Clinical trial: NCT02162732
Section: Alternatives
Subsections: 45 **What Other Choices Do I Have If I Do Not Take Part In This Study?**

46 1 You do not have to participate in this study to have a genetic analysis of your tumor. One choice 2 is to not be in this study and to receive your cancer treatment in the usual way. 3 4 If you decide that you don't want any more active treatment, one of your options is called 5 "comfort care." Comfort care includes pain medication and other support. It aims to maintain 6 your comfort and dignity rather than cure disease. Usually this care can be provided at home. 7 8 Please discuss your options with your study doctor as well as other trusted persons or family 9 members.  
10
Clinical trial: NCT02162732
Section: Confidentiality
Subsections: 11 **Will My Medical Information Be Kept Private?**|29 **Hipaa Authorization Form For Use & Disclosure Of Health** 30 **Information For Research Purposes**|38 **What Will Be Done With My Information?**|1 **Why Am I Being Asked To Give Permission For The Use And Disclosure Of My Information?**|7 **What Information Will Be Used And Shared For This Study?**|19 **With Whom Will My Information Be Shared (Disclosed)?**|43 **Can I Stop My Protected Health Information From Being Collected And Shared?**|9 **What Happens If I Do Not Want You To Use And Share My Health Information?**|15 **When Will My Information Be Destroyed?**

12 13 We will do our best to make sure that the personal information in your medical record will be 14 kept private. However, we cannot guarantee total privacy. Your personal information may be 15 given out if required by law. If information from this study is published or presented at scientific 16 meetings, your name and other personal information will not be used. 17 18 Each subject in this trial will be identified by a unique identifier that will be used on all report 19 forms and any other material submitted to the NMTRC. Report Forms for this study will be both 20 paper and electronic. Electronic data will be stored in a secure data center that is housed by a 21 third party. Your medical records are available to those caring for you at this hospital. Other 22 people or groups who may see or copy your medical record and other health information because 23 you are participating in this study include: 24 25 - The Neuroblastoma and Medulloblastoma Translational Research Consortium (NMTRC),
26 affiliates of the NMTRC, and the NMTRC009 study committee 27 - Spectrum Health and its affiliates 28 - Ashion Analytics, LLC at TGen 29 - The U.S. Food and Drug Administration
- The Western Institutional Review Board® (WIRB® 30 )
31 - The Spectrum Health Institutional Review Board 32 - Department of Health and Human Services (DHHS) agencies 33 34 Otherwise your name will not be released without your written permission, unless required by 35 law. If results of this study are published, your identity will remain confidential. 36 37 Please refer to the separate authorization form that explains more specifically how your personal 38 health information will be used. 39 40 Part of this study will be looking at genetic information collected from the samples you provide. 41 Your genetic information may be shared with and seen by individuals working at Ashion, TGen, 42 Dell Inc., and other organizations that are collaborating with NMTRC or funding this study. 43 While your genetic information, by itself, may not directly identify you, you should be aware 44 that certain other laws and regulations may provide additional protections for that information. 45 1 Specifically, a Federal law, called the Genetic Information Nondiscrimination Act (GINA), 2 generally makes it illegal for health insurance companies, group health plans, and most 3 employers to discriminate against you based on your genetic information. This law generally will 4 protect you in the following ways: Health insurance companies and group health plans may not 5 request your genetic information that we get from this research. Health insurance companies and 6 group health plans may not use your genetic information when making decisions regarding your 7 eligibility or premiums. Employers with 15 or more employees may not use your genetic 8 information that we get from this research when making a decision to hire, promote, or fire you 9 or when setting the terms of your employment.  
10 11 GINA does not protect you against genetic discrimination by companies that sell life insurance, 12 disability insurance, or long-term care insurance. GINA does not prohibit discrimination on the 13 basis of an already manifest genetic disease or disorder.  
14 15 A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by 16 U.S. Law. This Web site will not include information that can identify you. At most, the Web 17 site will include a summary of the results. You can search this Web site at any time. 18

31 **(TEMPLATE)**
32 33 The information we are asking to use and disclose (share) for this research study may include 34 your Protected Health Information (PHI). This information is protected by a federal law called 35 the Health Insurance Portability and Accountability Act (HIPAA). In general, we cannot use or 36 share your health information for research without your permission. 37

39 40 Each subject in this trial will be identified by a unique identifier that will be used on all report 41 forms and any other material submitted to the NMTRC. Report Forms for this study will be both 42 paper and electronic. Electronic data will be stored in a secure data center housed at a third party. 43 Your health information will be collected and entered in this password-secure database along 44 with the information from other people taking part in this study, and will only be accessible to 45 the people involved in conducting this research. 46

2 3 Your health information will be used to evaluate the feasibility (ability to be done) of an 4 experimental test to help plan your cancer treatment. To evaluate this test, we need to see and use 5 your health information, including your genetic information. 6

8 9 To complete this research study, we will need to collect and share (disclose) information about 10 you. This information may include: 11 12 - Your date of birth, name, contact information, medical record number, and insurance 13 information.  
14 - Genetic information about you and your cancer.  
15 - Existing medical records and medical history. 16 - New health information collected for purposes of this study.  
17 - Copies of medical records you have with other health care providers.  
18

20 21 - Dr. Giselle Sholler, the Neuroblastoma and Medulloblastoma Translational Research 22 Consortium (NMTRC), affiliates of the NMTRC, and the NMTRC009 study committee 23 - Your study doctor and his/her research staff 24 - Spectrum Health Hospitals staff or its agents 25 - Ashion Analytics, LLC at Tgen 26 - The Western Institutional Review Board® (WIRB®)
27 - The Spectrum Health Institutional Review Board (IRB) and its staff 28 - The Food and Drug Administration (FDA) and other government agencies who regulate 29 this study 30 31 Once your protected health information has been shared (disclosed), it is possible that anyone 32 who receives that information may re-disclose it. Because some of these individuals who receive 33 your protected health information may not be required by law to keep your information 34 confidential, we cannot guarantee that your information will not be released or made available to 35 another party once it leaves your treating institution. Therefore, we share your information only 36 if necessary and we use all reasonable efforts to request that those individuals who receive your 37 information take steps to protect your privacy. 38

44 45 You can tell us to stop collecting your health information at any time. We will stop using and 46 sharing your information, except in very limited cases if needed to comply with law, protect your 1 safety, or make sure the research was done properly. If you have any questions about this please 2 ask. 3 4 If you want us to stop using and sharing your health information, you must tell us in writing. 5 Send your written request to: 6 7 [insert study doctor contact information] 8

10 11 If you decide not to give permission for us to use and share your health information, you will not 12 be able to participate in this study. Your decision will in no way affect your medical care or 13 cause you to lose any benefits to which you are entitled.  
14

16 17 We do not know when your information will no longer be used. Unless you tell us to stop using 18 and sharing your information, it will be kept for an indefinite length of time. 19 20 [If the HIPAA authorization form will be a document separate from the consent form, 21 appropriate signatures blocks need to be inserted here].
Clinical trial: NCT02162732
Section: Participant's Rights
Subsections: 33 **Consent And Assent Instructions:**|4 **Consent Signature:**|40 **Assent Signatures, For Adult Subjects With A Legally Authorized Representative:**

34 Consent: *Subjects 18 years and older who can provide consent must sign on the subject line* 35 *below* 36 *Consent is provided by the Legally Authorized Representative for adult subjects* 37 *unable to consent* 38 *Competent subjects who become adults during the study must provide written consent* 39 using the subject line *below* 40 *For subjects under 18, consent is provided by the parent or guardian* 41 42 Assent: *Is not required for subjects 17 years and younger* 43 *Written assent is required for adult subjects where possible using the assent section* 44 *below* 45 46 1 2 Name of Subject Printed 3

5 6 7 8 Signature of Subject Date 9 10 11 12 Signature of Legal Guardian or Legally Authorized Representative Date 13 (applicable for children and subjects unable to provide consent)
14 15 16 17 Name of Legal Guardian or Legally Authorized Representative Printed 18 19 20 21 Authority of Subject's Legally Authorized Representative or Relationship to Subject 22 23 24 25 Signature of Person Conducting Informed Consent Discussion Date 26 27 28 29 Name of Person Conducting Informed Consent Discussion 30 31 32 33 Signature of Principal Investigator or Designee (if different from above) Date 34 35 36 37 Name of Principal Investigator or Designee Printed (if different from above) 38 39

41 42 Assent: 43 44 For adult subjects who have a legally authorized representative, I confirm that: 45 1 - I have explained the study to the extent compatible with the subject's understanding, and 2 the subject has agreed to be in the study. 3 4 OR 5 6 - The subject is not able to assent due to lack of mental capacity.  
7 8 9 10 Signature of Person Conducting Assent Discussion Date 11 12 ---------------------------- **Use this witness section only if applicable -------------------------**
13 14 If this consent form is read to the subject because the subject is unable to read the form, an 15 impartial witness not affiliated with the research or investigator must be present for the consent 16 and sign the following statement: 17 18 I confirm that the information in the consent form and any other written information was 19 accurately explained to, and apparently understood by, the subject. The subject freely consented 20 to be in the research study. 21 22 23 24 Signature of Impartial Witness Date 25 26 Note: This signature block cannot be used for translations into another language. A translated 27 consent form is necessary for enrolling subjects who do not speak English. 28
Clinical trial: NCT02162732
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 9 **Drug Risks:**|26 **Bone Marrow Examination Risks:**|37 **Reproductive Risks:**|19 What Happens If I Am **Injured?**

10 11 Your study doctor will provide you a more detailed list of the risks of the drugs involved in your 12 specific treatment plan. Attached to the end of this consent form is a list of the possible drug 13 therapies. Your study doctor will discuss your personalized plan with you.  
14 15 The following information is general information about chemotherapy risks. 16 17 All people who receive cancer treatment are at risk of having side effects. In addition to killing 18 tumor cells, cancer chemotherapy can damage normal tissue and produce side effects. Side 19 effects are usually reversible when the medication is stopped but occasionally persist and cause 20 serious complications. A person can die from these and other complications. 21 22 Common side effects include nausea, vomiting, hair loss, and fatigue. Drugs may be given to 23 prevent or decrease nausea and vomiting. Hair loss is usually temporary, but on very rare 24 occasions it may be permanent. Some chemotherapy may lead to sterility. Sterility is the inability 25 to have children. There is also the possibility that a second cancer may develop years later as a 26 result of the chemotherapy. 27 28 The most common serious side effect from cancer treatment is lowering of the number of blood 29 cells resulting in anemia, and increased chance of infection. 30 31 Allergic and infusion reactions have been reported. Symptoms of a reaction may include 32 headache, rash, itching, flushing, swelling, and shortness of breath. Severe reactions, such as 33 Stevens-Johnson Syndrome (SJS), Toxic epidermal necrolysis (TEN) or and Drug Reaction with 34 Eosinophillia and Systemic Symptoms (DRESS), could be life threatening. If you have 35 symptoms of a reaction, you should contact the study doctor or his/her study staff immediately. 36 37 Organ dysfunction, such as skin, liver or lung problems. These could be mild, such as abnormal 38 blood tests without symptoms, or could be life-threatening. 39 40 Abnormal blood clotting, either too much or too little. This could result in excessive bleeding or 41 clots in blood vessels, and could be life-threatening. 42 43 There also may be other side effects that we cannot predict. 44 45 There is a risk that the treatment plan will not get rid of the cancer for as long as possible or that 46 the cancer can go away after the treatment and then come back at a later date.  
1 2 You may be prescribed drugs in a combination that has not been used before or has limited use 3 together. Side effects can be increased when chemotherapy drugs are combined. Information 4 about how these drugs may interact could be based on theoretical knowledge that may not have 5 been tested before. There may be unknown interactions of using these drugs together. These drug 6 combinations may have serious side effects that we may not know about which could occur 7 immediately or at a later time after you have stopped taking the medication. Your study doctor 8 will discuss this with you at the time of your treatment decision. 9 10 If you do have side effects, we may recommend medicine or treatments to try to control them 11 and make you comfortable. 12 13 You should talk to your study doctor about any side effects that you have while taking part in the 14 study.  
15 16 **Device Risks:**
17 18 The "Pediatric Gene Analysis Platform" test is an experimental technology (not FDA-approved) 19 that will be used to help identify a drug, or combination of drugs for your treatment, based on the 20 molecular makeup of your tumor. No test is perfectly accurate and there is a risk that results from 21 this test may incorrectly identify/fail to identify the molecular makeup of your tumor. An 22 incorrect test result (indicating that your tumor has a particular molecular makeup, when it does 23 not) could result in your receiving a study drug, or combination of drugs that may have no 24 benefit to you, and which may have side effects and cause harm. 25

27 28 The test may be painful. There is also a small risk of infection or bleeding. The pain normally 29 lessens within minutes to hours. 30 31 **Risks of blood drawing:**
32 33 Risks associated with drawing blood are slight, but some risks include: pain, excessive bleeding, 34 fainting or feeling lightheaded, bruising, infection (a slight risk any time the skin is broken), and 35 multiple punctures to locate veins. 36

38 39 Because the drugs used in cancer treatment can affect an unborn baby, you should not become 40 pregnant or father a baby while on this study. You should not nurse your baby while on this 41 study. Both men and women should use one of the more effective birth control methods during 42 treatment and for six months after treatment is stopped. These methods include 43 44 - total abstinence (no sex), 45 - oral contraceptives ("the pill"),
46 - an intrauterine device (IUD),
1 - levonorgestrol implants (Norplant), or 2 - medroxyprogesterone acetate injections (Depo-provera shots).  
3 4 If one of these cannot be used, contraceptive foam with a condom is recommended. 5 6 The study doctor must be notified if pregnancy occurs during the course of the study. 7 8 A possible effect of drugs used to treat your tumor is the possibility of sterility (inability to have 9 children).  
10

20 21 Participating in research may result in an injury or illness. Medical treatment related to this 22 injury or illness will be available at your treating institution, but such treatment may not be free 23 of charge. No funding has been set aside to pay for the costs of treating an injury or illness that 24 results from this study. Your medical insurance may pay for such treatment, but you may 25 ultimately be billed for payment. 26 27 Ask the study doctor for more information about this. We also encourage you to determine your 28 health insurer's policy about paying for treatment in a research study. 29 30 By signing this consent form, you are not giving up any legal rights. 31 32 **WHO WILL PROVIDE FUNDING?**
33 34 Funding for this research study will be provided by the Neuroblastoma and Medulloblastoma 35 Translational Research Consortium (NMTRC) and Dell, Inc. 36
Clinical trial: NCT02162732
Section: Procedures
Subsections: 11 **What Will Happen If I Take Part In This Research Study?**|41 You Will Need The Following Tests And Procedures That Will Be Evaluated **In This Study.**|8 **Methods For Giving Drugs**|41 **You Will Need Tests And Procedures That Are Part Of Regular Cancer Care. They May Be Done** 42 **More Often Because You Are In This Study.**|4 **Testing Requirements For Study:**

12 13 You will need to have the following exams, tests and procedures to find out if you can be in the 14 study. Depending on the results of these studies, they may show that you are not eligible to take 15 part in this study. Most of these exams, tests and procedures are part of regular cancer care and 16 may be done even if you do not join the study. If you have had some of them recently, they may 17 not need to be repeated. This will be up to your study doctor. 18 19 - Medical history 20 - Physical exam 21 - Vital signs (blood pressure, pulse, temperature)
22 - Blood tests 23 - Urine tests 24 - MRI (use of a magnetic field to produce an image) or CT scan (test that produces a 25 picture of your body using radiation) of the tumor(s)
26 - Any other imaging studies or tests deemed necessary for assessing your tumor by your 27 treating physician 28 29 Additional Tests for Some Subjects 30 - MIBG scan (unless your tumor is pre-determined to not show up on an MIBG scan) or 31 PET scan (An MIBG scan involves injecting a radioisotope into the blood on the first 32 day, and then scanning the whole body on the second day to see where the isotope was 33 absorbed) 34 35 Additional Tests for Neuroblastoma Subjects and any Subject with suspected Bone Marrow 36 Disease Involvement: 37 38 - Bone marrow examination (this involves using a needle to extract a small amount of your 39 bone marrow from both of your hips usually under anesthesia) 40

42 43 - Analysis of your tumor sample and generation of a personalized genetic report 44 - Review of personalized genetic report with the study doctor 45 - If you are eligible, you will then be offered and placed on a treatment plan.  
46 1 As a part of your regular (standard of care) treatment you may have a surgical operation to 2 remove as much of the tumor as possible. You will be asked by the pediatric surgeon to sign a 3 separate consent form at the time of that surgery, which will review the risks and benefits of that 4 surgical procedure. If tumor is obtained by surgery, you will be asked if some of the tumor can 5 be saved for special research testing. There is a separate consent section for this at the end of this 6 consent form. 7

9 10 The study doctor will discuss with you the method of giving drug or drug combinations after the 11 treatment plan is determined. 12 13 **Study Plan:**
14 15 If the exams, tests and procedures show that you can be in the study, and you choose to take part, 16 a portion of your tumor tissue (either bone marrow biopsy or tissue) along with a blood sample 17 will be sent to the Ashion for testing. This testing will generate a personalized genetic report. 18 The personalized genetic report will provide information that predicts which of the drugs your 19 specific tumor may be most sensitive to. These reports will be used by the treatment 20 recommendation board to recommend a specific treatment plan for your tumor. Your treating 21 physician will know these recommendations when planning your treatment. Some of the factors 22 that will be taken into account in choosing your treatment may include the safety, mechanism 23 (how the drug works), availability, and cost of the drugs predicted. Once you have completed the 24 pre-study procedures and the treatment recommendation board has made a treatment 25 recommendation based on the testing results obtained from a portion of your tumor tissue (either 26 bone marrow or tissue), your physician will review your treatment options with you, and you 27 will be asked to begin a treatment. 28 29 Please read the section regarding drug risks for important information relating to this study. 30 31 One of the major goals of this study is to identify biologic treatment targets unique to your 32 individual tumor. Therefore the specific treatment plan developed may recommend drugs or 33 combinations of drugs with which there is little or no prior experience in children. 34 35 There will be specific testing done while you are on study to monitor your progress and health. 36 37 You may participate in this part of the study without agreeing to specific treatment therapy. 38 Deciding not to be in the study or leaving the study will not result in any penalty or loss of 39 benefits to which you are entitled. 40

43 44 If you have another tumor removal as part of your standard course of care during the time you 45 are on this study, you may be offered the opportunity to have the tumor tested again and to repeat 46 the treatment recommendation board. At this time a new treatment recommendation may be 1 made depending on the results of the repeat test. If this occurs and you agree to the new 2 treatment plan you will start over on the study. 3

5  
| 5                                                                                                                                                                                                                                         | Subsequent Cycles   | Off                                                                                                                                                                                                      |                                 |    |    |    |    |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|----|----|----|----|
| Day 1                                                                                                                                                                                                                                     | Therapy             |                                                                                                                                                                                                          |                                 |    |    |    |    |
| Informed consent                                                                                                                                                                                                                          | X                   |                                                                                                                                                                                                          |                                 |    |    |    |    |
| Medical history                                                                                                                                                                                                                           | X                   | X                                                                                                                                                                                                        | X                               | X  | X  | X  |    |
| Physical exam                                                                                                                                                                                                                             | X                   | X                                                                                                                                                                                                        | X                               | X  | X  | X  | X  |
| Vital signs                                                                                                                                                                                                                               | X                   | X                                                                                                                                                                                                        | X                               | X  | X  | X  | X  |
| Height                                                                                                                                                                                                                                    | X                   | X                                                                                                                                                                                                        | X                               |    |    |    |    |
| Weight                                                                                                                                                                                                                                    | X                   | X                                                                                                                                                                                                        | X                               | X  |    |    |    |
| Blood Tests                                                                                                                                                                                                                               | X                   | X                                                                                                                                                                                                        | X                               | X  | X  | X  | X  |
| Urine Tests                                                                                                                                                                                                                               | X                   | X                                                                                                                                                                                                        | X                               | X  |    |    |    |
| Surgical resection &/or  diagnostic biopsy                                                                                                                                                                                                | X                   |                                                                                                                                                                                                          |                                 |    |    |    |    |
| MRI or CT                                                                                                                                                                                                                                 | X                   | Radiologic measurements will be performed after Cycle 2 and then  should be performed every 8 weeks or every other cycle (whichever  occurs first) through Cycle 6, after which they may be performed as |                                 |    |    |    |    |
| MIBG                                                                                                                                                                                                                                      | X                   | per institutional standard.                                                                                                                                                                              | Cycle 1 Day 22 (if  applicable) |    |    |    |    |
| PreStudy                                                                                                                                                                                                                                           | Cycle 1             | Cycle 1                                                                                                                                                                                                  | Cycle 1                         |    |    |    |    |
| Procedure                                                                                                                                                                                                                                 | Day 1               | Day 8                                                                                                                                                                                                    | Day 15                          |    |    |    |    |
| Should be repeated after Cycle 2 and then should be performed every  8 weeks or every other cycle (whichever occurs first) if positive at  study entry through Cycle 6, after which they may be performed as per  institutional standard. |                     |                                                                                                                                                                                                          |                                 |    |    |    |    |
| B-HCG (pregnancy test)                                                                                                                                                                                                                    | X                   |                                                                                                                                                                                                          |                                 |    |    |    |    |
| EKG (as indicated)                                                                                                                                                                                                                        | X                   |                                                                                                                                                                                                          |                                 |    |    |    |    |
| 6 Bone Marrow (for any  subject with suspected  BM disease)                                                                                                                                                                               | X                   |                                                                                                                                                                                                          |                                 |    |    |    |    |  
Should be repeated after Cycle 2 and then should be performed every 8 weeks or every other cycle (whichever occurs first) if positive at study entry through Cycle 6, after which they may be performed as per institutional standard.  
B-HCG (pregnancy test) X EKG (as indicated) X  
6 7 All required scans (MIBG's and MRI/CT's) must be done at your study institution unless 8 otherwise approved by the sponsor. 9  
10 **HOW LONG WILL I BE IN THE STUDY?**  
11  
12 As a subject in this study you will remain in this study for as long as you have no disease 13 progression or until you need to come off study. 14  
15 **WHAT SIDE EFFECTS OR RISKS CAN I EXPECT FROM BEING IN THE STUDY?**  
16 17 Genetic testing: 18 19 Some of the risks associated with genetic testing include:  
20 - Inaccurate results  
21 - Unknown meaning of results 22 - Misuse of results by others  
23 24 Testing may give incorrect answers. This could mean a falsely positive result that you have the 25 gene, when you do not. Or it could mean a falsely negative result that the gene is absent, when  
1 you actually do have the gene. Either way, a false result would mean that your genetic test 2 information would be incorrect. 3 4 There are risks associated with a loss of confidentiality of your health information and genetic 5 testing results. Information about genetic test results may affect your employment, insurance, or 6 family relationships. The sponsor cannot be certain that your genetic test results could never be 7 linked to you. 8
Clinical trial: NCT02162732
Section: Purpose of Research
Subsections: 38 **The Goals Of This Part Of The Study Are:**|16 **Are There Benefits To Taking Part In The Study?**

39 40 - To determine feasibility (ability to be done) and safety of using tumor samples and the 41 experimental technology to guide therapy decisions in relapsed and refractory childhood 42 cancers.  
43 - To determine if our treatment recommendation board (at minimum a panel of 3 44 oncologists and 1 pharmacist) can use your bone marrow or tumor samples to make real45 time treatment recommendations using your specific genetic information and predicted 46 therapies identified in your personalized genetic report.  
1 - To deliver therapy based on molecular guided predictions.  
2 - To determine the activity of treatments chosen based on:
3  How each subject responds to treatment 4  How long a subject lives without their disease progressing 5

17 18 Because there is not much information about molecular guided therapy in your tumor type, we 19 do not know if you will experience personal benefit from taking part in this study. Information 20 learned from this study may help future children with cancer. 21
Clinical trial: NCT02162732
Section: Withdrawal from Study
Subsections: 37 **Can I Withdraw Or Be Withdrawn From The Study?**

38 39 Your participation in this study is voluntary. You may decide not to participate or you may leave 40 the study at any time. Your decision will not result in any penalty or loss of benefits to which 41 you are entitled. 42 43 Tell your study doctor if you are thinking about stopping or decide to stop. He or she will tell 44 you how to stop safely. It is important to tell the study doctor if you are thinking about stopping 45 so any risks from treatment can be evaluated by your study doctor. Another reason to tell your 1 study doctor that you are thinking about stopping is to discuss what follow-up care and testing 2 could be most helpful for you. 3 4 Your study doctor or sponsor may decide to take you off study at any time without your consent 5 if any of the following occur: 6 7 - You do not meet the requirements to take part in the study (for example, there is not 8 enough sample of tumor cells to perform the analysis needed for the personalized genetic 9 reports.)
10 - You need a treatment that is not allowed on this study 11 - Your tumor worsens 12 - The study doctor believes it is in your best interest 13 - New information becomes available that would suggest that continuing in this study 14 would not be in your best interest 15 - The study is stopped 16 - You do not consent to continue in the study after being told of changes in the research that 17 may affect you 18 - Or for any other reason.  
19 20 **CONTACT INFORMATION**
21 22 Contact [INSERT INSTITUTION PI NAME] at [INSERT INSTITUTION PI CONTACT 23 NUMBER] for any of the following reasons: 24 25 - if you have any questions about your participation in this study, 26 - if at any time you feel you have had a research-related injury, or 27 - if you have questions, concerns or complaints about the research.  
28 29 If you have questions about your rights as a research subject or if you have questions, concerns, 30 input or complaints about the research, you may contact: 31 Western Institutional Review Board® (WIRB® 32 )
33 1019 39th Avenue SE Suite 120 34 Puyallup, Washington 98374-2115 35 Telephone: 1-800-562-4789 or 360-252-2500 36 E-mail: Help@wirb.com 37 38 WIRB is a group of people who perform independent review of research. 39 40 WIRB will not be able to answer some study-specific questions, such as questions about 41 appointment times. However, you may contact WIRB if the research staff cannot be reached or if 42 you wish to talk to someone other than the research staff. 43 44 Do not sign this consent form unless you have had a chance to ask questions and have received 45 satisfactory answers to all of your questions. 46