Answers to Frequently Asked Questions.
At a glance:
- How do I take part?
- What is this study researching?
- What happens if I take part?
- How will the recruitment work?
- I am recruited in the study and want to withdraw
- How will my data be used?
- How is my privacy protected?
- How can I get in touch?
- Who is running the study, and how is it funded?
1. How do I take part?
2. What is this study researching?
We know from other research that the health and wellbeing of women during pregnancy can affect the health and wellbeing of their babies, both during development in the womb and whilst growing in childhood. The Born in Scotland study will link routinely available information on maternal and child outcomes, with biological samples and ultrasound data.
The research team hope to answer questions such as:
- Why are some babies in Scotland born early, or ill?
- How does our time in the womb influence our health throughout our lives?
3. What happens if I take part?
You don’t have to do anything extra to take part in the study. There are no extra appointments or blood tests - you just have to fill in a short consent form so that researchers can securely access your samples and health record data.
We plan to use routinely collected pregnancy data and biological samples (for example, blood from your first community midwife appointment) where possible.
We may also ask you if we can collect some additional samples from you and/or your baby at the time of birth (such as a blood sample or placenta). We may invite you to take part in other smaller studies but these are optional and you can still be a part of the main Born in Scotland study, without joining the additional studies. If you decide you would like to take part in any additional studies, we will provide you with more detailed information at the time, about exactly what is involved and we will be sure to get your informed consent.
4. How will the recruitment work?
You may be told about the study by your community midwife at your first (booking) pregnancy appointment, or see an advert in your pregnancy booking pack or on social media. You will need to go to a short online consent form to let the study team know you wish to take part.
You can take part at any point in pregnancy, although our team would encourage you to sign up as soon as possible.
It is hoped that this pilot study of 1,000 women, will pave the way for a larger national Scottish cohort of 100,000 pregnant women and their children.
5. I am recruited in the study and want to withdraw
If you have already been recruited into the study, you can change your mind and withdraw at any time and you do not have to give a reason. Withdrawing from the study will not affect your clinical care.
6. How will my data be used?
The Born in Scotland study is working in partnership with the Data Trust Initiative. A data trust is a mechanism for individuals to take the data rights that are set out in law, and pool these into an organisation - a trust - in which trustees make decisions about data use on their behalf.
Data Trust Initiative (this link will take you to a different website)
The 'Born in Scotland Data Trust' will develop an infrastructure for trustworthy data stewardship around the study. Stewarding healthcare, administrative and social data collected from pregnant women and their children, this pilot project will explore how data trusts can give research participants, including young people, a voice in decisions about data use.
7. How is my privacy protected?
All the information we collect during the course of the research will be kept confidential. There are strict UK laws which safeguard your privacy at every stage.
8. How can I get in touch?
Contact us for more information
9. Who is running the study, and how is it funded?
This study is being run by the Edinburgh University Pregnancy Research Team. The team can be viewed here.
The study is funded by the Medical Research Council.