You will be required to submit 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 form: list your contact information and the contact information for your next of kin. You will sign indicating your desire to donate.
- The Donor Pre-enrollment form: a questionnaire for basic medical history information.
When you return those completed forms to us, along with this form, you will have successfully enrolled in the TISSUE DONATION Project.
The Superficial Siderosis Research Tissue Donation Project collects and provides brain tissue samples for research into superficial siderosis. The authorization you are giving now allows the project coordinators to maintain your contact and health information in a database housed on the superficial siderosis patient registry website.
There is an additional process involved with completing the donation; your next of kin will undertake these steps on your behalf after your death. The project administrators and SS patient registry will make every effort to protect your privacy. You have a choice about enrolling in this project. You always have the option to opt out of participation in this project anytime before your death.
Who might see any data connected to my tissue donation? Once your tissue samples arrive for storage Harvard University, its affiliated hospital(s), and Massachusetts General Hospital have rules to protect information about you. In addition, 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 and patient registry administrators will see, use, or may disclose your pre-enrollment personally-identifying information only as necessary to facilitate the organization of the project, assist in project donors’ prearrangement procurement protocols, and any essential administrative obligations. We will do everything in our power to maintain the confidentiality of your personal information. Still, you acknowledge in this day and age of technology, confidentiality cannot be 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) 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 have jurisdiction over 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 and all hospitals involved in this project intend the tissue collected to 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 one day help patients heal.
The tissue collected during this project is vital for future research. If you agree to join this project:
- The tissue donated by you to the investigators for this project will no longer belong to your estate or next of kin once the procurement procedure has begun.
- 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. In addition, 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.
Working...