Research involving human participants
The journal requires that all research involving human participants complies with the applicable national and international ethical standards, namely:
- Declaration of Helsinki (WMA);
- COPE Guidelines;
- European and Portuguese legislation applicable to data protection and research involving human subjects.
Requirements for manuscripts involving human participation
Authors must declare in the manuscript:
- prior approval by an institutional ethics committee or equivalent;
- the informed consent process obtained from participants;
- the measures adopted to protect privacy, anonymity, and data security;
- how situations of participant vulnerability were addressed;
- how data storage and confidentiality were ensured, including recordings, transcripts, and associated documentation.
Informed consent
Must include:
- clear information on objectives, methods, risks, and benefits;
- consent for audio or video recording, when applicable;
- assurance that participation is voluntary and may be withdrawn without penalty.
Where a potential participant is unable to give free and informed consent, the consent of the legally authorised representative must be obtained. Whenever the participant is able to give assent, this must also be sought, and their refusal must be respected.
Data protection and anonymisation
Authors must:
- remove names, locations, and references that allow identification;
- explain how data were anonymised;
- comply with the General Data Protection Regulation and applicable Portuguese legislation.
Exemptions
Where research does not involve human participants, such as documentary analysis or the use of secondary data, ethical approval may not be applicable, and authors should state this in the manuscript. Where the data allow individuals to be identified or other ethical implications arise, the relevant institutional and legal rules apply.
