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

Table 2 Challenges and ethical dilemmas in reporting

Challenge	Ethical dilemma	Proposed solution
Reporting of negative outcomes	Balancing the ethical need for transparency with potential reputational or financial consequences for authors and sponsors	Implement policies for mandatory reporting of all outcomes, positive and negative
Commercial interests	Managing conflicts of interest that may influence the reporting and perception of off-label and experimental treatments	Strict disclosure requirements and independent review to mitigate the impact of commercial interests
Balancing innovation with caution	Navigating between the advancement of medical science and ensuring patient safety in the face of uncertain treatment outcomes	Development of comprehensive guidelines that prioritize rigorous scientific evaluation and patient safety

Table 3 Recommendations for ethical vigilance and reporting

Area of focus	Recommendation
Ethical guidelines development	Formulate comprehensive, clear guidelines specifically addressing off-label and experimental treatments, with input from a multidisciplinary team
Regulatory oversight	Enhance the role of regulatory bodies in monitoring and guiding the reporting on experimental treatments to ensure accuracy and ethical compliance
Education and training	Provide ongoing education for clinicians and researchers on ethical reporting practices and the importance of maintaining integrity in medical research

Table 4 Key areas for collaborative effort

Stakeholder	Role in advancing ethical reporting
Clinicians	Share clinical experiences and adhere to ethical guidelines in reporting of off-label and experimental treatments
Researchers	Conduct and report research with integrity, following ethical guidelines and contributing to the body of evidence on new treatments
Ethicists	Provide guidance on ethical dilemmas and contribute to the development of comprehensive ethical guidelines
Regulatory bodies	Oversee the reporting practices and dissemination of information to ensure public access to reliable and ethically reported data on new treatments