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Elsevier policies

Research ethics

Human research

Guidelines and approvals

If the work involves human participants, living or deceased, including their data and/or biological materials (e.g. organs, tissues), the author should ensure that all studies were performed in compliance with relevant laws, regulations, and institutional guidelines and that the appropriate institutional committee(s) has/have approved them. The authors should include a statement in the manuscript that confirms these requirements have been met. The statement should contain the date and reference number of the ethical approval(s) obtained (for exempt studies, see below).

Research involving human participants should be carried out in accordance with the World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Participants and any other guidelines that are specific to the relevant discipline(s) and type(s) of research.

Informed consent

Informed consent must be obtained for research with human participants, including their data or biological materials. Consent must be given without coercion, and the privacy rights of human participants must always be observed. Authors should include a statement in the manuscript confirming that they obtained informed consent from all participants or their parent, guardian, or other individual with legal authority to act on their behalf (“Legal Representative”) where applicable. Consent for publication should also be obtained.

Appropriate written consents, permissions and releases must be obtained where an author wishes to include case details, videos, recordings, images, photographs, and illustrations (or any other identifiable form) of patients and any other individuals in an Elsevier publication (see “Consent requirements for case reports, personal information, and images” below). 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.

For research with human participants where only verbal informed consent was obtained, authors should include justification for the absence of written consent, the name of the approving ethics committee, and a statement on how verbal consent was recorded. Authors should be aware that written (or electronic) consent is required for certain studies under national laws, including but not limited to clinical trials, case studies, studies with vulnerable populations, and studies that contain any personally identifiable data.

Research with vulnerable populations

Authors should ensure that appropriate consents and safeguards are in place for research with vulnerable populations, including but not limited to children, refugees and other displaced persons, minorities, indigenous peoples, members of the LGBT+ community, migrant laborers, persons with disabilities, older adults, and any persons lacking capacity to consent (“Vulnerable Populations”).

In many countries, additional ethical approval may be needed for research with those who lack the capacity to consent (e.g. children or those with mental health or neurological conditions including dementia). It is the responsibility of the author to ensure that all laws and regulations are appropriately followed, and that written consent was obtained from the participants’ Legal Representatives. Where possible, the participants should also give their assent to be included in the research.

A statement must be included in the manuscript detailing that the necessary consents and safeguards were in place, and that all laws and regulations were appropriately followed.

Human biological material

For all studies that use human organs or tissues, sufficient evidence must be provided that these were procured in line with WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation. The source of the organs or tissues used in clinical research must be transparent and traceable and must not be sourced from executed prisoners or prisoners of conscience, consistent with recommendations by Global Rights Compliance on Mitigating Human Rights Risks in Transplantation Medicine. If a manuscript describes organ transplantation, the authors must additionally declare within the manuscript that:

  • Autonomous consent free from coercion was obtained from the donor(s) or their next of kin.

  • Organs and/or tissues were not sourced from executed prisoners or prisoners of conscience.

Exempt studies

All studies involving human participants require an ethical statement (including surveys, sensory studies, and case reports). If ethical approval is not required by national laws or where a study has been granted an exemption from an ethics committee, the statement must explain why the study is exempt and confirm that the appropriate protocols for protecting the rights and privacy of all participants were utilized during the execution of the research (e.g. no coercion to participate, full disclosure of study requirements and risks, consent of participants (or their Legal Representatives), no release of participant data without their knowledge, etc.).

Consent requirements for case reports, personal information, and images

Appropriate written consents, permissions, and releases must be obtained where authors wish to include case details, videos, recordings, images, photographs, and illustrations (or any other identifiable form) of patients and any other individuals, living or deceased, in an Elsevier publication in order to comply with all applicable laws and regulations concerning the privacy and/or security of personal information. This includes, but is 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, and 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. For case reports, authors are also required to follow CARE guidelines and provide the CARE checklist at manuscript submission.

It is the responsibility of the author to ensure the following:

  • Each individual, or the individual’s Legal Representative, must give their explicit written and fully informed consent.

  • Each individual, or the individual's Legal Representative, should be made aware in advance of:

    • any photographs, videos, recordings, images, illustrations, or reports are 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.

  • 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 must comply with all applicable Data Protection and Privacy Laws.

  • Particular care should be taken with obtaining fully informed consent without coercion where Vulnerable Populations are concerned (see “Research with Vulnerable Populations” above).

  • In the case of a child, if parents or guardians disagree on the use of videos, recordings, photographs, images, illustrations, or case reports of that child, then consent should be deemed not to have been given and those materials should not be used.

  • In the case of deceased persons that did not previously provide consent, consent should be obtained from the nominated Legal Representative(s).

  • 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 article so that, where possible, the individual is properly informed in advance of the potential extent of the publicity and can make an informed decision about participation.

Identifiable information

Care should be taken to de-identify participant specific information.

  • Patients' and research participants’ 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 participants should only be used if 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 anonymized).

  • If consent has not been obtained, it is not sufficient to anonymize a photograph by using eye bars or blurring the face of the individual concerned.

Animal research

All animal experiments should comply with the ARRIVE (Animal Research: Reporting of In Vivo Experiments) guidelines (or national equivalent) and should be carried out in accordance with relevant laws and associated guidelines for animal welfare. This may include the U.K. Animals (Scientific Procedures) Act 1986; the EU Directive 2010/63/EU on the protection of animals used for scientific purposes; the National Research Council Guide for the Care and Use of Laboratory Animals; or those of an equivalent internationally recognized body.

Authors must ensure that the manuscript contains a statement that confirms which guidelines have been followed. This statement should include the ethics committee approval number, when available. If a study was granted exemption or did not require ethics approval, a statement detailing this should be included in the manuscript.

The sex of animals, and where appropriate, the influence (or association) of sex on the results of the study should be indicated.

Where applicable, researchers are encouraged to document informed consent from the client or owner in studies involving client-owned animals and adhere to best practices of veterinary care. For research on threatened and/or endangered species, authors are advised to consult international best practice guidelines such as the International Union for Conservation of Nature (IUCN) Policy Statement on Research Involving Species at Risk of Extinction and IUCN red list guidelines.

Please consult the journal’s Guide for Authors for journal-specific guidelines on animal studies.