You must provide personally identifying information to enroll in The Superficial Siderosis Research Tissue Donation Project. If you decide to participate, you'll need to complete two forms:
Donation Consent Form
This form includes your contact information and the contact information of your next of kin. By signing this form, you express your desire to donate.
Donor Pre-enrollment Form
This form contains a questionnaire about your basic medical history.
Once you submit these completed forms and the current state, you will successfully enroll in the TISSUE DONATION PROJECT.
The Superficial Siderosis Research Tissue Donation Project aims to collect and provide brain tissue samples for research on superficial siderosis. Authorizing this project allows the coordinators to keep your contact and health information in a database on an external Superficial Siderosis Patient Registry server.
After your death, there is an additional process for completing the donation, which your next of kin will handle. The project administrators and the SS patient registry will try to protect your privacy. It's important to note that participation in this project is voluntary, and you can opt-out before your death.
Who can access data related to my tissue donation?
Your tissue samples once received for storage at the Superficial Siderosis Clinic and Research Laboratory, are protected by rules that safeguard your information. Federal and state laws protect your privacy, including the Health Insurance Portability and Accountability Act (HIPAA). This section of the project form provides information on what data may be collected and stored by the project and who may access or use it.
The project coordinators and patient registry administrators will only access or disclose your pre-enrollment personally-identifying information when necessary to organize the project, assist with the donors' prearrangement procurement protocols, or fulfill essential administrative obligations. We will take all possible measures to maintain the confidentiality of your personal information. However, it's necessary to acknowledge that complete confidentiality cannot be guaranteed in today's technological age.
The records that identify you and the consent form you signed may be reviewed by individuals who have a legal right to access such information, including:
1. U.S. federal offices or authorities like the Office of Human Research Protections (OHRP) protect research subjects like you.
If you're not a U.S. resident at your death, any relevant government authority or official (local or national) has jurisdiction in these matters.
2. Dr. Michael Levy
3. Officials employed by institutions or hospitals where the research is conducted.
4. Local officials with jurisdiction over the location of your death.
5. Administrative staff at hospitals, nursing homes, hospital pathologists, or attending physicians
6. Employees of the funeral home
7. The party responsible for tissue procurement and shipment
Dr. Michael Levy and all researchers aim to utilize the collected tissue to advance the understanding of superficial siderosis pathophysiology. Furthermore, they intend to continue using available tissue and data to improve treatments that may benefit patients in the future.
Once the procurement procedure begins, the tissue you donate will no longer belong to your estate or next of kin. Dr. Michael Levy may allow members of the superficial siderosis research team or institutional sponsors to study non-identifying data from your medical history, records, or tissue. Your estate or heirs will not own any product or idea developed by future researchers working on related studies. Additionally, there is no plan for your estate or heirs to receive financial benefits from creating, using, or selling such products or ideas.
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