Informed consent
Informed consent
All individuals have individual rights that are not to be infringed. Individual study participants have, for example, the right to decide what happens to the (identifiable) personal data gathered, to what they have said during a study or an interview, and to any photograph taken. Informed consent is especially true concerning images of vulnerable people (e.g., minors, patients, and refugees) or using images in sensitive contexts. In many instances, authors will need to secure written consent before including images. Identifying details (names, dates of birth, identity numbers, biometrical characteristics (such as facial features, fingerprint, writing style, voice pattern, DNA or other distinguishing characteristics) and other information) of the participants that were studied should not be published in written descriptions, photographs, and genetic profiles unless the information is essential for scholarly purposes and the participant (or parent/guardian if the participant is a minor or incapable or legal representative) gave written informed consent for publication. Complete anonymity is difficult to achieve in some cases. Detailed descriptions of individual participants, whether of their whole bodies or body sections, may lead to the disclosure of their identity. Under certain circumstances, consent is not required as long as the information is anonymized and the submission does not include images that may identify the person. Informed consent for publication should be obtained if there is any doubt. For example, masking the eye region in photographs of participants is inadequate protection of anonymity. If identifying characteristics are altered to protect anonymity, such as in genetic profiles, authors should ensure that alterations do not distort meaning.
Exceptions where it is not necessary to obtain consent:
• Images such as x-rays, laparoscopic images, ultrasound images, brain scans, and pathology slides unless there is a concern about identifying information, in which case, authors should ensure that consent is obtained.
• Reuse of images: If images are being reused from prior publications, the publisher will assume that the prior publication obtained the relevant information regarding consent. Authors should provide the appropriate attribution for republished images.
Consent and already available data and biological material
Regardless of whether material is collected from living or dead patients, they (family or guardian if the deceased has not made a pre-death decision) must have given prior written consent. The aspect of confidentiality and any wishes from the deceased should be respected.
Data protection, confidentiality, and privacy
When biological material is donated, or data is generated as part of a research project, authors should ensure, as part of the informed consent procedure, that the participants are made aware of what kind of (personal) data will be processed, how it will be used and for what purpose. In the case of data acquired via a biobank/biorepository, they may apply a broad consent that allows research participants to consent to a broad range of uses of their data and samples, which research ethics committees regard as specific enough to be considered "informed." However, authors should always check the specific biobank/biorepository policies or any other type of data provider policies (in case of non-bio research) to ensure this is the case.
Consent to participate
For all research involving human subjects, freely given, informed consent to participate in the study must be obtained from participants (or their parent or legal guardian in the case of children under 16), and a statement to this effect should appear in the manuscript.
In the case of articles describing human transplantation studies, authors must include a statement declaring that no organs/tissues were obtained from prisoners and must also name the institution(s)/clinic(s)/department(s) via which organs/tissues were obtained.
For manuscripts reporting studies involving vulnerable groups with the potential for coercion or where consent may not have been fully informed, extra care will be taken by the Editor and may be referred to the Bioethics Committee of the Catholic University of Santiago de Guayaquil.
Consent to publish
Individuals may consent to participate in a study but object to having their data published in a journal article. Authors should also seek consent from individuals to publish their data before submitting their papers to a journal. The consent to publish is, in particular, applicable to case studies.
Summary of requirements
The above should be summarized in a statement and included in a " Declarations " section before the reference list. Other declarations include Funding, Conflicts of interest/competing interests, Ethics approval, Consent, Data and Code availability, and Authors' contribution statements.