Consent - Research – Pacemaker or Implantable Cardioverter Defibrillator (ICD) – Deceased Donor

Each year, hundreds of thousands of patients with pacemakers or implantable cardioverter defibrillators (ICDs) pass away andare buried with these devices. It is routine for the deceased who choose cremation to have the devices removed. Your loved one’s pacemaker or ICD may still work and could be donated to a patient in need. There are patientsthroughouttheworld, mostlyin poorer countries,that cannotafford pacemakers or ICDs. These patients do not have accessto thesesamelife-savingdevices.

TheUniversityofMichigan is working with World Medical Relief and withthesupportof citizens, physicians, and funeral directorsacrosstheUnited States to help these patients in need.

Project My Heart - Your Heart is collecting pacemakers and ICDs for potential use in a research study to determine if reusing these devices is safe and effective. Youmaybeabletohelpsave a lifebydonating your loved one’s devicetoourproject. A funeral director will respectfully remove the device and send it to the University of Michigan Hospital. Thereis nocosttoyou or your loved one’s estateor insurance company. You do not have to donate your loved one’s device.

IfyouhaveanyquestionsaboutProject MyHeart- YourHeartplease ask your health care provider, visit orcontact:

Thomas Crawford, M.D. (UniversityofMichigan Frankel CardiovascularCenter)

Email address: Phone number: (734) 936-6858

I am the closest adult relative of the deceased. I agree to donate my loved one’s pacemaker or ICD to the University of Michigan for Project My Heart - Your Heart. At this time, I understand that the device will only be used for research. My loved one’s device will not be delivered to another country or implanted into another person unless The U.S. Food and Drug Administration (FDA) approvesaclinical trial for the reuse of pacemakers and/or ICDs.

I HAVE READ AND UNDERSTAND THE INFORMATION ON THIS FORM BEFORE I SIGNED IT.

______Date: ______

Signature of Legally Authorized Representative (mm/dd/yyyy)

______

Printed Name of Legally Authorized Representative

Relationship: Spouse Parent Next-of-Kin Other (specify): ______

/ VER: A/14 HIM: 10/14
The content of this form can be altered for reformatting purposes but text should not be edited for content without express permission from Thomas Crawford, M.D. (University of Michigan Frankel Cardiovascular Center).
Email: Phone number: (734) 936-6858

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