FOR PROSPECTIVE DONORS
To inquire about volunteering to participate as a brain and/or body donor in the Brain and Body Donation Program, you must reside in greater metropolitan Phoenix, Arizona. There are also some other requirements that must be met. Donors must be healthy enough to come to the Institute for annual clinical assessments. Please read the following information and if the Program’s goals, activities and requirements are agreeable to you, please contact our Clinical Tissue Donation Coordinator:
Kathryn Davis – Clinical Tissue Donation Coordinator
PROGRAM DESCRIPTION FOR DONORS
Banner Sun Health Research Institute (“the Institute”) is a non-profit organization dedicated to the study of aging and the diseases of aging. Our goal is to discover new treatments and lifestyle methods that will lengthen life and improve the quality of life for all older persons. One of the most important ways to learn about aging and the disorders of aging is to study brain and body tissue from both normal and affected people after they pass away. Of equal importance is to learn how well older individuals perform functions of daily living during life, and how this performance is affected by the presence of disorders of aging. To reach these goals, the Institute maintains an active research program called the Brain and Body Donation Program (“the Program”). Also associated with the Program are cooperating researchers who are located at the University of Arizona, Arizona State University, Arizona Mayo Clinic, Tucson Veteran’s Administration Medical Center, Barrow Neurological Institute, Banner Health, the Chronic Condition Data Warehouse and the National Alzheimer’s Coordinating Center. If you are considering enrollment of a family member who is not able to make their own decisions, you must be legally qualified to do so on their behalf.
Some general features of the program are:
- There is no cost to participants.
- Participants must reside in the greater Phoenix metropolitan area.
- Participants are required to consent to periodic clinical assessments. The assessments are typically conducted at one to three visits per year, and do not involve painful procedures or experimental treatments unless the participants specifically consent to them at the time.
- Participants may quit the program at any time, may limit the types of organs they donate to research, may restrict what kind of research is done, and may limit the amount of medical information that can be released about them.
- For participants who donate their entire body for research, the program provides cremation of the remains at no charge if the participant wishes this.
- Diagnostic, genetic and other information about the participant may be provided, after death, to family members and others specifically requested by the participant if the participant chooses.
- Participants are not asked to take any experimental drug or treatment as part of this Program, as it is not the Program’s purpose to test experimental treatments. If participants are interested in entering into experimental treatment studies of Alzheimer’s disease or other diseases, the Institute has separate programs for this purpose; please contact the Cleo Roberts Center for Clinical Research at the Institute for information about these.
PURPOSE OF THE PROGRAM
The purpose of the program is three fold:
- During the participants’ lives, to study their functional abilities, as well as blood and saliva, in order to learn more about normal older people as well as people with diseases of aging. These diseases include, but are not restricted to, Alzheimer’s disease, Parkinson’s disease, stroke, cancer, atherosclerotic heart and vascular disease, arthritis, cataracts, macular degeneration and orthopedic problems. This type of information is called “clinical data”.
- Following the participants’ deaths, to study their brains, other bodily organs, and tissues or fluids (called “biological materials”), for the purpose of learning more about aging and the disorders of aging.
- To use the biological materials obtained after death not only for biomedical research, but also for general medical educational purposes, such as teaching healthcare personnel and for testing new medical and surgical techniques.
EXPLANATION OF PROCEDURES
If you are interested in taking part in this Program, or would like to enroll a family member as a potential participant in this Program, you will first be asked to sign this consent form. As mentioned before, to enroll a family member as a participant, you must be that individual’s legal representative. You will be asked to provide proof of this legal status.
After signing this consent form, the participant or the legal representative is asked to complete a medical health questionnaire and sign authorization forms so that we may obtain medical records from the participant’s medical doctors. We will request copies of the potential participant’s medical records from his or her primary care physicians, neurologists and any other medical practitioners as deemed necessary. After review of these medical records, a decision is made as to whether the participant is eligible for participation in the Program. Acceptance into the Program is based on our need to have a balance between normal and diseased individuals and therefore it is possible that the participant may not be accepted on this basis. Unfortunately, if there is a possibility that the participant has a serious infectious (contagious) illness, we may not be able to accept him/her into the Program now (or at a later date) due to the danger of exposing research workers to the infection. Illnesses that may prevent the participant from being enrolled include, but are not limited to, hepatitis B or C, tuberculosis, syphilis, HIV-AIDS, Creutzfeldt-Jakob disease or other prion or viral encephalopathies (infectious or highly contagious brain diseases).
