IRB No: Pro Approval Date: 3/8/2016 Expiration Date: 2/28/2017 RESEARCH BIOBANK CONSENT FORM PURPOSE

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1 IRB No: Pro Approval Date: 3/8/2016 Expiration Date: 2/28/2017 RESEARCH BIOBANK CONSENT FORM PURPOSE Cedars-Sinai Medical Center s Research Biobank is designed to help advance medical research in the future by serving as a central source for biological samples (such as blood, cell lines, stem cells) from many different people. This central library of samples enables researchers at Cedars-Sinai Medical Center (CSMC) and at other research institutions to conduct studies in a more timely fashion, which in turn can quicken the development of new ways to diagnose and treat disease. The Biobank also collects information from participants medical records. Samples and health information are used to conduct research to improve diagnosis, treatment and assessments of disease risk and outcome; future research may include genome sequencing (finding out the sequence/order of the building blocks of your DNA), stem cell research (a stem cell is a mother cell that can create/produce different types of daughter cells: e.g. a mother cell that is able to make skin cells and/or liver cells, etc.) or creation of cell lines (a cell line is a group of cells that continue to make new cells of their same type in the lab). Cells or cell products derived (made) from donated samples may be (1) kept for many years (2) used in research involving genetic research methods, including genetic manipulation (affecting the function of genes within a cell), and/or (3) transplanted into animals. Once your samples are donated, you will not be able to request or limit the type of research in which they are used. However, research will be reviewed, approved and monitored by oversight entities as required by regulations and laws. One of the entities is the Cedars-Sinai Medical Center Institutional Review Board (CSMC IRB), which is responsible for overseeing the rights and welfare of research participants. PROCEDURES Your consent and authorization will be obtained by participating researchers who have been approved by the CSMC IRB to obtain consent. We ask for your consent and authorization to allow the Biobank to do the following: 1. Forward any remaining tissue samples to the Biobank for future research after all tests necessary for clinical purposes have been completed on your tissue. 2. Use your past, present and future remaining tissue samples for research. 3. Obtain no more than 4 additional tablespoons (20 ml) of blood during blood draws that are needed for the treatment of your illness or that are part of your procedure. The frequency of this additional collection will be no more than every other month. 4. Provide a urine sample with your blood draw. 5. Obtain protected health information (PHI) from your medical records maintained by CSMC. As noted in the next section, your name and other identifying information will not be directly linked to your biological samples, to maximize the protection of your health information. We may collect any information from your medical records, including laboratory reports, x-rays and other radiology exams, hospital/medical records, doctor/clinic records, pathology reports, other information related to the course of your treatment (diagnosis, demographics e.g. age, gender), and genetic data that can be used to establish paternity (determine who is the father of an individual). We will not include information pertaining to your psychological wellbeing, illegal activity or sexual preferences, if this information existed in your medical records. If you sign this consent/authorization form, you are giving the Biobank permission to continue to collect your health information from your future medical records at CSMC up to 15 years from the date your last specimen was donated.

2 6. Contact you in the future to obtain health information that is not captured through your medical records, for example to better understand details of your diet. RISKS Blood drawing may cause some pain and has a small risk of bleeding, bruising or infection at the puncture site. There is also a small risk of fainting. Despite our robust system to protect your personal health information, the potential risk of a breach in confidentiality remains. When we share information with researchers at CSMC or outside of CSMC, your information will be labeled with a unique code and we will not release your name or any information that could be used to identify you (except in certain circumstances when we are required by law to do so). Information disclosed outside of CSMC may no longer be protected by the federal privacy law (HIPAA). However, in California, the law prohibits further disclosure of medical information without another signed authorization from you (unless the law specifically requires or permits the particular disclosure, such as to report suspected child abuse). BENEFITS Taking part in the Biobank is not intended to help you directly; there will be no direct medical benefit from your participation. However, the knowledge received may help others in the future and may significantly improve the quality of life for future generations. The analysis and research to be conducted with your donated samples and health information is preliminary; we are interested in understanding trends among groups of people. We do not anticipate learning information that could immediately impact your individual health. However, it is possible that research studies conducted with samples from the Biobank could be of importance to you in the future. WILL THE RESEARCH RESULTS BE SHARED WITH ME? As information is gathered, CSMC will carefully consider any potential implications to your individual health in deciding whether information should be shared with you and your health care provider. Information would only be shared with you after it is confirmed by a certified testing laboratory and if such sharing is approved by the CSMC IRB and is legally permitted. COMPENSATION You will not be paid for your samples or receive profits from patents, discoveries or any commercial development that may result from the use of your samples. You will not be charged for your participation in the Biobank. CONFIDENTALITY OF INFORMATION COLLECTED The Biobank has a system in place to maximize the protection of your health information. Data, including genetic information, are housed in a secure database and access is regulated and limited to authorized research personnel and those involved in the oversight and monitoring of research. Every reasonable effort will be made to protect the confidentiality of your samples and health information, including using a unique code to identify your sample so that your name, medical record number and other identifying information is not directly linked to your samples and health information. We will keep the list that links the code to your name separate from your samples and health information. Only a few of the Biobank staff will have access to the list and they sign an agreement to keep your

