Research ethics amd ethical oversight
Research involving human subjects
When reporting on research that involves human subjects, human material, human tissues, or human data, authors must declare that the investigations were carried out following the rules of the Declaration of Helsinki of 1975 (https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/), revised in 2013. According to point 23 of this declaration, an approval from the local institutional review board (IRB) or other appropriate ethics committee must be obtained before undertaking the research to confirm the study meets national and international guidelines. As a minimum, a statement including the project identification code, date of approval, and name of the ethics committee or institutional review board must be stated in Section ‘Institutional Review Board Statement’ of the article.
Example of an ethical statement: "All subjects gave their informed consent for inclusion before they participated in the study. The study was conducted in accordance with the Declaration of Helsinki, and the protocol was approved by the Ethics Committee of XXX (Project identification code)."
For non-interventional studies (e.g. surveys, questionnaires, social media research), all participants must be fully informed if the anonymity is assured, why the research is being conducted, how their data will be used and if there are any risks associated. As with all research involving humans, ethical approval from an appropriate ethics committee must be obtained prior to conducting the study. If ethical approval is not required, authors must either provide an exemption from the ethics committee or are encouraged to cite the local or national legislation that indicates ethics approval is not required for this type of study. Where a study has been granted exemption, the name of the ethics committee which provided this should be stated in Section ‘Institutional Review Board Statement’ with a full explanation regarding why ethical approval was not required.
A written informed consent for publication must be obtained from participating patients. Data relating to individual participants must be described in detail, but private information identifying participants need not be included unless the identifiable materials are of relevance to the research (for example, photographs of participants’ faces that show a particular symptom). Patients’ initials or other personal identifiers must not appear in any images. For manuscripts that include any case details, personal information, and/or images of patients, authors must obtain signed informed consent for publication from patients (or their relatives/guardians) before submitting to an MDPI journal. Patient details must be anonymized as far as possible, e.g., do not mention specific age, ethnicity, or occupation where they are not relevant to the conclusions. Editors reserve the right to reject any submission that does not meet these requirements.
You may refer to our sample form and provide an appropriate form after consulting with your affiliated institution. For the purposes of publishing in Adv Clin Exp Med, a consent, permission, or release form should include unlimited permission for publication in all formats (including print, electronic, and online), in sublicensed and reprinted versions (including translations and derived works), and in other works and products under open access license. To respect patients’ and any other individual’s privacy, please do not send signed forms. The journal reserves the right to ask authors to provide signed forms if necessary.
If the study reports research involving vulnerable groups, an additional check may be performed. The submitted manuscript will be scrutinized by the editorial office and upon request, documentary evidence (blank consent forms and any related discussion documents from the ethics board) must be supplied. Additionally, when studies describe groups by race, ethnicity, gender, disability, disease, etc., explanation regarding why such categorization was needed must be clearly stated in the article.
Ethical guidelines for the use of animals in research
The editors will require that the benefits potentially derived from any research causing harm to animals are significant in relation to any cost endured by animals, and that procedures followed are unlikely to cause offense to the majority of readers. Authors should particularly ensure that their research complies with the commonly-accepted '3Rs':
- Replacement of animals by alternatives wherever possible,
- Reduction in number of animals used, and
- Refinement of experimental conditions and procedures to minimize the harm to animals.
Authors must include details on housing, husbandry and pain management in their manuscript.
For further guidance authors should refer to the Code of Practice for the Housing and Care of Animals Used in Scientific Procedures, American Association for Laboratory Animal Science or European Animal Research Association.
If national legislation requires it, studies involving vertebrates or higher invertebrates must only be carried out after obtaining approval from the appropriate ethics committee. As a minimum, the project identification code, date of approval and name of the ethics committee or institutional review board should be stated. Research procedures must be carried out in accordance with national and institutional regulations. Statements on animal welfare should confirm that the study complied with all relevant legislation. Authors are responsible for correctness of the statements provided in the manuscript.
If ethical approval is not required by national laws, authors must provide an exemption from the ethics committee, if one is available. Where a study has been granted exemption, the name of the ethics committee that provided this should be stated with a full explanation on why the ethical approval was not required.
If no animal ethics committee is available to review applications, authors should be aware that the ethics of their research will be evaluated by reviewers and editors. Authors should provide a statement justifying the work from an ethical perspective, using the same utilitarian framework that is used by ethics committees. Authors may be asked to provide this even if they have received ethical approval.
Adv Clin Exp Med endorses the ARRIVE guidelines (arriveguidelines.org/) for reporting experiments using live animals. Authors and reviewers must use the ARRIVE guidelines as a checklist, which can be found at https://arriveguidelines.org/sites/arrive/files/documents/ARRIVE%20Compliance%20Questionnaire.pdf. Editors reserve the right to ask for the checklist and to reject submissions that do not adhere to these guidelines, to reject submissions based on ethical or animal welfare concerns or if the procedure described does not appear to be justified by the value of the work presented.
