Humanitarian Use Device Informed Consent and Privacy Authorization Form

LBH IRB Form #10B: Humanitarian Use Device Informed Consent and Privacy Authorization Form Page 1 of 6

Version 2 – 06-29-10

Humanitarian Use Device Informed Consent and Privacy Authorization Form

<REMOVE INSTRUCTIONS BEFORE PRINTING>

Title:

Principal Investigator:

Date:Insert the date this consent form is being submitted to the IRB>

1. What you should know about Humanitarian Use Devices (HUD):

You are being asked to allow the use of a HUD called <insert name of HUD>

This consent form explains how the device will be used.

Please read it carefully and take as much time as you need.

Please ask questions at any time about anything you do not understand.

We will explain what other treatment could be given other than the HUD. You should understand those options before you sign this form.

2. Why will the HUD be used?

The Food and Drug Administration (FDA) has approved humanitarian use of insert name of HUD>to provide treatment for patients who have problems with insert name of disease or injury> and who have failed other treatments. You are eligible to use name of HUD> because you have name of disease or injury>and you have not improved with available treatments.

3. What will happen if you agree to the use of the HUD?

If you agree to the use of insert name of HUD>, you will

4. What are the risks of using the HUD?

The HUD has not been proven effective for this use.

<If appropriate to the procedure, end with the statement:>There may be side effects and discomforts that are not yet known.

5. Are there benefits from the use of the HUD?

<State direct or possible benefit from the use of the HUD. Describe the generalizable or societal benefits and use a sentence such as:>Information collected about insertname of HUD>may improve treatment for future patients.

6. Will it cost you anything to use the HUD?

If your insurance company will not pay for the procedure or the device, you will be responsible for these costs. If your insurance company will pay for only a portion of the procedure or the device, you will be responsible for the costs that insurance does not cover. Your doctor will contact your insurance company to see if they will pay for the device.

7. Will you be paid for using the HUD?

You will not be paid for receiving the device.

8. Can you decide not to allow the use of the HUD?

You may withdraw your consent to have the device used at any time.

9. What are the options if you do not want to use the HUD?

You do not have to agree to the use of insert name of HUD>.If you do not agree, your care at LifeBridge Health will not be affected.

10. How will your privacy be protected?

LifeBridge Health has rules to protect information about you. Federal and state laws also protect your privacy. This part of the consent form tells you what information about your use of <insert name ofHUD> may be collected and who might see or use it.

Some people may see your health information and may give out your health information regarding the procedures and the use of <insert name of HUD>.Generally, only people directly involved with the use of the HUD will see your information. This would include the surgeon and the surgical staff.

However, there a few exceptions that are listed later in this section of the consent form. Unless you give permission or the board that reviews the use of the humanitarian devices approves it, no one else will be able to see or use your information.

The information collected about you can include things learned from the procedures described in this consent form. Other information including your name, address, date of birth, and other details may also be collected.

Sometimes other people at LifeBridge Health may see or give out your information. These include people who review the procedures for the use of humanitarian devices as well as their staff, lawyers, or other LifeBridge Health staff.

People outside of LifeBridge Health may need to see your information and information about the use of the HUD. Examples include government groups, safety monitors, other hospitals if involved with this procedure, and the manufacturer of the device insert name of manufacturer>, as part of its Humanitarian Device program.

We cannot do this procedure without your permission to use and give out your information and information about the use of the HUD. You do not have to give us this permission. If you do not, then you may not receive the HUD.

We will use and disclose your information only for the purposes stated in this consent form. The use of your information has no time limit. You can cancel your permission to use and disclose your information at any time by calling the LifeBridge Health IRB at (410-601-9021) or by sending a letter to:

Department of Research

SinaiHospital of Baltimore

2401 West Belvedere Avenue

ShapiroBuilding, Suite 203

Baltimore, MD21215

Your cancellation would not affect information already collected about the use of this humanitarian device.

We try to make sure that everyone who needs to see your information uses it only for evaluating the results of the use of <insert name of HUD> and keeps it confidential – but we cannot guarantee this.

11. Who will pay for treatment if you are injured as a result of the use of the HUD?

If you are injured as a result of the use of <insert name of HUD>, your insurance company will be billed for the costs of treatment. Neither LifeBridge Health, nor the FDA, nor the government has any program that would pay the costs of the complications of the procedures required or for the use of insert name of HUD>.

