STANFORD UNIVERSITY- Research Consent Form
`Protocol Title: Diagnosing Down Syndrome by Maternal Serum Analysis
`Protocol Director: Dr. Louanne Hudgins, Dr. Usha Chitkara, Stephen Quake, PhD., Dr. Yair Blumenfeld
`IRB Expiration Date: _____ _
`IRB Approval Date:
`
`Diagnosing Down Syndrome by Analyzing Maternal Blood
`
`Study Consent
`
`Are you participating in any other research studies? __ yes __ ,no
`
`!INTRODUCTION TO RESEARCH STUDIES
`
`A research study is designed to answer specific questions, sometimes about a
`drug or device's safety and its effectiveness. Being in a research study is
`different from being a patient. When you are a patient, you and your personal
`doctor have a great deal of freedom in making decisions about your health care.
`When you are a research subject, the Protocol Director and the research staff
`will follow the. rules of the research study (protocol) as closely as possible,
`without compromising your health.
`
`I PURPOSE OF RESEARCH
`
`You are invited to participate in a research study of diagnosing fetal Down
`Syndrome by analyzing maternal blood. We hope to be able to identify fetal Down
`Syndrome by analyzing fetal DNA found in your blood. You were selected as a
`possible subject in this study because you are currently at risk for having a child
`with Down Syndrome.
`
`Your participation in this study is entirely voluntary. Your decision whether or not
`to participate will not prejudice you or your medical care. If you decide to
`participate, you are free to withdraw your consent, and to discontinue
`participation at any time without prejudice to you or effect on your medical care.
`If you decide to terminate your participation in this study, you should notify Dr.
`Yair Blumenfeld at 650-269-4665.
`
`This research study is looking for 100 patients with pregnancies at risk for Down
`Syndrome. Enrollment will only occur at Stanford University.
`
`I DURATION OF STUDY INVOLVEMENT
`
`This research study is expected to take approximately 3 years.
`
`I Participant ID:
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`Page 1 of 13
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`STANFORD EXHIBIT 2108
`SEQUENOM v. STANFORD
`CASE IPR2013-00390
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`11~11111111111111111111111111111
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`STUDY
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`STANFORD UNIVERSITY- Research Consent Form
`Protocol Title: Diagnosing Down Syndrome by Maternal Serum Analysis
`Protocol Director: Dr. Louanne Hudgins, Dr. Usha Chitkara, Stephen Quake, PhD., Dr. Yair Blumenfeld
`IRB Approval Date:
`IRB Expiration Date: ___ _ _ _
`
`I PROCEDURES
`
`If you choose to participate, Dr. Hudgins and her research study staff will draw
`20 mL (5 tablespoons) of your blood for serum analysis and will send it to a lab
`at Stanford for evaluation. Our goal is to identify a way of diagnosing Down
`Syndrome without invasive testing. Participation in this study only includes this
`single blood draw and blood will not be stored for future analysis. The
`technique used to identify Down Syndrome by blood analysis is experimental
`and thus you and your doctor will not be notified of the results. We will also
`follow results from any invasive testing (amniocentesis and chorionic villus
`sampling) that you should decide to undergo. We will compare these results
`with the results of blood analysis. Following delivery, experts from the
`department of genetics will evaluate your neonate for any morphologic signs of
`Down Syndrome. They may recommend genetic testing following your
`delivery. We will not perform any tests related to this study on your newborn
`without your knowledge and permission.
`
`TISSUE SAMPLING FOR GENETIC TESTING
`
`Research using tissues is an important way to try to understand human
`disease and/or the role genes play in disease. You have been given this
`consent form because the investigators want to include your tissues in a
`research project. There are several things you should know before
`allowing your tissues to be studied:
`
`Your blood will be assigned a unique number and stored without any personal
`identifiers. Your name or other public identifiers will not be included with any
`data shared with other investigators.
`
`Once the sample is taken, it will forever be separated or unlinked from your
`name. This will protect your identity and preserve anonymity. However, once
`you donate the sample, you will not be able to withdraw your tissues from the
`research project because the samples will not be traceable.