Once accepted into the Program, the participant and/or his/her legal representative, will be contacted by telephone and scheduled for an initial series of clinical assessments. To obtain information about how participants function during life, the Program will require the participants to undergo periodic physical, neurological and neuropsychological examinations. The physical examinations will be like those that that a family doctor performs. The neurological examinations include tests of thinking and movements. The neuropsychological tests are tests of thinking, concentration, and memory. A partner, that is someone who knows the participant well and will be able to answer questions about the participant, may also be asked to attend the testing sessions or to answer questions by telephone. By matching this clinical information collected before death to the results of tests performed on the tissue collected after death, researchers will be able to determine how normal aging and diseases of aging affect brain and body functions. Participants, and possibly a partner, are expected to return to the Institute once each year for their periodic clinical assessment visits. Because these visits are sometimes as much as 4-6 hours long, many participants like to split the assessments into two or three 1-2 hour sessions over 2 or more days. To complete these, the participant will be required to come to the Cleo Roberts Center for Clinical Research at the Institute. We will do our best to accommodate your schedule.
During the neuropsychological testing, the purpose of which is to learn about the participant’s memory and thinking skills, it is helpful for the examiner to audiotape (or record) portions of the participant’s verbal responses to the questions asked. The tape is only used by the examiner to fill in anything that was unable to be copied or written down during the testing. It is also used by the examiner to check the examiner’s written notes for accuracy. This tape will be erased or recorded over after the examiner reviews it. You are free to choose whether or not to allow this recording.
Genetic Testing and Biomarker Studies
The Institute would also like to perform genetic tests and biomarker studies on participants. Genetic testing allows research into inherited factors (called “genes”, which are particular types of “DNA” that differ from person to person) that may cause diseases or increase your/participant's chances of contracting diseases. Genetic testing is performed to look for forms of these genes that may be associated with various diseases. One of the genetic tests that will be performed will determine what type of “apolipoprotein E” gene that you/the participant has. Different forms of this gene, especially the “E4” type, increase an individual’s chances of having heart attacks and Alzheimer’s disease. Other genetic tests may also be performed with your/participant's DNA, depending on future study requirements and the discovery of new disease gene types. The results of these genetic tests may be disclosed to your/participant's first degree relatives (father, mother, sisters, brothers, children), but only if they wish to be informed and only if disclosure is considered to be appropriate in ethical and medical terms by our Institutional Review Board. Many genetic test results are not disclosed to family members because the results of the tests may not have definite consequences for the health of family members, may not affect or change the physician's management of healthcare, and because learning of the test results may cause unwarranted and unnecessary emotional or mental distress. If you do not want to have your/participant's DNA used for genetic testing, you may refuse to participate in this part of the Program, or you may choose to have these tests done only after your death.
Biomarker studies are directed at measuring amounts of certain chemicals or molecules in blood or other biomaterials that may show whether or not you/participant may be at risk for a certain disease, or have a certain disease and/or how severely you/participant may be affected by a certain disease.
If you consent to genetic testing and biomarker studies, you/participant will be asked to give a blood sample, approximately 1.5 tablespoons, for this purpose. These samples would be used to obtain your/participant's DNA and the remainder of the sample would be stored indefinitely at the Institute for use in future biomarkers studies, if those studies are approved by our Institutional Review Board (no specific approval will be needed if these studies are done after you/participant is deceased), The blood sample (a volume equivalent to several tablespoons) will be drawn from an arm vein using a needle and syringe. If you/participant prefer not to give blood or saliva, you/participant may refuse to do so and biological materials obtained after death may be used for genetic and biomarker studies.
The family and caregivers will be given an information sheet that gives the telephone number to call when the participant dies. This call should be made immediately after death so that the biological materials may be obtained in the best possible condition. Institute staff are on call 24 hours every day and will arrange transportation of the body to Boswell Memorial Hospital in Sun City for the donation procedure. The donation may not be accepted if the participant dies in a location outside of greater metropolitan Phoenix, or if for some other reason Institute staff are not able to begin the donation procedures within 12 hours of death (for example if the family or caregivers fail to notify us or if the Medical Examiner decides to perform an investigation).
Blood samples will be obtained after death and used to perform tests for infectious organisms, including but not limited to, HIV/AIDS, syphilis, tuberculosis, hepatitis B and hepatitis C. These tests are performed to protect Institute staff and researchers/educators from getting infectious diseases. Positive results for these tests may be reported to state and/or federal government agencies as required by law.
The participants may elect to donate: 1) only their brain; 2) their brain and other bodily organs, including bodily fluids; or 3) their entire body. Bodily organs may include the spinal cord, spine, eyes, heart, lungs, blood vessels, liver, spleen, kidneys, stomach, intestines, gall bladder, pancreas, ovaries, uterus, prostate gland and testes, or other organs.
