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:
- Replacement – use of substitutes for animals in a study when they exist;
- 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;
- 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.
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 Editor-in-Chief determines that an allegation has merit, s/he will first attempt to address the matter with the Corresponding Author. Should that fail to resolve the situation satisfactorily, the Editor-in-Chief will contact the institution of the Corresponding Author to request an investigation; the Editor-in-Chief may also contact the coauthors 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 Editor-in-Chief will report his/her 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, coauthors, 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.
Authors are expected to retain the original, raw data presented in a published article for the length of time required by the authors’ funding source or institution; if the institution or funding source does not have a data retention policy, then data should be kept for at least 6 years after publication (as per HHS guidelines). Authors must submit original data upon the request of reviewers or editors.
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 first copy is mailed from the printer or the first day the article is posted online. Please note that the issue date and mail dates do not necessarily coincide. 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 article from publication or other measures that AAI may choose to take.
All funding sources must be disclosed in a footnote to the title; anonymous or pseudonymous funders are not permitted.
Any potential conflict of interest in a submitted manuscript must be disclosed in the "Conflict of Interest Statement" section of the online submission system.
Authors of submitted papers that contain information affecting actual or potential commercial products must declare any conflict of interest or financial interest in the product or in potentially competing products held by them, their spouses, or their minor children. Financial interests include consultancies, employment, service on Board of Directors, honoraria, royalties, research support, grants, or contracts, if any exceed $5,000 per year in any of the preceding 5 years. They also include expert testimony, or patents received or pending, stock, and equity interests (diversified mutual funds or investment trusts do not constitute competing financial interests). The conflict should be stated briefly on the online manuscript submission screen, e.g., "J. B. Doe has received royalty payments from PQR Incorporated."), It is the responsibility of the Corresponding Author to review this policy with all authors and to list collectively the relevant relationships.
All disclosures will remain confidential during the review process, but papers accepted for publication will acknowledge conflict of interest and financial interests in a published disclaimer describing the nature of the interests. If authors declare no conflict of interest or financial interests, this also will be noted in a published disclaimer.
Figures in manuscripts considered for acceptance will be screened for evidence of manipulation. Manuscript acceptance is contingent upon a satisfactory outcome of the screening process. As a result of screening, authors may be asked to supply the original (raw) data upon which the figures were based. Inability to supply the original data may result in rejection of the manuscript. If the editors deem that the manipulation has affected the interpretation of the data, the manuscript will be rejected for publication. Cases of suspected misconduct may be referred to the institution of the Corresponding Author; the Editor-in-Chief may also contact the coauthors and/or the funder(s) of the research. Please see the Digital Images section on the Information for Authors page for more information.
As of April 7, 2008, the U. S. National Institutes of Health (NIH) requires that manuscripts accepted for publication and that describe research funded in whole or in part with NIH funds be deposited into the NIH PubMed Central (PMC) repository.
AAI views this policy as a costly, duplicative effort that diverts federal dollars from biomedical research. For more information about how publishing in The Journal of Immunology relates to the policy, please see the Funding Body Public Access Policy FAQ.
Despite AAI's serious concerns about these policies, AAI has undertaken to help authors comply with them. On behalf of authors who are funded by NIH, AAI will deposit all articles that begin submission to The Journal of Immunology after 10 AM (EDT) March 29, 2011, and are ultimately accepted for publication; the author must select this option on the online submission form in order for AAI to do so. AAI will deposit the version of the manuscript that has undergone peer review and has been accepted for publication, before copyediting and formatting.
NIH mandates that articles be made available to the public in PMC at 12 months after publication; manuscripts deposited by AAI will comply with this embargo period. Authors will receive at least two email notifications from PMC about their manuscripts. Authors must respond to both emails in order for the process to be completed.
In addition to NIH, a number of additional funding agencies also mandate submission to PMC/Europe PMC. AAI will also deposit on behalf of authors funded by HHMI, Wellcome Trust, and MRC-UK; for details, see "Archiving in PMC/Europe PMC".
This free service is not applicable to authors who are not funded by NIH, HHMI, Wellcome Trust or MRC-UK.
Authors agree not to deposit the manuscript to any other repository (except a thesis repository if required), agency, or entity.
Other Funding Agencies:
Authors funded by agencies other than NIH, HHMI, Wellcome Trust and MRC-UK that mandate submission to PMC must deposit the accepted version of the manuscript themselves.
Authors funded by agencies that mandate submission to PMC with public access within 6 months after publication must sign the 6 month-PMC Submission Form during the online submission process.
Submission of a manuscript to The Journal of Immunology (The JI) implies that the content has not been published previously and will not be submitted for publication elsewhere while the manuscript is under review. The JI considers research results (excluding abstracts and student dissertations) to have already been published if they are publicly available with a fixed content, i.e., content is in an unalterable form and are citable in any language.
Previous publication of a particular figure may not prevent subsequent publication in The JI if that figure is essential to the submitted paper and does not constitute the major contribution. Previously published portions of a paper must be accompanied by a permission release from the copyright holder and must be cited.
Preprints, whether paper copies or postings on a publicly accessible Web site, are not considered publications, nor are poster presentations of work at a conference. Authors who post to a preprint site must retain copyright of the work. Authors who post to a preprint site should identify the preprint server and include the accession number or DOI in their cover letter. Manuscripts posted to the bioRxiv preprint server can be directly transferred to The JI for peer review, without the need to re-upload files or re-enter information at The JI submission site. To transfer a preprint, click the “Submit preprint to a journal” link on your bioRxiv page, and select The Journal of Immunology from the dropdown menu. If The JI publishes the manuscript, authors should request the preprint server to acknowledge publication and cite the journal reference (including the DOI to link to the published article).
An invited paper published in a non-peer-reviewed journal, however, would be considered a prior publication.
Submissions of previously published research, as defined by the criteria, must contain a disclosure statement; it is at the Editor-in-Chief's discretion whether to allow peer review of the work in these instances.
It is required that unique materials developed for manuscripts published in The JI that are not available from commercial supplier, will be made available, within reason, to qualified investigators for their own noncommercial use. An agreement to this effect is included in the Manuscript Submission Form. A reasonable amount may be charged by authors to cover preparation and shipping of the requested material.
Any restrictions on sharing of materials (for example, Material Transfer Agreements or patents) that apply to unique materials developed for the manuscript must be disclosed in the Materials and Methods section of the paper.