Informed Consent for Cancer Immunotherapy (Checkpoint Inhibitors)

Procedure Name

Form Sections

Section 1info grid

Cancer Center / Clinic Name

Attending Oncologist

Patient Full Legal Name

Date of Birth

Medical Record Number (MRN)

Immunotherapy Drug Name

Planned Dosing Interval

Section 2text block

Section 3text block

Section 4list block

Section 5list block

Section 6text block

Section 7text block

Section 8text block

Section 9text block

Section 10text block

Section 11text block

Section 12signature block

Patient Signature

Oncologist Signature

Witness Signature

Date and Time of Consent

Informed Consent for Cancer Immunotherapy (Checkpoint Inhibitors)

Patient and Treatment Information

Cancer Center / Clinic Name

Attending Oncologist

Patient Full Legal Name

Date of Birth

Medical Record Number (MRN)

Immunotherapy Drug Name

Planned Dosing Interval

Nature and Purpose of Immunotherapy

Immunotherapy is a type of cancer treatment that helps your own immune system fight the cancer. The most common type of immunotherapy uses drugs called immune checkpoint inhibitors. Checkpoints are proteins on immune cells that need to be turned on or off to start an immune response. Cancer cells sometimes use these checkpoints to hide from the immune system. Checkpoint inhibitors block these proteins, allowing your T-cells (immune cells) to recognize and attack cancer cells. The drug is administered as an intravenous (IV) infusion in an outpatient oncology clinic. A treatment course typically consists of multiple cycles spaced several weeks apart, continuing as long as the cancer responds and the side effects are manageable.

Immune-Related Adverse Events (irAEs) Disclosure

Because immunotherapy stimulates your immune system, it can cause your immune cells to attack healthy tissues and organs in your body. This can cause inflammation in any organ, leading to serious or life-threatening side effects called Immune-Related Adverse Events (irAEs). These side effects are different from chemotherapy side effects. They can occur at any time during treatment, or even months after treatment has stopped. Early detection and treatment of irAEs with high-dose corticosteroids (such as prednisone) is essential to prevent permanent organ damage. You must report any new or worsening symptoms to your oncology team immediately.

Material Risks and Potential Complications

Pneumonitis (lung inflammation): occurs in 2 to 5 percent of patients. Symptoms include new or worsening cough, shortness of breath, or chest pain. Can be life-threatening if untreated.

Colitis (colon inflammation): causes severe diarrhea, blood or mucus in stool, and abdominal pain. Can lead to bowel perforation.

Hepatitis (liver inflammation): usually detected by blood tests showing elevated liver enzymes, but can cause yellowing of the skin/eyes (jaundice), severe fatigue, or dark urine.

Endocrine issues (hormone gland inflammation): can affect the thyroid, pituitary, or adrenal glands, or cause new-onset type 1 diabetes. Symptoms include extreme fatigue, weight changes, mood swings, or severe headaches. Damage to these glands is often permanent, requiring lifelong hormone replacement medications.

Nephritis (kidney inflammation): detected by blood tests showing rising creatinine or reduced kidney function.

Infusion reactions: fever, chills, dizziness, or breathing difficulty during the infusion. Managed by slowing or stopping the infusion and giving allergy medications.

Common side effects: fatigue, skin rash, itching, joint pain, or mild nausea. These are usually mild and manageable.

Alternatives to Immunotherapy

Chemotherapy: drugs that target and kill rapidly dividing cells directly, carrying different side effects (hair loss, low blood counts).

Targeted therapy: drugs that block specific molecules needed for cancer growth, if the tumor has specific genetic mutations.

Radiation therapy or surgery: local treatments to shrink or remove tumors, if appropriate for the stage of cancer.

Palliative care: focusing on symptom control and quality of life without active cancer-directed treatment.

Corticosteroid Treatment Agreement

I understand that if I develop moderate to severe immune-related side effects (irAEs), my oncologist will stop the immunotherapy drug and start high-dose corticosteroid treatment (such as prednisone or methylprednisolone) to reduce the inflammation. I agree to take the steroids exactly as directed and understand that they must be tapered off slowly over several weeks. Stopping steroids too quickly can cause the side effects to return. I understand that steroids have their own side effects including mood changes, high blood sugar, increased infection risk, and fluid retention.

Right to Refuse

You have the right to refuse or discontinue immunotherapy at any time. The oncologist will explain the impact on your cancer treatment plan, which may include tumor growth or disease progression.

Patient Understanding and Questions

I confirm that I have read this document and understand the immunotherapy treatment, the unique risks of immune-related side effects (irAEs), the importance of early symptom reporting, and the alternative options. All my questions have been answered.

Language Access

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

Copy of Consent Acknowledgment

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

Patient Authorization

I voluntarily consent to undergo cancer immunotherapy treatment. I authorize the administration of the checkpoint inhibitor drug cycles as prescribed. I agree to report any side effects immediately and to follow the steroid treatment protocol if required.

Signatures and Verification

Patient Signature

Oncologist Signature

Witness Signature

Date and Time of Consent

Document ID: CC-PENDING

CONSENTCOLLECT