oncofertility.northwestern.edu · Web viewOvarian hyperstimulation syndrome occurs in five out of a...

of 14

Ovarian Tissue Freezing For Fertility Preservation In Post-Menarchal Girls Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen: A Study By The National

Physicians Cooperative of the Oncofertility Consortium At [INSTITUTION]

This consent describes a study being done at [INSTITUTION]. Research studies help us learn more about conditions and possible new treatments. Research studies are voluntary, which means that it is your choice whether or not to allow your child to participate in the study. The study staff will also explain the study to you and answer any questions that you may have before you make a decision.

WHY IS THIS STUDY BEING DONE?

You are invited to have your child take part in this study because she will be treated with chemotherapy and/or radiation that will likely affect her ovaries and cause her to become infertile (unable to become pregnant) or she will have one or both of her ovaries removed to treat or prevent her medical condition.

The ovaries are reproductive glands found only in women. These glands are located in the pelvis (hip area). The ovaries produce eggs and female hormones. During each monthly menstrual cycle, an egg is released from one ovary. This study seeks to find out if removing an ovary in adolescents and children who have not reached puberty, and who are about to undergo chemotherapy and/or radiation may preserve, or keep, their ability to have children in the future. The ovary tissue that is removed will also be used to do research for better ways to store them and use them in the future.

Participation in this study is completely voluntary. You can choose to allow your child to take part. If you agree to allow her to take part in this study, your child will have one of her two ovaries removed by surgery before having her chemotherapy and / or radiation therapy.

This study has two parts. The removal of the ovarian tissue, and the storage of the ovarian tissue. A special process called Ovarian Tissue Cryopreservation will be used to store the removed ovarian tissue. This special kind of freezing is a special method that is used to try to prevent the eggs from being damaged, and to keep them frozen for a long time. The frozen tissue will be available to you and your daughter to be used at a later time, of your choosing.

Also, we would also like to ask your permission to store some of your child’s tissue for use in future research studies that will study better ways to store tissue like this, and better ways to use them in the future.

However, if your child has been previously treated with chemotherapy that is considered likely to cause infertility, she will be required, as part of this study, to donate no more than 20% of her ovarian tissue to this future research before it is stored for her own use.

If your child has not been previously treated, there are two options for how your child’s ovarian tissue would be used in this study:

Parent Version 8/4/2014

of 14

Option A : With this option, the tissue will be split between storage for her own use in the future and storage for future research. The majority, 80%, of the tissue would be frozen for your child’s own use. The lesser amount, 20%, would be used for the future research.

Option B : With this option, all, 100%, of your child’s ovarian tissue will be frozen for your child’s own use in the future.

If you decide to have your child take part in this study and she has not been treated with chemotherapy, you will need to choose Option A or Option B for storage of your child’s tissue. Later in this permission form, you will indicate which option you choose.

At the present time, freezing of ovarian tissue is considered experimental. Also, the implantation of the thawed tissue to restore fertility is considered experimental. In order to use the tissue at a later time, the implantation will need to be performed as part of another research program. This may change in the future. Your child will determine in the future how and at what institution she wishes to use her own tissue to attempt a pregnancy.

If you agree to allow your child to take part, your child will undergo surgery to remove the ovarian tissue. This will require your child to be under general anesthesia (completely asleep) during that surgery. The surgeon who will perform this study will go over the surgery procedures an options and will ask you to sign a separate consent form for the surgery and anesthesia.

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify your child. At most, the website will include a summary of the results. You can search this website at any time.

WHAT IS INVOLVED IN THE STUDY AND HOW LONG WILL MY CHILD BE IN THE STUDY?

Tests and Procedures before Surgery: Before your child begins this study, your child will have tests and procedures done by her oncologist or pediatric surgeon to confirm that she is eligible for this study. She will also be checked by her oncologist and the surgeon to determine if surgery is safe for her. They will also check to see if her medical condition would make it difficult to remove an ovary. If this is the case, your child’s oncologist and surgeon will discuss with you all available options.

Your child will also be checked by an anesthesiologist. If the anesthesiologist thinks that it is unsafe for your child to have anesthesia, then she will not be allowed to take part in the study.

Your child’s surgeon will decide what is appropriate for her medical condition. Typically, the surgery used to remove an ovary is done by laparoscopy. If your child is scheduled for another surgery already, the surgery to remove the ovary will be done at the same time if possible.

This pre-surgery assessment will be done while your child is in the hospital or in the pediatric oncology, surgery, or anesthesia clinic as an outpatient.

Surgery to Remove the Tissue:


http://www.clinicaltrials.gov/

of 14

This surgery will be done solely for research purposes. It is not required for the treatment of her cancer. If your child’s surgeon decides, she will have the ovary tissue removed by a surgery called a laparoscopy. Laparoscopy surgery is done under general anesthesia (your child will be asleep during the surgery) in the operating room.

A telescope-like instrument (a laparoscope) will be put into her belly through a small (about half an inch) cut just below her belly button. Two or three other cuts may be made to allow for other instruments to help remove one of her ovaries. The surgeon will then look at both ovaries before the removal of one. Both of your child’s ovaries must appear normal and be free of any masses in order to complete the surgery. The ovary that will be removed, will be chosen by the surgeon at the time of surgery. This type of surgery is likely to last for 30 to 45 minutes

If your child’s has a laparoscopy, it will be done as an outpatient procedure. It won’t require an overnight hospital stay. The recovery time before your child can do normal activities or start their scheduled chemotherapy and/or radiation therapy is about 2 to 3 days. Her total time spent in the hospital will be about half a day.

After surgery is complete, she will not have any further procedures as part of this study. She will be required to have check-ups with the surgeon to make sure she has fully recovered from the surgery. If her ovary is removed as part of another surgery, the hospital recovery time may be different that the time stated above. The surgeon will discuss the hospital and recovery time with you.

Tissue Analysis at the Lab:After the surgery, a small piece of the removed ovary may be sent to the Pathology Laboratory and checked under a microscope. This will need to be done depending on your child’s current diagnosis.

The lab will look at the sample to check for cancer cells in the removed ovary. Sometimes the ovary can look healthy, but have a small amount of cancer that can only be seen under a microscope. If there are cancer cells in the ovary tissue, implanting them in your child at a later time to when she is trying to get pregnant, could cause the cancer to come back.

If the pathologists finds an something that is not normal, or cancer cells in the sample, they may request that all of the tissue taken during your child’s surgery be sent to them for a more detailed examination. If this occurs, there may be no tissue remaining for fertility preservation purposes. You and your child will receive a copy of the report from the Pathology lab about what was found when they looked at the sample under the microscope.

Tissue Storage and Use for Future Research:

If you choose to donate a portion of your child’s ovarian tissue to research, some of the ovarian tissue (never more than 20% of the total tissue taken) will be sent to an Oncofertility Consortium lab for research. This research may include studying how best to get usable eggs from the tissue.

The tissue reserved for research may also be studied before freezing. These studies will include looking at the number of eggs that are usable before and after the freezing and thawing process


of 14

and looking at how effective the tissue freezing and storage process is. Research done on the ovarian tissue will not include fertilization of the eggs the tissue contains. The 20% of the tissue donated for research will not made available to you and your child to use.

We will not be able to give you any information about the tissue that was donated to research. The samples that are used in the research will completely de-identified. They will not have any information that can identify your child, such as her name or social security number. They will be labeled with an assigned code only. Only [PI NAME] and the [INSTITUTION] research team will keep the linking document for this code, and it will not be shared with others. Some health information about your child may be sent along with the samples, but this information will not have any identifiers. The researchers will not know that the samples came from your child.

Tissue Storage for You/Your Child’s Use in the Future:The rest of100% of your child’s the ovarian tissue (80% if you choose study Option A or 100% if you choose study Option B) will be stored for your child’s possible future use at an accredited long term storage facility called ReproTech, Ltd. (RTL), in St. Paul, MN (http://www.reprot.com).

You will be asked to sign a separate storage agreement with RTL that addresses the ownership, storage, shipping, and future disposition of your child’s samples.

You will be responsible for the cost of the freezing of the tissue which is approximately $695, and the yearly storage fee of approximately $275. You will also be responsible for the costs of the initial shipping charges to RTL and any other charges, such as shipping the samples to another institution, at your request. Your child’s tissue will only be stored at [INSTITUTION] Lab for a short period after the freezing while shipment to RTL is arranged.

You and your child will have control over your child’s tissues and may use them as you and your child consider appropriate at the institution that your child chooses in the future. There is no limit to how long your child’s tissues may be stored at RTL, provided the storage fees are paid annually after the first year.

RTL has a financial assistance program in place for those who qualify and you will be provided with the information about this program if you want it, both before and after agreeing to your child’s participation in this study. You and your child may transfer your child’s tissues to another long-term storage facility at any time and at your own expense.

During the period your child’s tissue is stored, it is possible that technology for thawing stored ovarian tissues will advance. If such advances take place and are found to be safe, your child may request to thaw her tissue for re-implantation or egg recovery for in vitro fertilization to attempt pregnancy. At the time that your child wishes to use the tissue, your child’s stored tissue will be transferred by RTL to the facility of your child’s choice at her request and at her expense.

As part of your child’s participation in this study, you and your child will be updated on new options that become available to improve pregnancy outcomes with the use of frozen ovarian tissue and where those options are available.


http://www.reprot.com/

of 14

It is also possible that technological advances to thaw the stored ovarian tissue may never occur and the tissue may not be usable. Although unlikely, it is also possible that thawing techniques may require approval by outside agencies (like the Food and Drug Administration) before they could be used to attempt a pregnancy.

Infectious Disease Testing: The storage of tissue and later use is regulated by the Food and Drug Administration (FDA). Currently, the FDA requires that all tissue that is stored and later used be tested for certain infectious diseases. Also, the FDA requires that a blood sample be collected and stored with the tissue.

The tests for infectious diseases will include, but are not limited to, testing for HIV, Hepatitis B and C. The screening and tests that will be done are the same as those done on an anonymous tissue donor. This will also require a physical exam, answering questions about possible high risk behaviors, and blood tests. These tests may allow the tissue to be used by your child, or by another individual (such as a gestational carrier/surrogate), in the future. Your child’s ovarian tissue will be stored with tissue of the same infectious disease status.

Your child’s blood will be tested for HIV. HIV is the term used for the virus that produces HIV infection and may lead to AIDS. The Illinois AIDS Confidentiality Act is an Illinois law that sets up how HIV testing must be done and protects the confidentiality of information about someone’s HIV status. The study doctor will comply with this Illinois Law. If you have questions about this law, and what is required to be reported, please discuss them with your study doctor.

In addition, a sample of your child’s blood will be stored with her tissue to allow any additional future testing that may be required under federal regulations. Current FDA regulations are specific and must be performed on a blood sample taken within 7 days of tissue removal. If the FDA requires additional tests in the future, this stored blood might be used to perform those tests. It is also possible that federal regulations may change and it may not be possible to do the appropriate testing that will allow use of your daughter’s tissue in the future.

The blood samples can be drawn from your child’s central line if she has one in place. If she does not, then the blood will be drawn at a time that she is already scheduled to have blood taken for her regular care. About 2 tablespoons of blood will be drawn for the infectious disease testing.

Information to be Collected about Your Child: As a part of this study, certain medical information will be collected and used. Medical information collected from your child’s medical chart include: Hormone levels where possible, diagnosis, past cancer treatment, if any, information from physical exams, planned treatment associated with high risk of sterility, how the ovary is collected, the time from surgery to start of chemotherapy or radiation, the cancer care outcome (remission, relapse or death) and reproductive or menstrual history before cancer diagnosis, during and after treatment. Some of this medical information will be stored with the samples for research, but they will not include any identifying information about your child.


of 14

Follow-up:You and your child will be contacted once a year to answer questions, about a 10-minute phone call, to find out about how your child chose to use her own ovarian tissue within the past year and about your current attitudes and feelings on preserving fertility.

WHAT ARE THE POSSIBLE RISKS OR SIDE EFFECTS (BAD THINGS) OF THE STUDY?Your child might experience some side effects and discomfort while taking part in this study. Those seen in the past include the following risks. Most of these are related to the general risks of surgery.

Laparoscopy: Risks of the laparoscopy surgery include infection, damage to your child’s internal organs or bleeding problems. The chance of your child requiring hospitalization or more extensive surgery for the treatment of problems is about 4 in 100. Such problem(s) may result in a delay in further chemotherapy and/or radiation therapy treatments for her disease. Her chance of dying as a result of such problem(s) is about 2 in 1,000. Minor side effects, such as temporary pain or bruising at the cuts are common. A separate surgical consent will provide details about the risks of laparoscopy.

General Anesthesia: Your child’s chance of having a problem from the anesthesia including heart attack, stroke, or death, is less than 1 in 100,000. Minor side effects, such as sore throat or short-term nausea, are quite common. A separate anesthesia consent process will provide details about the risks of general anesthesia.

Elective (By Choice) Removal of an Ovary: Your child has been invited to participate in this study because we expect that the treatment or surgery that she will undergo to treat her medical condition or cancer will significantly affect her future fertility. There is a theoretical risk that your child may experience decreased fertility due to removal of an ovary and/or experience early menopause caused by the loss of hormones produced by ovaries. She is also potentially at risk for emotional upset from having one ovary removed.

At the same time, there is a small chance that your child’s fertility and menstrual monthly periods may return on its own after cancer treatment. If this is the case the tissue removal would have been unnecessary for your child. In addition, it is possible that the surgery itself could cause scar tissue or damage to the remaining ovarian tissue and the chances for pregnancy could be reduced. This is very unlikely (less than a 1% chance) and much less than her chance of losing fertility and having early menopause as a result of her cancer or other medical treatment.

Cryopreservation (freezing): There is always the risk that your child’s removed ovarian tissues may be damaged during any part of the freezing, shipping and storage process. Care will be taken to minimize this risk. The effects of long-term freezing and storage on human ovarian tissues are not known and possible damage to the tissues may occur. The risk of birth defect(s) and/or genetic damage to any child


of 14

who may be born following such a procedure is also unknown. However, thousands of children have been born following freezing of eggs and embryos and those freezing procedures have not resulted in an increased risk of birth defects.

The eggs from the ovarian tissue that has been removed may not be usable, or pregnancy may not result when the eggs are used in the future. Medications that your daughter has taken may also have some damaging effect on her ovary or egg quality. There are many medications whose effects on the ovary or egg quality are not yet known or have not yet been determined.

It is also possible that technological advancements to thaw the stored ovarian tissue may never occur and the tissue may never be usable.

Some subjects, particularly those with ovarian cancer, Non-Hodgkin Lymphoma or leukemia may have high risks associated with the transplantation of the ovarian tissue back into the body. The risk of greatest concern is reintroduction of the subject’s original cancer. If cancer or other disease already affects the ovarian tissue, it may never be possible to put the tissue back into the body. The extent of the risk may not be known until after the subject is healthy and wishes to use her ovarian tissue.

Tissue could be lost or made unusable due to equipment failure, or unforeseeable natural disasters beyond the control of this program.

Infectious disease testing: Infectious disease testing and screening performed around the time of your child’s surgery may not be enough to allow safe use of her tissue after long term storage. While a sample of your child’s blood will be stored to minimize this risk, the tests in the future may require a different sample, the plasma sample may be inadequate or it may be lost or damaged in the freezing or shipping process. Infectious disease testing may show an infection or disease of which you or your child was previously aware of and which may require additional treatment.

Blood Draws: Taking blood may cause some pain, bleeding or bruising at the spot where the needle enters your child’s body. Rarely, taking blood may cause fainting or infection. Care will be taken to try to avoid these complications. If your child has a central venous line in place, blood samples can be drawn from this catheter.

Emotional Risks: By taking part in this study your daughter may have some emotional stress beyond those directly related to her planned treatment.

Tissue may be unavailable for freezing: At the time of your child’s surgery, if her surgeon or the pathologist (the physician who examines your child’s tissue through the microscope) determines that all of your child’s tissue is needed to diagnose her disease, then no tissue may be available for freezing. If that occurs, your daughter will not have any tissue left over to be frozen for her future use.

ARE THERE BENEFITS (GOOD THINGS) TO TAKING PART IN THE STUDY?


of 14

Your child’s taking part in this study may give her advance our understanding of how to successfully freeze and thaw ovarian tissue in a way that allows later use by patients in the future. Her taking part may also advance our knowledge of how to successfully mature eggs that are in these tissues. If tissue is frozen for her own use, she may have a means to restore her fertility in the future. However, there is a big possibility that there may be no direct benefit to her from her participation in this research study.

WHAT OTHER OPTIONS ARE THERE?

Participation in this study is voluntary, and you have the choice to refuse to have your child participate in this study. If you do want to enroll her in this study she may receive chemotherapy and/or radiation therapy or other treatments without having one of her ovaries removed by surgery.

If your child is to receive radiation therapy to her pelvis, she may have her ovaries shielded or surgically moved to a different part of the body that is not being irradiated. This, however, does not protect her ovaries from the harmful effects of chemotherapy and the effectiveness of these procedures varies with the individual.

There is also the option of allowing her to take part in a study in which a medication such as gonadotropin releasing hormone (a protein which suppresses hormonal stimulation of your ovaries) is given before chemotherapy to try to protect her ovaries from the harmful effects of chemotherapy. There is some evidence that such treatment reduces the risk of damage to the ovaries by either chemotherapy or radiation therapy. However, there have also been reports that its use may reduce the effectiveness of certain types of chemotherapy. This treatment is considered experimental. It is not approved for this use at this time and is not part of this study.

Your child may also be eligible for other fertility preservation options such as oocyte (egg) or embryo banking. For egg and embryo banking, your child would be given hormones to stimulate egg production. The eggs are then removed surgically and frozen (egg banking) or used for in vitro fertilization using either your child’s partner’s sperm or donor sperm and the resulting embryos frozen (embryo banking).

This process takes several weeks and could put your child at risk for a condition called ovarian hyperstimulation syndrome (OHSS), which could delay her cancer treatment even more. Ovarian hyperstimulation syndrome occurs in five out of a hundred IVF cases and can be severe in one percent of cases. Pregnancy rate from embryo banking is 30 to 40 percent, while the live birth rate for every frozen egg is 2 percent.

There are no alternative means for preserving ovarian tissue available at this time. If your child becomes infertile from her cancer treatment and desires to have children in the future, she may choose to adopt a child or use donor eggs for in vitro fertilization. Adopting a child or using donor eggs for in vitro fertilization may be the best (safest) available options for these girls to become mothers.

Please talk to your child’s doctor about these and other options.


of 14

FUTURE USE OF YOUR CHILD’S OVARIAN TISSUE

The ovarian tissue that is stored for your child’s own use may be transplanted back into her body when she is ready to try to get pregnant. At present, about 15 70 pregnancies have occurred worldwide using this technique. The reports of these pregnancies were “case reports” and so did not state how often this technique is successful. At the present time, this procedure [is/is not] available at [INSTITUTION], but is available at other institutions in the United States.

If your child has certain types of cancer, such as ovarian cancer or certain kinds of leukemia or lymphoma, transplanting her ovarian tissue back into her body to attempt a pregnancy may not be an option due to the risk of reintroducing cancer cells into her body.

Your child’s ovarian tissue might be thawed in the future and the eggs it contains might be matured in the laboratory and then fertilized using in vitro fertilization (IVF). IVF is when the eggs are obtained from the ovarian tissue and fertilized by sperm outside of the body. At present, this procedure has resulted in pregnancies in mice only.

WHAT ARE THE COSTS?

You and your child will not receive compensation for your child’s participation in this study.

As a parent, you (or your insurance company) will be responsible for payment of all medications and medical care that would not normally be part of the treatment for your child’s condition, which may include the elective surgery to remove your child’s ovary (ovaries), costs of infectious disease testing, the FSH and AMH blood test and pathology.

How much you have to pay depends on whether or not you have health insurance and what costs your insurer will cover. The cost of the surgery on this study is approximately $18,000. If you have any questions concerning you insurance coverage, you should speak to your healthcare insurance carrier. If you or your insurance company are unable to pay for this surgery and related tests, the research team will assist you in applying for other funds or to [INSTITUTION] for possible financial help with these costs.

If a portion of your child’s tissue is donated to research, the research portion of your child’s ovarian tissue, which will be used only for this research, will not be sold. The research done with your child’s research tissue may lead to the development of new products in the future. No compensation will be given to you or your child now or in the future for the use of these samples.

The tissue that is stored for your child’s own use pwillortion of your child’s tissue that is for her own use will remain under your’s and her’s control and any expenses associated with future use of that tissue will be your’s and her’s responsibility. And will become her’s when she turns 18 years old. As part of your child’s participation in this study, you/your child will be updated on new options that are available for the use of her tissue and where those options are available. This information can be found on the website: www.myoncofertility.org www.oncofertility.northwestern.edu and will be communicated during the yearly call to you by a member of the research team.


http://www.myoncofertility.org/

http://www.myoncofertility.org/

of 14

Charges for infectious disease testing will be your responsibility since this testing is only required for your child’s use of her own tissue. This will be approximately $240. Insurance usually covers this expense. We will bill this to your insurance and any portion that is not covered will be your responsibility.

You will be responsible for the cost of the freezing of your child’s tissue, (about $695, the initial shipping of the tissue to RTL, about $215, the yearly storage fee and any other charges (e.g. shipping to another institution, at your request). This cost of storage is about $275 per year but discounts based on financial need are available.

You will have to enter into a separate storage agreement with RTL to cover the storage and disposition of your child’s tissue. You will be given a copy of this agreement prior to agreeing to have your child participate in this study. As part of the agreement, the ovary donor (your child and you as a parent) must decide what happens to your child’s stored ovary tissue if she dies.

You and your child have to decide, at the time of storage, what will happen to your child’s stored ovarian tissue if she dies before reaching her 18 th birthday—that is, whether the stored tissue should be discarded or ownership transferred at the time of her deathdonated to research. If your child does live past her 18th birthday, she will have authority to decide what will happen to her stored tissue if she dies without having used the tissue. She may decide to have ownership of the stored ovary tissue transferred at the time of her death, if she has notified RTL of this request. It is your child’s responsibility to notify RTL about her wishes upon reaching her 18th birthday.

If at any time, the storage fees are not paid, RTL may begin the process for accounts in default, as described in the storage agreement. RTL may refer the account to a lawyer or collection agency, and you or your child will pay all costs of such collection. It is important that you know that the agreement you sign with RTL gives RTL the option or choice of discarding or destroying the stored ovary tissue if storage fees have not been paid for 60 days after they are due. Discarded specimens cannot and will not be used for reproductive purposes by or on behalf of any person or persons.

What if I want my child’s ovarian tissue frozen for my child’s own use and do not want to donate any portion to research (Option B)?

You can choose to have your child’s ovarian tissue can be frozen for her own use only and not to donate any to the research effort. If you chose this option, you and your child will still receive a phone call for the long term follow-up on how your child uses this tissue, unless your child was previously treated with chemotherapy.

WILL I BE TOLD ABOUT NEW INFORMATION?

You have the right to know about new information that may affect your child’s health, welfare, or your child’s willingness to participate in the study. You will be provided with this information by a member of the research team as soon as it becomes available.

WILL I BE COMPENSATED FOR MY PARTICIPATION?


of 14

You and your child will not be compensated while your child is on this study.

WHAT DO I DO IF MY CHILD IS INJURED?

If your child is injured, medical facilities and treatment will be available. However, you will be required to pay a reasonable fee for such care. Your child can still receive medical benefits if otherwise entitled at [INSTITUTION].

WHO WILL KNOW ABOUT WHAT MY CHILD DID IN THE STUDY OR HAVE ACCESS TO MY CHILD’S PRIVATE INFORMATION?

The purpose of this clinical study is to collect medical information from a group of patients in order to see if it is possible to preserve fertility by removing and storing ovarian tissues by freezing. For this reason, the investigators/researchers will need access to the medical records of all those who participate in this study.

If you sign this consent form, you are giving permission for your child's physician and [INSTITUTION] to provide your child's medical records to the following people, agencies or companies to review and use in this research study:

study staff Institutional Review Board (the committee that is in charge of protecting the rights of all

adults and children who participate in research studies at [INSTITUTION] Members of the Oncofertility Consortium at Northwestern University

Representatives from the Food and Drug Administration (FDA) and the National Institutes of Health (NIH)

[INSTITUTION] and your child’s doctors will keep the records of this study confidential, and will release your child’s medical information only to the people or companies listed above. However, it is important for you to understand that, once your child’s doctor or [INSTITUTION] releases your child’s medical information to these people or companies, your child’s doctor or [INSTITUTION] cannot then guarantee that your child’s information will remain confidential. It is possible that these other persons or companies could give your child’s study information to others, without your permission.

Results of this study may be used for teaching, research, publications, or presentations at scientific meetings. If your individual results are discussed, your identity will be protected by using a study code number rather than your name or other identifying information. Examples of identifying information include medical record number, Social Security number, and address. The records of this study will be kept confidential with respect to any written or oral reports to the profession or the media, making it impossible to identify you individually.

WHAT ARE MY CHILD’S RIGHTS AS A PARTICIPANT?

By signing this consent form, you agree to have your child take part in this study. You are not giving up any of your or your child’s legal rights or releasing this hospital from responsibility for carelessness.


of 14

You may cancel your consent and take your child out of this study at any time without penalty or loss of benefits. Your child's treatment by, and relations with the physician(s) and staff at [INSTITUTION], now and in the future, will not be affected in any way if you refuse to have your child take part, or if you enter your child into the study and then withdraw your child from it.

At any time, you can tell your child’s doctor or [INSTITUTION] not to use or give out your child’s study information or other information from your child’s medical record to other people or companies. Withdrawal of this permission must be in writing. Any study information or other information from your child’s medical record collected before your written notice of permission withdrawal may still be used for the study, if that information is necessary for the study. Because the purpose of this study is to collect information about how well the study drug or treatment works, if you refuse to release your child’s study information, your child may not be able to start, or continue taking part in this study. Your decision will not affect your child’s regular care and your child’s doctor will not change his or her feelings about you.

If you agree to let your child take part in this research study, you will not be able to look at or ask for a copy of your child’s health information collected only for this study, while your child is taking part in the study. If you wish, you will be able to ask for this study information when the study is over or when your child is no longer taking part in the study. This does not affect your right to see your child’s medical record or the results of tests related to regular medical care that is given during the same time as the research study.

If you have or your child has any questions about the research methods, you should contact the principal investigator, Teresa Woodruff, PhD of the Oncofertility Consortium at 312-503-3378 or Yasmin Gosiengfiao, MD, or colleagues at 312.227.4090 during weekdays or 312.227.4000 at night or on weekends.

If you have any questions about your child's rights as a research subject, wish to discuss problems, concerns, and questions, obtain information, or offer input to someone who is not directly involved with this study, you may contact [INSERT IRB CONTACT INFORMATION].

You will be given a signed and dated copy of this consent form.


of 14

MAKING YOUR CHOICE:

As a part of this study, you can chose to have your child take part in Option A or Option B for the storage and use of the removed ovarian tissue. This option is available because your child has not received prior treatment with chemotherapy and/or radiation that is likely to cause infertility. If your child has had prior chemotherapy and/or radiation you will be required to donate some of the tissue for research.

Please read carefully, and make your choice below:

Option A:

____/___ I wish to donate no more than 20% of my child’s tissue to research and request that 80% of my child’s ovarian tissue be frozen for her own use. My child will take part in the long term follow-up on her use of this tissue as described. I understand and agree to the financial responsibilities described above.

Option B:

____/___ I do not wish to donate any of my child’s tissue to research and request that my child’s ovarian tissue be frozen for her own use only regardless of the amount of tissue available. My child will take part in the long term follow up on her use of this tissue as described. I understand and agree to the financial responsibilities described above.

For patients who have received prior chemotherapy that is considered sterilizing:

____/___I understand that my child’s participation in this protocol requires me to donate no more than 20% of my child’s tissue to research and request that 80% of her ovarian tissue be frozen for her own use. My child will take part in the long term follow-up on my use of this tissue as described. I understand and agree to the financial responsibilities described above.


of 14

SIGNATURES

The study has been explained to me and I have read this consent form, have been given the opportunity to consider my decision, and have had all my questions answered. I agree to have my child take part in this study as explained in this consent form. I agree to let my child’s doctor or Lurie Children’s use and give out my child’s health information in the way it is described in this consent form until the end of the research study.

________________________________________________________________________Date Signature of Parent or Legally Authorized Representative

(LAR)

_______________________ _______________________________ _________________Printed name of child Printed name of parent/LAR Relationship to child

I certify that I have explained the above to the parent(s) and/or LAR and believe that the signature(s) was affixed freely. I also agree to answer any questions that may arise.

_________________ ______________________________________________________Date Signature of Person Obtaining Consent (Investigator or designee)

______________________________________________________Printed Name of Person Obtaining Consent


oncofertility.northwestern.edu · Web viewOvarian hyperstimulation syndrome occurs in five out of a...

Documents

Transcript of oncofertility.northwestern.edu · Web viewOvarian hyperstimulation syndrome occurs in five out of a...