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For Donors

To volunteer as a brain and/or body donor in the Brain and Body Donation Program, you must live in the greater Phoenix, Arizona area and meet certain requirements. Donors must be healthy enough to visit the Institute for annual clinical assessments.

If you agree to the program’s goals, activities and requirements, please contact us at (623) 832-6500.

If you want to participate or enroll a family member, as , you will need to sign a consent form. To enroll a family member, you must be their legal representative and provide proof of this status.

Clinical assessments

After signing the consent form, participants or the legal representatives will complete a medical health questionnaire and authorization forms. These allow ups to request medical records from the participant’s doctors, including primary care physicians, neurologists and any other necessary specialists. Once we review these records, we will determine if the participant is eligible for the program.

Acceptance into the program depends on maintaining a balance between healthy and diseased individuals. A participant may not be accepted for this reason. Additionally, 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 later) due to the danger of exposing research workers to the infection. Conditions that may prevent participation include, but are not limited to, hepatitis B or C, tuberculosis (TB), syphilis, HIV/AIDS, Creutzfeldt-Jakob disease and other infectious brain diseases.

Once accepted, the participant or their legal representative will be contacted to schedule an initial series of clinical assessments. These assessments will help us understand how participants function during life. Participants will undergo periodic physical, neurological and neuropsychological exams:

  • Physical exams: Similar to a regular doctor’s visit.
  • Neurological exams: Tests for thinking and movement.
  • Neuropsychological tests: Evaluations of memory, concentration, and cognitive skills.

A person who knows the participant well (a “partner”) may also be asked to answer questions in person or by phone. By comparing this information to tests conducted after death, researchers can study how aging and disease affect the brain and body. Participants, along with their partners if applicable, are expected to return annually for assessments.

Because assessments can take four to six hours, participants may choose to complete them over multiple shorter sessions. These take place at the Cleo Roberts Center for Clinical Research and we will work with your to accommodate your schedule.

During the neuropsychological testing, the purpose of which is to learn about the participant’s memory and thinking skills, the examiner may record audio of the participant’s verbal responses. This helps ensure accurate records. The recordings are erased after review. Participants can decline to be recorded.

Genetic testing and biomarker studies

The Institute conducts genetic tests and biomarker studies to research inherited factors (genes) that may contribute to disease. One test determines the type of apolipoprotein E gene a participant has, which can indicate the risk of heart disease and Alzheimer’s disease. Additional genetic tests may be conducted based on new discoveries and study needs.

Test results may be shared with first-degree relatives (parents, siblings or children), only if they wish to be informed and if disclosure is considered appropriate in ethical and medical terms by our Institutional Review Board. Most genetic test results are not shared because they may not impact a family member’s health or medical care and could cause unnecessary distress.

If you do not want to have your DNA used for genetic testing, you may opt out. You can also choose to allow testing only after your death.

Biomarker studies measure specific chemicals or molecules in blood or other samples to assess disease risk, presence or severity. If you consent, we will collect about 1.5 tablespoons of blood for DNA testing and biomarker research. Any remaining samples will be stored indefinitely for future studies. If you prefer not to give a sample, biological materials obtained after death may be used instead.

Donation procedures

Family members and caregivers will receive instructions on whom to call immediately after the participant’s death. Our staff is available 24/7 to arrange transport to Banner Boswell Medical Center in Sun City.

Donations may not be accepted if:

  • The participant dies outside the greater Phoenix area
  • Institute staff are not able to begin the donation procedures within 12 hours of death (e.g., due to delayed notification or a medical examiner’s investigation)

After death, blood samples will be tested for infectious diseases, including but not limited to, HIV/AIDS, syphilis, tuberculosis, hepatitis B and hepatitis C, to protect Institute staff and researchers/educators. Positive results may be reported to state and/or federal government agencies as required by law.

The participants may choose to donate:

  1. Only their brain
  2. Their brain and other organs, including bodily fluids
  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 entire body is not donated, a funeral home of the family’s choice will transport the body. It will be suitable for an open-casket funeral. The family or estate is responsible for funeral costs.

If the entire body is donated, the Institute will arrange for cremation after use and the ashes will be returned to the family within two to four weeks. There is no cost to the family or estate. Participants who have prepaid for cremation at a chosen funeral home will be offered a $500 reimbursement to  offset this expense. This check will be issued to the participant’s estate representative after their passing.

Certified pathologists will perform a full diagnostic autopsy on donated organs and the family will receive a copy of the report.

Use of clinical data and biological materials

Clinical data and biological materials collected in this program will be stored indefinitely for future use by researchers and educators for various projects. If the participant has been seen by researchers at other institutes that are associated with the Brain & Body Donation Program, such as  the Mayo Clinic, Barrow Neurological Institute, the University of Arizona, Arizona State University, the Tucson Veterans Administration Hospitals, and Banner Health (referred to as the “Affiliated Institutes”), the participant’s clinical and postmortem data may be shared with researchers at these institutes.

Otherwise, any clinical data and biological materials shared with researchers or educators will be anonymous. This means those researchers or educators will not know the participant’s name or receive personal identifying information such as birthdate, date of death or social security number. The participant’s identity will only be known to Institute staff who manage records as well as the physicians and other clinical personnel performing the assessments.

Clinical data and biological materials will be shared with non-affiliated researchers and educators only after both Program Directors review the proposed use. They will decide if the researchers and educators are qualified and if their project has scientific or educational value.

The Institute may share the participant’s information with the National Alzheimer’s Coordinating Center (NACC), an organization funded by the National Institutes of Health that collects data from all Alzheimer’s Research Centers. This information may include birth and death dates, clinical details and possibly 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 that shares Medicare data with qualified researchers.

Clinical data and results from tests on biological materials will not be shared with participants unless the results are important for the participant or their family.

After enrolling in this program, the participant’s clinical data, biological materials and test results will be considered the property of the Institute. They may be used in grant applications and fundraising presentations. Clinical data, biological materials and test results may also be shared with private companies, as part of agreements that benefit the Institute. These agreements help cover the costs of nonprofit research and the Brain and Body Donation Program.

As part of such activity, the Institute may, alone or with private companies, obtain patents and/or other legal licenses for potential diagnostic or treatment methods. Through these agreements, the Institute, its scientists and physicians, and its partners may receive financial benefits. The Institute does not plan for the participant or their family to share in these benefits. Signing this document does not waive any legal rights of the participant or their family.

Risks and discomfort

If the participant agrees to have blood drawn, it may cause mild bruising, swelling or pain at the site where the blood was taken. There is also a very small risk of infection at the site in the days following the blood draw. If an infection develops, call 623-875-6500. Some participants may feel upset, tired or frustrated during mental skill and movement ability testing. If this happens, the testing may be postponed or stopped if necessary.

The Institute has strict precautions in place to protect personally identifiable information (see the CONFIDENTIALITY section below). However, if clinical data or data from study of biological material studies are accidentally disclosed, it could affect the participant’s insurability, employability, family relationships, immigration status and other legal issues. It may also lead to social stigmatization.

There may also be risks that are not yet known. However, the participant or legal representative will be informed of any new risks as they become known.

Benefits

The goal of the program is to help others by providing a better understanding of brain and body function in normal aging and in diseases related to aging. Participants may not personally benefit from the program’s activities. However, if Institute staff find conditions that may be harmful to the participant’s health, the participant, their legal representative or their doctor will be informed so that appropriate tests or treatments may be pursued.

After the participant’s death, their family or legal representative will receive an autopsy report. This report will include information from an examination of the participant’s brain and/or body tissues by qualified pathologists. It will provide details about the participant’s diagnosis and will be given free of charge. If whole body donation is chosen, cremation of the remains will also be provided at no cost.

Alternative to participation

Participation in this study is voluntary. No medical treatments or drugs are given to participants. The alternative is to choose not to participate in the study.

Financial compensation

Participants will not be reimbursed for any expenses related to their participation in this program. Participants who are scheduled for several required assessments on the same day will receive a lunch voucher (up to $7). Participants who have already made arrangements or paid a funeral home or mortuary for cremation will have the option to receive a $500 reimbursement check. This check will be issued after the participant’s death and will be made payable to the participant’s personal representative for the estate.

Financial obligations

There is no cost for participants, their legal representatives or their families to take part in this study. No charges will be made for clinical assessments or autopsy procedures as part of this research. If the participant does not donate their entire body, the usual costs for funeral services, including transporting the body from Banner Boswell Medical Center to the funeral home, will be the responsibility of the participant’s family or legal representative.

Confidentiality

The confidentiality of participants’ information will be strictly protected. 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 identifying information will not be published or shared with any individuals or organizations 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 necessary for data entry, record-keeping accuracy or approved research studies. Any request for data from the program's database must be approved by both program directors. If data is shared, it will be provided in a confidential manner with no identifying information, such as names or addresses. When clinical data, tissue samples or biological materials are shared with non-affiliated researchers, they will not include any identifiers that can be linked to an individual participant.

Representatives from agencies like the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) may audit Institute and program records, but they generally will not need to see participants’ identities. The Institute may also send participant information to the National Alzheimer’s Coordinating Center (NACC).

Termination or withdrawal from participation

A participant’s enrollment in the program may be stopped at any time by the Institute. In most cases, this would happen if the participant is 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 disease (such as Creutzfeldt-Jakob disease), or if the participant or their legal representative refuses to attend scheduled clinical assessments.

The participant will be removed from the program if they die outside the greater metropolitan Phoenix or Tucson areas, or if the Institute is unable to start donation procedures within 12 hours of death. This could happen if the family or caregivers fail to notify the Institute or if the medical examiner decides to investigate the death.

In some cases, Institute clinical research staff may visit the participant’s place of residence if they are unable to travel due to medical reasons or other specific situations. However, because clinical assessments are an important part of the program, the Institute may withdraw a participant if they refuse or are unable to complete the required clinical assessments.

The participant or their legal representative may choose to change or cancel the donation of biological materials at any time. If they wish to change the type of donation (for example, switching from brain-only to full body donation, or vice versa), they can contact the Institute to request a new consent form or come in to sign one.

The participant or the participant’s legal representative can withdraw from the program at any time. To do so, they 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.

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.

If you or a loved one is interested in learning more about the Brain and Body Donation Program, please contact us at (623) 832-6500.