Clinical trial: NCT01952730
Section: Alternatives
Subsections: C. What Other Options Are **There**?

Taking part in this study is voluntary. Instead of being in this study, you have these options:  
- Standard treatment including chemotherapy - Participation in another research study
- No therapy specific to your cancer
- Comfort care, also called palliative care. This type of care may help to reduce pain, tiredness, appetite problems and other problems caused by the cancer. It
does not treat the cancer directly, but instead tries to treat the symptoms.  
. Please talk to your regular doctor your options before you decide whether you will take part in this research study.
Clinical trial: NCT01952730
Section: Confidentiality
Subsections: L. W**Hat About Confidentiality**?|N. P**Rivacy Of Protected Health Information**|2. **Why Will Protected Information About Me Be Used Or Shared With** Others?|3. **Who Will Use Or Share Protected Health Information About Me?**|4. With Whom Outside Of Df/Hcc **May My Protected Health Information** Be Shared?|5. **For How Long Will Protected Health Information About Me Be Used Or** Shared With Others?|6. **Statement Of Privacy Rights:**|8. **Why Will Protected Information About Me Be Used Or Shared With Others?**|9. **Who Will Use Or Share Protected Health Information About Me?**|10.With Whom Outside Of Df/Hcc **May My Protected Health Information Be** Shared?|11.For How Long Will Protected Health Information About Me Be Used Or Shared With Others?|12.Statement Of Privacy Rights:

We will take measures to protect the privacy and security of all your personal information, but we cannot guarantee complete confidentiality of study data. Medical information created by this study may become part of your hospital medical record. Information that does not become part of your medical record will Page 14 of 22  
| DFCI Protocol Number:   | 12-436     | Approved Date (DFCI IRB Approval):   | 06/03/2019   |
|-------------------------|------------|--------------------------------------|--------------|
| Date Posted for Use:    | 06/10/2019 |                                      |              |  
BIDMC/BWH/CH/DFCI/MGH/Partners Network Affiliates OHRS 01/06/12 be stored in your study file. It may also become part of a DF/HCC research database called CORIS. Study files are coded and not labeled with your name.  
The code linking your name to the file will be kept in a safe location. Information contained in your records is used by study staff and in some cases it will be shared with the sponsor of the study. If your information is being shared with the sponsor, no information that could identify you will be given to the sponsor. Occasionally, a sponsor representative may come to the study site to review your study files. This person will never take any information that can identify you back to the sponsor. There may be times when we are required by law to share your information. In those cases, we do not need your permission.  
The results of this study may be published. You will not be identified in any publication without your permission.

Federal law requires Dana-Farber/Harvard Cancer Center (DF/HCC) and its affiliated research doctors, health care providers, and physician network to protect the privacy of information that identifies you and relates to your past, present, and future physical and mental health conditions ("protected health information"). If you enroll in this research study, your "protected health information" will be used and shared with others as explained below.  
Page 15 of 22  
| DFCI Protocol Number:   | 12-436     | Approved Date (DFCI IRB Approval):   | 06/03/2019   |
|-------------------------|------------|--------------------------------------|--------------|
| Date Posted for Use:    | 06/10/2019 |                                      |              |

The main reasons include the following:
- To conduct and oversee the research described earlier in this form;
- To ensure the research meets legal, institutional, and accreditation requirements;
- To conduct public health activities (including reporting of adverse events or situations where you or others may be at risk of harm); and
- Other reasons may include for treatment, payment, or health care operations. For example, some medical information produced by this research study may become part of your hospital medical record because the information may be necessary for your medical care. (You will also be given a notice for use and sharing of protected health information.)

- DF/HCC and its affiliated research doctors and entities participating in the research will use and share your protected health information. In addition, other DF/HCC offices that deal with research oversight, billing or quality assurance will be able to use and share your protected health information.