`
`You and your doctor will not be notified of the test results so that they don't
`effect any clinical decision making for this pregnancy. The decision regarding
`whether or not to proceed with the current diagnostic procedures of
`amniocentesis or chorionic villus sampling will be based on your discussions with
`
`I Participant ID:
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`STANFORD UNIVERSITY- Research Consent Form
`Protocol Title: Diagnosing Down Syndrome by Maternal Serum Analysis
`Protocol Director: Dr. Louanne Hudgins, Dr. Usha Chitkara, Stephen Quake, PhD., Dr. Yair Blumenfeld
`IRB Expiration Date: _ ____ _
`IRB Approval Date:
`
`the genetic counselors and doctor. The result of this blood test will not be
`revealed in the future and thus will not affect any future pregnancies.
`
`Even with special precautions, there is no absolute protection against
`discrimination on the basis of disease or genetic information. For this
`reason, the investigator will use the results of this study as research only
`and not include them in your medical record. Generally, you will not be
`told the results, even if there might be some potential benefit to you.
`
`Your blood sample will be destroyed after this study.
`
`Any tissues you have donated which are used in research may result in new
`products, tests, or discoveries. In some instances, these may have potential
`commercial value and may be developed and owned by the Investigators,
`Stanford University and/or others. However, donors of tissues do not retain any
`property rights to the materials. Therefore, you would not share in any financial
`benefits from these products, tests, or discoveries.
`
`SUBJECT'S RESPONSIBILITIES.
`
`• You should tell the Protocol Director or research staff if you change your
`mind about staying in the study
`
`While participating in this research study, you should not take part in any other
`research project without approval from all of the Protocol Directors. This is to
`protect you from possible injury arising from such things as extra blood drawing.
`I WITHDRAWAL FROM STUDY
`
`If you first agree to participate and then change your mind, you are free to
`withdraw your consent and discontinue your participation at any time. Your
`decision will not affect your ability to receive medical care for your disease and
`you will not lose any benefits to which you would otherwise be entitled. If you
`withdraw from the study please notify the protocol directors.
`
`The Protocol Director may also withdraw you from the study for one or more of
`the following reasons:
`
`The study is cancelled.
`Other administrative reasons.
`Unanticipated circumstances.
`
`I Participant ID:
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`Page 3 of13
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`STANFORD UNIVERSITY- Research Consent Form
`Protocol Title: Diagnosing Down Syndrome by Maternal Serum Analysis
`Protocol Director: Dr. Louanne Hudgins, Dr. Usha Chitkara, Stephen Quake, PhD., Dr. Yair Blumenfeld
`IRB Expiration Date: _____ _
`IRB Approval Date:
`
`I POSSIBLE RISKS, DISCOMFORTS, AND INCONVENIENCES
`
`There are risks, discomforts, and inconveniences associated with any research
`study. These deserve careful thought. You should talk with the Protocol
`Director if you have any questions.
`
`• There may be some pain/discomfort with the blood draw.
`• The blood draw may involve risks to you which are currently
`unforeseeable.
`
`I POTENTIAL BENEFITS
`
`• This study does not have any direct benefit to you or this pregnancy but
`we hope to use the knowledge gained by this study to assist future
`pregnacies.
`• WE CANNOT AND DO NOT GUARANTEE OR PROMISE THAT YOU
`WILL RECEIVE ANY BENEFITS FROM THIS STUDY.
`I ALTERNATIVES
`
`• There are no alternatives to this study. The alternative is not to
`participate.
`
`I SUBJECT'S RIGHTS
`
`You should not feel obligated to agree to participate. Your questions should be
`answered clearly and to your satisfaction.
`
`If you decide not to participate, tell the Protocol Director. You will still receive
`care for your disease and will not lose any benefits to which you would otherwise
`be entitled.