3 identity a secret. Researchers will only be given coded samples and health information and will not know who you are. In addition, other laws are in place to further protect your privacy and the confidentiality of your health information. By agreeing to participate in the Biobank, you authorize the use and sharing of your health information indefinitely. Information collected about you during the course of this research may be subject to inspection by CSMC entities responsible for research oversight, accrediting agencies, government and regulatory groups. Your coded samples and health information may be shared with researchers at other academic institutions or commercial companies. In addition, your coded health information may be published. CSMC may receive compensation from such third party entities to cover costs incurred by CSMC in connection with the collection and maintenance of samples and health information in the Biobank. Because the Biobank is funded by the National Institutes of Health (NIH), it is required to share information from certain studies (that are part of the NIH s database of genotypes and phenotypes (dbgap) with other researchers. The goal of this NIH policy is to facilitate broad and consistent access to NIH-supported data to speed the translation of basic genetic research into treatments that benefit the public health. PROTECTIONS FROM FORCED DISCLOSURES (SUBPOENAS) CERTIFICATES OF CONFIDENTIALITY To further protect your identifiable health information, we have obtained a Certificate of Confidentiality (Certificate) from the federal government. Under subpoena, CSMC may be asked to reveal information that would identify you. The Certificate is intended to prevent CSMC from being forced to share your research records under any circumstances, including a subpoena. If for some reason the Certificate is not obtained for this research study or would not apply to your identifiable health information, we will let you know. A Certificate of Confidentiality would not prevent CSMC or its researchers from disclosing, without your consent, information that would identify you in order to protect a child, dependent adult, elder, yourself or another person from abuse or harm. PARTICIPATION Your participation in the Biobank or any research study is voluntary. Other than the risks associated with blood drawing described above, you will not be in danger of any physical illness or injury from participating. You may refuse to sign this consent and authorization form; doing so will not affect your ability to obtain treatment at CSMC, nor will it affect the quality of any future care. You have the right to revoke (void or withdraw) at any time your authorization, in writing, for us to use or share your health information for this research. You must contact Dr. Beatrice Knudsen (her contact information is below) to revoke your authorization. However, if you revoke this authorization, the revocation will not have any effect on any actions taken prior to receiving the revocation. Any information already obtained at the time you revoke your authorization may continue to be used as necessary to ensure study integrity.

4 SUBJECT'S BILL OF RIGHTS In accordance with California Health and Safety Code 24172, any person who is required to consent to participate as a subject in a research study involving a medical experiment, in this case, participation in the biobank, or who is requested to consent on behalf of another has the right to: 1. Be informed of the nature and purpose of the experiment. 2. Be given any explanation of the procedures to be followed in the medical experiment and any drug or device to be utilized. 3. Be given a description of any attendant discomforts and risks to the subject reasonably to be expected from the experiment. 4. Be given an explanation of any benefits to the subject reasonably to be expected from the experiment, if applicable. 5. Be given a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to the subject and their relative risks and benefits. 6. Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if complications should arise. 7. Be given an opportunity to ask for questions concerning the experiment or the procedure involved. 8. Be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation in the medical experiment without prejudice. 9. Be given a copy of any signed and dated written consent form used in relation to the experiment. 10. Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on the subject s decision.

5 SIGNATURE BY THE PARTICIPANT By signing and checking 'ACCEPT', my signature reflects that: I have received the information concerning the Biobank and understand the risks and benefits of participation. I permit (authorize) the use and sharing of my health information as described in this document. I have read the Subject Bill of Rights. First Name Last Name Year of Birth Last 4 SSN CONSENT DECISION - Check One [ ] I Accept [ ] I Decline Patient Signature Date SIGNATURE OF THE INTERPRETER/WITNESS: (Signature of an interpreter is only required when a non-english speaking subject is consented with the assistance of an interpreter and an IRB-approved short form. The witness may be any person who is conversant in both English and the language of the Non-English speaking subject, such as the interpreter (the certified hospital interpreter), study staff, a family member, or other person. The witness signs the consent forms to confirm that the oral interpretation occurred.) Signature of the Interpreter/Witness Date of Signature A copy of this consent form will be ed to you once you have completed signing. If you have questions about this consent/authorization, or about the study, or wish to withdraw and revoke your authorization from the Biobank, please contact: Beatrice Knudsen, MD, PhD Medical Director, Cedars-Sinai Research Biobank 116 N. Robertson Blvd., Suite 500 Los Angeles, CA GroupBiobank@cshs.org Phone: If you have questions, problems, and concerns that you want to discuss with someone who is not associated with this study, please contact: CSMC IRB ResearchConcerns@cshs.org Phone: (310) The CSMC IRB has been established to protect the rights and welfare of research participants. You may also contact the CSMC IRB if you want to offer input or obtain information of the Biobank. For Office Use Only Medical Record Number: