The Brain Donation Program at Sun Health Research Institute
The Brain Donation Program has been in existence since 1987 and has enrolled more than 2500 donors over that time, which constitutes about 2% of the current combined populations of the surrounding retirement communities. Of these, 1042 donors have expired and their brains have been collected and stored, while there are 1061 living donors. Donors have all volunteered specifically for the program and are highly motivated, with an annual drop-out rate of only 1.8%. Recruitment relied initially on hospital staff, who obtained consents from family members of individuals who died while admitted. Recruitment gradually became almost entirely done on a prospective basis, primarily by word-of-mouth, through interactions of the population with physicians and nursing staff belonging to the Sun Health provider network, and through public speaking events and tours of the Institute given by Institute staff to community groups and the general public. Institute staff give approximately 60 such public interactive events each year. Relatively frequent media releases also contribute to recruitment. Eligibility criteria for the Program are simple in that the subjects must be free of hazardous infectious diseases and must consent to annual clinical assessments at SHRI. Additionally, at least two years of the applicant’s private medical records must be received and reviewed by Brain Donation Program staff prior to acceptance. The medical records review is directed mainly at excluding hazardous infectious disease conditions. All enrolled subjects or legal representatives sign an Institutional Review Board-approved informed consent form allowing both clinical assessments during life and several options for brain and/or bodily organ donation after death. A separate section requests the subject to allow or disallow DNA isolation and storage as well as genetic testing. Donors are allowed to withdraw from the program at any time. When a donor loses his/her mental capability, ordinarily a family member will be appointed as the donor’s legal representative. That legal representative would then have the power to withdraw the donor from the program. The informed consent has a section that fully discloses the possible commercial use of our tissue, stating that SHRI, personnel from SHRI, personnel from other institutions, or other organizations that utilize our tissue may obtain monetary benefit from the use of the tissue.
Between 1987 and 1995 brain donors did not receive formal neuropsychological testing. Their mental status was determined by requisitioning medical records from their primary care physicians, neurologists, psychologists and psychiatrists, and through telephone interviews with family members and caregivers, both at the time of enrollment and in the immediate postmortem period. In 1996 a clinical psychologist was hired and from then onwards, a standardized neuropsychological screening assessment has been administered to most of the subjects enrolled in the Brain Donation Program. Also since 1996, most donors have received a standardized neurological evaluation tailored to detect overt and incipient movement disorders. In 2000, the clinical operations of the Program were greatly expanded, with the hiring of a neurologist, another neuropsychologist and associated support staff, allowing the administration of a full neuropsychological test battery. If a previously undetected medical abnormality is discovered in the course of the annual clinical assessment, the donor is informed and advised to visit their physician for further investigation and/or treatment. The SHRI physician will also ask the donor’s permission to inform their private physician of this finding.