- NSW Department of Primary Industries and Animal Research Review Panel. Three Rs. Available online: https://www.animalethics.org.au/three-rs
- Home Office. Animals (Scientific Procedures) Act 1986. Code of Practice for the Housing and Care of Animals Bred, Supplied or Used for Scientific Purposes. Available online: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/388535/CoPanimalsWeb.pdf
- American Association for Laboratory Animal Science. The Scientific Basis for Regulation of Animal Care and Use. Available online: https://www.aalas.org/about-aalas/position-papers/scientific-basis-for-regulation-of-animal-care-and-use
- European Animal Research Association. EU regulations on animal research. Available online: https://www.eara.eu/animal-research-law
Research involving cell lines
Methods sections for submissions reporting on research with cell lines should state the origin of any cell lines. For established cell lines the provenance should be stated and references must also be given to either a published paper or to a commercial source. If previously unpublished de novo cell lines were used, including those gifted from another laboratory, details of institutional review board or ethics committee approval must be given, and confirmation of written informed consent must be provided if the line is of human origin.
An example of Ethical Statements:
The HCT116 cell line was obtained from XXXX. The MLH1+ cell line was provided by XXXXX, Ltd. The DLD-1 cell line was obtained from Dr. XXXX. The DR-GFP and SA-GFP reporter plasmids were obtained from Dr. XXX and the Rad51K133A expression vector was obtained from Dr. XXXX.
Clinical trials registration
Registration
Adv Clin Exp Med follows the International Committee of Medical Journal Editors (ICMJE) guidelines which require and recommend registration of clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication.
Purely observational studies do not require registration. A clinical trial not only refers to studies that take place in a hospital or involve pharmaceuticals, but also refer to all studies which involve participant randomization and group classification in the context of the intervention under assessment.
Authors are strongly encouraged to pre-register clinical trials with an international clinical trials register and cite a reference to the registration in the Methods section. Suitable databases include clinicaltrials.gov, the EU Clinical Trials Register and those listed by the World Health Organisation International Clinical Trials Registry Platform.
Approval to conduct a study from an independent local, regional, or national review body is not equivalent to prospective clinical trial registration. Adv Clin Exp Med reserves the right to decline any paper without trial registration for further peer-review. However, if the study protocol has been published before the enrolment, the registration can be waived with correct citation of the published protocol.
CONSORT statement
Adv Clin Exp Med requires a completed CONSORT 2010 checklist and flow diagram as a condition of submission when reporting the results of a randomized trial. Templates for these can be found here or on the CONSORT website (http://www.consort-statement.org) which also describes several CONSORT checklist extensions for different designs and types of data beyond two group parallel trials. At minimum, your article should report the content addressed by each item of the checklist.
Sex and gender in research
We encourage our authors to follow the ‘Sex and Gender Equity in Research – SAGER – guidelines’ and to include sex and gender considerations where relevant. Authors should use the terms sex (biological attribute) and gender (shaped by social and cultural circumstances) carefully in order to avoid confusing both terms. Article titles and/or abstracts should indicate clearly what sex(es) the study applies to. Authors should also describe in the background, whether sex and/or gender differences may be expected; report how sex and/or gender were accounted for in the design of the study; provide disaggregated data by sex and/or gender, where appropriate; and discuss respective results. If a sex and/or gender analysis was not conducted, the rationale should be given in the Discussion.
Borders and territories
Potential disputes over borders and territories may have particular relevance for authors in describing their research or in an author or editor correspondence address, and should be respected. Content decisions are an editorial matter and where there is a potential or perceived dispute or complaint, the editorial team will attempt to find a resolution that satisfies parties involved.
Adv Clin Exp Med stays neutral with regard to jurisdictional claims in published maps and institutional affiliation.
Image integrity
Images submitted with a manuscript for review should be minimally processed. No specific feature within an image may be enhanced, obscured, moved, removed, or introduced. The grouping or consolidation of images from multiple sources must be made explicit by the arrangement of the figure and in the figure legend. Adjustments of brightness, contrast, or color balance are acceptable if they are applied to the whole image and if they do not obscure, eliminate, or misrepresent any information present in the original, including backgrounds.
Unprocessed data files may be requested to help in manuscript evaluation during the peer review process or may be needed to respond to post-publication issues that may arise with published papers. Unprocessed data and metadata files should be retained, ideally forever.
Authorship and AI tools – COPE position statement
The use of artificial intelligence (AI) tools, such as ChatGPT or Large Language Models, in research publications is expanding rapidly. COPE joins organisations, such as WAME and the JAMA Network among others, to state that AI tools cannot be listed as an author of a paper.
AI tools cannot meet the requirements for authorship, as they cannot take responsibility for the submitted work. As non-legal entities, they cannot assert the presence or absence of conflicts of interest nor manage copyright and license agreements.
Authors who use AI tools in the writing of a manuscript, production of images or graphical elements of the paper, or in the collection and analysis of data, must be transparent in disclosing in the Materials and methods (or similar section) of the paper how the AI tool was used and which tool was used. Authors are fully responsible for the content of their manuscript, even those parts produced by an AI tool, and are thus liable for any breach of publication ethics.
The above statement has been published by the Committee on Publication Etics (COPE) and is available on the official website of COPE: