EXPOSURE in UTERO
PREGNANT PARTNER RELEASE OF INFORMATION FORM
Study title: ………………………………………………………………
Investigators: …………………………………………………………...
Your partner (is/was) participating in a clinical trial for treatment of his …………………………
The study title appears above in this document. As you are pregnant and the effects of the
study treatment are unknown on pregnancies and their outcomes, we would like to follow your
pregnancy and collect medical information about your pregnancy and its outcomes. Please
read further regarding how this information will be collected and what is involved.
This study is bound by the National Privacy Principles contained in the Commonwealth Privacy
Act of 1988. The Principles are designed to protect the confidentiality of personal and medical
information and the privacy of individuals by regulating the way personal information is
managed.
If you sign this document, you are giving permission for the use and disclosure of your health
information for the purposes of the safety monitoring activity described below. You do not have
to give this permission.
Use and disclosure of pregnancy information
In compliance with the requirements of the study noted above, your partner has informed the
study doctor that you are pregnant. Regulatory agencies recommend that information be
collected about pregnancy in women; women who are pregnant or become pregnant while they
or their partner are participating in a clinical trial. You are therefore invited to participate in an
important safety monitoring activity. This may help to understand the effects, if any, that
………………………………………….……(name of drug)……………………………….. may
(have/have had) on your pregnancy or your unborn child. We would like to collect this
information for approximately …………………. months / years .
We would also like to collect information as to whether the pregnancy (goes/went to) term or
not. Although the study doctor will collect information about your pregnancy and outcome, the
study doctor will not be responsible for any expenses related to this pregnancy.
Type of information requested
Information related to the progress of your pregnancy and its outcome will be collected by the
study doctor. This may include information related to your health, the date of conception, the
course of your pregnancy, medical treatments that you receive and the health of your child after
birth.
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Confidentiality
The information will be collected by the study doctor and his or her research staff. Any
identifiable information that is collected about you in connection with this study will remain
confidential and will be disclosed only with your permission, or except as required by law. Only
the researchers named above [or others - as appropriate] will have access to your details and
results that will be held securely at [institution].
Right to withdraw authorisation to release information
Your participation is voluntary and you are free to withdraw your authorisation at any time by
informing the study doctor. If you revoke your authorisation the study doctor will not collect any
new health information about you or your child. Refusal to participate in this safety monitoring
activity will not affect your partner’s continued participation in this study or future studies.
Questions
If you have any questions about this form or how your information will be used, please contact
the study doctor or their representative at the address and/or telephone number provided. The
study doctor is collecting only information related to the progress of your pregnancy and its
outcome; you should contact your regular health care provider for any health concerns you may
have.
Study Doctor (or representative) Name: ……………………………………………………
Address: ………………………………………………….
………………………………………………….
Telephone: ………………………………………………..
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Please complete this release of information form and return it to the study doctor.
PLEASE PRINT
AUTHORISATION FOR RELEASE OF MEDICAL INFORMATION

I voluntarily agree to allow the use and disclosure of my health information in
connection with this safety monitoring activity as described in the Information
sheet.

I understand that I will receive a signed and dated copy of this Information and
Authorisation sheets.

I understand that I may revoke my Authorisation at any time.

I have had a chance to ask questions and I understand the answers I received.
…………………………………..
Full name (Printed)
…………………………………….
Signature
…………………………
Date
If individual is a minor or non-legally consenting adult:
………………………………….
Parent/Guardian’s full name
(Printed)
……………………………………..
Parent/Guardian’s Signature
Pregnancy Healthcare Provider’s Name:
(eg physician, midwife)
……………………..
Date
…………………………………………………………
Address: ………………………………………………………………..
……………………………………………………………….
Telephone: ………………………………………………………………
A copy of this signed authorisation form may be provided to your pregnancy healthcare provider
by the study doctor.
Your information is very important to us.
Thank you for taking the time to complete this form.
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STANDARD OPERATING PROCEDURE – PREGNANT PARTNER
Study Title:
……………………………………………………………….
Investigators:
……………………………………………………………….
As part of the Informed Consent discussion, male participants of the abovementioned study are
advised to practice an appropriate method of birth control as the effects of the study drug is
unknown. However if a partner is to become pregnant, the following procedure would be
followed:
1. The male study participant would be given the ‘Consent to Approach’ form to pass on to
his partner.
2. If the partner is interested in obtaining further information about why the researchers
would be interested in their pregnancy, a signed consent approach would be returned to
the Investigator.
3. An appointment would be made at which the pregnant partner to the study participant
would be given the ‘Pregnant Partner Release of Information ‘ form by the Investigator.
The Investigator would then explain why the information is requested and how the
information would be obtained. Signing of the ‘Release of Information’ form is voluntary
and the pregnant partner’s decision will be respected.
4. Once a signed ‘Pregnant Partner Release of Information’ form is obtained the
Investigator will then seek information from the pregnant partner’s obstetrician.
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