How do we make sure that we maintain high ethical standards in publishing? By including clear statements in support of results reported in articles. Here is guidance, with examples of sample statements, for:
All studies involving humans, for example including patients, their samples, data or any other study involving human participants must be evaluated by a suitably qualified research ethics committee prior to undertaking the research in line with the Declaration of Helsinki.
All studies involving people, whether patients or research participants, must be evaluated by a qualified research ethics committee prior to undertaking the research in line with the Declaration of Helsinki.
Ethics statements should be included in the methods section of all relevant submissions (unless the journal you’re submitting to publishes them under a separate heading – the journal’s submission guidelines will make this clear) and must include the name and location of the review board, approval number and date, as in the examples below.
These examples can be used If ethics approval was obtained:
This study was approved by the XXXX Research Ethics Committee (approval no. XYZ123) on Month DD, YYYY.
This study received ethical approval from the XXXX IRB (approval #XYZ123) on Month DD, YYYY.
Examples of ethics approval statements suitable for different scenarios:
The XXXX Ethics Review Committee at XXXX University approved our interviews (approval: XYZ123) on Month DD, YYYY. Respondents gave written consent for review and signature before starting interviews.
This study received ethical approval from the XXXX IRB (approval #XYZ123) on Month DD, YYYY. This is an IRB-approved retrospective study, all patient information was de-identified and patient consent was not required. Patient data will not be shared with third parties.
The study was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of XXXX (no. XYZ123) on Month DD, YYYY, with the need for written informed consent waived.
This study was conducted in accordance with the Declaration of Helsinki. Approval was granted on Month DD, YYYY. The Institutional Review Board (IRB) at XXXX acted as the central IRB, whose review was accepted by all participating institutions’ IRBs (Ref. XYZ123). The central IRB determined that this research involved minimal risk and approved a waiver for informed consent.
This study was approved by the Ethics Committee of XXXX University (Ethics Code: XYZ123) on Month DD, YYYY. All participants provided written informed consent prior to enrolment in the study. This research was conducted ethically in accordance with the World Medical Association Declaration of Helsinki.
The ethics review committee of the XXXX University approved this study on Month DD, YYYY. Number: XYZ123. Date: Month DD, YYYY. Written informed consent for inclusion in this research was obtained from the patients prior to surgery.
The experimental protocols were approved by the Institutional Review Board (IRB) of the XXX University (No. XYZ123) on Month DD, YYYY. All research activities complied with ethical regulations and were performed in accordance with regulations of each hospital. Informed consent to use histopathological samples and pathological diagnostic reports for research purposes was obtained from all patients prior to surgery. They were given the option to refuse to participate by opting out.
These examples can be used if ethics approval and patient consent were waived:
The Ethics Committee of the XXXX waived the need for ethics approval and patient consent for the collection, analysis and publication of the retrospectively obtained and anonymised data for this non-interventional study.
The study was approved by the Danish Data Protection Agency. According to Danish legislation, neither ethics approval nor patient consent is required for registry linkage studies [23].
Ethical approval to report this case (or case series) was obtained from *name of ethics committee or institutional review board (approval number/ID) *.
Our institution does not require ethical approval for reporting individual cases or case series.
In all cases, it’s important to state that consent has been granted to use any personal information, and how that consent has been gathered. Informed consent includes three key components:
For research articles, you need to state in the methods section whether the participants provided written or verbal informed consent. This statement should include whether the participants provided consent to conduct the study, publish the study, and have their photos or other images used. If information has been anonymized, that should be clearly stated too. If you are publishing on an open access basis, patients or participants must be aware that the article will be available to anyone with an internet connection.
The American Psychological Association (APA) recommends that for those who are legally incapable of giving informed consent, researchers should:
If the law doesn’t permit or require a legally authorized person to provide consent, you’ll need to show that you’ve taken reasonable steps to protect the individual's rights and welfare. Participants should be informed about:
You can access Sage’s Participant Consent Form here. Authors should not submit completed consent forms alongside the manuscript files unless specifically requested to do so, owing to potential legal/privacy issues with sending and receiving confidential information. Instead, they should confirm in the relevant section of the – e.g. manuscript – text that the individual(s) or their proxy has provided written informed consent for the publication of this information in the present work.
Ethnographic research requires similar ethics approvals from an International Review Board or independent local, regional, or national review body as well as participant consent to conduct and publish the research. Consent should obtained before the research is conducted and it should be part of the project design, implementation, and other parts of the research process. Consultation with groups or communities affected by the studies and consideration of their input on the study design should happen throughout the entire research period. If consent is not obtained before the study perhaps because of the research context, process, or researcher/participant relations, you can seek to obtain it retroactively if necessary.
Participants should also understand that there is a possibility that confidentiality might be compromised, despite best efforts. This is especially important to note for small communities where participants may be more easily identifiable.
Examples below if consent was obtained:
1. Written informed consent
The study was approved by the XXXX (Ethical Clearance Reference Number: XYZ123) on Month DD, YYYY. All participants provided written informed consent prior to participating.
Written informed consent was obtained from a legally authorised representative for anonymised patient information to be published in this article.
2. Verbal informed consent
Informed consent was obtained verbally before participation. The consent was audio-recorded in the presence of an independent witness.
3. Patient consent for studies involving minors
Written informed consent to participate in this study was provided by the participants’ legal guardians/next of kin.
4. Patient or participant consent for use of images including faces
Written informed consent was obtained from the individual(s) for the publication of any potentially identifiable images or data included in this article.
If patient consent was not obtained:
Informed consent for information published in this article was not obtained because [please state the reason].
All studies involving animals, particularly vertebrate animals, must be evaluated by a qualified animal ethics or welfare committee. Ethics statements should include the name and location of the reviewing committee, approval number and date, as in these examples:
Protocols for animal experiments were approved by the Animal Experimental Ethics Committee of the XXXX University (Approval no. XYZ123) on Month DD, YYYY, in compliance with the National Institutes of Health guidelines for the care and use of laboratory animals.
All animals were cared for in strict accordance with the Guide for the Care and Use of Laboratory Animals (NIH Publication No. 85-23, revised 1996), and the experimental design was approved by the Ethics Committee of XXXX (Approval no. XYZ123) on Month DD, YYYY.
If IACUC approval was obtained you can use the example below:
The XXX Institutional Animal Care and Use Committee approved the experimental procedures used in this study (approval no. XYZ123) on Month DD, YYYY.
An example on animal welfare:
All animal housing and experiments were conducted in strict accordance with the institutional Guidelines for Care and Use of Laboratory Animals at [insert name of institution where the research was conducted and/or where the author is based].
These statements can be used in situations where a study did not involve human or animal participants as well as non-research articles such as reviews:
This article does not contain any studies with human or animal participants.
There are no human participants in this article and informed consent is not required.
If your article reports on global research, you should follow the TRUST Code. We recommend including a statement in your methods section describing how your work adheres to the Articles in the Code. Some journals may require a statement under the separate heading ‘Global research ethics and inclusion’ at the end of your article. This should cover the following:
We also recommend the guidance provided by Consensus statement on measures to promote equitable authorship in the publication of research from international partnerships (Morton, B. et al, 2022).
