Sample Consent Form - Simple Blood Draw

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SAMPLE CONSENT FORM – SIMPLE BLOOD DRAW
PLEASE NOTE: This form is a sample and requires editing for each specific study,
particularly the statements in italics and the statements in brackets.
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
CONSENT TO BE IN RESEARCH
Study Title: [Insert study title here]
This is a medical research study, and you do not have to take part. 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.
You are being asked to take part in this study because you have [medical condition, or other
reason, e.g., “…because you are a healthy volunteer”].
In this study, the researchers are collecting blood samples to learn more about … [Try to limit
explanation to one or two sentences.] [Sponsor] is paying for this research. About [total
accrual goal] people will give blood samples for this research.
What will happen if I 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.
The 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 and fainting, and a rare risk of
infection.
Are there benefits?
There is no benefit to you. The blood will be used only for research.
Can I say “No”?
[Sample Consent Form for Drawing Blood]
[JULY 2015]
Page 1 of 3
Yes, you do not have to donate a blood sample for this study. If you decide not to be in this
study you will not lose any of your regular benefits, and you can still receive medical care from
UCSF.
Will my medical information be kept confidential?
We will do our best to protect the information we collect from you and 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]
The University of California
Are there any costs or payments?
You will be paid [$] for taking the time to donate a blood sample. [Specify method and timing of
payment. See the CHR website for more info and sample consent form language by payment
method."]
You will not be charged for the blood sample.
What if I get injured?
Tell the study doctor, [Principle Investigator] if you feel that you have been injured because of
being in this research. You can tell the doctor in person or call him/her at [phone number].
Treatment and Compensation for Injury: If you are injured as a result of being in this
study, the University of California will provide necessary medical treatment. The costs
of the treatment may be billed to you or your insurer just like any other medical costs, or
covered by the University of California or the study sponsor [sponsor name], depending
on a number of factors. The University and the study sponsor do not normally provide
any other form of compensation for injury. For further information about this, you may
call the office of the Committee on Human Research at 415- 476-1814. [NOTE: This
statement must be used without changes. See the CHR website for standard wording for
the VAMC and for other comments].
Who can answer my questions about the study?
You can talk to the study doctor about any questions, concerns, or complaints you have about
this study. Contact the study doctor(s) __________________ [name(s)] at
__________________ [telephone number(s)].
[Sample Consent Form for Drawing Blood]
[JULY 2015]
Page 2 of 3
If you wish to ask questions about the study or your rights as a research participant to someone
other than the researchers or if you wish to voice any problems or concerns you may have about
the study, please call the Office of the Committee on Human Research at 415-476-1814. [If
there are additional informational sources related to the study (e.g., patient representatives or
individuals at other study sites as appropriate), list here with contact information.]
[For broad sharing of genomic data in studies that are subject to the NIH Genomic Data
Sharing Policy, insert the consent form wording at:
http://www.research.ucsf.edu/chr/Guide/chrGWAS.asp]
CONSENT
You have been given copies of this consent form and the Experimental Subject's Bill of Rights 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.
Date
Participant's Signature for Consent
Date
Person Obtaining Consent
[STOP! Only include the following signature line if you may consent non-English speaking
subjects using the short form consent method AND this request has been addressed in the
CHR application.]
Date
Witness – Only required if the participant is a non-English speaker
[Sample Consent Form for Drawing Blood]
[JULY 2015]
Page 3 of 3
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