While all reasonable efforts will be made to protect the confidentiality of your protected health information, it may also be shared with the following entities:
- Outside individuals or entities that have a need to access this information to perform functions on behalf of DF/HCC and its  
| DFCI Protocol Number:   | 12-436     | Approved Date (DFCI IRB Approval):   | 06/03/2019   |
|-------------------------|------------|--------------------------------------|--------------|
| Date Posted for Use:    | 06/10/2019 |                                      |              |  
Page 16 of 22 BIDMC/BWH/CH/DFCI/MGH/Partners Network Affiliates OHRS 01/06/12 affiliates (for example, data storage companies, insurers, or legal advisors).  
- The sponsor(s) of the study, its subcontractors, and its agent(s): - Other research doctors and medical centers participating in this research, if applicable
- Federal and state agencies (for example, the Department of Health and Human Services, the Food and Drug Administration, the National Institutes of Health, and/or the Office for Human Research Protections), or other domestic or foreign government bodies if required by law and/or necessary for oversight purposes. A qualified representative of the FDA and the National Cancer Institute may review your medical records.  
- Hospital accrediting agencies
- A data safety monitoring board organized to oversee this research, if applicable Some who may receive your protected health information may not have to satisfy the privacy rules and requirements. They, in fact, may share your information with others without your permission.

- There is no scheduled date at which your protected health information that is being used or shared for this research will be destroyed, because research is an ongoing process.

- You have the right to withdraw your permission for the research doctors and participating DF/HCC entities to use or share your protected health information. We will not be able to withdraw all the information that already has been used or shared with others to carry out related activities such as oversight, or that is needed to ensure quality of the study. To withdraw your permission, you must do so in writing by contacting the researcher listed above in the section: "Whom do I contact if I have questions about the research study?"
- You have the right to request access to your protected health information that is used or shared during this research and that is related to your treatment or payment for your treatment, but you Page 17 of 22  
| DFCI Protocol Number:   | 12-436     | Approved Date (DFCI IRB Approval):   | 06/03/2019   |
|-------------------------|------------|--------------------------------------|--------------|
| Date Posted for Use:    | 06/10/2019 |                                      |              |  
BIDMC/BWH/CH/DFCI/MGH/Partners Network Affiliates OHRS 01/06/12 may access this information only after the study is completed. To  
  
request this information, please contact the researcher listed above in the section: "Whom do I contact if I have questions about the research study?  
Federal law requires Dana-Farber/Harvard Cancer Center (DF/HCC) and its affiliated research doctors, health care providers, and physician network to protect the privacy of information that identifies you and relates to your past, present, and future physical and mental health conditions ("protected health information"). If you enroll in this research study, your "protected health information" will be used and shared with others as explained below.

The main reasons include the following:
- To conduct and oversee the research described earlier in this form;
- To ensure the research meets legal, institutional, and accreditation requirements;
- To conduct public health activities (including reporting of adverse events or situations where you or others may be at risk of harm); and
- Other reasons may include for treatment, payment, or health care operations. For example, some medical information produced by this research study may become part of your hospital medical record because the information may be necessary for your medical care. (You will also be given a notice for use and sharing of protected health information.)

- DF/HCC and its affiliated research doctors and entities participating in the research will use and share your protected health information. In addition, other DF/HCC offices that deal with research oversight, billing or quality assurance will be able to use and share your protected health information.  
| DFCI Protocol Number:   | 12-436     | Approved Date (DFCI IRB Approval):   | 06/03/2019   |
|-------------------------|------------|--------------------------------------|--------------|
| Date Posted for Use:    | 06/10/2019 |                                      |              |  
BIDMC/BWH/CH/DFCI/MGH/Partners Network Affiliates OHRS 01/06/12

While all reasonable efforts will be made to protect the confidentiality of your protected health information, it may also be shared with the following entities:
- Outside individuals or entities that have a need to access this information to perform functions relating to the conduct of this research such as analysis by outside laboratories on behalf of DF/HCC and its affiliates (for example, data storage companies, insurers, or legal advisors).  
- Other research doctors and medical centers participating in this research, if applicable
- Federal and state agencies (for example, the Department of Health and Human Services, the Food and Drug Administration, the National Institutes of Health, and/or the Office for Human Research Protections), or other domestic or foreign government bodies if required by law and/or necessary for oversight purposes. A qualified representative of the FDA and the National Cancer Institute may review your medical records.  
- Hospital accrediting agencies - A data safety monitoring board organized to oversee this research, if applicable Some who may receive your protected health information may not have to satisfy the privacy rules and requirements. They, in fact, may share your information with others without your permission.

- There is no scheduled date at which your protected health information that is being used or shared for this research will be destroyed, because research is an ongoing process.

- You have the right to withdraw your permission for the research doctors and participating DF/HCC entities to use or share your protected health information. We will not be able to withdraw all the information that already has been used or shared with others to carry out related activities such as oversight, or that is needed to ensure quality of the study. To Page 19 of 22  
| DFCI Protocol Number:   | 12-436     | Approved Date (DFCI IRB Approval):   | 06/03/2019   |
|-------------------------|------------|--------------------------------------|--------------|
| Date Posted for Use:    | 06/10/2019 |                                      |              |  
BIDMC/BWH/CH/DFCI/MGH/Partners Network Affiliates OHRS 01/06/12 withdraw your permission, you must do so in writing by contacting the researcher listed above in the section: "Whom do I contact if I have questions about the research study?"
- You have the right to request access to your protected health information that is used or shared during this research and that is related to your treatment or payment for your treatment, but you may access this information only after the study is completed. To request this information, please contact the researcher listed above in the section: "Whom do I contact if I have questions about the research study?"
Clinical trial: NCT01952730
Section: Duration of Study Involvement
Subsections: After The Screening Procedures Confirm That You Are Eligible To Participate In The Research Study: Research Study Plan:|E. How Long Will I **Be In This Research Study**?

If these tests indicate you are eligible for this study and you agree to participate, you will be referred to a surgeon for the surgical removal of tumor tissue from which the vaccine will be made. The surgery will be performed at Massachusetts General. You will be asked to sign a separate consent form to give permission to the surgeon to perform this operation. That consent will describe the risks of the operation which involves removing the tumor cells from your liver. After your surgery, there is a possibility that your physician will recommend other treatment before starting the vaccines if he or she feels it would be beneficial to your care and medically appropriate. This part of the treatment would not be experimental (for example, chemotherapy or radiation therapy) Then, in this case, the vaccines made from your cancer will not be administered to you until at least 4 weeks after your last chemotherapy or radiation treatment. If the time between your operation and the first scheduled vaccine injection is 8 weeks or longer, we will ask you to undergo another chest, abdomen and pelvic CT scan and clinical blood work to confirm that it is still safe for you to proceed with the vaccines. After this 4 week rest period, vaccine administration will occur as previously outlined.  
| DFCI Protocol Number:   | 12-436     | Approved Date (DFCI IRB Approval):   | 06/03/2019   |
|-------------------------|------------|--------------------------------------|--------------|
| Date Posted for Use:    | 06/10/2019 |                                      |              |  
  
  
BIDMC/BWH/CH/DFCI/MGH/Partners Network Affiliates OHRS 01/06/12 If these tests indicate you are eligible for this study and you agree to participate, you will be referred to a surgeon for the surgical removal of tumor tissue from which the vaccine will be made. The surgery will be performed at Massachusetts General Hospital. You will be asked to sign a separate consent form to give permission to the surgeon to perform this operation. That consent will describe the risks of the operation which involves removing the tumor cells from your liver.  
It is important to know that sometimes we are unable to collect enough cells from the tumor collection. In those cases we can try to grow the tumor cells for a short period of time to get enough cells to make vaccine, but we can not guarantee that we will always be able to produce vaccine for every participant who undergoes tumor cell collection. The vaccines created from your colorectal cancer cells are scheduled to be given to you on days 1, 8, 15 and then every two weeks after that until 6 total vaccines have been administered. The amount of vaccines is dependent on the total amount of cells collected when your colorectal cancer liver metastasis is processed and prepared into vaccine in our lab. It is hoped that you will receive at least six vaccines. All scheduled treatment will occur in the outpatient clinic. The vaccines will be administered in two injections that will be placed underneath your skin. The two injections will be given at the same place on your body. The recommended sites are your arms, thighs or trunk area and the sites will rotate per vaccine.  
Day 1: This is the first day of treatment on study. The following procedures are planned on this day:  
- Update of medical history
- Physical Exam - Blood Samples for Routine Labs (2 tsp)
- Required Blood Sample for Immune Studies (4 tsp). You will have blood taken for immune testing every *month* after starting the research study to monitor the cells in your immune system for 3 months and then every 3 months for the first 2 years. The blood will be frozen and stored for future analysis.  
- Vaccine administration  
| DFCI Protocol Number:   | 12-436     | Approved Date (DFCI IRB Approval):   | 06/03/2019   |
|-------------------------|------------|--------------------------------------|--------------|
| Date Posted for Use:    | 06/10/2019 |                                      |              |  
BIDMC/BWH/CH/DFCI/MGH/Partners Network Affiliates OHRS 01/06/12
- If enough cells can be grown, you will also receive an injection of cancer  
  
cells that have been killed but not able to secrete GM-CSF. This is done to measure the amount of reaction of your immune system caused by the vaccine alone.

It is estimated that receiving all the vaccine created from your cancer cells would take about 3 months. A second course of vaccination, if administered, lasts approximately 3 more months.  
The research doctor may decide to take you off the research study for many reasons including if:
- It is considered to be in your best interest - The study treatment or procedures are found to be unsafe or ineffective - There is any problem with following study treatments and procedures - There are any problems with research funding or drug supply
- Your condition worsens
- Or other unforeseen reasons
If you are removed from the research study, the research doctor will explain to you why you were removed. If you are removed from the research study, you will still be followed for at least 15 years as mentioned in the section above. In addition, you can stop participating in the research study at any time. However, before you decide to stop participating in this research study, we encourage you to talk to the research doctor and your regular doctor first. New findings developed during the course of this research, which may relate to your willingness to continue participation will be provided to you by your doctor.
Clinical trial: NCT01952730
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: F. What Are The Risks Or **Discomforts Of The Research Study**?|Risks Associated With Vaccination Risks Associated With Gm-Csf: Likely (More Than A 50% Chance That This Will Happen)|Occasional **(Between A 1-10% Chance That This Will Happen)**|Rare (Chance Of Less Than 1% This Will Happen)|Risks Of Using Viruses In Making The Vaccine:|Risks Of Skin Biopsy:|Risks Of Blood Draws:|Reproductive Risks:|Radiation Risks Associated With Ct Scans:|Risks Associated With Mri Scans:|K. What Happens If I Am Injured Or Sick Because I **Took Part In This Research** Study?

While on this study, you are at risks for the side effects described below. You should discuss these with your treating doctor. There may also be other side effects we cannot predict. Your doctor can prescribe other drugs to make some of these side effects less serious and make you more comfortable. A significant risk to taking part in this study is the likelihood of receiving a treatment that is not effective in helping to treat your disease. This means that you many spend time and experience side effects of the vaccine treatment that does not provide you with any health related benefits.  
| DFCI Protocol Number:   | 12-436     | Approved Date (DFCI IRB Approval):   | 06/03/2019   |
|-------------------------|------------|--------------------------------------|--------------|
| Date Posted for Use:    | 06/10/2019 |                                      |              |  
BIDMC/BWH/CH/DFCI/MGH/Partners Network Affiliates OHRS 01/06/12 During the research study, you will be notified of newly discovered side effects or significant findings, which may affect your health or willingness to participate.  
You may be asked to sign a new consent form that shows that you have been informed of new information relating to this research study.

- Localized skin reaction - Erythema (redness of the skin) - Induration (firm swelling of the skin around the vaccine site) - Pruritis (itching at the vaccine site) - Fatigue - Nasal congestion

- Pustular eruption - Necrotizing vasculitis (inflammation of blood vessels) - Recall erythema at previous injection sites - General papular rash - Fever
- Bone pain
- Malaise (A vague feeling of bodily discomfort) - Diarrhea
- Liver damage (When your liver is not functioning properly this can cause fatigue, and jaundice (yellowing of the skin and eyes). Although this is usually mild and reversible, this can be serious or life threatening.)
- Kidney damage (When the kidneys do not work properly, wastes can build up in your blood, leading to swelling in the arms and legs, tiredness and weakness. This could become severe, requiring hospitalization and dialysis to clean the wastes out of your blood. If the wastes are not removed from your blood, this could cause seizures and be life threatening.)
- Thyroid gland abnormalities Page 9 of 22  
| DFCI Protocol Number:   | 12-436     | Approved Date (DFCI IRB Approval):   | 06/03/2019   |
|-------------------------|------------|--------------------------------------|--------------|
| Date Posted for Use:    | 06/10/2019 |                                      |              |  
BIDMC/BWH/CH/DFCI/MGH/Partners Network Affiliates OHRS 01/06/12
- Leucopenia (Condition in which the number of white blood cells circulating in the blood is abnormally low. This increases the risk of infection, which may be serious or life threatening)
- Leukocytosis (Condition in which the number of white blood cells circulating in the blood is abnormally high)
- Anemia (Low number of red blood cells that can causes tiredness and shortness of breath. May require a blood transfusion.)
- Arthralgia (joint pain) - Dyspnea (shortness of breath) - Fluid retention (Build up of fluid in the body or extremities causing swelling)
- Serous effusions (Collection of fluid around the lungs in the chest cavity, which can cause shortness of breath and may require treatment)
- Return various auto-immune diseases (Conditions where the body's immune system attacks normal tissues.)

Auto-immune diseases: There is a possibility of inducing an autoimmune reaction against normal body tissues. This is when your immune system may start to attack normal body tissues. No serious reactions such as these were observed in our other vaccine trials using GM-CSF as part of the vaccine.  
Although your tumor cells will be killed to prevent their growth in you it is possible, though highly unlikely, that they may grow after being injected in you causing new tumor deposits.

Since viruses are used to insert the GM-CSF into your tumor cells, it is possible that these viruses may still be present in the tumor cells and may be transmitted to you. Extensive testing will be performed prior to injection to try to make sure that no viruses are present. The consequences of transmission of these viruses to humans are unclear. This virus can produce an upper respiratory infection (common cold) or redness in the eyes (conjunctivitis) when it infects healthy people. Viral transmission has not been documented in any of the other clinical human studies using this type of virus.  
| DFCI Protocol Number:   | 12-436     | Approved Date (DFCI IRB Approval):   | 06/03/2019   |
|-------------------------|------------|--------------------------------------|--------------|
| Date Posted for Use:    | 06/10/2019 |                                      |              |  
Page 10 of 22 BIDMC/BWH/CH/DFCI/MGH/Partners Network Affiliates OHRS 01/06/12

This procedure may be associated with complications such as pain, bleeding, infection, scarring and problems with wound healing. Local anesthetic numbing agents may be associated in unusual cases with central nervous system effects, including lightheadedness, dizziness, blurred vision, ringing in the ears, seizures, or respiratory arrest, or cardiovascular effects including a slow heart rate or low blood pressure. Allergic reactions may also occur rarely.

Likely side effects of having your blood drawn are bleeding at the site, bruising and slight pain. Less likely effects are fainting and infection with inflammation of the vein at the site where the blood is drawn.

Because the vaccine used in this research study might affect an unborn baby, you should not become pregnant while on this research study. There may be risks which are currently unforeseen or unknown. Pregnant women must not take part in this research study; neither should women who plan to become pregnant during the research study. Women who are able to have children will be asked to have a pregnancy test before taking part to exclude the possibility of pregnancy. Women who could become pregnant must use an effective contraceptive during the course of this research study. Any woman who finds that she has become pregnant while taking part in this research study should immediately tell her research study doctor and she will be removed from the research study. You should also not breast feed your baby while on this study.

While you are in this research study, CT scans may be used to evaluate your disease. The frequency of these exams is similar to that which you would receive as standard care. There is a very small risk of developing a new cancer as a result of the radiological evaluation and treatment for your cancer.

When having an MRI (Magnetic Resonance Imaging) scan, you will lie still on a table that slides into a tunnel slightly wider than your body. People who feel uncomfortable in confined spaces (claustrophobia) may feel uncomfortable in the Page 11 of 22  
| DFCI Protocol Number:   | 12-436     | Approved Date (DFCI IRB Approval):   | 06/03/2019   |
|-------------------------|------------|--------------------------------------|--------------|
| Date Posted for Use:    | 06/10/2019 |                                      |              |  
  
BIDMC/BWH/CH/DFCI/MGH/Partners Network Affiliates OHRS 01/06/12 narrow cylinder. If you feel uncomfortable in confined spaces, please tell your doctor. Your doctor may give you a medication to make you feel more comfortable. MRIs use powerful magnets to make images. Therefore, persons with certain metal implants, such as pacemakers should not have an MRI. (If you have an implant or any metal in your body, please check with your study care doctor to know whether you can have an MRI or not.) For people without metal implants, there is no known health risks associated with exposure to the magnet. As images are taken, a loud banging noise will be produced. Earplugs or headphones will be available if needed. The MRI can be stopped at any time at your request, but the scan may not be complete. There is a small risk with using the contrast agent that is injected into a vein during the scan. Recent information has suggested that gadolinium, the contrast agent, may contribute to kidney disease in people with poor kidney function. Therefore, we will monitor your kidney function closely while you participate in this study. If there is any change in your kidney function, we may have to remove you from the study. Rarely, some people have allergic reactions to the contrast agent. On rare occasions, allergic-type reactions (such as hives and itching) have occurred. Serious reactions (for example, drop in blood pressure or difficulty breathing or severe allergic reaction and death) are rare. Non-Physical Risks: There is a small chance that we are not able to produce vaccine from your tumor cells and this could cause some psychological distress because you would be unable to receive the vaccine. If this happens, your doctor will explain to you why the vaccines were not able to be produced.

We will offer you the care needed to treat injuries directly resulting from taking part in this research. We may bill your insurance company or other third parties, if appropriate, for the costs of the care you get for the injury, but you may also be responsible for some of them. There are no plans for DF/HCC to pay you or give you other compensation for the injury. You do not give up your legal rights by signing this form. If you think you have been injured as a result of taking part in this research study, tell the person in charge of this research study as soon as possible. The research doctor's name and phone number are listed in this consent form. There are no plans for MGH to pay you or give you other compensation for the injury. You do not give up your legal rights by signing this form. If you think you have been injured as a result of taking part in this research study, tell the person in charge of this research study as soon as possible. The research doctor's name and phone number are listed in this consent form.
Clinical trial: NCT01952730
Section: Procedures
Subsections: D. W**Hat Is Involved In The Research Study**?

Sometimes it is hard to keep track of all of the details and procedures that are part of a research study. We will describe them in this consent form and you can refer to this at any time during the research study. We will also provide you with a calendar that will be an easy reference for you to keep track of the procedures and when you get the vaccines in this research study.
Clinical trial: NCT01952730
Section: Purpose of Research
Subsections: B. W**Hy Is This Research Study Being Done**?

| Page 1 of 22          |            |                                            |            |
|-----------------------|------------|--------------------------------------------|------------|
| DFCI Protocol Number: | 12-436     | Approved Date (DFCI IRB Approval):         | 06/03/2019 |
| Date Posted for Use:  | 06/10/2019 | ClinicalTrials.gov Identifier: NCT01952730 |            |  
BIDMC/BWH/CH/DFCI/MGH/Partners Network Affiliates OHRS 01/06/12 You are being asked to participate in a Phase I clinical trial. Phase 1 clinical trials test the safety of an investigational combination of drugs. Phase I studies provide information on what effects, both good and bad, the Investigational agent might have on your disease. "Investigational" means that the intervention is still being studied and that research doctors are trying to find out more about it. It also means that the FDA (U.S. Food and Drug Administration) has not approved the treatment for your type of cancer. The main purposes of this study are to determine:  
- The amount of vaccine that can be made for your colorectal tumor cells
- If the vaccine can be given safely - What the effects of the vaccine are, both good and bad
- How the vaccine affects your immune system - Whether this vaccine might have any effect on the return of your cancer in the liver after surgical removal
This study is being done because there are currently no treatments which have demonstrated to cure disease which has progressed, or moved beyond the site of the primary site of disease (colon or rectum). These vaccinations will be given after you have completed the standard of care treatment as determined by your doctor. Laboratory research has made vaccines from cancer cells by inserting genetic material from a protein called granulocyte-macrophage colony stimulating factor (GM-CSF) into the cancer cell. Once complete, the cancer cells are able to produce large amounts of GM-CSF. The vaccine made from these cells has a greater anti-tumor effect than cancer cells without GM-CSF. The purpose of this research study is to determine the safety of an investigational vaccine that will be made using your own colorectal cancer cells in the manner described above. This vaccine has been used in several other research studies for treatment for other cancers (skin, lung, ovarian, sarcoma and leukemia.) Information from these other research studies suggests that this vaccine may help to reduce the risk of your colorectal cancer returning after you have your colorectal cancer surgery. Due to these results in melanoma and several other tumors we are encouraged to use this vaccine approach in patients with liver metastases from colorectal cancer, after the cancer in the liver has been removed by surgery.  
| DFCI Protocol Number:   | 12-436     | Approved Date (DFCI IRB Approval):   | 06/03/2019   |
|-------------------------|------------|--------------------------------------|--------------|
| Date Posted for Use:    | 06/10/2019 |                                      |              |  
BIDMC/BWH/CH/DFCI/MGH/Partners Network Affiliates OHRS 01/06/12
Clinical trial: NCT01952730
Section: Withdrawal from Study
Subsections: H. Can I **Stop Being In The Research Study And What Are My Rights**?

You have the right to choose not to sign this form. If you decide not to sign this form, you cannot participate in this research study. You can stop being in the research study at any time. Tell the research doctor if you are thinking about stopping or decide to stop. He or she will tell you how to Page 12 of 22  
| DFCI Protocol Number:   | 12-436     | Approved Date (DFCI IRB Approval):   | 06/03/2019   |
|-------------------------|------------|--------------------------------------|--------------|
| Date Posted for Use:    | 06/10/2019 |                                      |              |  
  
BIDMC/BWH/CH/DFCI/MGH/Partners Network Affiliates OHRS 01/06/12 stop. Leaving the research study will not affect your medical care. You can still get your medical care from your hospital or doctor.  
If you choose to not participate, or if you are not eligible to participate, or if you withdraw from this research study, this will not affect your present or future care and will not cause any penalty or loss of benefits to which you are otherwise entitled. It is important to tell the research doctor if you are thinking about stopping so risks from the vaccine can be evaluated by your research doctor. In some cases, the abrupt stopping of a drug can have risks in itself. Another reason to tell your research doctor that you are thinking about stopping is to discuss what follow-up care and testing could be most helpful for you.