The American Association of Immunologists and its journals, The Journal of Immunology and ImmunoHorizons, are committed to the ethical use of animals, humans, and their associated data. To that end, all ethical statements regarding animal and human samples should be stated within the Materials and Methods.
All research involving regulated animals (i.e., all live vertebrates and higher invertebrates) must have been reviewed and approved by an Institutional Animal Care and Use Committee prior to commencing the study and must be performed in accordance with relevant institutional and national guidelines and regulations. The journals of The American Association of Immunologists (AAI) follow the International Association of Veterinary Editors guidelines for publication of studies involving animal research. Pre-clinical studies involving animals and interventions outside of routine care require ethics committee oversight as per the American Veterinary Medical Association (AVMA).
The editors encourage authors to explore and practice methods that follow the 3Rs:
1. Replacement – use of substitutes for animals in a study when they exist;
2. Reduction – use of methods that enable researchers to obtain comparable levels of information from fewer animals, or to obtain more information from the same number of animals;
3. Refinement – use of methods that alleviate or minimize potential pain, suffering, or distress, and enhance animal welfare for the animals used.
Laboratory animals: For all laboratory animal experimentation described in the manuscript, the editors require that authors state in the Materials and Methods their adherence to the NIH Guide for the Care and Use of Laboratory Animals or the equivalent, and that they obtained the appropriate animal care and use approvals from their institution. Additionally, species, strain, sex, age, origin, care (including pain reduction and humane euthanasia procedures), and housing of laboratory animals must be detailed in the Materials and Methods.
Wild or temporarily captive animals: Methods and approaches should meet the requirements of the United States Animal Welfare Act or the equivalent. Researchers must state that the work has been approved by their institutional animal care and use committee and they should strive to meet all requirements recommended by scientific societies (e.g., mammalogical, ornithological, herpetological, ichthyological, etc.) focused on the specifics of their study organism(s).
Genetically modified animals: Authors must meet the above stated guidelines for laboratory animals. To avoid confounding effects of inbred strain background, littermate controls should be used when necessary. Depending on the type of experiments, particularly the use of inducible gene-targeting, use of littermate controls might be necessary. Justification for other control animals should be included. Authors should fully describe the source of their animals and the number of times backcrosses were performed.
Humane endpoints: All manuscripts describing studies where death is an endpoint will be subject to additional ethical considerations. The editors also recommend consulting the AVMA Guidelines for the Euthanasia of Animals (2020), as a comprehensive resource for guidance on veterinary best practices for the anesthesia and euthanasia of animals. AAI reserves the right to reject manuscripts lacking appropriate justification.
All human studies must be conducted in compliance with institutional and national policies and guidelines, such as the U.S. Food and Drug Administration Policy for the Protection of Human Subjects or Medical Research Council guidelines and must be approved by the authors’ institutional review board (IRB). A statement to this effect with the number and name of the approved IRB(s) must be included in the Materials and Methods section. All investigations with human subjects must be conducted according to the principles expressed in the World Medical Association Declaration of Helsinki and must include a statement that informed consent was obtained from all subjects.
Clinical trials: The World Health Organization defines a clinical trial as "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes." In accordance with the Clinical Trial Registration Statement from the International Committee of Medical Journal Editors (ICMJE), all clinical trials must be registered in a public trials registry at or before the onset of participant enrollment. To meet the requirements of the ICMJE, clinical trials can be registered with any Primary Registry in the WHO Registry Network or an ICMJE approved registry. Authors should provide the trial registration number in the Acknowledgments section and provide a link to the trial registration, to be cited as a reference.
Clinical trial reports should be compliant with the Consolidated Standards of Reporting Trials (CONSORT) by including a flow diagram presenting the enrollment, intervention allocation, follow-up, and data analysis with number of subjects for each and taking into account the CONSORT Checklist of items to include when reporting a randomized clinical trial. The recommended trial flow diagram may be presented as a figure (usually Figure 1). Reports of randomized controlled trials that do not conform to the CONSORT guidelines may be returned to authors for revision prior to formal review.
