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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. 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 will not be published without Consent for Publication obtained from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 Ethical Approval and Informed Consent for Retrospective/Database Studies
Researchers must confirm they have obtained ethical approval from ethical review boards to perform the study, as
well as permission from the dataset owner to use the information in databases for the purposes of the research they are
performing. If permission to use information from a database is not required (e.g., it is publicly available and unrestricted
re-use is permitted under an open license), a statement explaining this must be included in the manuscript. For studies
which ethics approval has been waived, authors must state clearly in the manuscript and provide brief details of the waive
policy. The statement should include details of the policies under which the waive was granted.
Authors must keep data anonymized. If participants’ details are not to be anonymized, authors must ensure that written
informed consent, including consent for publication, was obtained from each participant, and consent statement must be
included in the manuscript.

3.1.4 Ethical Approval and Informed Consent for Survey Studies
Researchers must ensure the participant’s right to confidentiality has been considered, and they must inform all
participants about the aims of the research and if there are any possible risks, and how the collecting data is being stored.
The voluntary consent to participate of participants should be recorded and any legal requirements on data protection
should be adhered to. Same with all research studies, ethics approval from IRB/local ethics committee for survey studies
must be obtained before performing study. If ethics approval for certain survey study is not required, authors must include
a statement to explain this clearly in the manuscript.

3.1.5 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.

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