Page 80 - Read Online

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 will not be published without Consent for Publication obtained from that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 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

Hepatoma Research XI