`
`I CONFIDENTIALITY
`
`Your identity will be kept as confidential as possible as required by law. Except
`as required by law, you will not be identified by name, social security number,
`address, telephone number, or any other direct personal identifier. Your
`research records may be disclosed outside of Stanford, but in this case, you will
`be identified only by a unique code number. Information about the code will be
`kept in a secure location and access limited to research study personnel.
`
`I Participant ID:
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`STANFORD UNIVERSITY- Research Consent Form
`Protocol Title: Diagnosing Down Syndrome by Maternal Serum Analysis
`Protocol Director: Dr. Louanne Hudgins, Dr. Usha Chitkara, Stephen Quake, PhD., Dr. Yair Blumenfeld
`IRB Approval Date:
`IRB Expiration Date: ___ __ _
`
`The results of this research study may be presented at scientific or medical
`meetings or published in scientific journals. However, your identity will not be
`disclosed.
`
`Patient information may be provid~d to Federal and other regulatory agencies as
`required. The Food and Drug Administration (FDA), for example, may inspect
`research records and learn your identity if this study falls within its jurisdiction.
`
`Participant ID:
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`Page 5 of13
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`STANFORD UNIVERSITY- Research Consent Form
`Protocol Title: Diagnosing Down Syndrome by Maternal Serum Analysis
`Protocol Director: Dr. Louanne Hudgins, Dr. Usha Chitkara, Stephen Quake, PhD., Dr. Yair Blumenfeld
`IRB Approval Date:
`IRB Expiration Date: ___ _ _
`
`I USE AND DISCLOSURE OF PROTECTED HEALTH INFORMATION
`
`Authorization To Use
`Your Health Information For Research Purposes
`
`Because information about you and your health is personal and
`
`private, it generally cannot be used in this research study without
`
`your written authorization. If you sign this form, it will provide that
`
`authorization. The form is intended to inform you about how your
`
`health information will be used or disclosed in the study. Your
`
`information will only be used in accordance with this authorization
`
`form and the informed consent form and as required or allowed by
`
`law. Please read it carefully before signing it.
`
`What is the purpose of this research study and how will my health
`information be utilized in the study?
`
`The purpose of this research study is to identify a way of diagnosing
`
`Down Syndrome in the neonate by analyzing maternal blood. Your
`
`blood will be assigned a special code so that your personal
`
`information is not available to the lab personnel at the time of
`
`analysis. Only the protocol directors will have access to the log
`
`linking your name and medical record to the specimen. The results of
`
`the blood analysis will not be reported to you , your doctor, or any third
`
`party in order to maintain confidentiality.
`
`I Participant ID:
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`Page 6 of 13
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`STANFORD UNIVERSITY- Research Consent Form
`Protocol Title: Diagnosing Down Syndrome by Maternal Serum Analysis
`Protocol Director: Dr. Louanne Hudgins, Dr. Usha Chitkara, Stephen Quake, PhD., Dr. Yair Blumenfeld
`IRB Approval Date:
`IRB Expiration Date: __ ___ _
`
`Do I have to sign this authorization form?
`
`You do not have to sign this authorization form. But if you do not, you
`
`will not be able to participate in this research study. Signing the form
`
`is not a condition for receiving any medical care outside the study.
`
`If I sign, can I revoke it or withdraw from the research later?
`
`If you decide to participate, you are free to withdraw your
`
`authorization regarding the use and disclosure of your health
`
`information (and to discontinue any other participation in the study) at
`
`any time. After any revocation, your health information will no longer
`
`be used or disclosed in the study, except to the extent that the law
`
`allows us to continue using your information (e.g., necessary to
`
`maintain integrity of research). If you wish to revoke your
`
`authorization for the research use or disclosure of your health
`
`information in this study, you must contact: Dr. Yair Blumenfeld at
`
`650-269-4665.
`
`What Personal Information Will Be Used or Disclosed?
`
`Your health information related to this study may be used or
`
`disclosed in connection with this research study including, but not
`
`limited to your name, medical record number, medical diagnostic
`
`results, and neonatal outcome results.
