Informed Consent Template For Expanded Access to an Investigational Drug

This legal template is designed to provide a framework for obtaining informed consent from individuals who wish to participate in expanded access programs for investigational drugs under USA law. Expanded access, also known as compassionate use, refers to the provision of investigational drugs to patients outside of clinical trials when no other satisfactory treatment options are available and they are facing serious or life-threatening conditions.

The template includes provisions that clearly describe the nature of the investigational drug, its potential risks and benefits, and the eligibility criteria for participating in the program. It outlines the responsibilities of both the patient and the healthcare provider, emphasizing the voluntary nature of participation and the right to withdraw at any time.

Additionally, the template covers the disclosure of financial interests, conflicts of interest, and other relevant information related to the drug's manufacturer or sponsor. It addresses privacy and confidentiality concerns, ensuring that patient information will be handled in accordance with applicable data protection laws.

The legal document also contains sections to capture the patient's acknowledgment of their understanding of the information provided, as well as their agreement to participate. It emphasizes the importance of ongoing communication between the patient and the healthcare provider and highlights the need for monitoring and reporting adverse events or other unexpected outcomes during the expanded access program.

Overall, this template aims to protect the rights and well-being of patients while facilitating their access to potentially life-saving investigational drugs outside of traditional clinical trials, complying with the legal requirements of expanded access programs under USA law.