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Sample Consent Form - Simple Blood Draw

By Julie Wells,2014-05-09 22:16
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Sample Consent Form - Simple Blood Draw

    SAMPLE CONSENT FORM SIMPLE BLOOD DRAW- 03/05/12

    PLEASE NOTE: This form is a sample and requires editing for each specific study, particularly the

    statements in italics and the statements in brackets.

    Donation of Blood Sample for Laboratory Research

     Consent to Participate

Study Title: [Insert study title here]

    Study Investigator: [Insert PI here]

    Sponsor: [List sponsor if applicable]

You are being invited to participate in this blood sample donation study. The study doctor, … M.D.,

    or … from the Department of … will explain this study to you. If you have any questions, you may ask the study doctor.

    Donation of blood for research is voluntary and you should not be placed under any pressures to do so. You do not have to agree to give a blood sample nor need to explain why you should choose not to donate. Any personal information provided by you in connection with the donation will be held in confidence. For reasons of safety, you should not donate if:

    ; You know, or think that you might be infected with hepatitis B or hepatitis C.

    ; You know, or think that you might be infected with HIV the AIDs virus

    ; You have a sexual partner who is infected with hepatitis or HIV

    ; You are unwell at the moment

    ; You are anemic or receiving treatment for anemia or iron deficiency

    ; You are, or may be, pregnant

    ; You have given blood in the last 1 month (if more than 100 ml is requested)

Study Purpose

    In this study, the researchers are collecting blood samples to learn more about [Try to limit

    explanation to one or two sentences.] About [total accrual goal] people will give blood samples for

    this research.

What will happen if you take part in this study?

    If you agree to be in this study, you will go to [clinic or lab location] and give a blood sample. You will be seated and blood will be drawn by putting a needle into a vein in your arm. One small tube of blood will be taken. This will take about five minutes.

    [If there will be multiple blood draws over time, describe the frequency and include the total amount of blood to be drawn in the course of the study.]

    [If information about the research subject will be collected from medical records, by questioning the individual, or by any other means, describe what information will be gathered. If additional information will be gathered over time, say so.]

Are there risks?

    The needle stick may hurt. There is a small risk of bruising, a rare risk of infection, and you may feel lightheaded.

[Sample Consent Form for Drawing Blood] Page 1 of 3

Are there benefits?

    There is no benefit to you. The blood will be used only for laboratory research.

Can I say “No”?

    Yes, you do not have to donate a blood sample for this study. If you decide not to donate, it will not affect your job standing, class standing, grades or status on an athletic team.

Will my personal/medical information be kept confidential?

    We will do our best to protect the information we collect from you and/or your medical record. Information which identifies you will be kept secure and restricted. However, your personal information may be given out if required by law. If information from this research is published or presented at scientific meetings, your name and other identifiers will not be used. Information which identifies you will be destroyed when this research is complete. The following organizations may look at information about you in your medical and research records: [List relevant organizations, e.g. study

    sponsor, UVM’s Committee on Human Research or the Instutional Biosafety Committee]

Are there any costs or payments?

    You will be paid [$] for taking the time to donate a blood sample. You will be paid in cash immediately after the blood draw. You will not be charged for the blood sample.

    For studies that include reimbursement in any form to the subject of $25 or more include the following:

    Your name, social security number, and address will be disclosed one time to either the University of Vermont’s Procurement Services Department or Fletcher Allen’s Accounts Payable Department for purposes of reimbursing you for participation in this study. Your information will be coded and this code and the information will be kept under lock and key with only authorized personnel accessing the data.

Who can answer my questions about the study?

    You can talk to the study doctor about any questions or concerns you have about this study. Contact the study doctor(s) __________________ [name(s)] at __________________ [telephone number(s)]. If you have any questions about your rights as a participant in a research project or for more information on how to proceed should you believe that you have been injured as a result of your participation in this study you should contact Nancy Stalnaker, the Director of the Research Protections Office, at the University of Vermont at 802-656-5040.

************************************************************

[Sample Consent Form for Drawing Blood] Page 2 of 3

CONSENT TO PARTICIPATE

    You have been given copies of this consent form to keep.

[If Protected Health Information is involved] You will be asked to sign a separate form authorizing

    access, use, creation, or disclosure of health information about you.

    If you wish to be in this study, please sign below.

     ____________________________________

    Participant's Signature and Date

    ________________________________________________ Participant’s Name Printed

________________________________________________

    Person Obtaining Consent Signature and Date

Person Obtaining Consent Printed

Name of Principal Investigator:

    Address:

    Telephone Number:

If applicable:

    Name of Faculty Sponsor:

    Address:

    Telephone Number:

[Sample Consent Form for Drawing Blood] Page 3 of 3

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