Research Ethics and Patient Consent
Statement of Human and Animal Rights
Medical research involving human subjects must be conducted according to the World Medical Association Declaration of Helsinki. If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach, and demonstrate that the institutional review body explicitly approved the doubtful aspects of the study.
Submitted manuscripts should conform to the ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals, and all papers reporting animal and/or human studies must state in the methods section that the relevant Ethics Committee or Institutional Review Board provided (or waived) approval. Please ensure that you have provided the full name and institution of the review committee, in addition to the approval number.
For research articles, authors are also required to state in the methods section whether participants provided informed consent and whether the consent was written or verbal.
Information on informed consent to report individual cases or case series should be included in the manuscript text. A statement is required regarding whether written informed consent for patient information and images to be published was provided by the patient(s) or a legally authorized representative. Please do not submit the patient’s actual written informed consent with your article, as this in itself breaches the patient’s confidentiality. The Journal requests that you confirm to us, in writing, that you have obtained written informed consent but the written consent itself should be held by the authors/investigators themselves, for example in a patient’s hospital record. The confirmatory letter may be uploaded with your submission as a separate file.
Please also refer to the ICMJE Recommendations for the Protection of Research Participants.
Hazards for Human or Animal Subjects
If the work involves chemicals, procedures or equipment that have any unusual hazards inherent in their use, the author must clearly identify these in the manuscript. If the work involves the use of animal or human subjects, the authors should ensure that the manuscript contains a statement that all procedures were performed in compliance with relevant laws and institutional guidelines and that the appropriate institutional committee(s) have approved them. Authors should include a statement in the manuscript that informed consent was obtained for experimentation with human subjects. The privacy rights of human subjects must always be observed.
When reporting experiments on animals, authors have to indicate whether the institutional and national guide for the care and use of laboratory animals was followed.
Research involving human embryos, gametes, and stem cells
Manuscripts that report experiments involving the use of human embryos and gametes, human embryonic stem cells and related materials, and clinical applications of stem cells must include confirmation that all experiments were performed in accordance with relevant guidelines and regulations (See also Research involving human participants and/or animals).
The manuscript should include an ethics statement identifying the institutional and/or national research ethics committee (including the name of the ethics committee) approving the experiments and describing any relevant details. Authors should confirm that informed consent (See also Informed consent) was obtained from all recipients and/or donors of cells or tissues, where necessary, and describe the conditions of donation of materials for research, such as human embryos or gametes. Copies of approval and redacted consent documents may be requested by a Journal Editorial Board.
We encourage authors to follow the principles laid out in the 2016 ISSCR Guidelines for Stem Cell Research and Clinical Translation.
In deciding whether to publish papers describing modifications of the human germline, the Journal is guided by safety considerations, compliance with applicable regulations, as well as the status of the societal debate on the implications of such modifications for future generations. In case of concerns regarding a particular type of study the Journal may seek the advice from the Springer Nature Research Integrity Group.
The decision to publish a paper is the responsibility of the Editor-in-Chief of the Journal.