Thank you for considering enrolling your loved one in the SUDEP Registry. You may have many questions about medical research and what it means to be enrolled in a medical study. We hope you will find the following information helpful in making an informed decision about participating in the Registry.
Medical research is conducted to expand our current body of medical knowledge. Over the past century, great strides have been made in improving health outcomes through medical research. The term "medical research" can mean clinical trials confuted to test new treatments, or other kinds of research that ultimately contribute to the development of new treatments. Through the SUDEP Registry, researchers hope to better understand SUDEP, its mechanisms and risk factors, why it occurs in certain people with epilepsy, and whether or how it might be prevented.
Personal medical information is highly sensitive, and as such the decision to participate in medical research is not to be taken lightly. The idea of "informed consent" is meant to safeguard study participants. In order for studies to be able to include human subjects, the study participants must be volunteers, and must be informed of the potential risks and benefits of participating. It is the responsibility of the researchers conducting the study to share these risks and benefits with potential participants.
Informed consent means that you fully understand what participation in the study will entail. In a study with living subjects, this includes the length of the study, how many visits are required, which medical procedures will be conducted, which medications you will be required to take, potential risks and benefits, and expected outcomes. Decisions to participate in medical research should always be discussed with your doctor and your family. If you change your mind in the middle of a study and wish not to continue volunteering as a subject, you may do so at any time.
If you would like to learn more about medical research, the National Institutes of Health (NIH) has developed some excellent, easy-to-understand information about participating in medical research on their website.
Tissue Donation and How it is Related to the SUDEP Registry
Tissue donation is the removal of tissue from a recently deceased person, to be transplanted into a living human being or used in medical research. In order to remain viable for transplantation or medical research, tissue must be procured very soon after death.
The purpose of the SUDEP Registry is to collect information about people with epilepsy who have died unexpectedly, to determine if they died from SUDEP or other causes, and to collect DNA and tissue for scientific studies about the causes of SUDEP. If an unexpected epilepsy-related death has occurred within 72 hours, tissue may be donated for research purposes, in order to help researchers better understand epilepsy and seizures. If you or your family is interested in tissue donation, please call us at 855-432-8555 as soon as possible.
Tissues that may be donated for the purposes of this study include whole brain as well as partial tissue from the brain, heart, and, liver. Family members can decide which kinds of tissue are donated. DNA may be obtained from individuals who have died more than 72 hours ago. DNA data will be deidentified and made available to the scientific community in order to better understand epilepsy-related mortality.