UCSD Project [fill in HRPP project number]
[Instructions: Choose Edit...Select All, or click and drag to select all text below, then copy this text and paste it into your word processor consent document. Fill in the information noted in blue.]
University of California, San Diego
Consent to Act as a Research Subject
Pregnancy Follow-Up Consent Form
[Title of study]
Who is conducting the study, why you have been asked to participate, how you were selected,
and what is the approximate number of participants in the study?
[fill in name of PI (and associates, if appropriate)] is [are] conducting a research study to find out more about the effects of the experimental drug, [fill in name of experimental drug] , your partner is taking on the developing fetus in humans. You are being asked to take part because you are the pregnant partner of a participant who is or was taking part in a clinical research study in which he is or was taking [fill in name of experimental drug] . The purpose of this pregnancy follow-up research is to provide the study sponsor, [fill in name of study sponsor] with information about your pregnancy, the outcome of your pregnancy, and your baby.
This research study is sponsored by [fill in name of study sponsor] . UCSD is being paid by [fill in name of study sponsor] for conducting this study.
Because you are the pregnant partner of a participant who is or was taking part in a clinical research study in which he is or was taking [fill in name of experimental drug] and as the risk to you and your developing fetus is unknown, it is recommended that you receive appropriate prenatal care. Your partner’s Study Doctor may need to disclose details of this study and your pregnancy to those associated with your prenatal care.
Why is this study being done?
The effects of [fill in name of experimental drug] on the developing fetus in humans are not known.
The information is being collected by [fill in name of study sponsor] and will be maintained in its Safety Database. This information may help in the study effects of [fill in name of experimental drug] on the course of pregnancy in partners of study participants and the effects of the study drug on their children.
What will happen to you in this study and which procedures are standard of care and which are experimental?
If you agree to participate, the following will happen to you:
1. You will be asked questions regarding the outcome of your pregnancy. This may be done during your partner’s study visits, or you may be contacted by telephone. You may decline to answer any question.
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UCSD Project [fill in HRPP project number]
2. You will be asked to provide information about yourself including medications you may be taking, medical history, and laboratory test information. The research staff may request your medical records to gather this information or information regarding your pregnancy. You will be asked to sign a medical release form for the purpose of reviewing your medical record. You may decline to provide any information.
Your information will be saved in [fill in name of study sponsor] Safety Database and shared with other regulatory agencies as needed.
Information concerning the outcome of your pregnancy may be analyzed by [fill in name of study sponsor] to determine whether and how the drug(s) has affected your baby. You will not be asked to take any study drug or other medications, and there are no medical procedures associated with your participation in this study.
How much time will each study procedure take, what is your total time commitment, and how long will the study last?
[Provide the duration/time associated with each study procedure and a separate statement indicating the overall duration of the subject’s involvement in the study and how long the study will last] .
Participation in this study may involve some added risks or discomforts. These include the following:
Loss of Confidentiality: Although all information is coded in a way that your identity and that of your baby will be protected, a risk of taking part in this study is the possibility of a loss of confidentiality. Loss of confidentiality includes having your personal information shared with someone who is not on the study team and was not supposed to see or know about your information. The plans for keeping your information private are described in the
“Confidentiality” section below.
What are the alternatives to participating in this study?
Because the purpose of this data collection is not to treat a specific illness, the alternative is not to participate. Your partner will still be able to take part in the main study if you decide not to participate.
What benefits can be reasonably expected?
You will not receive any direct benefit from participating in this study. However, this information may help further evaluate the effects of [fill in name of experimental drug] on the course of pregnancy and in babies who have been exposed to the drugs.
Can you choose to not participate or withdraw from the study without penalty or loss of benefits?
Participation in research is entirely voluntary. You may refuse to participate or withdraw at any time without penalty or loss of benefits to which you, your partner, or baby are entitled. If you decide that you no longer wish to continue in this study, you will be requested to inform your partner’s Study Doctor,
[fill in name of study doctor] , in person or by calling [fill in phone number for study doctor] . If you withdraw your consent, study personnel will stop collecting
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UCSD Project [fill in HRPP project number] information from you and your baby, but the Study Sponsor may continue to use and disclose information already collected before you withdrew your consent.
Will you be compensated for participating in this study?
There is no compensation for participation in this study.
[However, if the participant will be compensated use: In compensation for your time and travel, you will receive [fill in amount of compensation]] for participating in this research [Stipulate how compensation is established. The compensation must be prorated. Be very specific. However, if no compensation will be given, it should be stated.] .
Are there any costs associated with participating in this study?
There will be no cost to you for participating in this study [However, if there are costs associated to participation, these should be stated (i.e., parking, travel costs) and who will be responsible for the cost(s), as appropriate.].
What if you are injured as a direct result of being in this study?
[As this is a industry-sponsored study, please use the following:]
If you are injured as a direct result of being in this study, treatment will be available. The costs of such treatment will be covered by the University of California or the study sponsor [must be named ], depending on a number of factors. The University and the study sponsor [must be named] do not normally provide any other form of compensation for injury. You may call the
UCSD Human Research Protections Program Office at (858) 657-5100 for more information about this, to inquire about your rights as a research subject, or to report research-related problems.
What about your confidentiality?
Research records will be kept confidential to the extent allowed by law. Study personnel will collect personal and medical information related to your pregnancy and the health of your child.
Your identity and that of your baby and information about you and your baby will be kept confidential. Although the information collected about you and your baby will be held by the [fill in name of study sponsor] , your name and any other information that may allow you or your baby to be identified will not be included in any records sent to [fill in name of study sponsor] .
Instead you will be identified by a code. In the event of any publication regarding this study, your identity will remain confidential.
[fill in name of study sponsor] may communicate this de-identified information about you and your baby to its affiliates or individuals who are involved in, or authorized to monitor or audit, the clinical trial that your partner is/was participating in. The Institutional Review Board, the committee that oversees research in humans at the University of California, San Diego may also need to access your personal information. Government agencies (such as the United States Food and Drug Administration or the Department of Health and Human Services) may also need access to your research records. These people, companies and agencies may be located in the
United States and other countries outside the United States.
You have certain rights to gain access to and correct any inaccuracies in information held about you and your baby. If you have any questions about the collection and the use of this
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UCSD Project [fill in HRPP project number] information, or would like to exercise rights that you may have with respect to this information, you should ask your partner’s Study Doctor.
Who can you call if you have questions?
[fill in name of PI] and/or ________________ has explained this study to you and answered your questions. If you have other questions or research-related problems, you may reach [fill in name of PI] at [fill in telephone number of PI] .
You may call the Human Research Protections Program Office at (858) 657-5100 to inquire about your rights as a research subject or to report research-related problems.
Your Signature and Consent
You have received a copy of this consent document and a copy of the “Experimental Subject's
Bill of Rights” to keep.
You agree to participate.
________________________________________________
Subject's signature
_______________
Date
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