Informed Consent for Procedure

INFORMED CONSENT FOR PROCEDURE / SURGERY / TREATMENT

[FACILITY NAME]
[ADDRESS]
[PHONE]

PATIENT INFORMATION

Patient Name: [PATIENT FULL LEGAL NAME]

Date of Birth: [DATE OF BIRTH]

Medical Record Number: [MRN]

Date: [DATE]

SECTION 1: PROCEDURE INFORMATION

1.1 Planned Procedure/Surgery/Treatment

Name of Procedure: [FULL NAME OF PROCEDURE]

Description in Plain Language:
[DESCRIBE THE PROCEDURE IN TERMS THE PATIENT CAN UNDERSTAND]

Body Site/Location: ☐ Left ☐ Right ☐ Bilateral ☐ N/A

Site Marking: ☐ Completed ☐ Not Applicable

1.2 Performing Physician(s)

Primary Physician: [PHYSICIAN NAME], [CREDENTIALS]

Assisting Physician(s): [NAME(S)]

Anesthesiologist (if applicable): [NAME]

1.3 Location

☐ Operating Room
☐ Procedure Suite
☐ Clinic/Office
☐ Bedside
☐ Other: [SPECIFY]

1.4 Anesthesia

Type of anesthesia planned:

☐ General anesthesia
☐ Regional anesthesia (spinal, epidural, nerve block)
☐ Local anesthesia
☐ IV sedation/conscious sedation
☐ Topical anesthesia
☐ No anesthesia required

SECTION 2: INDICATION / REASON FOR PROCEDURE

Diagnosis/Condition: [DIAGNOSIS]

Reason this procedure is recommended:
[EXPLAIN WHY THE PROCEDURE IS BEING RECOMMENDED FOR THIS PATIENT'S CONDITION]

SECTION 3: NATURE OF THE PROCEDURE

The following has been explained to me regarding the procedure:

☐ What the procedure involves and how it will be performed

☐ The anticipated duration of the procedure

☐ What to expect before, during, and after the procedure

☐ Pre-procedure instructions and preparations

☐ Post-procedure care and recovery

☐ Expected hospital stay (if applicable): [DURATION]

☐ Expected recovery time: [DURATION]

Additional Explanation:
[DOCUMENT ANY SPECIFIC EXPLANATION PROVIDED TO THE PATIENT]

SECTION 4: EXPECTED BENEFITS

The following potential benefits have been explained to me:

☐ [BENEFIT 1]
☐ [BENEFIT 2]
☐ [BENEFIT 3]
☐ [BENEFIT 4]

I understand that the expected benefits cannot be guaranteed.

SECTION 5: MATERIAL RISKS AND COMPLICATIONS

5.1 General Risks (applicable to most procedures)

☐ Bleeding
☐ Infection
☐ Pain
☐ Scarring
☐ Allergic reaction to medications or materials
☐ Nerve damage
☐ Blood clots (deep vein thrombosis, pulmonary embolism)
☐ Damage to surrounding tissues or organs
☐ Need for additional procedures
☐ Unsatisfactory result or failure to achieve desired outcome

5.2 Anesthesia Risks (if applicable)

☐ Adverse reaction to anesthesia medications
☐ Breathing problems
☐ Heart problems
☐ Nausea and vomiting
☐ Sore throat (from breathing tube)
☐ Damage to teeth or dental work
☐ Awareness during anesthesia (rare)
☐ Death (rare)

5.3 Procedure-Specific Risks

The following risks specific to this procedure have been explained to me:

☐ [RISK 1]
☐ [RISK 2]
☐ [RISK 3]
☐ [RISK 4]
☐ [RISK 5]
☐ [RISK 6]

5.4 Risk Level

The estimated complication rate for this procedure is approximately: [PERCENTAGE OR DESCRIPTION]

I understand that my individual risk may be higher or lower based on my specific health conditions.

SECTION 6: ALTERNATIVES

6.1 Alternative Treatments

The following alternatives to this procedure have been explained to me:

☐ [ALTERNATIVE 1] - Benefits: [BENEFITS] Risks: [RISKS]
☐ [ALTERNATIVE 2] - Benefits: [BENEFITS] Risks: [RISKS]
☐ [ALTERNATIVE 3] - Benefits: [BENEFITS] Risks: [RISKS]
☐ No treatment/watchful waiting

6.2 Consequences of No Treatment

I understand that if I choose not to have this procedure, the likely consequences include:

☐ [CONSEQUENCE 1]
☐ [CONSEQUENCE 2]
☐ [CONSEQUENCE 3]

SECTION 7: ADDITIONAL CONSENTS

7.1 Blood Transfusion

☐ I consent to blood transfusion and blood products if deemed medically necessary
☐ I do NOT consent to blood transfusion (discuss with physician and sign separate form)

7.2 Tissue Specimens

☐ I consent to the examination, retention, and disposal of any tissue or specimens removed during the procedure

7.3 Photography/Recording

☐ I consent to photographs, video recordings, or other recordings for medical documentation, education, or research purposes (with face/identifying features obscured for non-medical use)
☐ I do NOT consent to photography/recording

7.4 Observers

☐ I consent to the presence of observers (medical students, trainees, industry representatives) during my procedure
☐ I do NOT consent to observers

7.5 Additional Procedures

☐ I consent to additional procedures that may be necessary if conditions are discovered during the planned procedure that require treatment

Limitations on additional procedures (if any): [SPECIFY]

SECTION 8: PATIENT QUESTIONS

Questions asked by patient:
[DOCUMENT PATIENT'S QUESTIONS]

Answers provided:
[DOCUMENT ANSWERS TO PATIENT'S QUESTIONS]

SECTION 9: PATIENT ACKNOWLEDGMENTS

By signing below, I acknowledge and agree to the following:

☐ I have read (or had read to me) this informed consent form

☐ My physician has explained the procedure, including its nature, purpose, benefits, risks, and alternatives

☐ I have had the opportunity to ask questions and all my questions have been answered to my satisfaction

☐ I understand that no guarantees have been made regarding the outcome of this procedure

☐ I understand the risks and complications that may occur

☐ I understand the alternatives to this procedure

☐ I understand the consequences if I choose not to have this procedure

☐ I consent to the procedure described above and any additional procedures that may be necessary

☐ I have been informed of my right to refuse or withdraw consent at any time before the procedure

☐ I consent voluntarily, without coercion or undue influence

☐ I am the patient, or I am authorized to consent on behalf of the patient

☐ I have received or been offered a copy of this signed consent form

SECTION 10: SIGNATURES

Patient/Authorized Representative

Signature: ______________________________________

Printed Name: [NAME]

Relationship to Patient (if not patient):
☐ Parent/Legal Guardian of Minor
☐ Legal Guardian/Conservator
☐ Healthcare Power of Attorney
☐ Spouse (if permitted by state law)
☐ Other Legal Representative: [SPECIFY]

Date: ______________

Time: ______________

If Patient Unable to Sign

Reason patient unable to sign:
☐ Minor (age [AGE])
☐ Incapacitated - Nature: [DESCRIBE]
☐ Emergency - Life-threatening situation
☐ Physical inability to sign

Two-Physician Consent (for emergency when no representative available):

Physician 1 Signature: ______________________________________ Date: ______________

Physician 2 Signature: ______________________________________ Date: ______________

Physician Obtaining Consent

I have explained the procedure, its benefits, risks, alternatives, and consequences of no treatment to the patient/representative. I have answered all questions and believe the patient/representative understands the information provided and is giving informed consent.

Physician Signature: ______________________________________

Physician Printed Name: [NAME], [CREDENTIALS]

Date: ______________

Time: ______________

Witness

Witness Signature: ______________________________________

Witness Printed Name: [NAME]

Title/Role: [TITLE]

Date: ______________

Interpreter (if applicable)

☐ Interpreter services used

Interpreter Signature: ______________________________________

Interpreter Printed Name: [NAME]

Language: [LANGUAGE]

Date: ______________

☐ Certified interpreter ☐ Qualified bilingual staff ☐ Telephone interpreter service

VERIFICATION (DAY OF PROCEDURE)

Pre-Procedure Verification

Patient Identity Verified: ☐ Yes

Procedure Site Verified: ☐ Yes

Site Marked: ☐ Yes ☐ N/A

Consent Form Reviewed with Patient: ☐ Yes

Patient Confirms Understanding: ☐ Yes

Any Changes to Consent: ☐ No ☐ Yes - Documented: [LOCATION]

Verified By: [NAME] Date/Time: [DATE/TIME]

WITHDRAWAL OF CONSENT

I hereby withdraw my consent for the procedure described above.

Patient/Representative Signature: ______________________________________

Date: ______________

Time: ______________

Witness Signature: ______________________________________

Date: ______________