Informed Consent and data protection

Informed consent from human subject must be obtained and this must be mentioned in the article.
1. Authors should not include identifying patient information, including patients' names, initials, or hospital numbers, in written descriptions, photographs, and pedigrees unless the information is essential for scientific purposes and the patient (or parent/ guardian) gives written, informed consent for publication. 
2. The authors must try to achieve complete anonymity, but informed consent should be obtained if there is any doubt. For example, masking the eye region in photographs of patients is inadequate protection of anonymity. 
3. When informed consent has been obtained, it should be indicated in the published article and a copy of the 'Patient Informed Consent Form' for each patient should be included along with article submission. 
4. Authors should provide written verification that any study participants who are identifiable have been shown the final manuscript to be published and their permission to do so has been obtained.
5. Masked Study Participants- If identifying characteristics are altered to protect anonymity, such as in genetic malformations, authors should provide written assurance to the editors that alterations do not distort scientific meaning.

 

Protection of individual rights and privacy

The rights of subjects should not be infringed. The personal data taken, including clinical or general photographs must be kept safe, protected and used in a manner agreed upon by the subject. Special care must be taken for the data of vulnerable people, such as minors and patients.

No identifying details of the subects, such as names, date of birth, identification numbers of biometrical characteristics, fingerprints, writing style, DNA or any other such personal feature should not be published unless it is essential for scholarly purposes and the participant has given full written and detailed consent to make use of such information. In case of a minor, an adult or a legal guardian should decide and take decisions on such consents. With an aim to maintain complete anonymity, efforts should be made to mask personal information to the best possible extent; nevertheless, the subject must have full right to decide how the information is used. If identifying characteristics are altered to protect anonymity, such as in genetic profiles, authors should provide assurance that alterations do not distort meaning.

 

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. 
 

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.

 

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.

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.