If a clinical investigator wants to treat a gravely ill patient outside of the protocol inclusion criteria, what should they do?

Obtaining approval from the competent authority (CA) for compassionate use is the correct approach when a clinical investigator seeks to treat a gravely ill patient outside of the protocol inclusion criteria. Compassionate use allows for the provision of unapproved medical treatments on a case-by-case basis for patients who have no other treatment options. This process is typically governed by regulations that require proper documentation and justification, ensuring that the safety of the patient is prioritized while allowing access to potentially life-saving therapies.

This approach not only aligns with ethical standards but also meets regulatory requirements. It's essential for clinical investigators to follow this pathway to mitigate legal risks and ensure compliance with applicable laws. The compassionate use route often involves a review of the individual circumstances of the patient and the treatment's potential benefits compared to the risks.

Choosing to seek approval from the hospital ethics board could help ensure ethical compliance, but it does not necessarily provide the legal authority to administer the investigational treatment outside of the protocol. Continuing treatment under the existing protocol may not be feasible or ethical, especially if the patient does not meet the inclusion criteria. Referring the patient to another investigator may not guarantee that the other investigator will have access or the ability to treat the patient outside the established protocol.

In summary, obtaining compassionate use approval