consentiment
Ethical considerations
The basic professional ethical principles are respect for human rights, individual autonomy and freedom. Thus, the use of natural persons for research purposes without them being aware of it or giving their consent is ethically dubious, as it may affect individual rights and freedoms under public international law and be contrary to the principles of Directive (EU) 2016/679, on the protection of natural persons with regard to the processing of personal data and on the free movement of such data.
Any proposal involving the use of data from natural persons must respect the definition for personal data set out in the General Data Protection Regulation: any information relating to an identified or identifiable natural person ('data subject'); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specified to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person.
Much of the research conducted within the fields of social science, psychology and learning science, amongst others, is based on the use of personal data. The solution to the ethical conflict involved in using individuals in research is to achieve compliance; to turn use into participation. In order to accomplish this, data subjects must give their informed consent, this being the only way to ensure their right to autonomy is observed. In other words, potential participants must be informed of the objectives of the research, the types of participation required, the expected results and who is funding the study and by what means. In accordance with this information, potential participants may freely agree to participate in the research and consent to the use of the information or data they provide. They must also be guaranteed the right to interrupt participation and revoke consent at any time, as well as all other rights derived from data protection regulations.
Where the data required to carry out the research or project are insufficient to identify the data subject they shall not be considered as personal data, and thus shall not be affected by data protection regulations. However, in such cases it is ethically advisable that the persons from whom the data will be obtained give their consent, albeit tacit, to participate freely and voluntarily in the study. For this reason, before taking part in the research they should be informed, either orally or in writing, of the objectives and usefulness of the results obtained, and of the voluntary nature of their participation and their right to interrupt it at any time. For instance, participants may fill in a free, anonymous survey in which no personal details are requested. In this case, it is recommended that the title of the study, the name and affiliation of the lead researcher, the type of participation requested, the source of funding for the project and the intended uses of the research results be provided in the heading.
Stylistic considerations
All information addressed to potential participants, both written and oral, should be attractive and presented in plain language. In order to explain the objectives and describe participation requirements, it is advisable that direct, easy-to-understand language be used, and that the recipients are directly addressed. It is also recommendable to avoid technical terms or an excess of information.
The practice of this committee with regard to informed consent since its constitution allows us to set some recommendations for this type of document. Thus, we think it is important that the information and the declaration of consent be in the same document (not on two separate pages), so that both parts cannot be divided. This does not exclude, where necessary, the drawing up of an additional, more extensive information document on the project.
Contents and informed consent forms
There is no single informed consent form. The variety of cases, participant types and study methodologies make it difficult to set a standard informed consent template. Each researcher shall develop the informed consent document that best suits his/her proposal.
In any event, when giving their informed consent, participants must:
- Receive unambiguous information identifying the study, including the project/study title and the name and affiliation of the lead researcher (with his/her contact details).
- Receive information regarding the project, the research objectives, the source of funding and the intended uses of any research results.
- Be informed of the type of participation requested, the data collection method used, the duration, the planned schedule, the number of sessions, etc.
- Authorise the use of the collected information.
- Have the right to interrupt their participation and revoke their consent at any time.
- Be informed of their rights regarding the protection of their personal data.
In order to facilitate the researchers' work, the committee has prepared some informed consent templates, which may be used as a reference to draw up the most appropriate consent for their study.
Special considerations for the participation of minors
In such cases it is necessary to differentiate between the consent or authorisation for the participation of the minor and the consent for the processing of the minor's personal data.
Participation. According to Act 26/2015, of 28th July, on amendment of the protection system for childhood and adolescence, in the modification of article 1263 of the Civil Code, in the case of minors consent of the father / mother or legal guardian shall be required for them to participate in the study.
The minor will be heard if deemed sufficiently mature.
For minors between 12 and 16 years of age whose capacity for understanding is not reduced, the following paragraph must be included in the informed consent document: 'The minor has not expressed any opposition to participating in this research project'.
With regard to health matters, Act 26/2015, of 28th July, on amendment of the protection system for childhood and adolescence, modified section 4 of article 9, which refers to emancipated minors or those over the age of 16 in relation to whom consent may not be granted by representation, except in the case of an action involving severe risk to life or health. (Final provision two. Amendment of Act 41/2002, of 14th November, on basic regulation of patient autonomy and on rights and obligations in matters of clinical information and documentation.)
Personal data processing. According to article 7 of Organic Law 3/2018, of 5th December, on data protection and guarantee of digital rights, and article 7 of Directive (UE) 2016/679 of the European Parliament and of the Council, of 27th April 2016, on the protection of natural persons with regard to the processing of personal data and the free movement of such data:
The processing of the personal data of a child shall be lawful where the child is at least 14 years old. Where the child is below the age of 14 years, such processing shall be lawful only if and to the extent that consent is given or authorised by the holder of parental responsibility over the child.
Special considerations regarding voice or image recordings
Voice and image recording enables identification of the person involved, and thus shall be regarded, for all purposes, as a personal data collection activity.
Participants must give their consent to the researcher for the recording, processing, analysis and custody of these data. Where this is optional, and it is included in the consent document required to participate in the study, participants must be given the choice to give or withhold their consent for the recording and use of their images, which they shall express with a 'yes' or a 'no'.
Special considerations for the organisation of discussion groups
Where the project foresees the organisation of discussion groups, this must be reported in the informed consent document.
Those who participate in the discussion groups must undertake to maintain confidentiality with regard to the opinions and comments expressed in the course of the sessions. This confidentiality commitment may be included in the informed consent document.
Data protection legend for informed consent
'In compliance with the provisions set out in Organic Law 3/2018, of 5th December, on personal data protection and guarantee of digital rights, we hereby inform you that the collected data shall be included in one or more files managed by the UIB in the record of processing activities created expressly for the study 'title of study'. The requested data are required in order to fulfil the aforementioned purpose and, in this sense, failure to provide them would hinder the processing of your request/application.
The UIB is responsible for the processing of data and as such guarantees you the rights of access, rectification, opposition, deletion, portability, limitation of processing and the right not to be subject to automated individual decisions regarding the data provided and processed. To exercise the aforementioned rights, you must write to: the University of the Balearic Islands; Office of the Secretary General; DPO: data protection officer; cra. de Valldemossa, km 7.5, 07122 Palma (Balearic Islands) or you can send an email to <dpo@uib.es>. You also have the right to claim before the Control Authority: <https://www.aepd.es>. Likewise, the UIB undertakes to respect the confidentiality of your data and use them for the purpose for which they were collected.'
For more information on data protection and access to templates, please see: https://seu.uib.cat/LOPDGDD/Models-i-llegendes/