Free Compassionate Use Consent Form Template

Informed Consent for Expanded Access / Compassionate Use of an Investigational Drug

Patient Informed Consent Documentation

Patient and Investigational Product Information

1. Nature and Purpose of Expanded Access

Expanded access, also known as compassionate use, is a regulatory pathway that allows patients with serious, immediately life-threatening, or advanced conditions to receive investigational medical products (drugs, biologics, or medical devices) outside of clinical trials when no comparable alternative therapy options exist. An investigational product is one that has not yet been approved by the FDA for general sale. Your physician has determined that you meet the strict criteria for expanded access and has obtained specific approval from both the drug manufacturer and the FDA to prescribe this investigational product to you.

2. FDA Regulatory Status and Efficacy Disclosures

3. Material Risks and Potential Toxicities

4. Cost and Billing Exclusions

Standard health insurance plans (including Medicare and Medicaid) rarely cover the cost of investigational drugs or the clinic fees associated with administering them. I understand that: (1) The drug manufacturer may charge a fee for the drug under FDA regulations, which I will be responsible for if not covered by a specialized program. (2) I am responsible for all associated administration, lab, and hospital billing fees. (3) I agree to review my financial plan with the clinic's billing department before starting treatment.

5. Alternatives to Compassionate Use

6. Monitoring and Safety Commitment

Receiving an investigational drug requires strict safety monitoring. You must attend all scheduled clinic visits, blood draws, and imaging scans (CT or MRI) to check for side effects and evaluate how your disease is responding. You must report any new symptoms, changes in medications, or visits to other doctors to your primary physician immediately.

7. Emergency Warning Signs

8. Right to Refuse or Stop Treatment

You have the right to refuse or stop the investigational treatment at any time. Stopping the drug will not affect your relationship with your doctors or your access to standard supportive care at this facility.

9. Data Collection and Reporting

Your physician is required to collect details about your treatment, side effects, and clinical outcomes and report them to the drug manufacturer and the FDA. Coded (de-identified) records will be used for these reports to protect your privacy.

10. Patient Understanding and Questions

I confirm that I have read this document and understand the expanded access/compassionate use program, the unproven efficacy of the drug, the risk of severe or unknown side effects, the financial exclusions, and the monitoring rules. All my questions have been answered.

11. Language Access Services

If English is not your primary language, a qualified interpreter is available at no cost. Please inform staff before signing.

12. Copy of Consent Acknowledgment

I acknowledge that I have been offered a copy of this signed consent form.

13. Patient Authorization

I voluntarily consent to receive the investigational drug under the FDA expanded access pathway. I authorize my physician to coordinate the drug delivery, administer the infusions, perform the safety monitoring, and report my de-identified data to the manufacturer and the FDA.

Signatures and Verification