If the participant does not donate his or her entire body, the Institute will have the family’s chosen funeral home transport the body to the funeral home. The body will be suitable for an open coffin funeral. The family or estate will be responsible for the usual funeral costs. If the participant donates his or her entire body, the Institute will have the non-retained remains cremated after use and have the ashes returned to the family, usually within 2-4 weeks. There will be no charge to the family or estate. If the participant has already made arrangements (or pre-paid) for cremation of his/her body at a chosen funeral home and wishes to use that funeral home for their services, the Institute will arrange to have the body transported to that location. Participants that
have pre-paid for cremation service will be offered a $500 reimbursement to help compensate some of this expense. This check will be issued upon the death of the participant and made payable to the participant’s personal representative for the estate.
A complete diagnostic autopsy will be performed on donated organs by certified pathologists and the family will be given a copy of the autopsy report.
USE OF CLINICAL DATA AND BIOLOGICAL MATERIALS
Clinical data and biological materials obtained in the Program will be stored indefinitely for future use by researchers and educators for multiple projects. If the participant has been seen by researchers at other institutes that are associated with the Brain & Body Donation Program, including the Mayo Clinic, Barrow Neurological Institute, the University of Arizona, Arizona State University, the Tucson Veterans Administration Hospitals, and Banner Health (called the “Affiliated Institutes”), the participant’s clinical and postmortem data may be released to the researchers at these other institutes.
Otherwise, any clinical data and biological materials distributed to researchers or educators will be anonymous, meaning that those researchers or educators will not know the participant’s name and will not receive any personal identifying information such as date of birth, date of death or social security number. The participant’s identity will be known only to Institute staff responsible for record keeping and to the physicians and other clinical personnel performing the clinical assessments. Clinical data and biological materials will be distributed to non-affiliated researchers and educators only after both Program Directors evaluate the proposed use and decide that the researchers and educators are competent and that their project has scientific or educational value.
The Institute may send participant’s information to the National Alzheimer’s Coordinating Center (NACC), which is an organization funded by the National Institutes of Health to collect data from all Alzheimer’s Research Centers. This information includes dates of birth and death and clinical information, and could include other personal information as required by NACC. The participant’s Social Security Number will be used to obtain their Medicare data from the Chronic Condition Data Warehouse, a federally funded agency enabled by Congress to share US citizens’ Medicare data with qualified researchers.
Clinical data and the results of tests done on biological materials will not be disclosed to participants, unless these are deemed to be important for the participants or their families.
Following enrollment in this program, the participant’s clinical data, biological materials and results of tests done on biological materials will be considered the property of the Institute and may be used in grant applications and fundraising presentations. Clinical data, biological materials and results of tests done on biological materials may be shared with private companies, as part of commercial agreements that are beneficial to the Institute. These agreements provide funds that help the Institute recover the costs of its nonprofit research and its Brain and Body Donation Program. As part of such activity, the Institute may obtain, alone or in partnership with private companies, patents and/or other legal licenses relating to potential diagnostic or treatment methods. Through such means, the Institute, its scientists and physicians, and its collaborators or commercial partners may obtain economic (or financial) benefit. The Institute has no plans for the participant and his or her family to share in this economic benefit. The participant and family do not waive any legal rights by signing this document.
RISKS AND DISCOMFORT
If the participant consents to having his or her blood drawn, this may cause mild bruising, swelling, and pain at the site at which the blood was taken. There is also a very small risk of infection at the site within the few days after the blood draw. If an infection develops, contact Dr. Marwan Sabbagh at 623 875-6500. Some participants may become upset, tired or frustrated during mental skill and movement ability testing. If this occurs, the testing may be postponed or stopped if necessary.
The Institute has extensive precautions in place to prevent any unauthorized disclosure of personally identifiable information. (See discussion in CONFIDENTIALITY section below.) However, if there is an inadvertent or accidental disclosure of clinical data or data obtained from study of biological materials, this could have adverse effects on the participant’s insurability, employability, family relationships, immigration status and other legal issues and could lead to social stigmatization.
There may also be unforeseeable risks that are not known at this time. However, the participant or legal representative will be informed of any new risk as it becomes known.
The intent of the Program is to ultimately benefit others by providing a greater understanding of brain and body function in normal aging and in diseases of aging. Participants may not personally benefit from the activities of the Program. However, if Institute personnel discover conditions that may be harmful to the participant’s health, the participant, the participant’s legal representative, or the participant’s doctor will be informed of this so that appropriate tests or treatments may be sought.
The participant’s family or legal representative will receive, after the death of the participant, an autopsy report based on an examination of the participant’s brain and/or body tissues by qualified pathologists. This will be informative about the participant’s diagnosis and will be provided free of charge to the participant’s family or legal representative. If whole body donation is chosen, cremation of the remains will be provided free of charge.
ALTERNATIVE TO PARTICIPATION
This is a voluntary study. No medical treatments or drugs are given to participants. The alternative is to not participate in this study.
