Consent IUSCC Tissue Bank

IUSCC-0280-Indiana University Simon Cancer Center Tissue Bank a Collection of Human Biological Material and Clinical Data for Research

You are being asked to participate in a research study that involves the collection, storage, and use of your information and biospecimens for future research. Scientists do research to answer important questions which might help change the way we do things. Your information and biospecimens will be stored in a repository called IU Simon Cancer Center Tissue Bank. A repository is a storage bank of medical information and biospeimens. Biospecimens are samples from your body such as urine, blood, tissue, saliva, pleural fluid, ascites, breast milk, hair and nail clippings. Tissues are groups of cells that work together to do a job in the body, such as skin or lungs.

You may choose not to take part or may leave the study at any time. Deciding not to participate, or deciding to leave the study later, will not result in any penalty or loss of benefits to which you are entitled, and will not affect your relationship with Indiana University or your physician.

This consent form will give you information about the study to help you decide whether you want to participate. Please read this form and ask any questions you have before agreeing to be in the study.

IMPORTANT INFORMATION
This information gives you an overview of the research. More information about these topics may be found in the pages that follow.

The purpose of this research study is to collect and store biospecimens and personal health information to use in future research studies. The purpose of this study is to collect a variety of specimens from both healthy and sick volunteers and look for differences between the specimens to better understand, treat, and prevent cancer. For more information, please see the Why is this Study being Done section below.

WHY IS THIS RESEARCH BEING DONE?
You are invited to participate in a long-term program to collect biological specimens (tissue, blood pleural fluid, ascites fluid, breast milk, hair and nail clippings) for future research purposes. You are not being invited to participate in a specific study at this time, but the specimens collected could be used in multiple research studies in the future.

The purpose of this study is to collect a variety of specimens from both healthy and sick volunteers and look for differences between the specimens. Differences between specimens may be related to the development of disease. Researchers will study the nature of disease with the goal of improving ways to prevent, diagnose and treat cancer. For example, tissues and bodily fluids (such as blood) are the source of DNA, RNA, and proteins. Scientists have found that changes in individual genes and/or proteins may cause, or be associated with, the development of disease. We would like to collect a blood sample, tissue, pleural fluid, ascites fluid, breast milk, hair and nail clippings and medical information to use for research. Tissues collected in this study can be new samples from a biopsy or surgical procedure and old/archived samples from a previous surgery which are no longer needed for your care.

The study is being conducted by a Professor at Indiana University School of Medicine. It is partially funded by Indiana University Simon Cancer Center and the National Cancer Institute. Up to 2,000 participants each year are asked to donate biospecimens for this research study.

Researchers will study the differences between people with the goal of improving ways to prevent, diagnose and treat cancer. You will not be informed of any specific future research studies that might be conducted using your identifiable biospecimens and identifiable private information, and will not be asked to consent for such future use. Researchers will be required to have IRB approval to request your specimens from the biorepository.

We may use the specimens collected as a part of this study for whole genome sequencing, which involves mapping all of your DNA. This would allow researchers to better understand how your DNA leads you to developing diseases. This could lead to better understanding of causes and treatments for cancer. Any sequencing information gained will be securely stored on password-protected computers.

The specimens may also be stored in a way that allows the cells to grow and multiply. These multiplying cells may result in what is called a cell line. Cell lines can be used for multiple future studies and these cells may be kept alive for many years. Because the research will be conducted in the future, it is hard to know what kinds of research methods will be used and it is not possible identify all the ways in which the specimens will be used.

All participants will have their medical information collected. Each participant may be asked for any combination of the biospecimens below.

For more information, please see the Collection of Information and Biospecimens section below.

WHAT INFORMATION AND BIOSPECIMENS WILL BE COLLECTED?
If you agree to be in the study, the following will be collected and stored:

INFORMATION and BIOSPECIMENS
• Examples of information include: age, sex, medical diagnosis, medical history, list of medications, side effects experienced from cancer treatment, additional medical information related to your cancer such as test results and CT scans and other imaging studies may be reviewed for research purposes.
• Examples of biospecimens being collected include both healthy and cancerous tissues, cancerous fluid in the lungs or abdomen, blood, as well as urine, saliva, breast milk, hair and nail clippings. In some cases, only archived tissue (from an old surgery or procedure) that is no longer needed for your medical care and treatment may be used for research purposes.
• If you wish for a specific biospecimen to not be collected, please mark that specimen type above.