Identifiable human data: AAI follows the International Committee of Medical Journal Editors (ICMJE) recommendations on the protection of research participants, which states that patients have a right to privacy that should not be violated without informed consent. The editors require nonessential identifiable details to be omitted from all manuscripts and written informed consent will be required if there is any doubt that anonymity can be maintained.
It is the responsibility of the researchers and authors to ensure that these principles are complied with, including the obtaining of written informed consent for publication of any potentially identifiable data or images. Written informed consent can be documented on a form provided by an institution or ethics committee, and it must clearly state how the identifiable data will be used and meet ICMJE recommendations. The editors consider it to be the author’s duty to ensure patient understanding of the ICMJE guidelines, prior to patient completion of the consent form. Study participants should also be encouraged to ask any questions and to ensure they are comfortable before they sign the consent form.
The completed consent forms should be stored by authors or their respective institutions, in accordance with institutional policies. The determination of what constitutes identifiable data lies with our editors, and manuscripts may be rejected if the required consent documents cannot be provided.
Studies involving vulnerable groups: For manuscripts reporting studies involving vulnerable groups where there is the potential for coercion or where consent may not have been fully informed, extra care will be taken by the editor. The manuscript may be referred to an internal editorial oversight group for further scrutiny. Consent must be obtained for all forms of personally identifiable data including biomedical, clinical, and biometric data. Documentary evidence of consent must be supplied if requested.
Human biospecimens: For describing human biospecimens, the editors recommend referring to the Biospecimen Reporting for Improved Study Quality (BRISQ) reporting guidelines and ensuring at least Tier 1 characteristics are provided. Any biospecimens obtained and used from a biorepository should have proper consent.
Studies involving human embryos, gametes, and stem cells
Manuscripts that report experiments involving the use of human embryos, gametes, human embryonic stem cells, or related materials and clinical applications of stem cells must include confirmation that all experiments were performed in accordance with relevant guidelines and regulations.
The manuscript must include an ethics statement identifying the institutional and/or licensing committees approving the experiments and describing any relevant details. The ethics statement must also confirm that 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 the editors.
The editors encourage authors to follow the principles laid out in the 2016 ISSCR Guidelines for Stem Cell Research and Clinical Applications of Stem Cells. Editors are guided by these principles in their evaluation of the ethical and regulatory aspects of the reported research. When appropriate, ethical and regulatory advice may be sought in parallel with the scientific peer review process.
In deciding whether to publish papers describing modifications of the human germline, the editors are 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.
For manuscripts considered to be in press or approved for publication, the public release of information should not precede the actual publication of the work. The publication date is defined as the date the article is posted online. This embargo policy protects the peer-review process and the newsworthiness of the scientific content of published articles, and minimizes the chance for the appearance of misinformation in the lay press. The policy also ensures that scientists have access to all relevant information at the same time as the public. These restrictions do not apply to the presentation of the work at scientific conferences or symposia that precede the actual publication date. Although news reporters may be present at such meetings or symposia, information, tables, or illustrations that in any way duplicate the content of a manuscript submitted for publication or in press should not be provided to reporters by the authors. In particular, press conferences should not be held before the embargo date. The official release of videotape presentations and electronic prepublication of articles on the Internet should adhere to the embargo policy. Violations of these policies are legitimate grounds for withdrawal of the manuscript from publication or other measures that AAI may choose to take.
AAI will evaluate the credibility of all allegations of scientific misconduct, e.g., suspected fabrication or falsification of data, double publication, or plagiarism. If the Editors-in-Chief determine that an allegation has merit, they will first attempt to address the matter with the Corresponding Author. Should that fail to resolve the situation satisfactorily, the Editors-in-Chief will contact the institution of the Corresponding Author to request an investigation; the Editors-in-Chief may also contact the co-authors and/or the funder(s) of the published research.
Until the matter is clarified, no additional submissions by any author of the disputed manuscript or published article will be considered for publication. If scientific misconduct is confirmed by the institution, and no request for retraction is made either by the institution or by any author, the Editors-in-Chief will report their findings to a representative of the AAI Publications Committee, and in consultation with a representative of the AAI Council, will decide appropriate action.
Only the Corresponding Author, co-authors, and appropriate representative(s) of the relevant institution(s) will be apprised of the status of, or any action(s) taken in response to, allegations of scientific misconduct.