Participants will not be reimbursed for any expenses they incur as a result of their participation in this program. Payment in the form of a lunch voucher (not to exceed $7.00) will be offered to participants who are scheduled for several required assessments on the same day. Participants that have already made arrangements with (or paid) a funeral home or mortuary for cremation of their body will be given
the option of accepting a $500 reimbursement check. This check will be issued upon the death of the participant and made payable to the participant’s personal representative for the estate.
There is no cost to participants, their legal representatives or families for taking part in this study. There will be no charge for any clinical assessments or autopsy procedures performed as part of this research study. If the participant does not donate his or her entire body, the usual costs associated with funeral services, including transportation of the body from Boswell Memorial Hospital to the funeral home, will be the responsibility of the participant’s family and/or legal representative.
Confidentiality of participants’ information will be strictly maintained. Each participant’s clinical data and biological materials will be assigned unique numbers or codes. The list matching participants’ names to their numbers or codes will be kept in a secured computer database and in a locked file at the Institute. Participants’ names and other potentially identifying information will not be published and will not be distributed to any individuals or organizations that are not affiliated with the Program. Within the Program, access to names and potentially identifying information is restricted to certain Institute staff and is allowed only when essential for data entry, record-keeping accuracy or when needed for approved research studies. All requests for data from the Program's database must be approved by both Program Directors and any data will be provided in a confidential manner with no names, addresses, or other identifying information. When clinical data, tissue samples, or biological materials are supplied to a non-affiliated researcher, there will be no identifiers that can be directly related to any individual participant associated with the data, samples or materials.
Representatives from agencies (such as the Food and Drug Administration and the National Institutes of Health) that provide funding for or regulate Program-related research studies may audit Institute and Program records, but will not generally need to see participants’ identities. The Institute may also send participant’s information to the National Alzheimer’s Coordinating Center (NACC).
TERMINATION OR WITHDRAWAL OF PARTICIPATION
A participant’s enrollment in the Program may be stopped at any time by the Institute. In general, this would only be done if the participant is judged to be no longer eligible for the Program. For example, if the participant develops a dangerous infectious disease such as hepatitis B or C, HIV-AIDS, or a prion encephalopathy (an infectious or highly contagious brain disease) such as Creutzfeldt-Jakob disease, or if the participant or the participant’s legal representative refuses to attend scheduled clinical assessments. The participant would be terminated from the Program if the participant dies in a location outside of greater metropolitan Phoenix or greater metropolitan Tucson, or if for some other reason Institute staff are not able to begin the donation procedures within 12 hours of death (for example if the family or caregivers fail to notify us or if the Medical Examiner decides to perform an investigation).
In certain cases, Institute clinical research staff may visit the participant’s place of residence if the participant is medically, or because of a specific situation, unable to travel. However, as the clinical assessments are a vital part of the Program, a participant’s enrollment in the Program may be withdrawn by the Institute if they refuse or are unable to complete the clinical assessments.
The participant or the participant’s legal representative may choose to revoke or change the donation of biological materials at any time. If, at a later time, the participant or the participant’s legal representative decide to change the type of donation (such as changing from brain-only to full body donation or the reverse), please phone and ask to have a new consent sent to you or come in to the Institute and ask for help in signing a new consent. The participant or the participant’s legal representative may withdraw from the Program at any time. To do so, the participant or legal representative must submit a signed statement to the Clinical Coordinator of the Brain and Body Donation Program at 10515 W. Santa Fe Drive, Sun City, AZ 85351.
WHOM TO CONTACT FOR ANSWERS
If participants, their legal representatives, or family members, have any questions regarding the Program, they may call the Directors of the Program, Dr. Thomas Beach or Dr. Marwan Sabbagh.
For questions about enrollment procedures, clinical assessments and use of clinical data, they may call Dr. Marwan Sabbagh in the Cleo Roberts Center for Clinical Research at 623-875-6500.
For questions regarding autopsy procedures, autopsy reports, biological materials storage and distribution to researchers, participants may contact Dr. Thomas Beach in the Civin Laboratory for Neuropathology at 623-876-5458.
RIGHTS AS A PARTICIPANT IN A RESEARCH STUDY
Participants in a research study have the right to know:
- The purpose of the research study.
- Exactly what will be done to you and if any of the procedures, drugs, or devices are experimental.
- Any potential risks or discomforts that may occur as a result of your participation.
- Any potential benefits you might expect as a result of your participation.
- Any alternative or other treatments that might be available.
- That you can ask questions concerning the research at any time either before agreeing to participate or during the course of the research study.
- What medical treatment is available in case of an injury.
- That you can refuse to participate now or that you can change your mind about participating after the study has started.
- That you will receive a copy of the signed and dated consent form.
- That you should not be coerced or influenced in any way regarding your decision to participate or not.