Protocol
1. Project Title: Establishment of UF Brain Tumor Tissue Repository
2. Investigator(s):
Principal Investigator: William A. Friedman, MD
Co-Investigator: Anthony T. Yachnis, MD
Sub-Investigators: D. Steindler, B. Scheffler, H.V. Baker, A. Smith, E.M. Dunbar, D. Pincus, K. Foote, S.
Roper, S. Lewis, T.A.Eskin, N. Tereda, J. Qiu, J. Streit, S. Sullivan, K. D. Robertson, B. Fankhouser, B.
Frentzen.
3. Abstract:
Brain tumors remain incurable and often rapidly fatal, despite aggressive treatment. Despite these realities,
clinicians and researchers are making improvements in both the length and quality of patients’ lives by
harnessing the information contained in brain tumor tissue and translating it into novel scientific and
therapeutic advances.
Recent basic science and pre-clinical advances in analysis of brain tumor tissue at the genetic and epigenetic
levels have revolutionized the way brain tumor researchers collect and use brain tumor tissue. Historically
limited to diagnosis alone, the future of brain tumor therapy involves the collection of large numbers of brain
tumor samples, as well as multidisciplinary analysis and data-sharing.
Only centers equipped with Tissue Repositories are able to successfully analyze brain tumor tissue in a way
that yields information critical to better understanding the development and growth of a tumor, measurements
of treatment response, and variables of survival and quality of life. This information can directly lead to new
treatments.
This proposal is part of a multidisciplinary effort to establish a world-class Brain Tumor Tissue Repository at
UF that will yield internationally competitive research. It is designed to maximize the use of each specimen
and facilitate collaboration and discovery. Ultimately, this proposal is an essential step in our goal of
establishing a UF Brain Tumor Therapy Center and helping UF to achieve NCI designation.
4. Background:
This proposal involves the collection, storage, characterization, analysis, and distribution of brain tumor tissue
donated by patients undergoing neurosurgical procedures for brain tumors. Potential research subjects will
be offered the opportunity to donate their “extra” brain tumor tissue (not needed for their medical care), as well
as peripheral venous blood, and cerebrospinal fluid, into the UF Brain Tumor Tissue Repository, for the
purposes of current and future brain tumor research. In addition, a few patients undergoing neurosurgery for
other disorders, will be asked to donate their “extra” brain tissue as “controls”. From this point forward “tissue”
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will refer to any and all tissue donated by patients, including brain tumor, peripheral blood, and cerebrospinal
fluid.
With the goal of maximizing the investigational yield of each donated sample, this proposal also invites
potential research subjects to voluntarily allow their specimens to be “linked” to the existing IRB-approved
“Human Brain Tissue Databank” (HBTB), which provides post-mortem specimens to qualified researchers.
This would allow research subjects, who independently consent to prospectively donate their brain tissue to
the Human Brain Tissue Bank, the opportunity to give the Investigators of UF Brain Tumor Repository the
ability to request post-mortem tissue for comparative analysis. The research subjects may learn about and
independently consent for either or both at any time and in any order (discussed below in “Subject Consent”).
However, the resultant designation of being consented to both independent protocols (Tissue repository and
HBTB) at anytime would enable the specimens from both research projects to be “linked” by the same unique
identification number. When a research subject’s tissue becomes available to the HBTB, then the
Investigators of the tissue repository could request samples. The comparative analysis of this voluntarily
“linked” tissue represents a unique and powerful opportunity to better understand how tissue differs when
collected from a person under different conditions. This opportunity includes comparisons of specimens from
diagnosis through the post-mortem time-period, specimens from different stages of tumor growth, and
specimens exposed to a variety of sequential treatments.
