REC Reference Number: 07/H0606/148
Case-Control Study: Normal Controls
Version Number 2, 14/06/2013
NUFFIELD DEPARTMENT OF
OBSTETRICS & GYNAECOLOGY
Ian L Sargent
Professor of Reproductive Science
Participant Information Sheet
Study of the maternal inflammatory response in pre-eclampsia
We are inviting you to take part in a research study. Before you decide you need to know why
the research is needed and what it would involve for you. Please take time to read the following
information carefully. Talk to others about the study if you wish. (Part 1 tells you the purpose of
this study and what will happen to you if you take part. Part 2 gives you more detailed
information about the conduct of the study).
Ask us if there is anything that is not clear or if you would like more information. Take time to
make your decision.
Part 1
What is the purpose of the study?
Its purpose is to find out more about what causes, and how to predict, the problem of preeclampsia (or toxaemia of pregnancy), which gives some women high blood pressure and other
problems at the end of their pregnancies. In particular, we are interested in how the mother’s
immune system responds to the presence of the baby’s placenta. An abnormal immune
response could be the cause of the mother’s problems in pre-eclampsia.
Why have I been invited?
We have asked you for your help because your pregnancy is normal. We need to compare the
results of certain blood and/or urine tests from absolutely healthy pregnant women with those
of women with pre-eclampsia so that we can see where the important differences are. We are
therefore asking women with healthy pregnancies to help us with this study, and you are one of
these.
Do I have to take part?
It is up to you to decide. We will describe the study and explain this information sheet, which we
will then give to you. We will then ask you to sign a consent form to show you have agreed to
take part. You are free to withdraw at any time, without giving a reason. This would not affect
the standard of care you receive.
What will happen to me if I take part and what will I have to do?
The study involves taking a blood (30ml - which is about 2 tablespoons) and/or urine sample
during your pregnancy. Occasionally, we may approach you again for further samples.This is a
straightforward procedure. It would not cause you any more discomfort than a routine blood
test, and can often be taken at the same time. Your notes will be checked by one of our
research midwives for current details of your pregnancy and re-checked later to determine when
and how you have your baby.
Level 3, Women’s Centre, John Radcliffe Hospital, Oxford, OX3 9DU, UK
Tel: 01865 221019
[email protected]
www.obs-gyn.ox.ac.uk
REC Reference Number: 07/H0606/148
Case-Control Study: Normal Controls
Version Number 2, 14/06/2013
Expenses and payments
No payments will be made. The samples will be taken in the clinic or at your home, whichever is
the most convenient so no additional travel will be required on your part.
What are the possible disadvantages and risks of taking part?
There may be slight discomfort from the venepuncture.
What are the possible benefits of taking part?
This test is not important for your care, so that if you would prefer not to have it you should feel
free to say so. The rest of your care would be entirely unaffected. However, if you do take part
you will be helping us to learn more about the distressing condition of pre-eclampsia, which will
benefit others in the future.
What if there is a problem?
Any complaint about the way you have been dealt with during the study or any possible harm
you might suffer will be addressed. The detailed information on this is given in Part 2.
Will my taking part in the study be kept confidential?
Yes. We will follow ethical and legal practice and all information about you will be handled in
confidence. The details are included in Part 2.
This completes part I.
If the information in Part 1 has interested you and you are considering participation, please read
the additional information in Part 2 before making any decision.
Part 2
What will happen if I don’t want to carry on with the study?
If you withdraw from the study, we will destroy all your samples, but we would like to use the
data collected up to your withdrawal.
What if there is a problem?
If you wish to complain about any aspect of the way in which you have been approached or
treated during the course of this study, you should ask to speak to the researchers who will do
their best to answer your questions (Mrs Carol Simms (01865 221107), Professor Chris
Redman (01865 221010) or Professor Ian Sargent (01865 221019) or contact the University of
Oxford Clinical Trials and Research Governance office on 01865 743005.
Compensation for harm arising from an accidental injury and occurring as a consequence of
your participation in the study will be covered by the University of Oxford. If you are harmed and
this is due to someone’s negligence then you may have grounds for legal action for
compensation against the University of Oxford (in respect of any harm arising out of the
participation in the Clinical Trial) or the NHS (in respect of any harm which has resulted from the
clinical procedure being undertaken).
Will my taking part in this study be kept confidential?
All information which is collected about you during the course of the research will be kept strictly
confidential, and any information about you which leaves the hospital or surgery will have your
name and address removed so that you cannot be recognised.
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REC Reference Number: 07/H0606/148
Case-Control Study: Normal Controls
Version Number 2, 14/06/2013
What will happen to any samples I give?
The blood/urine samples taken will be extra to those taken for your clinical care. For
confidentiality reasons, your name will be removed by the Research Midwife from the sample
and replaced by a number before sending it to the laboratory for research analyses. The
samples will either be used immediately, or stored for future use. Your samples will be used
mainly by local researchers but may also be used in the EU and overseas. Research may take
place in hospitals, universities, non-profit institutions or commercial laboratories and must be
approved by an ethics committee and meet all regulatory guidelines.All samples will be
destroyed at the end of the study. The results of the tests will have no bearing on your clinical
care.
What will happen to the results of the research study?
The results of the study will be published in scientific and clinical journals and presented at
conferences. You will not be identified in any report or publication.
Who is organising and funding the research?
This research is funded by the Medical Research Council and sponsored by the University of
Oxford. None of the researchers will receive any extra payment for the study.
Who has reviewed the study?
All research in the NHS is looked at by independent group of people, called a Research Ethics
Committee to protect your safety, rights, wellbeing and dignity. This study has been reviewed
and given favourable opinion by Oxford Research Ethics Committee C.
If you participate in this study you will be given a copy of this information sheet and a
signed consent form to keep.
Further information and contact details
If you require any further information about this research please contact Mrs Carol Simms
(01865 221107), Professor Chris Redman (01865 221009) or Professor Ian Sargent (01865
221019).
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