Informed consent

Informed consent based on clear information about the aims and implications of the research is an instrument for involving research subjects in the project and must be obtained in all cases. This consent must include, among others, the use of images, personal data, transfer of this data to third parties (especially if these are in non-EU countries), open-access publication of the basic data after the project has ended, and freedom to withdraw from the project without explanation and without consequences of any type.

When obtaining written consent could run counter to the objectives of the research, as in the case of illiterate or vulnerable groups, oral consent may be obtained provided the same criteria of information and personal autonomy are applied to the participants. Such oral consent must be safeguarded in the same way as signed consent and its traceability must be ensured.
 

In online surveys, even if they are anonymous, consent will be collected through explicit action by the participant indicating that they agree to participate. These records must be kept separately and under security measures.

The following are some examples of informed consent documents. Each informed consent proposal may specify additional conditions:

• Sample informed consent form (for people over 18)
• Sample informed consent form: (Parents and/or legal guardians involved minors)
• Sample informed consent form: minors
• Models for exercising the rights of interested parties
• Sample informed consent form: biobanks, generic
• Sample informed consent form: biomedicine
• Sample informed consent from: animal owners

See also:

• Example of an oral script (University of Oxford)
• Ponència conjunta membres de la CEEAH “El consentimiento informado en investigaciones sobre poblaciones vulnerables y/o culturalmente diversas” i Pòster