National Physicians Cooperative (NPC)
of the Oncofertility Consortium®
Letter of Agreement
We (insert name and department of institution or medical group) herby indicate our
intention to join the National Physicians Cooperative (NPC) of the Oncofertility
Consortium®. Specifically, we will participate in research studies to preserve fertility for
women and girls with medical conditions in which treatment or the condition itself will
likely result in the loss of fertility. We will contribute fresh and frozen ovarian tissue (as
instructed by the Oncofertility Consortium® Steering Committee) as described in the
protocol to the Oncofertility Consortium® at Northwestern University. We will also have
the option to participate in other multicenter studies as they become available. We
affirm that we are able to enter into this agreement on behalf of our institution and/or
medical group. We agree to terms outlined below for participation in the NPC and
Oncofertility Consortium®.
The following conditions relate to our membership in the National Physicians
Cooperative of the Oncofertility Consortium®, in general. We acknowledge and agree to
the following:
1. We will perform experimental procedures under IRB approved protocols and
obtain informed consent. This provision includes any fertility preservation
procedure that is deemed experimental by the American Society for
Reproductive Medicine (ASRM) such as ovarian tissue cryopreservation.
2. We will follow American Society of Clinical Oncologist (ASCO) guidelines for
advising patients of the range of options available to them for fertility preservation
and utilize the most mature technology that is appropriate for a given patient
based on her age, timeline to treatment, medical condition and personal wishes.
3. We understand and agree that all NPC and Oncofertility Consortium® documents,
protocols, procedures, logos, promotional materials, reagents, formulas etc. are
considered proprietary and confidential and may not be shared with anyone
outside of the NPC.
4. Decisions about clinical care are the responsibility of the individual physicians
and member sites. We will hold the National Physicians Cooperative and the
Oncofertility Consortium® harmless in any actions (including malpractice)
regarding our clinical judgment, clinical care or tissue banking practices.
The following conditions relate to our participation in the ovarian tissue cryopreservation
study of the National Physicians Cooperative and the Oncofertility Consortium®. We
acknowledge and agree to the following:
1. We have been asked to participate in this NPC study because we see female
cancer patients (ages 0 to 41) who wish to preserve their fertility by freezing
ovarian tissue prior to undergoing surgery, chemotherapy, drug treatment and/or
radiation to treat their cancer. This protocol may also be extended to patients
with a chronic disease (example, rheumatoid arthritis, lupus, etc.), which may
lead to infertility itself or through its treatments. We may limit the age of patients
treated at our center as we see fit.
2. We understand and agree that freezing of ovarian tissue is considered
experimental and that participation in this NPC study requires IRB approval from
our own institution. We will utilize the templates provided to obtain approval from
our Institutional Review Board (IRB) for participation in this program. We also
agree that we will seek IRB approval for any other related procedures that are
considered experimental.
3. We agree to provide IRB approved versions of our protocol, consent and the
approval letter for each of our procedures on initial approval and with each
continuing review or amendment. We agree to make any revisions requested as
needed.
4. We will not harvest or prepare any tissues for use by the NPC without IRB
approval in advance. We will also not harvest or prepare ovarian tissue on
protocols other than those approved by the National Physicians Cooperative and
Oncofertility Consortium®.
5. We understand and agree that, under the terms of this study, research ovarian
tissue is contributed (as described in the protocol) to the Oncofertility
Consortium® at Northwestern University. The research use of this tissue (either
fresh or frozen) will be determined by the Oncofertility Consortium® Steering
Committee according to the priorities of the Oncofertility Consortium® grant
projects, and the suggestions and proposals received by the Oncofertility
Consortium® Steering Committee.
6. Participation in the NPC study to freeze ovarian tissue requires:
 Obtaining informed consent from a female patient to remove all or part of one
or both of her ovaries prior to surgery, chemotherapy, drug treatment or
radiation; The patient has the option to give consent to donate approximately
20% of this ovarian tissue to research; the remainder will be cryopreserved
for own use.
 Providing patient information to the NPC that will assist in utilizing the tissue,
including but not limited to diagnosis, age, fertility history, cancer diagnosis,
previous cancer treatment, serum FSH, AMH, etc.
 Removing an ovary using appropriate surgical techniques including
laparoscopy; When indicated, a portion of the ovary will be provided for
pathologic examination. With the remainder of the tissue the patient can
donate approximately 20% of remaining ovarian cortex to the NPC for
research use and the remainder will be frozen for the patient’s own use.
 Screening and testing the patient for infectious diseases as though she were
an anonymous reproductive tissue donor of leukocyte rich tissues; Testing
must occur within 7 days of tissue removal according to FDA Tissue Banking
Regulations as described in the Federal Register 21 CFR 1271 (and any
updates or guidance documents). This must include a donor history and
physical and donor eligibility determination to permit use of the tissue in the
future.
 Infectious disease testing should be performed at Memorial Blood Centers in
St. Paul, MN using protocols for plasma provided by NPC and Memorial
Blood Centers, unless the center is located in New York State.
 Infections disease testing is required for tissue being stored for personal use
and the cost of testing is the responsibility of the patient.
 Plasma samples will be obtained and stored along with the tissues to
facilitate any additional testing federally mandated in the future to permit
utilization of the tissues.
NPC: Phase 1. Letter of Agreement
Version: 1/20/2015
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Please view disclaimer here: oncofertility.northwestern.edu/disclaimer
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Freezing, labeling, inventory control and shipping of tissues will be performed
according to NPC protocols as specified at the time the tissue is frozen and
according to the NPC Users Manual Online Version.
All patient tissues and plasma samples will be transported to and stored at
Reprotech, Ltd. (RTL) (Roseville, MN), an AATB accredited and FDA
compliant long term storage facility. The patient’s tissue and plasma sample
will be shipped and stored under a direct storage agreement between the
patient and Reprotech. The patient will retain control over her own ovarian
tissue and may choose to use it when and at whatever institution she
decides. The patient will be responsible for all storage and shipping fees.
All research tissues are being sent to the Oncofertility Consortium® at
Northwestern University. In most cases, the research tissue will be sent fresh
and instructions will be provided for the handling and transport of the fresh
tissue.
Use of approved freezing kits and other media is required for this study.
These materials may be used only under IRB approval for their labeled use
and may not be shared with other entities or be used by patients who are not
part of this study protocol.
The patient will agree to long-term follow-up regarding her fertility status and
use of her tissue and will be updated on new options for the use of her
tissues within the NPC. This follow-up will be done by the enrolling center
using an approved script.
No tissue (other than samples provided to pathology) will be retained by the
harvesting institution.
Patients who wish to donate 100% of their tissue to the research pool (minus
any portion required for pathology) may also be enrolled in the study.
Fees: We understand and agree that:
 National Physicians Cooperative (NPC) and the Oncofertility Consortium®
has budgeted for expenses associated with freezing and storage of ovarian
tissue for each patient who provides tissue to the research pool as
follows:
i. NPC will pay for the shipping of the research tissue to
Northwestern University or other designated location.
ii. The originating center will be paid $500 capitation once the
research tissues have reached Northwestern University or
other designated location (limited to the first 24 tissues per
year).
iii. NPC will provide freezing media for cryopreservation
procedures.
iv. There are no funds available for surgical or clinical services.
 All clinical fees including but not limited to consultation, surgical removal of
ovarian tissue and preparation of the tissue and follow-up will be determined
by the NPC member site in consultation with their local IRB. It is not known if
these services will be covered by insurance. No funds are available from the
NPC to cover these costs.
 Infectious disease testing (approximately $220) is the responsibility of the
patient. The infectious disease testing is required for the patient’s use of her
own tissue and is not a requirement of the research study. This testing
should be performed at Memorial Blood Centers in St. Paul, MN unless the
procedure is performed in New York State.
NPC: Phase 1. Letter of Agreement
Version: 1/20/2015
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Please view disclaimer here: oncofertility.northwestern.edu/disclaimer
Benefits and Risks to Program: We understand and agree that:
 We will receive consultation regarding establishing a fertility preservation
program.
 We will have access to consultation on how to perform freezing of ovarian
tissue, including labeling, storage and inventory control so that we may offer it
to patients under our IRB protocol. We agree to perform these procedures
precisely as written in the NPC Users Manual, Online Version
 Newly diagnosed patients will be able to utilize cryopreservation of ovarian
tissue as one alternative for fertility preservation.
 We will have access to improvements in freezing and thawing protocols as
they become available.
 We will receive a $500 research capitation if we are one of the first 24 tissues
provided to the NPC in the given year).
 We will have access to new technologies for the use of thawed tissues for
fertility restoration as they become available.
 Human pregnancies have occurred following transplant of ovarian cortical
strips. However, this technique may be contraindicated in some types of
cancer (ovarian, leukemia and lymphoma) because of the risk of
reintroduction of cancer cells.
 We will receive consultation regarding FDA regulations for tissue
procurement, labeling, storage, testing and screening to facilitate the future
use of these tissues.
 We will not be responsible for the long-term storage of these tissues.
 We understand that the NPC and the Oncofertility Consortium® accepts no
risk, liability, or expense for medical care or services provided at your facility
and that clinical care and medical decisions are the sole responsibility of the
individual center.
 We understand that neither we nor the patient will receive any compensation
for participation in this research study.
 As part of the long term follow up of the patients, they we will be updated on
new options for the use of their tissue within the NPC.
We have read, understand and agree with the terms listed above. We understand that
we may withdraw from participation in the NPC and the Oncofertility Consortium® at any
time by prior written notice to the Director of the Oncofertility Consortium® and that we
will return any NPC materials that we have obtained and still be bound by the
Oncofertility Consortium® Agreement. We understand that we can direct any questions
to the Director, Mary Ellen Pavone, MD, MSCI, by contacting the NPC coordinator,
Brigid M. Smith, at brigid.smith@northwestern.edu or (312) 503-2506.
________________________________________________
Signature for Insert Institution
________________
Date
________________________________________________
Signature for National Physicians Cooperative
Mary Ellen Pavone, MD, MSCI
Director, National Physicians Cooperative
________________
Date
NPC: Phase 1. Letter of Agreement
Version: 1/20/2015
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Please view disclaimer here: oncofertility.northwestern.edu/disclaimer