Research ethics and consent

All research published in The Journal must have been conducted according to international and local guidelines ensuring ethically conducted research.

Research involving humans

All research studies on humans (individuals, samples or data) must have been performed in accordance with the principles stated in the Declaration of Helsinki. Prior to starting the study, ethical approval must have been obtained for all protocols from the local Institutional Review Board (IRB) or other appropriate ethics committee to confirm the study meets national and international guidelines for research on humans. A statement to confirm this must be included within the manuscript, which must provide details of the name of the ethics committee and reference/permit numbers where available.

For non-interventional studies (e.g. surveys), where ethical approval is not required (e.g. because of national laws) or where a study has been granted an exemption by an ethics committee, this should be stated within the manuscript with a full explanation.

Non-stigmatizing and non-discriminatory language should be used when describing different groups by race, ethnicity, age, disease, disability, religion, sex, gender, sexual orientation, etc.

Ethics approval for all studies must be obtained before the research is conducted. Authors must be prepared to provide further information to the journal editorial office upon request.

Study design specific ethics considerations

Prospective studies on humans

Where the research involves an intervention (e.g. a clinical trial), participants must provide informed written consent to be part of the study. A statement to confirm this must be included within the manuscript.

Clinical trials

In addition to the required informed written consent (as stated above), clinical trial protocols must also be registered in a publicly accessible registry prior to participant recruitment. The public registry must be open to all prospective registrants and managed by a not-for-profit organization. The trial registration number must be included in the manuscript.

Case reports

Given the specificity of details provided in a case report, case series or clinical dataset authors are required to obtain consent from patients (or their guardians if they are not adults or lack capacity to provide informed consent, or next of kin if deceased) for the publication of the case(s). This must be done even if the authors have removed direct identifiers and authors are advised to adhere to CARE guidelines in order to ensure all key details about the case are reported. A statement confirming consent to publish has been obtained must be included within the manuscript.

Organ or tissue transplants

The Journal endorses the ethics guidelines described by the World Health Organisation (WHO), the World Medical Association (WMA) and the Declaration of Istanbul. Specifically, all studies involving transplantation of donated human organs should be conducted with ethical approval from an appropriate committee, and all sources of donor tissue must be provided in the submitted manuscript. Authors must be able to verify that donated organs were obtained with full informed consent from the donor or their next of kin if the donor is deceased. Consent must have been given with free will, under no coercion or bribery of any kind. Authors must include a statement within the manuscript to specify the source of transplanted organs and must include a statement to confirm informed consent was obtained. This applies for all studies (including follow-up studies) involving donors, or patients who have received organ or tissue transplantation.

Human embryos and human stem cells

Authors of research reporting the use of human embryos, human embryonic stem cells (including clinical applications of stem cells) and related materials, must include a statement within the manuscript to confirm that all experiments were performed in accordance with all safety considerations, ethical guidelines and applicable regulations. Authors must be able to verify that all recipients and/or donors of stem cells or tissues (or their next of kin if the donor is deceased) provided full informed consent. Specifically, authors must include a statement within the manuscript to provide details of the name of the ethics committee(s) which approved the study and include the reference/permit numbers where available, and must include a statement to confirm informed consent was obtained.

The Journal endorses the principles on ethical stem cell research outlined in the ISSCR Guidelines for Stem Cell Research and Clinical Translation.

Consent from children, adolescents and vulnerable or incapacitated study participants

Written informed consent must be obtained from the parent or guardian of any participants who are not able to provide full informed consent themselves. Age of legal adulthood is determined by the country in which study participants are based, which is typically between ages 16-18. A statement to confirm informed consent has been obtained must be included within the manuscript.

In settings where verbal informed consent has been obtained rather than written informed consent, this must be explained and stated within the manuscript.

Retrospective studies

Researchers must confirm they have obtained ethical approval from an institutional or local ethics review board, to conduct the study, as well as permission from the dataset owner to use the information in databases/repositories for the purposes of the research they are conducting. Where permission to use information from a database/repository is not required (e.g., where it is publicly available and unrestricted re-use is permitted via an open licence), a statement needs to be included that states the study proposal was reviewed by an institutional or local review board, the name of the ethics board, and that the need for ethics approval had been waived. If any exemption for requiring ethics approval for a database study has been based on organizational policies, these policies need to be mentioned in a statement in the manuscript in addition to the name of the organization. Data acquired must be kept anonymized unless otherwise advised by the owners of the content in the database. If this has been approved by the owners of the content in the database, a statement outlining this should also be included in the manuscript. Where participants’ details are not required to be anonymized, authors must be able to provide evidence that written informed consent, including consent to publish, was obtained from each participant. A statement to confirm this must be included in the manuscript.

Survey studies

Researchers must ensure they have informed all participants why the research is being conducted, whether or not anonymity is assured, and how the data they are collecting is being stored. The participant’s right to confidentiality should always be considered and they should be fully informed about the aims of the research and if there are any risks associated. Their voluntary consent to participate should be recorded and any legal requirements on data protection should be adhered to. As with all research studies, ethics approval from an appropriate IRB/local ethics committee must be obtained prior to conducting study. A statement to confirm this must be included within the manuscript. In settings where ethics approval for survey studies is not required, authors must include a statement to explain this within the manuscript.

Participant/patient privacy and informed consent

The Journal endorses the recommendations of the International Committee of Medical Journal Editors (ICMJE) which emphasizes that patients and study participants have a right to privacy that should not be infringed without informed consent. In accordance with the principles outlined in the Nuremberg Code and the Belmont Report, informed consent must be voluntarily obtained from the participant who should be informed of the study including any of the benefits and risks involved.

Consent to participate

For all studies involving human participants informed written consent to take part in the research must have been obtained prior to the commencement of the study, and a statement to confirm this must be included in the manuscript.

If only verbal informed consent was obtained, a full explanation for why this was not obtained in written form should be included, along with the name of the IRB/local ethics committee which gave approval for verbal consent. A statement of how this was documented must also be included in the manuscript.

For patients or study participants who are not adults or are considered to be vulnerable or unable to provide informed consent, this must then be obtained from their legal guardians.

Where participant data have been anonymised, this should be clearly stated within the manuscript with a note to confirm that such alterations have not distorted the scholarly meaning.

Research involving animals

Experiments involving vertebrates or regulated invertebrates, field studies and other non-experimental research on animals must have been carried out in accordance with institutional, national or international guidelines, and with approval of an appropriate ethics committee where available.

Where applicable, a statement of ethics approval, or animal licenses should be included within the manuscript. Where a study has been granted an exemption from requiring ethical approval, this should be stated along with the name of the ethics committee which provided the exemption, and the reasons for the exemption.

For non-human primate studies, it must be demonstrated the work meets the standards set out in the NC3Rs primate’s guidelines and follows best practice procedures. For experimental studies involving client-owned animals, authors must also document informed consent from the client or owner and adherence to best practices of veterinary care.

The Journal endorses the principles on ethical animal research outlined in the Basel Declaration and the ethical guidelines by the International Council for Laboratory Animal Science (ICLAS). The Journal advises all authors conducting animal research to read NC3Rs ARRIVE guidelines. The guidelines set out the currently accepted procedures for the reporting of research using animals and are available in a number of translations.