The Tissue Repository will characterize and analyze the specimens using the most up-to-date methods. This
characterization and analysis, as well as any results of experiments donated by qualified researchers will be
re-incorporated (when possible) into the Repository. The Repository would provide a centralized “banking” of
difficult-to-obtain and rare brain tumor tissue, not otherwise obtainable to individual researchers, and
provide a unique medium for a wide-variety of basic-science and clinical research. Ultimately, the goal of
the Investigators is to rapidly translate research advances to the community. The research resulting from
the Repository will increase our ability to collaborate and compete in the international scientific community.
5. Specific Aims:
1. Establish a Brain Tumor Tissue Repository at the University of Florida. The purpose will be to collect,
store, characterize, analyze and distribute donated brain tumor tissue for current and future research. All
patients undergoing neurosurgical procedures will be offered the opportunity to donate their “extra” brain
tissue (left over after medical use), as well as peripheral blood and cerebrospinal fluid (CSF) for the purpose
of comparison analysis. In addition, those undergoing neurosurgical procedures for other reasons may be
asked to serve as “control subjects”.
The Investigators of this proposal have established the infrastructure necessary to successfully develop and
maintain a brain tumor tissue repository. The researchers will comprise neurosurgical, neuropathology,
pediatric and adult medical oncology, and basic scientists who already successfully collaborate. Significant
financial, logistical, and space resources have been reserved by Dr. Steindler, the director of the McKnight
Brain Institute, and the Department of Neurosurgery. Current and future research costs will be maintained by
Dr. Friedman and his collaborations with Dr. Steindler and the University of Florida.
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2. The establishment of a Brain Tumor Tissue Repository includes ongoing attention to both the
routine medical care and research requirements of each research subject. A clinical research nurse
(CRN) position has already been created for this purpose. The nurse, or his/her designee(s), will consent and
enroll research subjects; assist in collection, labeling, and transfer of tissue specimens; provide ongoing data-
entry; serve as a liaison between the IRB, investigators, researchers and research subjects; and provide
clinical support to subjects receiving medical care.
Only information necessary to perform research will be collected and it will be kept with the strictest
confidentiality. All PHI will be removed from tissue specimens. Specimens will only be labeled with a unique
identification number. Anyone involved in this research will only have access to the most limited set of
information required to complete the necessary functions of his/her job. The Investigators and approved
researchers will not have access to the PHI, other than explicitly within the context of specimen
characterization and analysis.
3. Ongoing characterization and analysis will be necessary to maintain a scientifically relevant Tissue
Repository and to provide qualified researchers with sufficient information regarding the tissue. The
clinical research nurse will be responsible for ongoing data entry, which may include information about the
tissue specimen and the research subject. This data will be securely stored on the McKnight Brain Institute’s
Computer Server and maintained by the Department of Neurosurgery.
The processes of characterization and analysis will evolve with scientific discovery and may incorporate
technologies such as histopathology, immunohistochemistry, cytogenetics, flow-cytometry, DNA microarray
“gene-chips”, high-throughput analysis, laser-micro-dissection, genetic and epigenetic analysis, analysis of
regenerative cells and their growth factors, or methods of the future. Relevant characterizations will be made
between the tissue and the donor, including details regarding survival, prognosis, response to treatment, and
quality of life. The result of these efforts may lead to improved methods for characterization and analysis,
novel prognostic variables, as well as enhanced measurements of treatment response and quality of life.
4. Tissue specimens will be prepared and preserved by the appropriate techniques necessary for
distribution to qualified researchers. A repository manager will be responsible for preparation,
preservation, accounting, and storage of the tissue. The Human Brain Tissue Bank Coordinator, or his/her
successor, will serve as the tissue repository manager for all specimens within the Tissue Repository, The
methods for preparing and preserving tissue will evolve over time and currently involve formalin-fixed, frozen,
and cryopreserved tissue (outlined in the method section). Potential uses of the specimens within the Tissue
Repository will require approved IRB protocols and the expressed permission by the Tissue Repository
Oversight Committee (discussed below). The current methods will incorporate preparation and preservation
techniques necessary for cell-culture development and analysis, establishment of viable cell-lines, analysis of
viable cell lines, extraction of DNA, RNA, proteins or growth-factors for analysis, and other future
technologies. These efforts may lead to the development of novel technologies, compounds, cell-lines, and
therapies.
5. The Tissue Repository will facilitate the maximal use of rare and difficult to obtain brain tissue. A
Tissue Repository Oversight Committee, composed of multidisciplinary Investigators from this protocol, will
designate use of the tissue to qualified researchers with approved IRB protocols. As discussed above,
research subjects will have the options of allowing their donated tissue to be “linked” to the Human Brain
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Tissue Bank post-mortem specimens, through their unique identification number. This will allow for sharing of
tissue and data, devoid of PHI.
Another way to increase the usefulness of the donated tissue is to maximize the data entered on each
specimen. Results of research performed on repository specimens may be re-entered into the tissue
repository by the clinical research nurse, using only the unique identification number. Researchers will be
encouraged to voluntarily provide their results for this purpose.
Lastly, when permission by the research subject and IRB has been prospectively obtained, “limited-data” sets,
subsets of PHI-devoid information, may be made available to international scientific collaborators and brain
tumor research forums.
6. Research Plan:
Please refer to our attached sample flow charts, informed consent, and data collection forms.
Subject Selection:
Potential research subjects present to the Neurosurgery clinic with a presumed or known brain tumor. In
addition, potential research subjects present to Neurosurgery with another indication for surgery. This
target population will encompass adult, adolescent, and pediatric research subjects. The Principal-
Investigator Dr. Friedman, his successor, his clinical research nurse, or a member of the medical team
screen potential subjects for eligibility. Education and consent for proposal (potentially more than one)
occurs by the clinical research nurse and medical staff specifically trained for this purpose. The clinical
research nurse serves as a liaison between subjects, clinicians, researchers, and the IRB. The education
and consent process occurs within the clinic or hospital setting, within the context of routine medical care.
Potential research subjects undergoing Neurosurgical evaluation may be screened for eligibility, as
outlined by the IRB. The clinical research nurse may approach and communicate with potential research
subjects only regarding existing IRB-approved research protocols. They may contact the research subject
in the future, if needed, and only if the subject documents agreement.
The inclusion of “protected and vulnerable populations”, such as individuals younger than 18 years and
older than eighty-nine (89), including those designated as terminally-ill, is intended only for the purpose of
examining their brain tumor tissue. Given that brain tumors are rare, difficult to sample, and are well-known
to arise and behave differently at the extremes of age and health, their inclusion is essential.
Subject Consent:
There is minimal to no additional risk, beyond that of routine medical care, by participating in this study. If
the potential research subject is a protected/vulnerable population, such as an individual under the age of
eighteen (18), the individual’s guardian may consent on their behalf. If they are over seven (7) years old,
they may designate their understanding of their involvement by signing their name at the designated place
on the last page of the informed consent. Their tissue and medical information will be stored securely and
confidentially. When this individual turns 18 years, the Principal-Investigator and Co-Investigator will share
in the responsibility of actively seeking out the subject for their re-consent.
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All consented subjects will undergo routine surgical medical care. There will be NO experimental
procedures NOR exposure to experimental substances. Therefore, there will be no experimental control
arm or standard of care subject arms. There will be no requirement for a Data Safety Monitoring Board
(DSMB) or oversight committee, other than the routine monitoring by the IRB. There will be no need to
monitor study subject conduct.
