PROTECTION OF RESEARCH PARTICIPANTS

Helsinki Declaration

All investigators should ensure that the planning, conduct, and reporting of human research are in accordance with the Helsinki Declaration as revised in 2013 (https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/).

All authors should seek approval to conduct research from an independent local, regional, or national review body (e.g., ethics committee, institutional review board).

If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach and demonstrate that the local, regional, or national review body explicitly approved the doubtful aspects of the study.

Approval by a responsible review body does not preclude editors from forming their own judgment where the conduct of the research was appropriate.

 

Publication on vulnerable populations

Vulnerable populations are individuals who are at greater risk of poor physical and social health status. Some groups and individuals are particularly vulnerable due to characteristics such as age, gender and sexual identities, race, culture, religion, disability, socio-economic status, geographical location, or migration status and may have an increased likelihood of being wronged or of incurring additional harm.

When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated. All vulnerable groups and individuals should receive specifically considered protection.

Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.

In cases where research involves potentially vulnerable groups, for example, children, older persons or adults with learning disabilities, every effort should be made to secure freely given informed consent that participants have actively provided.

Informed consent and anonymity

Patients have a right to privacy that should not be violated without informed consent.

For all studies involving human subjects, the manuscript of the article should contain a statement on obtaining informed consent to participate in the study and/or to publish their data (for the data of any individual).

Consent to participate

For all research involving human subjects, informed consent must be obtained from participants or their parents or legal guardians for children under the age of 16. If any ethical violation is identified at any stage of the publication, the matter will be investigated based on COPE CORE PRACTICES.

The authors should include a statement of consent to participate in the study, which indicates that written informed consent to participate in the study was obtained. If informed consent is not required, the name of the ethics committee that granted the exemption and the reason for the exemption must be indicated.

Consent to publish

Identifying information, including names, initials, or hospital numbers, should not be published in written descriptions, photographs, or pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication.

Informed consent for this purpose requires that an identifiable patient be shown the manuscript to be published.

Authors should disclose to these patients whether any potential identifiable material might be available via the Internet as well as in print after publication.

Patient consent should be written and archived with the authors. Informed consent should be obtained if there is any doubt that anonymity can be maintained.

When informed consent has been obtained, it should be indicated in the published article. 

 

Experiments on Animals

When reporting experiments on animals, authors should indicate whether institutional and national standards for the care and use of laboratory animals were followed.

Further guidance on animal research ethics is available from the International Association of Veterinary Editors’ Consensus Author Guidelines on Animal Ethics and Welfare.