Human Research

Please note: The policies described on this page apply to all submissions to SAFE Journal of One Health.

Summary of Requirements

All researchers submitting studies that involve human participants must satisfy the following requirements:

Secure prior ethical approval for the research from an institutional review board (IRB) or an equivalent ethics committee.
Provide documentation from the review board or ethics committee confirming approval of the research. Any information that could identify study participants must be removed from this document before it is submitted to the journal.
Confirm at submission that the study was conducted in compliance with the ethical standards set out in the Belmont Report and/or the Declaration of Helsinki, as applicable.
Name the review board or ethics committee that approved the research, and supply the approval number where one was issued.
State how informed consent was obtained for the research, or explain the circumstances under which consent was not obtained.
Refrain from including identifying information unless it is essential for the submission. Where an identifiable individual appears in the submission, confirm that the individual has provided written consent for the use of that information.
For clinical trials, include trial registration details, the study protocol, and CONSORT documentation.

These requirements apply to research involving human participants as well as studies using human specimens and data, unless the study qualifies as exempt under applicable IRB or ethics committee regulations.

Complete the Human Participants Checklist and submit it alongside your manuscript. Also review the submission guidelines for studies involving human participants research.

Compliance and Policy Enforcement

All submissions describing clinical research or research involving human participants will be reviewed to verify that the requirements outlined above have been met. Failure to satisfy these requirements may be grounds for rejection. Where issues come to light after a manuscript has been published, a correction or retraction may be issued as appropriate. The journal also reserves the right to contact the author's institution.

Alignment with International Ethical Frameworks

All research involving human participants, biospecimens, or data must be conducted in accordance with the ethical principles set out in the Belmont Report.

Clinical investigations must additionally be conducted in line with the principles expressed in the Declaration of Helsinki.

Classification and Description of Human Groups

Where a study involves the classification of human participants by race, ethnicity, age, disease or disability, religion, sex, gender, sexual orientation, or other socially constructed groupings, authors must:

Clearly describe the methods and criteria used to recruit and classify human populations.
Define each category in as much detail as the study protocol allows.
Justify the choice of definitions and categories — including, for example, whether any rules of human categorisation were required by the funding agency.
Explain whether, and if so how, the researchers controlled for confounding variables such as socioeconomic status, nutrition, environmental exposures, or comparable factors in their analysis.

Current and appropriate terminology must be used when referring to human participants and population groups. Outdated terms and potentially stigmatising labels must not be used. Person-first language should be adopted when writing about individuals with diseases, disorders, or other conditions, except for communities that prefer identity-first terminology as their current standard. See https://www.nih.gov/nih-style-guide/person-first-destigmatizing-language for further guidance.

Examples of preferred terminology

"White" or "of [Western] European descent" (as appropriate) should be used rather than "Caucasian".
"People with [name of disease, condition, or disorder]" should be used in place of terms such as "diabetics", "cancer victims", or "lepers".

Clinical Trials

The journal adopts the World Health Organization's (WHO) definition of a clinical trial:

A clinical trial is 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. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, and preventive care.

The journal's policies for clinical trial submissions are designed to encourage transparency and reproducibility, and to protect the integrity of reporting for patient-centred trials. Compliance with these policies is required at submission in order for a manuscript to proceed.

Editors and reviewers are expected to carefully evaluate trial protocols and registration details, and to assess manuscripts against CONSORT or other applicable guidelines. Most clinical trial submissions will also be assessed by a statistician.

Any concerns about a clinical trial submission should be raised with the editorial office at the earliest opportunity.

Trial Registration

All trials submitted to the journal must be entered in a publicly accessible registry approved by the WHO or ICMJE. A list of approved registries is available.

Prospective trial registration — that is, registration completed before the enrolment of participants has begun — is considered best practice, as recommended by the ICMJE. Trials that had begun enrolling participants before ICMJE recommendations came into effect on 1 July 2005 may be registered retrospectively.

Further information about trial registration, including the WHO definition of a clinical trial, is available in the ICMJE FAQ.

Authors who wish to submit a clinical trial that was not registered in a publicly accessible registry before participant enrolment began must register the trial retrospectively in such a registry. They must also:

Register all related clinical trials and confirm this has been done in the Methods section.
State in the Methods section the specific reasons for not registering before participant enrolment began.
Confirm that all future trials will be registered prospectively.

The editorial team may decline to consider any clinical trial for which, in the editor's assessment, the absence of prospective registration raises concerns about selective publication or selective reporting of research outcomes.

The journal supports the public disclosure of all clinical trial results, as required — for example, by the 2007 FDA Amendments Act. Prior disclosure of results on a clinical trial registry site will not affect a manuscript's consideration for publication.

Required Documentation for Clinical Trials

Clinical trial reports must adhere to the relevant reporting guidelines for their study design, including CONSORT for randomised controlled trials, TREND for non-randomised trials, and other applicable specialised standards.

All clinical trial submissions must include the following:

Registration details (to be reported in the Abstract).
The CONSORT checklist or the relevant reporting guideline checklist (uploaded as supporting information).
The CONSORT flow diagram (uploaded as Fig 1).
The trial protocol (uploaded as supporting information).
Documentation of prior approval for human subjects research by an IRB or equivalent ethics committee.

Submissions that do not provide this documentation will not be considered. The checklist, flow diagram, and protocol will be published alongside the article if the manuscript is accepted.

The manuscript must also include the following information:

An account of any deviations from the trial protocol.
A description of how informed consent was obtained from participants.
Any information on statistical methods or participant characteristics not captured in the CONSORT documentation.

The journal reserves the right to request a blank sample copy of any forms used in the trial.

Refer to the submission guidelines for further information about submitting clinical trials.

Participant Privacy and Publication Consent

The journal is committed to protecting the anonymity of research participants and takes all necessary steps to safeguard the privacy of those who take part in research.

Authors must refrain from including identifying information unless it is strictly necessary for the submission. Where a submission includes information that identifies, or could potentially identify, patients or other participants, authors must confirm that the individual concerned has provided written consent for the use of that information, in accordance with the Consent Form for Publication in SAFE Journal of One Health.

Consent forms are available for download in the following languages:

All submissions are screened for evidence of patient consent for publication and for any potentially identifying information. Submissions that include identifying patient information without the appropriate patient consent will not be considered for publication.

Where identifying information is discovered after a manuscript has been published, or if it becomes known that an individual's personal information was published without their consent, the journal will remove the relevant content as necessary to ensure that the individual's privacy and data are protected. Details of changes made in this context will be treated as confidential and will not be disclosed in a public notice.

Additional guidance on preparing clinical data for publication can be found in the journal's Data Availability policy.

Cell Lines Derived from Human Tissue

For newly established (de novo) cell lines originating from human tissue, authors must confirm that they obtained approval from an institutional review board or equivalent ethics committee, and that consent was obtained from the donor or their next of kin.

Refer to the journal's research reporting standards for further details on reporting the use of cell lines.

Manuscripts involving cell lines are reviewed at the point of initial submission. Those that do not satisfy the requirements for cell line research will be rejected. Problems concerning cell line identity, ethical oversight, or possible contamination that come to light after publication may lead to a correction or retraction.

Editors and reviewers are expected to assess cell line information during peer review and to notify the journal if any concerns arise.

Contact

Authors with questions about research involving human participants are welcome to contact the Editorial Office.

Editorial Office — SAFE Journal of One Health
Published by The SAFE Society Publishing
Email: editor@thesafesociety.com
Website: https://journal.thesafesociety.com