Brain Tissue Donation Program

Program Description Mission: To promote the understanding of brain aging, dementia, serious mental illness and the brain features that govern behavior and cognition through the detailed and direct study of the human brain. The Brain Bank aims to distribute tissue specimens to research laboratories for expert study and advancement of knowledge. Characteristics of the Brain Bank •

The Mount Sinai / JJ Peters VA Medical Center Brain Bank has been in continuous operation since 1982.

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Brain specimens are banked in both flash frozen and formalin fixed form for maximal utilization. In addition to brain, cerebrospinal fluid, muscle tissue and DNA are banked for most cases.

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Frozen specimens are stored in redundant -80 oC freezers.

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Many donations are received from persons who have participated in longitudinal studies during life and have received research level diagnostic and cognitive work-ups.

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All specimens are characterized by detailed neuropathological assessments.

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The postmortem delay in freezing the brain specimens is among the shortest in the world.

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Brain tissue specimens have been distributed to over 50 laboratories within and outside the US.

History of the Mount Sinai / JJ Peters VA Medical Center Brain Bank •

The Brain Bank was established in 1982 as an Alzheimer’s disease brain bank and was expanded to include specimens from persons with schizophrenia and serious mental illness in 1990. In 2013 the Brain Bank expanded its mission further to include multiple other brain disorders and functions.

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Dr. Vahram Haroutunian has directed the Brain Bank from inception.

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Results of studies using specimens from the Brain Bank have been published in over 350 peer-reviewed articles in scientific journals including: Nature, PNAS, JAMA, Lancet, Archives of Neurology, Archives of General Psychiatry, Neurology, American Journal of Psychiatry, American Journal of Human Genetics, Molecular Psychiatry, Gerontology, Neurobiology of Aging, etc.

Studies using specimens from the Brain Bank have contributed to: •

The understanding of the neurochemical deficits in AD and the development of the current FDA approved treatments for AD. The staging of AD neuropathology, i.e., the order in which neuropathology develops in AD. The genome-wide expression of RNA in different brain regions at different stages of AD and the transcriptional vulnerability of the brain at different ages and stages of dementia. The similarities and differences in the neuropathological features of dementia in young-old (65-85 years) vs. oldest-old (above 85 years) persons. The relationship between cardiovascular disease risk factors and the neuropathological features of dementia. The relationship between diabetes and Alzheimer’s disease and the potential of anti-diabetes therapies in reducing the burden of Alzheimer’s disease neuropathology. The association between antihypertension drugs and reduced Alzheimer’s disease neuropathology (press articles attached). The relationship between depression and the neuropathological features of dementia.

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The neurobiology of the glutamine-to-glutamate-to-GABA pathway in schizophrenia. The genome-wide expression of RNA in different brain regions of persons with schizophrenia. Identification and broad acceptance of myelin and oligodendroglial abnormalities in schizophrenia (press article attached). The role of other glial (non-neuronal) cells of the brain in the etiopathophysiology of schizophrenia. Neural systems level analysis of neurobiological changes in schizophrenia. Initiation of pilot clinical trials with a novel class of drugs for the treatment of schizophrenia. Identification of the unique neurobiology of suicide and possible predictive biomarkers for vulnerability to suicide and aggressive behavior.

Brain Tissue Donation Program Important Facts to Keep in Mind • Indicating your intent to participate in research on the enclosed form is not a binding commitment. You may change your mind at any time. • Research Center physicians and investigators will review the participant’s medical records. • The procedures for brain tissue donation are ethical and respectful. • Brain tissue donation will not affect any funeral or burial arrangements that the family may choose. There is no disruption to the participant’s appearance and no significant postponement to funeral arrangements. • Families will incur no costs as a result of study participation.

• As both a medical and a research procedure, autopsy is performed by specially trained personnel. We retain participants’ brain tissue for research purposes. • Following autopsy, a neuropathology report is available to the participant’s family and/or designated physicians, with whom our staff is always available to discuss the findings if requested. • The Autopsy HOTLINE, 212-807-5541, is staffed 24 hours a day, seven days a week. The operator will provide instructions at the time of death.

Brain Tissue Donation Program

What to do at the time of death and what to expect. • At the time of death immediately contact the Autopsy Hotline at 212-8075541 (day or night) • Be prepared to be contacted by the Brain Tissue Donation Program Autopsy Coordinator. • You will be asked to: o Read, understand and sign a formal consent to autopsy and brain tissue donation. o Read, understand and sign a formal Release of Medical Records form. o Read, understand and sign a HIPAA form describing what information will be collected regarding the deceased. • The Autopsy Coordinator will arrange for the transportation of the deceased to our morgue facilities if none are available at the site where death occurred. • The Autopsy Coordinator will work with you to arrange for the transportation of the deceased to your funeral home of choice after the autopsy has been completed. • Members of the Brain Tissue Donation Program may contact you at a later date for additional information regarding the donor and/or for your help in securing medical records. • The detailed neuropathology evaluation of the brain will take several months, but you will be able to contact the Brain Tissue Donation Program if you wish to receive a copy of the neuropathology findings. • The Brain Tissue Donation Program will distribute tissue specimens to investigators at Mount Sinai and multiple other facilities to promote the better understanding of the brain in heath and disease.

Brain Tissue Donation Program

Contact Information Program Director V. Haroutunian, Ph.D. Professor, Psychiatry and Neuroscience

Donation Coordinator Maxwell Bustamante

Clinical Assessment Maria Maroukian, MD, Ph.D.

Office Room 4F-33 James J Peters VA Medical Center 130 West Kingsbridge Road Bronx, NY 10468

Program Information Telephone: 718-584-9000, Extension 6083 Fax: 718-365-9622 Email:[email protected] Web: http://icahn.mssm.edu/research/labs/neuropathology-andbrain-banking

24-Hour Autopsy Hotline (Time of Death) 212-807-5541

The Mount Sinai Medical Center The Mount Sinai School of Medicine One Gustave L. Levy Place New York, NY 10029-6574

Department of Psychiatry (212) 659-8760 Tel (212) 369-2344 Fax

Schizophrenia, Mental Illness and Dementia Neurobiology Laboratories Voice: (718) 584-9000 Ext. 6082 Fax: (718) 365-9622 Email: [email protected]

Address for Correspondence Psychiatry Research Service, 4F-33 James J Peters Medical Center 130 West Kingsbridge Road Bronx, NY 10468

PERMISSION / CONSENT FOR AUTOPSY/BRAIN DONATION Request for Consent of an Anatomical (Brain) Gift Date:

Time:

I hereby authorize that an autopsy be performed on the body of my , Mr./Mrs./Miss (Relationship - please print)

_______________________________

(Name of decreased: first, middle, last - please print)

for diagnostic and research purposes. I understand that tissues and bodily fluids may be removed and retained or diagnostic and research purposes. I also understand that all pertinent medical records will be reviewed and duplicated as necessary. Specifically Personal Health Information relating to medical, psychological, psychiatric and neurological status; Name: first, last, middle names; Address: including apartment number, street, city, county, zip code, telephone number, fax number; Dates (day, month, year): including date of birth, date of admission(s), date of discharge(s), date or dates associated with medical or psychiatric diagnoses, date or dates associated with receipt of medications, date or dates associated with laboratory tests and medical or psychiatric procedures; and Medical record(s) number will be reviewed and information retained for research purposes. However, NO information that may identify me, other than age, will be intentionally revealed to anybody unless required by law. Permission for Autopsy/Brain Donation is Granted: ___________________________ (Signature, consenting next-of-kin)

(Signature, Witness)

(Name: first, middle, last - please print) _______________________________________________ (Name: first, middle, last - please print)

Address and telephone number of Next-Of-Kin giving consent for autopsy. Address

Telephone Number

_____________________ (City, State, Zip Code) DOB and Social Security # (for coding purposes) of Deceased: _________________________________________

