Page 47 - Read Online

Author Instructions

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 Case Report/Case Series/Clinical Dataset
A case report is considered the diagnosis, treatment and post-treatment follow-up of a single patient. A case series is
considered a group of case reports involving patients who were all given similar treatments. A clinical dataset is a list of
well-defined variables collected during ongoing patient care or as part of a clinical trial program. It includes electronic
health records, administrative data, patient registries, and clinical trial data.
In some instances, a case report or case series containing information on less than three patients may not require ethical
approval. However, this requirement is dependent on the institution, country or region implementing it and authors must
ensure they have followed the correct regulatory requirements of their institution or country. A statement explaining this
requirement must be included in the manuscript.
Given the specificity of details provided in a case report, case series or clinical dataset, authors are required to obtain
consent for the publication of the case(s) from patients, or their guardians if they are not adults or lack capacity to provide
informed consent, or next of kin if deceased. A statement confirming consent for publication has been obtained must be
included in the manuscript. Authors should share this with the journal Editorial Office if requested.

3.1.4 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.

3.1.5 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.
3.1.6 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