Ethical Issues and Data Protection
If access to data is restricted for ethical reasons or because the data must be protected, the manuscript must include:
- a description of the restrictions related to the data;
- the opinion of the ethics committee or other competent body regarding data publication; and
- how readers or reviewers can request access to the data and the conditions under which access will be granted.
Data Protection
To protect the privacy of participants, research data must not be published if it is not possible to effectively remove personally identifiable information from the dataset, unless individuals have provided explicit written consent for the public release of data containing personal information.
- If the data cannot be made publicly available, the manuscript must include a justification for why data protection is necessary.
- It must include related data from which personally identifiable information can be removed.
- It must state the opinion of the ethics committee or other competent body regarding data publication.
- It must describe how readers or reviewers can request access to the data and the conditions under which access will be granted.
In addition, the addresses where the data are stored must be indicated in the Data Availability Statement within the submitted manuscript. If the data are not available, the statement should explain why. Depositing data related to a manuscript submitted for publication entails the following:
- The repository in which the data are deposited must be thematically appropriate and sustainable.
- Data must be deposited under an open license that allows unrestricted access (e.g., CC0, CC-BY). More restrictive licenses should be used only if there is a justified reason (e.g., legal).
- Deposited data must include a version in an open, non-proprietary format.
- Deposited data must be labeled so that a third party can understand it (e.g., reasonable column headers, descriptions in a readme text file).
- Research involving human subjects, human material, or data about human subjects must be conducted in accordance with the Declaration of Helsinki. In certain cases, studies must have approval from the relevant Ethics Committee. The identity of research subjects should be anonymous whenever possible. For research involving human subjects, informed consent from participants (or their legal guardians) is required.