiments, the procedures that will be carried out and their anticipated impact (e.g. potential for pain, suffering, distress) and how that has been minimised. Furthermore, details should be provided on what procedures have been implemented to ensure the welfare of the animals during their lives (e.g. husbandry, minimising harms, criteria for humane endpoints, inspection protocols). The applicant should provide evidence of awareness of relevant European legislation and regulations covering animal experimentation and that the Principle of the Three Rs will be rigorously applied.
5. If applicable, copies of the training certificates and/or personal licenses of the staff involved in animal experiments must be provided.
For additional information, please see the Horizon 2020 guidance on how to complete your ethics self assessment