Ethics and consent

Ethics Approval

All research involving human participants, human materials, or human data must comply with the Declaration of Helsinki and receive approval from a competent ethics committee prior to the start of the study.

Benefits and Harms of Research

Research must uphold the dignity and rights of participants, as well as the rights of individuals or groups connected to the study and the communities where the research is conducted. Ethical considerations should also extend to non-human life, tangible and intangible heritage, and natural resources.

Potential harms arising from research include:

• Physical or psychological injury to human participants
• Unnecessary suffering for non-human animals used in experimentation
• Material compromise of tangible heritage
• Disruption of ecosystems

Harm may also arise indirectly through publication or scholarly communication, such as:

• Stigmatization of vulnerable groups
• Misuse of research findings (e.g., policies that violate human rights or threaten public health)

New Clinical Tools and Procedures

When reporting new clinical tools or procedures, authors must justify why these approaches were chosen over standard clinical practice to meet the specific clinical needs of the patient. If a procedure is already approved for routine clinical use at the authors’ institution, no additional justification is required.

For novel procedures used experimentally, ethics committee approval and informed patient consent are mandatory, even if no clear clinical advantage is anticipated.

Approval for Retrospective Ethics

Ethics committee approval is generally not granted retrospectively. Manuscripts lacking prior approval may not be considered for peer review. In exceptional cases, the Editor will determine whether to proceed with review.

Ethnicity, Race, and Racism

Racism is unethical and scientifically invalid. Editors may refuse publication, request modification, or retract published content that is discriminatory or misrepresents ethnicity or race.

Researchers must clearly explain how participant data on race or ethnicity were collected:

• What classification terms were provided by participants, researchers, or third parties
• The methodology used to establish participants’ racial or ethnic identity

This information must be included in the manuscript’s Methods section.

Consent to Participate

Informed consent must be obtained from all human participants, or from parents or legal guardians for participants under 16 years of age. A statement confirming consent must appear in the manuscript.

For studies involving vulnerable populations (e.g., unconscious patients, prisoners) where coercion may occur or consent may not be fully informed, the Editor may refer the manuscript for additional internal review.

Consent is also required to collect personally identifiable data, including biomedical, clinical, and biometric information.

Manuscripts describing human transplantation must include a statement confirming that no organs or tissues were obtained from prisoners, and identify the institution(s)/clinic(s)/department(s) from which the materials were obtained. Copies of approval may be requested.