12. What other things should you know?

What is the Institutional Review Board (IRB) and how does it protect you?

The LifeBridge Health IRB is made up of:

Doctors
Nurses
Clergy
Non-scientists
and people from the local community.

Humanitarian Use Devices may only be used if approved by the IRB. The IRB is responsible for protecting participant’s rights. You may contact the IRB if you have questions about your rights as a participant or if you think you have not been treated fairly. The IRB office number is 410-601-9021.

b.Whom should you call if you have questions about the device?

Call the principal investigator, Dr. ______at <insert telephone number.>

c.What should you do if you have a device-related problem?

If you have an urgent medical problem related to the use of the HUD, call designated physician>at phone or beeper number available 24 hours.>

If you think you are injured or ill as a result of the use of the HUD, call the principal investigator, Dr. ______, at insert telephone number.>

The medical services at LifeBridge Health will be open to you as they are to all sick or injured individuals. LifeBridge Health does not have a program to pay you if you are hurt or have other bad results from receiving this device. You are financially responsible for payment of any treatment or hospitalization. At your request, your insurance provider will be billed for payment of any treatment or hospitalization.

d.Do you have to agree to receive the HUD?

You do not have to agree to receive the HUD. If you do receive the HUD, and later change your mind, you may stop using the device. If you refuse to have the device used, or want to stop using it, you will not be penalized or lose any benefits to which you are otherwise entitled.

e.What happens to Data, Tissue, Blood and Samples that may be collected as a result of the use of the HUD?

<If the use of the HUD does not require collection of tissue, blood and samples, you may delete these words from the heading and text>

Scientists at LifeBridge Health work to find the causes and cures of disease. The data, tissue, blood and samples collected from you during any procedure related to receiving the HUD may be important to medical science.

If you agree to receive the HUD:

LifeBridge Health and/or its outside partners will own these data, tissue, blood and samples.
Scientists may study, test and use this material.
Scientists may study, test and use this material in future research only with your consent or with the approval of a special review board.
If this material is used to create a product or idea, the scientists and LifeBridge Health will own that product or idea.
You will not receive any financial benefit from the creation, use or sale of that product or idea.

<Note: If the PI has a participant who wishes to enroll but does not agree to this provision, the PI or consent designee may cross out this section and initial and date the action. The participant should initial and date the crossed out section at the same time.>

f.What are the Organizations that are part of LifeBridge Health?

LifeBridge Health includes the following:

SinaiHospital of Baltimore
NorthwestHospitalCenter
LevindaleHebrewGeriatricCenter and Hospital
Jewish Convalescent & Nursing Home
LifeBridge Health & Fitness Centers ∙
LifeBridge Medical Care Centers

13. What does your signature mean?

By signing this consent form you are not giving up any legal rights. Your signature means that you understand the information given to you about the HUD in this form, you accept the provisions in this form, and you agree to receive the HUD.

WE WILL GIVE YOU A COPY OF THIS SIGNED AND DATED CONSENT FORM

NOT VALID WITHOUT THE LBH IRB

STAMP OF CERTIFICATION

Do not sign after the expiration date of: ______

FOR ADULTS AND CHILDREN CAPABLE OF GIVING CONSENT:

______

Participant's Signature Date

FOR ADULTS NOT CAPABLE OF GIVING CONSENT:

______

Signature of Surrogate/Guardian/Health Care Agent for Participant Date

Relationship of Surrogate to Participant:______

FOR CHILDREN NOT CAPABLE OF GIVING CONSENT:

______

Signature of Parent #1 Date

______

Signature of Parent # 2 (when applicable) Date

______

Signature of Legal Guardian (when applicable) Date

SIGNATURE(S):

______

Signature of Person Obtaining Consent Date

(Investigator or IRB Approved Designee)

______

Witness (Optional unless IRB or Sponsor required) Date

NOTE:A COPY OF THE SIGNED AND DATED CONSENT FORM MUST BE KEPT BY THE PRINCIPAL INVESTIGATOR, A COPY GIVEN TO THE PARTICIPANT, AND A COPY OF THE CONSENT FORM MUST BE PLACED IN THE PARTICIPANT’S RECORD

LBH IRB Form #10B: Humanitarian Use Device Informed Consent and Privacy Authorization Form Page 1 of 6

Version 2 – 06-29-10