Page 76 - Read Online
P. 76

Author Instructions

           according to COPE Guidelines.
           3.1.1 Front Matter
           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 will not be published without Consent for Publication obtained from that person(s), or for children,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 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
   71   72   73   74   75   76   77   78   79   80