Informed Consent
On this page:
- Consent and already available data and/or biologic material
- Data protection, confidentiality and privacy
- Consent to participate
- Consent to publish
- Summary of requirements
All individuals have individual rights that are not to be infringed. Individual participants in studies 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, as well as to any photograph that was taken. This is especially true concerning images of vulnerable people (e.g. minors, patients, refugees, etc) or the use of 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DNA or other distinguishing characteristic) and other information) of the participants that were studied should not be published in written descriptions, photographs, and genetic profiles unless the information is essential for scholarly purposes and the participant (or parent/guardian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 of body sections, may lead to disclosure of their identity. Under certain circumstances consent is not required as long as 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 provide assurance 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, 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/or biologic material
Regardless of whether material is collected from living or dead patients, they (family or guardian if the deceased has not made a pre-mortem decision) must have given prior written consent. The aspect of confidentiality as well as any wishes from the deceased should be respected.
Data protection, confidentiality and privacy
When biological material is donated for 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 what kind of (personal) data will be processed, how it will be used and for what purpose. In case of data acquired via a biobank/biorepository, it is possible they apply a broad consent which allows research participants to consent to a broad range of uses of their data and samples which is regarded by research ethics committees 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 be sure that 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 where there is 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 Springer Nature Research Integrity Group.
Consent to publish
Individuals may consent to participate in a study, but object to having their data published in a journal article. Authors should make sure to also seek consent from individuals to publish their data prior to submitting their paper to a journal. This is in particular applicable to case studies.
Summary of requirements
The above should be summarized in a statement and included in a section entitled “Declarations” before the reference list. Other declarations include Funding, Conflicts of interest/competing interests, Ethics approval, Consent, Data and/or Code availability and Authors’ contribution statements.
Please see the various examples of wording below and revise/customize the sample statements according to your own needs.
Provide “’Consent to participate” as a heading (see template)
Sample statements consent to participate:
- Informed consent was obtained from all individual participants included in the study.
- Informed consent was obtained from legal guardians.
- Written informed consent was obtained from the parents.
- Verbal informed consent was obtained prior tothe interview.
-
The patient has consented to the submission of the case report for submission to the journal.
Provide “’Consent to publish” as a heading (see template)
- The patient has consented to the submission of the case report for submission to the journal.
- The authors affirm that human research participants provided informed consent for publication of the images in Figure(s) 1a, 1b and 1c.
- The participant has consented to the submission of the case report to the journal.
- Patients signed informed consent regarding publishing their data and photographs.
Sample statements if identifying information about participants is available in the article:
- Additional informed consent was obtained from all individual participants for whom identifying information is included in this article.
If any of the sections are not relevant to your manuscript, please include the heading and write 'Not applicable' for that section.
Authors are responsible for correctness of the statements provided in the manuscript. See also Authorship Principles. The Editor-in-Chief reserves the right to reject submissions that do not meet the guidelines described in this section.
Images will be removed from publication if authors have not obtained informed consent or the paper may be removed and replaced with a notice explaining the reason for removal.