REQUIRED COLLECTION PROCEDURES FOR RESEARCH
• Your medical records will be reviewed to obtain information about you and your health.

BIOSPECIMENS BEING COLLECTED FOR EACH PERSON WILL BE DIFFERENT, based on their disease and the surgery or procedure being done.
• When possible, a sample of blood will be taken while you are already having blood drawn for your clinical care or another research study.
- If it is not possible to get blood during an already scheduled blood draw, we may do a blood draw specifically for this research.
- Blood will be drawn from a vein in your arm or your chemotherapy port (if you have one). Blood will be drawn one time at the beginning of the study and up to 3 teaspoons of blood will be collected.
• You may be asked to have one additional blood drawn during or after you finish treatment.
• We will keep any leftover tissue or bodily fluid biospecimens which are not needed for your clinical diagnosis and/or medical treatment.
- This leftover tissue can be from procedures that have happened in the past, related to the diagnosis.

In some cases, you may also be asked to donate a random urine sample, saliva, pleural fluid, or ascites samples. Urine and saliva samples will be collected only for research purposes and are not a part of your regular medical care while pleural fluid and ascites will only be collected as part of a scheduled medical procedure.
- If you agree to donate urine, up to 4 tablespoons will be collected.
- If you agree to donate saliva, up to 2 tablespoons of saliva will be collected. To collect the saliva, you will be asked to spit into a special plastic cup or tube that is used to collect saliva.
-If you agree to donate breast milk, up to 4 tablespoons will be collected.
-If you agree to donate hair, several hairs (up to 10) can be removed from the scalp.
-If you agree to donate nail clippings, a small amount of excess nail material will be collected from either the hands or the feet or both. Less than one ounce of clippings is needed.
- If you agree to donate excess fluid from thoracentesis or paracentesis procedures, a goal of a minimum of 50 fluid ounces (approximately 2 pints) of fluid will be collected during your normally scheduled procedure.

Tissue collection procedures will only occur during normally scheduled surgeries or procedures. Blood, pleural fluid, ascites and breast milk collection may occur once or more than once if you agree, review of your data will be performed annually.
• The expected amount of your time for a study visit is 10 to 15 minutes.

Your specimens will be collected once, but they will be part of this biorepository until they are used up. If you are a participant with cancer you may be asked to donate additional blood samples during treatment or after treatment. Your medical records will also be followed for your long-term outcome.

We don't expect you to receive any benefit from taking part in this study, but we hope to learn things which will help scientists and patients in the future.

This research may include physical risks to you such as pain from the blood draw or biopsy. For details, please see the What Are the Risks of Taking Part in the Study section below.

The main risk of this type of study is possible loss of confidentiality. Every effort will be made to protect your confidential information from being accessed or looked at by unauthorized persons.

The physical risks associated with participation in this research are related to:
• Drawing blood, these could include pain or discomfort, bleeding, or bruising at the needle site, light-headedness or fainting. To minimize these risks, your blood will be drawn by experienced technicians, the area will be cleaned before your blood is drawn, sterile supplies (needles, gauze, etc.) will be used and a bandage will be applied after the sample is drawn.

• Biopsies, these could include pain or discomfort, bleeding, or bruising at the needle site, light-headedness or fainting. To minimize these risks, your surgeon or interventional radiologist will perform your biopsy. The area will be cleaned before your biopsy, sterile supplies (needles, gauze, etc.) will be used and a bandage will be applied after the biopsy.

• Tissue Collection, there is no additional risk to you if you agree to donate tissue from a biopsy or surgical procedure. These procedures would be done whether or not you participate in this study. No extra tissue will be taken during your surgical procedure as part of this collection effort.

• Pleural Fluid and Ascites: Thoracentesis and paracentesis procedures may be associated with local discomfort and minor bleeding. There is less likelihood of moderate or major bleeding, need for blood transfusion, hospitalization due to bleeding or other complications, infection, pneumothorax, damage to adjacent organs, bowel perforation (paracentesis). In order to minimize the risk of these outcomes occurring, only qualified personnel will perform these procedures. Prior to the procedure, the medical professional performing the procedure will discuss the risks with each study participant, answer any questions, and obtain a separate procedure consent.

• Urine Collection: There is no physical risk in donating a urine sample.

• Saliva Collection: There is no physical risk in donating a saliva sample.

• Breast Milk Collection: There is no physical risk in donating a breast milk sample.


Other risks associated with participation:
• DNA can be extracted from these biospecimens, which means potentially harmful information could be gained (for example, paternity). If we utilize your DNA, you should realize that every person's DNA is unique; therefore, it may be possible someday that someone could find out who you are just from knowing your DNA sequence. The greatest risk to you is the release of information from your health records. The chance that this information will be given to someone else is very small. However, every effort keep your medical information confidential.

The greatest risk to you is the release of information from your health records. Your information will never be given to someone else unless required by law; however, there is a small chance that the information might be obtained unlawfully as part of a data breach.

This research is using your information or specimens for future research. Since we do not yet know the exact questions that will be studied by scientists in the future, we cannot tell you what specific information they will be looking at or what that might mean to you. For details, please see the How Will My Information Be Protected section below.

HOW WILL MY INFORMATION OR BIOSPECIMENS BE STORED?
Your information and biospecimens will be stored in a secure, protected area belonging to and
managed by the Indiana University School of Medicine.

• Samples will be stored until they are completely used
• Information and biospecimens will be linked to identifiers through a study ID.
• Medical record information and biospecimens will only be available for research purposes.
• The Indiana University Melvin and Bren Simon Cancer Center Tissue Procurement Core will manage the storage of information and specimens within the secure facilities.

Your name, address, phone number, and other identifying information will be taken off anything
connected with your specimens before it is sent to a lab at Indiana University for this study. This
would make it very difficult for any research results to be linked to you or your family. Also,
people outside the study team will not have access to results about any individual person, which will help to protect your confidentiality. The files that contain any information linked to your name can only be accessed by a limited number of staff approved by the Indiana University School of Medicine. Researchers using your biospecimens will not have access to this information.

HOW WILL MY INFORMATION OR BIOSPECIMENS BE SHARED?
Information or specimens collected from you for this research will be shared with other researchers in the future. Information will be shared with researchers at Indiana University and other collaborators approved by Indiana University (like academic institutions and other industry collaborators). If this happens, only the study ID number will be used to identify your samples, no other personally identifiable information will be provided. We do not plan to ask your consent before we share this information. Research requests will be reviewed by a committee which will determine who will be given access to information and samples. However, there will be other facts about you that will be released such as age, gender and ethnicity (race) that could be used in an attempt to identify you, particularly if these are linked to. the genetic information from your specimens. Information such as age, gender and ethnicity is important for researchers to know because it will help them learn if certain factors cause disease or if response to treatment is the same or different in men, women and children, differing age groups, in people of different ethnic backgrounds, or in people living under different environmental or behavioral conditions.

Specimens collected from you for this research may be used to develop products which could be sold in the future. The researchers do not plan to share any profits or losses from the sale of those products with you.

Efforts will be made to keep your personal information confidential. We cannot guarantee absolute confidentiality. Your personal information may be disclosed if required by law. No information that could identify you will be shared in publications about this study and databases in which results may be stored.

Organizations that may inspect and/or copy your research records for quality assurance and data analysis include groups such as the study investigator and his/her research associates, the Indiana University Institutional Review Board or its designees,

• Study doctor and his research associates
• The Cancer Genome Atlas (TCGA)
• Treatment providers and (as allowed by law) state or federal agencies, specifically the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) for FDA-regulated research and research involving positron-emission scanning, National Cancer Institute (NCI) for research funded or supported by NCI, and/or National Institutes of Health (NIH) for research funded or supported by NIH, etc., who may need to access your medical and/or research records.

For the protection of your privacy, this research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers may not disclose or use any information, documents, or specimens that could identify you in any civil, criminal, administrative, legislative, or other legal proceeding, unless you consent to it. Information, documents, or specimens protected by this Certificate may be disclosed to someone who is not connected with the research:

(1) If there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases);
(2) if you consent to the disclosure, including for your medical treatment;
(3) if it is used for other scientific research in a way that is allowed by the federal regulations that protect research subjects
(4) for the purpose of auditing or program evaluation by the government or funding agency
(5) if required by the federal Food and Drug Administration (FDA)

You should understand that a Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it.

WHAT WILL YOU DO WITH MY GENETIC INFORMATION?

This research follows the Genetic Information Nondiscrimination Act (GINA), a federal law that generally makes it illegal for health insurance companies, group health plans, and most employers to request the genetic information we get from this research and to discriminate against you based on your genetic information.

We may use the specimens collected as a part of this study for whole genome sequencing, which involves mapping all of your DNA. This will allow researchers to compare the difference between those with a disease and those without a disease. This information will be stored on secure computers and/or databases.

You do not have to participate in this research, and no one will hold it against you if you decide not to take part.

You will not receive any payment for taking part in this study. For more information, please see the Will I be Paid to Participate section below.

WILL I BE PAID TO PARTICIPATE?
You will not be paid for taking part in this study. The collection and storage of your specimens are being done for research purposes. You or your insurance company will not be billed for the preparation and shipment of these specimens or the testing that will be done with these specimens.

WHO WILL PAY FOR MY TREATMENT IF I AM INJURED?
In the event of physical injury resulting from your participation in this research, necessary medical treatment will be provided to you and billed as part of your medical expenses. If you have a government insurer, your insurer will not be billed and you may be responsible for those costs. Costs not covered by your health care insurer will be your responsibility. Also, it is your responsibility to determine the extent of your health care coverage. There is no program in place for other monetary compensation for such injuries. However, you are not giving up any legal rights or benefits to which you are otherwise entitled. If you are participating in research that is not conducted at a medical facility, you will be responsible for seeking medical care and for the expenses associated with any care received.

There is no cost to you for taking part in this study.

WHO SHOULD I CALL WITH QUESTIONS OR PROBLEMS?
For questions about the study or a research-related injury, contact the researcher, George Sandusky at (317) 278-2304. If you cannot reach the researcher during regular business hours (i.e., 8 a.m. to 5 p.m.), please contact the IU Human Subjects Office at 800-696-2949 or at irb@iu.edu. After business hours, please call pathology on call at (317) 944-5000 for emergencies.

For questions about your rights as a research participant, to discuss problems, complaints, or
concerns about a research study, or to obtain information or to offer input, please contact the IU
Human Subjects Office at 800-696-2949 or at irb@iu.edu.

CAN I WITHDRAW FROM THE STUDY?
If you decide to participate in this study, you can change your mind and decide to leave the study at any time in the future. If you decide to withdraw, you may contact your study doctor's office at any time to end your participation and have your specimens destroyed, if they have not been used up. You should send a written request to Dr. George Sandusky, who is managing the collection of specimens.

Write to:
George Sandusky, DVM, PhD
Attn: Mary Cox
Clinical Research Office
535 Barnhill Drive, Room 380
Indianapolis, IN 46202

If you withdraw, you must specify what you want to happen to your already collected biospecimens and associated information:

• Have your remaining specimens and information permanently destroyed or
• Allow your specimens to stay in the Tissue Bank but with all personal identifiers permanently removed from the database.

Any data that has been obtained from testing your biological specimens until that point will remain part of the research. If your specimens have already been sent to a researcher, it will not be possible to withdraw them. This is because of the methods used to protect your confidentiality and because your specimens may have already been used for research.

In consideration of all of the above, I give my consent to participate in this research study. I will be given a copy of this informed consent document to keep for my records. By signing below, I agree to take part in this study and that:
• I have read this consent.
• I have had the chance to ask questions and they have been answered.
• I understand that taking part in this study is voluntary.
• I give permission to use and share my health data as described in this document.
• I may choose not to be in the study or leave the study at any time by telling the study doctor. I will not be penalized or lose any benefits to which I am otherwise entitled.