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Author Instructions
3. Research and Publication Ethics

3.1 Research Involving Human Subjects
All studies involving human subjects must be in accordance with the Helsinki Declaration and seek approval to conduct the
study from an independent local, regional, or national review body (e.g., ethics committee, institutional review board, etc.).
Such approval, including the names of the ethics committee, institutional review board, etc., must be listed in a declaration
statement of Ethical Approval and Consent to Participate in the manuscript. If the study is judged exempt from ethics
approval, related information (e.g., name of the ethics committee granting the exemption and the reason for the exemption)
must be listed. Further documentation on ethics should also be prepared, as Editors may request more detailed information.
Manuscripts with suspected ethical problems will be investigated according to COPE Guidelines.

3.1.1 Consent to Participate
For all studies involving human subjects, informed consent to participate in the studies must be obtained from participants,
or their parents or legal guardians for children under 16. Whenever possible, consent should be written. Statements regarding
consent to participate should be included in a declaration statement of Ethical Approval and Consent to Participate in the
manuscript. If informed consent is not required, the name of the ethics committee granting the exemption and the reason
for the exemption must be listed. If any ethical violation is found at any stage of publication, the issue will be investigated
seriously based on COPE Guidelines.

3.1.2 Consent for Publication
All articles published by OAE are freely available on the Internet. All manuscripts that include individual participants’
data in any form (i.e., details, images, videos, etc.) will not be published without Consent for Publication obtained from that
person(s), or for children, their parents or legal guardians. If the person has died, Consent for Publication must be obtained
from the next of kin. Authors must add a declaration statement of Consent for Publication in the manuscript, specifying
written informed consent for publication has been obtained.

3.1.3 Trial Registration
OAE requires all authors to register all relevant clinical trials that are reported in manuscripts submitted. OAE follows the
World Health Organization (WHO)’s definition of clinical trials: “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, other biological products, surgical procedures,
radiologic procedures, devices, behavioral treatments, process-of-care changes, preventive care, etc.”.
In line with International Committee of Medical Journal Editors (ICMJE) recommendation, OAE requires the registration
of clinical trials in a public trial registry at or before the time of first patient enrollment. OAE accepts publicly accessible
registration in any registry that is a primary register of the WHO International Clinical Trials Registry Platform or in
ClinicalTrials.gov. The trial registration number should be listed at the end of the Abstract section.
Secondary data analyses of primary (parent) clinical trials should not be registered as a new clinical trial, but rather
reference the trial registration number of the primary trial.
Editors of OAE journals will consider carefully whether studies failed to register or had an incomplete trial registration.
Because of the importance of prospective trial registration, if there is an exception to this policy, trials must be registered
and the authors should indicate in the publication when registration was completed and why it was delayed. Editors will
publish a statement indicating why an exception was allowed. Please note such exceptions should be rare, and authors
failing to prospectively register a trial risk its inadmissibility to OAE journals.
Authors who are not sure whether they need trial registration may refer to ICMJE FAQs for further information.

3.2 Research Involving Animals
Experimental research on animals should be approved by an appropriate ethics committee and must comply with
institutional, national, or international guidelines. OAE encourages authors to comply with the AALAS Guidelines,
the ARRIVE Guidelines, and/or the ICLAS Guidelines, and obtain prior approval from the relevant ethics committee.
Manuscripts must include a statement indicating that the study has been approved by the relevant ethical committee and the
whole research process complies with ethical guidelines. If a study is granted an exemption from requiring ethics approval,
the name of the ethics committee granting the exemption and the reason(s) for the exemption should be detailed. Editors
will take account of animal welfare issues and reserve the right to reject a manuscript, especially if the research involves
protocols that are inconsistent with commonly accepted norms of animal research.

3.3 Research Involving Cell Lines
Authors must describe what cell lines are used and their origin so that the research can be reproduced. 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. For de novo cell lines derived from human tissue, appropriate approval from an institutional review board or
equivalent ethical committee, and consent from the donor or next of kin, should be obtained. Such statements should be
listed on the Declaration section of Ethical Approval and Consent to Participate in the manuscript.

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