`
`Who May Use or Disclose the Information?
`
`I Participant ID:
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`Page 7 of 13
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`STANFORD UNIVERSITY- Research Consent Form
`Protocol Title: Diagnosing Down Syndrome by Maternal Serum Analysis
`Protocol Director: Dr. Louanne Hudgins, Dr. Usha Chitkara, Stephen Quake, PhD., Dr. Yair Blumenfeld
`IRB Approval Date:
`IRB Expiration Date: ____ _
`
`The following parties are authorized to use and/or disclose your
`
`health information in connection with this research study:
`
`The Protocol Director Dr. Louanne Hudgins
`
`The Stanford University Administrative Panel on Human Subjects in
`
`Medical Research and any other unit of Stanford University as
`
`necessary.
`
`The research team
`
`Who May Receive I Use the Information?
`
`The parties listed in the preceding paragraph may disclose your
`
`health information to the following persons and organizations for their
`
`use in connection with this research study:
`
`· The Office for Human Research Protections in the U.S. Department
`
`of Health and Human Services
`
`Your information may be re-disclosed by the recipients described
`
`above, if they are not required by law to protect the privacy of the
`
`information.
`
`When will my authorization expire?
`
`Your authorization for the use and/or disclosure of your health
`
`information will expire on December 31, 2015
`
`I Participant ID :
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`Page 8 of 13
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`STANFORD UNIVERSITY· Research Consent Form
`Protocol Title: Diagnosing Down Syndrome by Maternal Serum Analysis
`Protocol Director: Dr. Louanne Hudgins, Dr. Usha Chitkara, Stephen Quake, PhD., Dr. Yair Blumenfeld
`IRB Approval Date:
`IRB Expiration Date: ____ _
`
`Will access to my medical record be limited during the study?
`
`To maintain the integrity of this research study, you may not have
`
`access to any health information developed as part of this study until
`
`it is completed. At that point, you would have access to such health
`
`information if it was used to make medical or billing decision about
`
`you (e.g., if included in your official medical record).
`
`Signature of Subject
`
`Date
`
`I Participant ID:
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`Page 9 of 13
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`STANFORD UNIVERSITY- Research Consent Form
`Protocol Title: Diagnosing Down Syndrome by Maternal Serum Analysis
`Protocol Director: Dr. Louanne Hudgins, Dr. Usha Chitkara, Stephen Quake, PhD., Dr. Yair Blumenfeld
`IRB Approval Date:
`IRB Expiration Date: __ ___ _
`
`FINANCIAL CONSIDERATIONS
`
`PAYMENT
`
`You will not be paid to participate in this research study.
`
`COSTS
`
`There are no costs to participating in the study
`
`SPONSOR
`
`Fluidigm is providing financial support and/or material for this study.
`
`CONSULTATIVE OR FINANCIAL RELATIONSHIPS
`
`Dr. Stephen Quake is a co-founder and has stock in Fluidigm.
`
`I CONTACT INFORMATION
`
`Questions, Concerns, or Complaints: If you have any questions, concerns or
`complaints about this research study, its procedures, risks and benefits, or
`alternative courses of treatment, you should ask the Protocol Director, Dr.
`Louanne Hudgins. You may contact him/her now or later at (650) 723-6858
`Injury Notification: If you feel you have been hurt by being a part of this
`study, please contact the Protocol Director, Dr. Louanne Hudgins at (650) 723-
`6858
`Independent Contact: If you are not satisfied with how this study is being
`conducted, or if you have any concerns, complaints, or general questions about
`the research or your rights as a participant, please contact the Stanford
`Institutional Review Board (IRB) to speak to someone independent of the
`research team at (650)-723-5244 or toll free at 1-866-680-2906. You can also
`write to the Stanford IRB, Stanford University, Stanford, CA 94305-5401.
`Alternate Contact: If you cannot reach the Protocol Director, please page the
`research team at beeper 23015.