PATIENT AUTHORIZATION FOR RELEASE OF MEDICAL INFORMATION TO MOUNT SINAI Patient’s Name:______________________________________________________________________________ (Last) (First) (Middle) Date of Birth: __________________ Month/Day/Year

Unit Number: ________________

Tel. No.:___/_____/___________

Address: ____________________________________________________________________________________ (Street) (City) (State) (Zip Code) Please check the box that describes the person filling out this form and fill in required information:  I authorize ________________________________ to disclose medical information about my: Please request/check all that apply: ___Emergency Room visit on: __________________________________________________ Date(s) ___OPD Clinic visit, specify clinic: _______________________________________________ Date(s) ___Private MD/provider_________________________________________________ Name of Provider Date(s) ___ Hospitalization from: __________________________ to __________________________ Admission Date(s) Discharge Date(s) ___ Ambulatory Surgery:

Date: ________________________

____Specify (i.e. Lab tests, Operative Reports)______________________________ Date____________ Records to be disclosed ____ do include ____ do not include HIV-related information. (check one) To:

Brain Tissue Donation Program

Name: Attn: Ms. Josephine Dodge Address: Bronx VA Medical Center, Psychiatry Research, 4F-33B; 130 West Kingsbridge Road, Bronx NY 10468 Phone:

(718) 584-9000 x6082;

Fax (718) 365-9622

Reason for Disclosure  Patient Request

X Other: Research Project Participation

We will not condition treatment or payment on whether you sign this authorization. However, if you refuse to sign we will not release your records.

1 – Medical Record Copy 2- Patient Copy

MR -230 (4/03)

I understand that this authorization is valid for one year from this date or until __________________and may be revoked by me at any time except to the extent Mount Sinai has already taken action based on my authorization. SPECIFIC UNDERSTANDINGS I understand that this consent may include disclosure of Alcohol and Drug Abuse records and/or Psychiatric records and or HIV-related information (indicating that I have had an HIV-related test, or have HIV infection, HIVrelated illness or AIDS, or that could indicate that I have been potentially exposed to HIV). If I am authorizing the release of HIV-related information, the recipient(s) is prohibited from re-disclosing any HIVrelated information without my authorization unless permitted to do so under federal and state law. I also have a right to request a list of people who may receive or use my HIV-related information without authorization. If you experience discrimination because of the release or disclosure of HIV-related information, you may contact the New York State Division of Human Rights at (800) 523-2437/(212) 480-2493 or the New York City Commission on Human Rights at (212) 306-7450. By signing this authorization form, I am authorizing the use or disclosure of my protected health information as described above. This information may be re-disclosed if the recipient(s) as described on this form is not required by law to protect the privacy of the information, and such information is no longer protected by federal health information privacy regulations. Patient Signature: ___________________________________ Date: ___________________________________ Personal Representative Signature: ________________________________

Print Name: ______________________________

Authority: ________________________________

Tel. No: _________________________________

Address: ________________________________

Date: ___________________________________

{Personal Representative to sign only if patient is a minor or incompetent}. To request records or to revoke authorization, send a written request to releasing provider.

1 – Medical Record Copy 2- Patient Copy

MR -230 (4/03)

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GCO #_______________ Protocol Title:

NIMH, NICHD, and NINDS Brain and Tissue Repository

Principal Investigator:

V(Harry). Haroutunian, Ph.D. The Mount Sinai School of Medicine & JJ Peters VA Medical Center Room, 4F-33 130 West Kingsbridge Road Bronx, NY 10468 Voice: 718-584-9000, Ext 6082

Co Investigator(s):

