Under what circumstances can an investigational drug be administered?

An investigational drug can be administered only when prior approval of the protocol is granted and informed consent is provided. This requirement aligns with regulatory guidelines set forth by authorities such as the FDA, which emphasize the importance of protecting patient rights and ensuring their understanding of the investigational nature of the treatment. Informed consent involves giving patients comprehensive information about the potential risks, benefits, and alternatives to the investigational drug, allowing them to make an educated decision regarding their participation in clinical trials.

The necessity of having a protocol approved ensures that the study is scientifically valid and ethically sound, addressing safety and efficacy concerns before patients receive the drug. This process protects patients from being subjected to unregulated or untested medications without adequate safeguards. Therefore, the requirement for both protocol approval and informed consent is critical in the administration of investigational drugs.