Informed consent
Informed consent documents, which include comprehensible information about the objectives and implications of research, are an instrument for research subjects to be able to co-participate in research and must be collected in all cases.
These informed consent documents must include the use of images, personal data, transfer of data to third parties (especially if they are used in countries outside the European Union), the eventual publication of open access basic data once the project is finished, the ability to withdraw from research without providing an explanation and without consequences of any kind, among other issues.
In cases where obtaining written consent can be counterproductive to the research objectives, such as among illiterate or vulnerable populations, it is possible to obtain oral consent if the same criteria relating to the information and autonomy of the participants are respected. These oral consents must be safeguarded in the same way as signed consent forms and their traceability guaranteed.
In the case of online surveys, even if they are anonymous, consent must be explicitly obtained from the participant indicating that they agree to participate. These records must be kept separately and securely.
Informed consent models
Useful information
- Exercici dels drets de les persones interessades This link opens a new window
- Generic informed consent Biobanks This link opens a new window
- Oral script example (University of Oxford) This link downloads a document
- Presentation by CERec members "The IC in research on vulnerable and/or culturally diverse populations" This link opens a new window
- Bulletin of the Asociación de Comités de Ética de la Investigación (ANCEI) This link opens a new window