Patient consent
Requirement for consent
Appropriate consents, permissions and releases must be obtained where authors wish to include case details or other personal information or images of patients and any other individuals in an Elsevier publication in order to comply with all applicable laws and regulations concerning the privacy and/or security of personal information, including, but not limited to, the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") and other U.S. federal and state laws relating to privacy and security of personally identifiable information, the General Data Protection Regulation (GDPR) (EU) 2016/679 and member state implementing legislation, Canada's Personal Information Protection and Electronic Documents Act, India's Information Technology Act and related Privacy Rules, (together "Data Protection and Privacy Laws").
Elsevier does not provide a standard form since the specific requirements will vary between different jurisdictions and different institutions. It is the responsibility of the author to ensure that:
Each individual, or the individual's legal guardian or other person with legal authority to act on the individual's behalf, who appears in any video, recording, photograph, image, illustration or case report (or in any other identifiable form) is made aware in advance of:
the fact that such photographs are being taken or such video, recording, photograph, image, illustration or report is being made, and
all the purposes for which they might be used, including disclosure to Elsevier and use by Elsevier or its licensees in any work or product and in promotional or publicity materials for those works or products. Individuals should also be made aware that individual images from such works or products may be discoverable via search engines.
That individual, legal guardian or person with legal authority must give his/her explicit written and fully informed consent.
If such consent is made subject to any conditions (for example, adopting measures to prevent personal identification of the person concerned), Elsevier must be made aware in writing of all such conditions. Individuals must be informed that such consent cannot be revoked once the material has been published. Written consents must be retained by the author and copies of the consents or evidence that such consents have been obtained must be provided to Elsevier on request, but these should not be sent to Elsevier unless specifically requested in writing.
The form of written consent complies with each requirement of all applicable Data Protection and Privacy Laws. Particular care should be taken with obtaining fully informed consent without coercion where children are concerned, where an individual has cognitive or intellectual disabilities, where an individual's head or face appears, where reference is made to an individual's name or other personal details, or with other vulnerable groups or individuals.
In the case of a child, if parents or guardians disagree on the use of the images of that child, then consent should be deemed not to have been given and those images should not be used.
Even if consent has been obtained, care must be taken to ensure that the portrayal and captioning of the individual concerned are respectful and could not be seen as denigrating that individual.
Special care should also be taken where there is a strong likelihood of extensive media coverage of a particular case report so that the individual is properly informed in advance of the potential extent of the publicity and can make an informed decision about participation.
Special considerations
Patients' and research subjects' names, initials, hospital or social security numbers, dates of birth or other personal or identifying information should not be used.
Images of patients or research subjects should not be used unless the information is essential for scientific purposes and explicit permission has been given as part of the consent. Even where consent has been given, identifying details should be omitted if they are not essential.
If identifying characteristics are altered to protect anonymity, authors should provide assurances that such alterations do not distort scientific meaning.
Non-identifiable images
Formal consents are not required for the use of entirely anonymized images from which the individual cannot be identified- for example, x-rays, ultrasound images, pathology slides or laparoscopic images, provided that these do not contain any identifying marks and are not accompanied by text that might identify the individual concerned. Although formal consents are not required, it is good practice and a matter of courtesy for the author to inform the patient that their images will be used in a scientific publication. (This does not apply to case reports where informed consent is always required whether or not the images are anonymised).
For case reports, while details that might identify a patient, or that might enable a patient to identify him or herself, should be eliminated, complete anonymity cannot always be guaranteed and therefore informed consent should be obtained for all case reports. This also applies for case reports of deceased persons where consent should be obtained from the nominated representative(s) if it was not provided by the individual. If consent has not been obtained, it is generally not sufficient to anonymize a photograph simply by using eye bars or blurring the face of the individual concerned.