Research subjects who independently consent to prospectively donate their brain tissue to the Human Brain
Tissue Bank, have the opportunity to give the Investigators of UF Brain Tumor Repository the ability to
request post-mortem tissue for comparative analysis. The research subjects may learn about and
independently consent for either or both protocols at any time and in any order. Example # 1: If a new patient
presents for routine Neurosurgery, the Clinical Research Nurse (CRN) will educate, offer participation, and
consent for the Tissue Repository. In addition, the CRN will provide introductory information and contact
information regarding the IRB-approved HBTB. Example # 2: In the event that a person has already
independently enrolled in the HBTB, then the research subject will have the opportunity to designate this on
number 6 on the Tissue Repository consent. Example # 3: In the event that the enrollment for the HBTB
occurs after the enrollment into the Tissue Repository, then the research subject will inform the Investigators
and their answer to item 6 on the Repository informed consent will be retrospectively documented. No matter
which order the research subject may independently enroll in both the HBTB and the Tissue Repository, the
research subject’s participation in both protocols, as well as his/her consent to number 6 of the informed
consent, will be designated within the confidential computerized records of the Tissue Repository and the
HBTB. Item 6 on the Repository informed consent, which designates consent for information to be “linked” by
a unique identification number and shared with respect to the HBTB, will be confidentially documented by the
CRN, Tissue Repository Manager, and the HBTB coordinator, including the dates that the subject consented.
Ultimately, the resultant designation of being consented to both independent protocols, as well as consenting
to item 6 on the Tissue Repository informed consent, at anytime would enable the specimens from both
research projects to be “linked” by the same unique identification number and used as specified.
Tissue Collection:
From this point forward, the term “tissue” refers to brain, blood and CSF specimens. “Extra” brain tissue
(not used for medical care), and/or ~10 ml of peripheral blood, and/or ~10 ml of CSF are collected from
consented subjects during routine surgical care. Serial brain tissue will be collected if the subject
undergoes more than one neurosurgical procedure. Peripheral blood may be collected at additional time-
points, but only when blood would be collected for routine medical care.
Samples will be collected by the clinical research nurse and delivered to Dr. Yachnis, Co-Investigator, or
his successor, in the Pathology Department for routine medical use. The tissue will be fixed and prepared
in accordance to standard pathological methods currently required for routine diagnostic evaluation.
Standard tissue sectioning and neuro-pathological characterization and documentation, required for routine
medical care, will occur.
Any tissue deemed “extra” by either Principal-Investigator, Dr. Yachnis or his designee, will be passed
along to the tissue repository manager, who will proceed with preparation, preservation, and storing (as
below).
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Tissue Labeling:
A unique identification number is assigned to all tissue specimens and will be assigned by the Pathology
Department after tissue has been deemed “extra”. The “extra” tissue specimens of enrolled research
subjects will be identified only by their unique identification number. This number will enable the clinical
research nurse to link the tissue to corresponding characterization and analysis data. In contrast, the
“extra” tissue specimens of non-enrolled (non-consented) or unidentified persons will be also identified by a
unique identification number, but this number will be not be linked to any PHI. For the research subjects
who at any time have designated participation in the HBTB, the unique identification number will be used to
request samples of their tissue when available.
The integrity and confidentiality of the tissue and data will be strictly maintained forever, or until it is
destroyed. Only the clinical research nurse, or his/her designee(s) or successor(s), will have access to
both the unique identification number and a research subjects identity (name, medical record number,
address, phone). The Principle-Investigator, Principal-Investigator, Sub-Investigators, and designated
researchers, will only be given a minimal data set by the clinical research nurse, as required to answer
specific research questions.
Research subjects who also prospectively enroll in the Human Brain Tissue Bank will have their post-
mortem specimens collected and maintained under the separate HBTB protocol. The research subjects
who are participating in both research projects will be designated within the tissue repository and be kept
securely forever (or until destroyed). The clinical research nurse and the tissue repository manager will
identify them only by their unique identification number. This will enable the Investigators to request
samples of post-mortem specimens of patients enrolled within the Tissue Repository, as they become
available.
Tissue preparation and preservation:
“Standard Operating Procedures” exist within the Pathology Department for samples undergoing routine
medical analysis. Likewise, the coordinator of the Human Brain Tissue Bank, who will also serve as the
manager for our Tissue Repository, will use the “Standard Operating Procedures” outlined in the HBTB
protocol to prepare and preserve tissue donated from this research project. These procedures will evolve
with time and allow for maximal use of tissue for current and future research. Currently, “extra” tissue will
either be fixed in formalin, flash-frozen in liquid nitrogen, placed in appropriate culture medium or
refrigerated at the appropriate temperature. All Tissue Repository samples will be stored in the HBTB’s
tissue rental space.
Tissue Storage and Maintenance:
The physical functions of tissue storage and maintenance, including specimen preparation, preservation,
storage, maintenance and specimen-security, will be the primary responsibilities of the tissue repository
manager. At the present time, the tissue will be stored within the research space provided by the Human
Brain Tissue Bank (HBTB). The HBTB is located on the 5th floor of the UF MBI. Shelf space in a regular
“minus-40 degree” freezer and liquid nitrogen freezer has already been reserved for up to 200 research
subjects per year. A fee for renting and maintenance of this space, approximately $500-1,000 will be paid
to the HBTB annually. Administrative support will currently be provided by the HBTB Coordinator, who will
serve as our research project’s tissue repository manager. The tissue will be jointly counted, logged-in, and
labeled by our clinical research nurse and the HBTB coordinator. Each will sign off on each other’s
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documentation, for accountability and auditing purposes, all tissue will be entered into the HBTB database.
Routine verification of our active IRB status, location and number of specimens, and quality-monitoring will
be performed by the HBTB coordinator and a summary letter provided to the IRB annually.
All other functions of tissue storage and maintenance, excluding the physical ones listed above, will be the
primary responsibility of the clinical research nurse. Functions include subject enrollment and consent,
tissue collection and transfer, ongoing data-entry, and data-security. The tracking of the distributions and
uses of tissue; the verification of consents and active IRBs; and all required paperwork will be maintained
by the clinical research nurse. Routine quality assurance and necessary maintenance will be performed. All
departmental, UF, and state and federal regulations will be maintained.
No matter which order the research subject may independently enroll in both the HBTB and the Tissue
Repository, the research subject’s participation in both protocols, as well as his/her consent to number 6 of
the informed consent. This information will be designated within the confidential computerized records of the
Tissue Repository and the HBTB by the CRN, Tissue Repository Manager, and the HBTB coordinator,
including the dates that the subject consented.
Tissue Allocation Procedure:
The Tissue Repository Oversight Committee currently composed of a multidisciplinary complement of
clinical and research investigators, including the Principal-Investigator, Dr. Friedman (Neurosurgery), the
Co-Principal Investigator, Dr. Yachnis (Neuro-pathology), and the Sub-Investigator, Dr. Amy Smith
(Pediatric Neuro-Oncology). The Tissue Repository Oversight Committee will review all requests from
qualified researchers. Requests will be judged on scientific merit, potential research importance,
credentials of researchers, and current IRB approval. The latter will be personally verified by the Oversight
Committee. The clinical research nurse and tissue repository manager will only process requests from
researchers approved by the Tissue Repository Oversight Committee. Preference will be given to not-for-
profit organizations, the NIH, or University grants.
In addition, the Principal-Investigator, Co-Principal Investigator and approved researchers may ask the
clinical research nurse to query the repository for either the inclusion or sufficiency of potential research
variables. This will be devoid of all PHI and would only be shared in a context to allow the researcher to
know if a successful research answer could be generated.
Tissue Repository Security:
The Investigators and any qualified researchers, must sign a “Confidentiality agreement”, specifying the
limits to the information they obtain from the tissue repository. For instance, a research question might be:
all brain metastases; their histologies; their # hospital days; their radiation dose; and their total steroid
dose. This data can be delivered to the researcher without giving PHI and can be listed only using their
unique identification number. Likewise, the clinical research nurse and tissue repository manager must
abide by the rules for conducting research, as outlined by this protocol, the IRB, UF, and governmental
agencies.
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The physical security of the tissue specimens and its data will be the responsibility of the tissue repository
manager. The annual fee for renting space for samples in the HBTB is, in part, a fee for utilizing their
security protocols. The manager will ensure that specimens are accurately labeled and appropriately
stored. All data kept by the manager must remain within a password-protected computer, using the latest
encryption equipment, and located behind locked doors. Tissue and corresponding data will be kept
forever, unless or until it is destroyed (in accordance with HBTB policy and procedures). Documentation for
specimen QA/QC, IRB-status, and other records related to physical security will be maintained by the
manager. Regulations of the University of Florida, UF IRB, state and federal government will be followed.
The security of the non-physical aspects of the tissue repository will be the responsibility of the clinical
research nurse, including ongoing data-entry. This data will remain within a password-protected
computerized database, currently residing within the McKnight Brain Institute’s computer server, which
uses the latest encryption software. The hardware and software required for this ongoing data-entry will be
developed and maintained by the Department of Neurosurgery and located behind locked doors.
Documentation for tissue repository QA/QC, IRB status or audits, as well as protocols for information-
tracking and information-sharing, will be maintained by the clinical research nurse.
Tissue Repository Maintenance, Characterization and Analysis:
Medical information, necessary to establish, update and maintain the security and integrity of the Tissue
repository will be serially collected, both currently and in the future. Examples of information used for this
characterization and analysis include:
a. other research protocols in which the subject is enrolled
b. the explicit Yes/No answers to multiple items within number 6 in the Informed Consent, specifically
delineating how and what information they agree to allow researchers to use
c. any research variables generated by specific researchers who wish to re-enter their data into the
Repository for future researchers.
d. if the research subject was less than 18 yo when their guardian consented, the date in which the Co-
Investigators much seek them out for re-consent.
e. documentation of what, how, how often, and to whom a research subject’s tissue or data is shared. This
also includes the “limited data sets”, as outlined in the informed consent.
f. all safety, quality control, quality assurance, regulatory or administrative documentation, as required by
the University, the IRB, or state/federal law.
g. current and future medical information, as it relates to optimal tissue characterization and analysis. This
includes details of treatment, response to treatment, survival, prognosis, and quality of life.
h. information on the characterization and analysis techniques used on samples, as required to provide
quality tissue to qualified researchers.
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The ultimate responsibility for maintenance of the Tissue Repository will be held by the Principal-
Investigator and Co-Principal Investigator. In the event that the Principal-Investigator and/or Co-Principal
Investigator leave UF or is unable to carry out his duties, they will assign a successor.
Use of tissue from Non-Enrolled (Non-Consented) or Unidentified specimens:
In the event that there is not a corresponding consent for the Tissue Repository when “extra” tissue is
available, the “Non-consent clause” takes affect. Under this clause, tissue from non-enrolled (non-
consented) or unidentified individuals, will be assigned a unique identification number and submitted to the
repository without PHI. This de-identified or unidentified tissue may still be useful for some types of
research, but will never have attached PHI.
Resultant Research after Tissue Distributions:
The Tissue Repository Oversight Committee will allocate specimens, as outlined above. The tissue
preparation and preservation techniques will be continually updated to allow for the maximal variety and
number of research uses. Re-entry of research results will be encouraged. The use of the unique
identification number to “link” the tissue from this protocol with that of specimens of subjects also
prospectively enrolled in the HBTB will facilitate correlative analysis, while preventing the unnecessary
transfer of PHI.
Quality of Life Questionnaires
Subjects will be asked to complete two Quality of Life Questionnaires (FACT-Br and SF-36). Both are
short (each takes 10 to 20 minutes or less to complete). The research nurse will administer the
questionnaires prior to surgery. Because many subjects receive medical follow-up at their local hospitals,
the questionnaires will be sent to them via mail, E-mail (if they authorize electronic communication) or they
will be called and asked the questions by telephone.
7. Possible Discomforts and Risks:
Collection of the venous blood sample, cerebrospinal fluid, and brain tumor tissue at the time of
neurosurgical procedure will involve minimal to no additional discomforts or risks, other than those
encountered during routine medical care.
Brain Tissue:
The brain tissue used for research includes only the "excess" brain tumor tissue that is left over after
routine diagnostic procedures have been completed and would otherwise be discarded. The discomforts
and risks are those of the routine neurosurgical procedure.
Peripheral blood:
Approximately ~10ml of blood is collected at the time of a routine blood draw, from a IV site if possible. The
discomforts and risks are those of the routine neurosurgical procedure and subsequent medical care.
Cerebrospinal fluid (CSF):
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If possible, approximately ~10ml of CSF will be collected at the time of routine neurosurgery. The
discomforts and risks are those of the routine neurosurgical procedure.
Genetic Tests
If the results of a genetic test obtained for research purposes were to unintentionally be released to a
research subject, it might cause psychological distress. If a third party (employer or insurer) were to learn
of the results, there is a small but potential risk of discrimination that could affect employability or
insurability, social stigma, or other unforeseen repercussions. At any time, a visit with a nurse, doctor, or
Genetic Counselor can be requested to discuss the potential risks.
Protected Health Information:
Regardless of a subject’s decision to voluntarily enroll in separate research protocols, such as the Human
Brain Tumor Bank, participation in the Tissue Repository will require at least some collection, storage, and
use of current and future protected health information (PHI). A subject’s answers to the Yes/No questions
in section 6 of the Informed Consent, determine this. Every effort will be made to keep this information and
samples secure forever, or until destroyed. The potential unanticipated disclosure of this information does
carry a small but potential risk of discrimination that could affect employability or insurability, social stigma,
or other unpredicted repercussions. In the rare event that there is an unintentional disclosure of PHI by an
investigator unassociated with the Repository, neither the Investigators, nor their colleagues or the
University, are responsible for any actions regarding these 3 rd parties.
Tissue Repository Security:
“Extra” tissue will only be labeled with the unique identification number assigned at the time of enrollment
and stored within the HBTB space. The clinical research nurse will maintain a secure list of the unique
identification number which will be “linked” with the subject’s PHI, only for the purpose of ongoing entry into
the tissue repository. This “link” between the PHI and the unique identification number will only be
accessible to the clinical research nurse, who will maintain and secure the repository. This PHI will include
such as name, medical record number, and contact information (see data collection form). The patient’s
name will never be used in any research studies that are published or presented at scientific meetings. The
clinical research nurse does not participate in research and will not give out a subject’s medical
information, unique identification number, or research results to anyone, unless required by law.
All subjects who have prospectively enrolled in the separate research protocol of the Human Brain Tissue
Bank will be designated in the tissue repository with the same unique number, such that their post-mortem
tissue can be requested by our researchers at a later time.
Any data shared with current/future qualified researchers, including at UF or elsewhere, will only be listed
by unique identification number and limited to their research question. All disclosures of data, will only be
shared after approval of the Oversight Committee. All security regulations will be strictly followed.
8. Possible Benefits: There are no direct benefits to the research subject. The research has
potential to improve the lives of patients with brain tumors and related diseases.
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9. Conflict of Interest: Since there is NO exposure to experimental procedures, tests or substances,
there is no direct conflict of interest with a potential subject and the clinician regarding their options for routine
medical care. However, there is a potential for financial compensation or academic advancement for the
investigators participating in this research. The researchers may hold patents, licenses for materials, object,
or process products used in the research or produced by the research. The production of cell lines or tests
or products resulting form the analysis or alteration of the subjects tissue or information may become
available and may be financially valuable. In addition, researchers may own stock in companies, and/or
consult for companies, associated with the products used for the collection, storage, use, and analysis of
your tissue and medical information.
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