`
`I Participant ID:
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`STANFORD UNIVERSITY- Research Consent Form
`Protocol Title: Diagnosing Down Syndrome by Maternal Serum Analysis
`Protocol Director: Dr. Louanne Hudgins, Dr. Usha Chitkara, Stephen Quake, PhD., Dr. Yair Blumenfeld
`IRB Expiration Date: ___ __ _
`IRB Approval Date:
`
`I COMPENSATION
`
`All forms of medical diagnosis and treatment -- whether routine or experimental -
`- involve some risk of injury. In spite of all precautions, you might develop
`medical complications from participating in this study. If such complications
`arise, the Protocol Director and the research study staff will assist you in
`obtaining appropriate medical treatment but this study does not provide financial
`assistance for additional medical or other costs. Additionally, Stanford is not
`responsible for research and medical care by other institutions or personnel
`participating in this study. You do not waive any liability rights for personal
`injury by signing this form.
`
`I EXPERIMENTAL SUBJECT'S BILL OF RIGHT
`
`As a human subject you have the following rights. These rights include but are
`not limited to the subject's right to:
`
`• be informed of the nature and purpose of the experiment;
`• be given an explanation of the procedures to be followed in the medical
`experiment, and any drug or device to be utilized;
`• be given a description of any attendant discomforts and risks reasonably
`to be expected;
`• be given an explanation of any benefits to the subject reasonably to be
`expected, if applicable;
`• be given a disclosure of any appropriate alternatives, drugs or devices
`that might be advantageous to the subject, their relative risks and
`benefits;
`• be informed of the avenues of medical treatment, if any available to the
`subject after the experiment if complications should arise;
`• be given an opportunity to ask questions concerning the experiment or
`the procedures involved;
`• be instructed that consent to participate in the medical experiment may
`be withdrawn at any time and the subject may discontinue participation
`without prejudice;
`·
`• be given a copy of the signed and dated consent form;
`• and be given the opportunity to decide to consent or not to consent to a
`medical experiment without the intervention of any element of force,
`
`Page 11 of 13
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`STANFORD UNIVERSITY- Research Consent Form
`Protocol Title: Diagnosing Down Syndrome by Maternal Serum Analysis
`Protocol Director: Dr. Louanne Hudgins, Dr. Usha Chitkara, Stephen Quake, PhD., Dr. Yair Blumenfeld
`IRB Approval Date:
`IRB Expiration Date: __ ____ _
`
`fraud, deceit, duress, coercion or undue influence on the subject's
`decision.
`
`Participant ID:
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`Page 12 of13
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`STANFORD UNIVERSITY- Research Consent Form
`Protocol Title: Diagnosing Down Syndrome by Maternal Serum Analysis
`Protocol Director: Dr. Louanne Hudgins, Dr. Usha Chitkara, Stephen Quake, PhD., Dr. Yair Blumenfeld
`IRB Expiration Date: ___ __ _
`IRB Approval Date:
`
`YOUR SIGNATURE INDICATES THAT YOU HAVE READ AND UNDERSTAND THE
`ABOVE INFORMATION, THAT YOU HAVE DISCUSSED THIS STUDY WITH THE
`PERSON OBTAINING CONSENT, THAT YOU HAVE DECIDED TO PARTICIPATE
`BASED ON THE INFORMATION PROVIDED, AND THAT A COPY OF THIS FORM
`HAS BEEN GIVEN TO YOU.
`
`Signature of Adult Participant
`
`Date
`
`Person Obtaining Consent
`
`I attest that the requirements for informed consent for the medical research
`project described in this form have been satisfied- that the subject has been
`provided with the Experimental Subject's Bill of Rights, if appropriate, that I have
`discussed the research project with the subject and explained to him or her in
`non-technical terms all of the information contained in this informed consent
`form, including any risks and adverse reactions that may reasonably be expected
`to occur. I further certify that I encouraged the subject to ask questions and
`that all questions asked were answered.
`
`Signature of Person Obtaining Consent
`
`Date
`
`I Participant ID:
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