The REC is responsible for validating research protocols for research projects, doctoral theses and other research activities involving human participants and their biological samples (as defined by Law 14/2017, of 3 July, on biomedical research), and where personal health and biomedical data are processed, in accordance with Additional Provision 17 of Organic Law 3/2018 on the protection of personal data and guarantee of digital rights.
The aim is to ensure that the proposed project, thesis or research activity is ethically and legally sound in terms of the methodologies employed. The validation process involves reviewing each submission, assessing whether it meets the necessary criteria for validation, issuing a final decision and safeguarding all documentation generated throughout the process.
The REC operates independently, ensuring the anonymity and confidentiality of personal data, as well as the impartiality and fairness of its decisions.
For this reason, both the REC and the Technical Secretary's Office are also committed to advising, supporting and training researchers and students in the ethical and legal alignment of research methodologies, and to promoting a culture of compliance.
Review procedure for research projects
To request an ethical review of a project, UOC researchers must complete the appropriate form available on the dedicated research staff web page, accessible via the university intranet. There are two forms, and the procedure is as follows:
- Self-assessment/Self-responsibility form.
This applies when the research does not involve human participants or the collection or processing of personal data.
The form contains a checklist covering ethical and personal data protection considerations. If the research raises no issues in these regards, the principal investigator (PI) must sign the section stating this at the end of the form.
- Ethics and data protection protocol form.
This applies when the research involves human participants and the collection and processing of personal data.
The form requires the following information: project objectives; a detailed summary of the methodology (including research procedures, inclusion and exclusion criteria for participants, and other ethical considerations); data collection, processing, storage, retention and deletion procedures; plans for open data publication; and any international data transfers, among other aspects.
- Receipt of the form and review of the information.
The Technical Secretary's Office of the REC receives the form and begins its protocol review. If additional information is required or amendments are necessary, the PI will be notified and must submit the requested information as soon as possible, and no later than two months from the date of notification. If the information is not received within this period, the file will be closed ex officio and shelved, and the requesting party will be informed accordingly.
For projects involving human participants and data collection, the PI may be asked to provide the questionnaire, interview or focus group script so that its ethical aspects can be assessed. Similarly, the PI must submit a draft information sheet and informed consent form tailored to the purpose and objectives of the project, using the university's official template.
- Ethical protocol assessment.
Once the information and documentation have been reviewed and the protocol accepted, the Technical Secretary's Office proceeds with its assessment. This includes verifying compliance with ethical principles, such as the proper handling of personal data to be collected. All documentation and measures are reviewed in coordination with the data protection officer. This final review assesses potential risks posed by the project or study and identifies and proposes appropriate control measures to mitigate them. These security and risk mitigation measures are compiled in a document that accompanies the favourable decision of the assessed protocol.
For complex projects or studies, the Technical Secretary's Office submits the relevant protocol to the REC's monthly meeting for collective review and assessment.
- Discussion of protocols.
The REC meets monthly to assess protocols and discusses in detail those that are particularly complex. A decision is then issued, weighing the identified risks and proposing appropriate measures and controls to mitigate them. All requests assessed by the Technical Secretary's Office are presented at the REC meeting to obtain final approval and a favourable statement.
- Statement and issuance of reports.
Once the meeting has concluded and the issuance of a favourable statement has been approved in the minutes, the Technical Secretary's Office issues the corresponding certificate of ethical compliance. The communication sent to the PI includes the signed statement and, if favourable, the document outlining the tailored security and protection measures designed to mitigate potential risks associated with the research project or study.
Schedule and time frames
The REC meets regularly on a monthly basis. The specific dates of the meetings are posted on the dedicated web page for research staff, accessible via the university intranet.
The time frame for resolving the ethical review process is between one (1) and three (3) months, approximately. However, an initial response is always provided within one (1) month if any information is missing or additional documentation is required.
Favourable decisions are issued within two (2) days of receiving the signed statement from the REC chair.
All time frames indicated in days refer to working days. They do not include Saturdays, Sundays, public holidays or the month of August.