You have agreed to participate in the study mentioned above and have signed a separate informed consent that explained the procedures of the study and the confidentiality of the personal health information of the deceased. The federal Health Insurance Portability and Accountability Act (HIPAA) requires us to give you more detailed information about how we intend to use and share the health information of the deceased in connection with this study. We also need to ask your permission to receive, use and share that information. You authorize The Mount Sinai Hospital, your doctors and other health care providers to disclose your health information for the purposes described below: What personal health information is collected and used in this study, and might also be disclosed (shared)? − The following personal health information will be collected, used for research and may be disclosed or released in connection with this research study. − Name, Address, Telephone number Dates (day, month, year): including date of birth, date of admission(s), date of discharge(s), date or dates associated with medical and/or psychiatric diagnoses, date receipt of medications, laboratory tests and medical and/or psychiatric procedures. − Identifying numbers including medical records numbers and social security number. − Medical History (includes current and past medications or therapies, illnesses, conditions or symptoms, family medical history, allergies, etc.). − Photographs of collected/banked specimens. − Medical Records from private doctor(s) and institution(s) as well as from Mount Sinai Hospital or other facilities. − Information from a physical examination performed by your health care providers that generally also includes blood pressure reading, heart rate, breathing rate and temperature − The collected/banked brain tissue and related specimens are subject to detailed physical, chemical, molecular, anatomical and pathological evaluations and are then made available to the world-wide research community for further study. These studies can include, but are not limited to anatomical, pathological, molecular, neurochemical, genetic and immunological experiments. To date, such studies have advanced our knowledge of the neurobiology of the brain in health and illness. This knowledge has been disseminated through hundreds of scientific papers in peer-reviewed publications. − HIV-related information, which includes any information indicating that you have had an HIV related test, or have HIV infection, HIV related illness or AIDS, or any information which could indicate that you have been potentially exposed to HIV. − Mental health records. − Alcohol or Substance Abuse records.

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HIPAA Authorization MSH

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GCO #_______________ Why is the personal health information of the deceased being used? Your personal contact information is important to be able to contact you during the study. The health information and results of tests and procedures of the deceased are being collected as part of this research study and for the advancement of medicine and clinical care. We hope to gain a better understanding of brain function and dysfunction by assessing the biology of the brain in the context of the whole person and their medical and psychological history. The research team may use and share this information to ensure that the research meets legal, institutional or accreditation requirements. Which of our personnel may use or disclose your personal health information? The following individuals and organizations may use or disclose the personal health information of the deceased for this research project: - The Principal Investigator and the Investigator’s study team (other Mount Sinai Hospital, Mount Sinai School of Medicine and James J. Peters VA Medical Center staff associated with the study) - The Mount Sinai School of Medicine and the James J Peters VA Medical Center Institutional Review Board (the committee charged with overseeing research on human subjects) and the Mount Sinai Hospital’s and Mount Sinai School of Medicine’s Privacy Officers. - Authorized members of the Mount Sinai Hospital, Mount Sinai School of Medicine and James J Peters VA Medical Center workforce who may need to access your information in the performance of their duties (for example: to provide treatment, to ensure integrity of the research, accounting or billing matters, etc.). Who, outside of the Mount Sinai School of Medicine, the Mount Sinai Hospital and James J Peters VA Medical Center, might receive the personal health information of the deceased? As part of the study the Principal Investigator, study team and others listed above may disclose the personal health information of the deceased, including the results of the research study tests and procedures to the following people or organizations. It is possible that there may be changes to the list during this research study. You may request an up-to-date list at any time by contacting the Principal Investigator. - Other collaborating research center(s) and their associate research/clinical staff who are working with the investigators on this project: Mount Sinai School of Medicine and James J. Peters VA Medical Center and other sites available on request. - Research data coordinating office and/or their representative who will be responsible for collecting results and findings from all the centers: National Institutes of Health. - The sponsoring Government agency and/or their representative who need to confirm the accuracy of the results submitted to the government or the use of government funds: National Institutes of Health. - United States Department of Health and Human Services and the Office of Human Research Protection. - New York State Department of Health. - In all disclosures outside of the Mount Sinai School of Medicine, the Mount Sinai Hospital and James J Peters VA Medical Center, the deceased will not be identified by name, social security number, address, telephone number, or any other direct personal identifier unless disclosure of the direct identifier is required by law. - In records and information disclosed outside of the Mount Sinai School of Medicine, the Mount Sinai Hospital and James J Peters VA Medical Center, the deceased will be assigned a unique code number. The Principal Investigator will ensure that the key to the code will be kept in a locked file, or will be securely stored electronically.

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HIPAA Authorization MSH

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GCO #_______________ How long will the Mount Sinai School of Medicine, the Mount Sinai Hospital and James J Peters VA Medical Center be able to use or disclose the personal health information of the deceased? Since the brain and related specimens are banked for research use by multiple current and future research projects there is no specific termination date. Your authorization for use of your personal health information for this specific study does not expire. Will you be able to access to the records of the deceased? During your participation in this study, you will have access to the medical record of the deceased that you are legally authorized to have. The investigator is not required to release to you research information that is not part of your medical record. Do you have to sign this Authorization? NO! If you decide not to sign this authorization the brain of the deceased will not be included in the research study. If you do not sign, it will not affect your treatment, payment or enrollment in any health plans or affect your eligibility for benefits. Can you change your mind? You may withdraw your permission for the use and disclosure of any of the personal information of the deceased for research, but you must do so in writing to the Principal Investigator at the address on the first page. Even if you withdraw your permission, the Principal Investigator for the research study may still use the personal information of the deceased that was already collected if that information is necessary to complete the study. If you withdraw your permission to use of the personal health information of the deceased for research that means that the donated tissue of the deceased will also be withdrawn from the research study, but standard medical care and any other benefits to which you are entitled will not be affected. You can also tell us you want to withdraw your authorization for the use of the donated tissue in the research study at any time without canceling the Authorization to use your data.

You will be given a copy of this Research Subject Authorization Form describing confidentiality and privacy rights for this study. If you have not already received it, you will also be given The Mount Sinai Hospital Notice of Privacy Practices that contains more information about the privacy of your health information. By signing this document: •

You are permitting The Mount Sinai Hospital and James J Peters VA Medical Center, doctors and other health care providers to disclose the health information of the deceased to the researcher for the purposes described above.

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You are permitting the Icahn School of Medicine at Mount Sinai, The Mount Sinai Hospital and the James J Peters VA Medical Center to use the personal health information collected about the deceased for research purposes within our institutions.

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You are also allowing the investigators, Icahn School of Medicine at Mount Sinai, The Mount Sinai Hospital and the James J Peters VA Medical Center to disclose that personal health information collected about the deceased to outside organizations or people for research purposes as described above.

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You recognize that once information is disclosed to others outside Icahn School of Medicine at Mount Sinai, The Mount Sinai Hospital and the James J Peters VA Medical Center the information may be redisclosed and no longer be covered by the federal privacy protection regulations.

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HIPAA Authorization MSH

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GCO #_______________

Notice Concerning HIV-Related Information

If you are authorizing the release of HIV-related information, you should be aware that the recipient(s) is (are) prohibited from re-disclosing any HIV-related information without your authorization unless permitted to do so under federal or state law. You also have a right to request a list of people who may receive or use your HIVrelated information without authorization. If you experience discrimination because of the release or disclosure of HIV-related information, you may contact the New York State Division of Human Rights at (888) 392-3644 or the New York City Commission on Human Rights at (212) 306-5070. These agencies are responsible for protecting your rights.

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HIPAA Authorization MSH

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GCO #_______________

SIGNATURE I have read this form and all of my questions about this form have been answered. By signing below, I acknowledge that I have read and accept all of the above. _________________________________________ Signature of Subject or Personal Representative _________________________________________ Print Name of Subject or Personal Representative _________________________________________ Date _________________________________________ Description of Personal Representative’s Authority

CONTACT INFORMATION The contact information of the subject or personal representative who signed this form should be filled in below. Address: ______________________________ ______________________________ ______________________________ ______________________________

Telephone: ___________________ (daytime) ___________________ (evening) Email Address (optional): ____________________________

THE SUBJECT OR HIS OR HER PERSONAL REPRESENTATIVE MUST BE PROVIDED WITH A COPY OF THIS FORM AFTER IT HAS BEEN SIGNED.

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HIPAA Authorization MSH