Principal Investigator: Michael Levy, MD
You are being asked to submit some personally identifying information because you have expressed interest in donating tissue to The Superficial Siderosis Research Tissue Donation Project after your death. If you decide to join this project, you will fill out two forms:
- The donation consent: list your contact information and the contact information for your next of kin. You will sign indicating your desire to donate. You will download a copy of this form, complete it, send a scanned copy back to the website via email, and keep the original signed copy with your end-of-life essential papers such as your will, insurance policies, pre-arrangement plan, etc.
- The donor pre-enrollment form: is a questionnaire asking for some necessary medical history information you will submit directly to the website.
The brain and spine tissue collected from you during this project is important to future research. If you agree to join this project:
- The tissue donated by you to the investigators for this project, once the procurement procedure has begun, will no longer belong to your estate or next of kin.
- Dr. Michael Levy may allow superficial siderosis research team members or any institutional sponsor of this research to study non-identifying data collected from your medical history, records or tissue.
- Any product or idea created by future researchers working on any related study will not belong to your estate or your heirs. There is no plan for your estate or your heirs to receive any financial benefit from the creation, use or sale of such a product or idea.
The purpose of the Superficial Siderosis Research Tissue Donation Project is to collect and provide tissue samples for research into superficial siderosis. The permission you are giving now is only for the project coordinators to maintain your contact and health information in a database housed offline of people who are interested in donating.
Who might see any data connected to my tissue donation? Harvard University, its affiliated hospital(s) and Massachusetts General Hospital have rules to protect information about you. Federal and state laws including the Health Insurance Portability and Accountability Act (HIPAA) also protect your privacy. This section of the project form tells you what information about you may be collected and stored by this project and who may access or use it.
The project coordinators will see, use or may disclose your pre-enrollment personally identifying information only as necessary to facilitate organization of the project, assist in project donors prearrangement procurement protocols and any necessary administrative obligations. We will do everything in our power to maintain the confidentiality of your personal information but you acknowledge in this day and age of technology confidentiality cannot be absolutely guaranteed.
The records that identify you and the consent form signed by you may be looked at by others who have a legal right to see that information, such as:
- U.S.federal offices or authorities such as the Office of Human Research Protections (OHRP) that protect research subjects like you.
- If you are not a resident of the United States at the time of death any government authority or official (local or national) who has jurisdiction in these matters.
- Officials of Harvard University
- Dr. Michael Levy
- Officials employed by any institution or hospital where the research is conducted.
- Local officials having jurisdiction where your death occurs.
- Administrative hospital staff, nursing home personnel, hospital pathologist or attending physician
- Funeral home employees.
- Party responsible for tissue procurement and shipment.
Dr. Michael Levy, Harvard University and all hospitals involved in this project intend the tissue collected be used to further the work towards understanding the pathophysiology of the disease identified as superficial siderosis and once a better understanding is met to continue using available tissue and data in pursuit of improving treatments that might possibly one day help patients heal.