Navigating the ethical terrain: Off-label and experimental treatments in medical case reports

Table 1 Ethical principles and considerations in reporting off-label and experimental treatments

Ethical principle	Description	Application in case reporting
Patient autonomy and informed consent	Ensures patients are fully informed about the nature, benefits, and risks of off-label or experimental treatments and consent to their use	Detailed process for obtaining and documenting informed consent in case reports
Non-maleficence and beneficence	Obligation to do no harm and to act in the best interest of the patient, assessing potential risks against benefits	Criteria for evaluating the risk-benefit ratio of off-label or experimental treatments for reporting
Justice	Focus on equitable treatment access and the implications of reporting on treatment availability and disparities	Analysis of how case reports address or could exacerbate health care access disparities
Transparency and integrity	Requirement for honest reporting of the experimental status of treatments and outcomes, including adverse effects	Guidelines for transparent and unbiased reporting, including disclosures of conflicts of interest