Frequently asked questions

There are no special precautions or requirements for you or your baby. 

There are no direct benefits to you taking part in this study, but the results from this study might help to improve the healthcare of patients in the future.

There are no known risks from MRI when it is used according to guidelines in place in the NHS and the university. It does not involve ionising radiation. The MRI scanner makes a loud knocking noise during the scan, so ear plugs and muffs are used to prevent discomfort due to noise, and to encourage your baby to sleep. As MRI scanners use a strong magnet, care must be taken to keep metallic objects away.

A consultant radiologist will review your baby’s scan. The scan is unlikely to show any problems that are known to affect your baby. Rarely, there may be a finding that requires further assessment or treatment. If this is the case, we will tell you and your general practitioner and refer your baby to appropriate NHS services.

The DNA is collected from saliva with a special mouth swab sampling kit. This is like a cotton bud, which we use to rub along the gum to soak up saliva – in our experience babies don’t seem to mind. The type of genetic analysis we are planning provides information that is relevant for large groups of babies: we do not expect to identify genetic problems that are of direct clinical relevance for your baby.

Some of the questionnaires ask for personal information about your wellbeing. If you prefer not to disclose information, then you can stop any time without giving a reason; the rest of the information we collect from records, samples and scans can still contribute usefully to our research. 

If any findings, such as post-natal depression, are identified from the questionnaires we will discuss with you, ask your permission to let your general practitioner know, and refer you to appropriate NHS services if that is your wish.

Having a baby can be a stressful time, especially if she or he is preterm. If you are having difficulty coping then please don’t hesitate to mention this to a member of the research team, who would, with your permission, let your nurse / doctor / midwife know because the clinical team will be able to provide you with the support you need.

We do not envisage risks or disadvantages from any other form of assessment proposed by this study.

If you have a concern about any aspect of this study please contact Professor James Boardman (Telephone 0131 242 2567) who will do his best to answer your questions.

In the unlikely event that something goes wrong and you are harmed during the research and this is due to someone’s negligence then you may have grounds for a legal action for compensation against NHS Lothian but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you (if appropriate).

You are free to change your mind at any point. Your baby’s medical care will not be affected if you withdraw from the study. If you decide you do not want to attend the MRI appointment, we ask that you contact one of our team on 0131 242 1665 or 07443274839 so that we can re-assign the appointment to another baby. 

If you withdraw from the study, we will keep the information about you and your child that we have already collected.  You can change your mind at any point about allowing us to store your and your baby’s samples.  If you change your mind we will destroy the samples. 

Anonymised research data will be preserved for all time. At the end of the project, data will be archived in safe, long-term storage within the University of Edinburgh. Researchers leading ethically approved projects will be able to request access to the anonymised data and a data sharing agreement between organisations will be used to ensure your information is used responsibly. You will not be identifiable from any published results.

Any leftover tissue samples will be stored by the research team at the University of Edinburgh for up to 2 years after the study has finished, for use in an ethically approved project. 

We need to keep your personal data for 10 years after the end of the study.  It will then be destroyed.

All the information we collect during the course of the research will be kept confidential and there are strict laws which safeguard your privacy at every stage.

We will need to use information from you, your medical records and your child’s medical records for this research project.

We will collect your Community Health Index (CHI) number and your child’s CHI number. Note that the CHI is a population register, used in Scotland for health care purposes. The CHI number uniquely identifies a person on the index and is personal identifiable information. Your CHI number is being collected to allow us to accurately identify you and your child to collect information from your medical records.

Other personal identifiable information collected will include

•             Your name, ethnicity, address, post code, telephone number, and e-mail address.

•             Your child’s name, ethnicity, address, post code and date of birth.

People will use this information to do the research or to check your records to make sure that the research is being done properly.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number assigned instead.

We will keep all information about you safe and secure in the University of Edinburgh.

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.

We manage your records in specific ways for the research to be reliable. This means that factually correct information cannot be altered after it is entered in the research records. 

If you agree to take part in this study, you will also have the option to allow the research team (within the sponsoring organisation) to securely store your contact details and agree to be contacted about other ethically approved research studies. You will only be contacted by a member of this research team to determine if you are interested in taking part in another research study.  Your verbal consent may then be sought to pass your contact details to another research team within the University of Edinburgh and/or NHS Lothian. Agreeing to be contacted does not oblige you to participate in further studies.

You can find out more about how we use your information

•             at www.hra.nhs.uk/information-about-patients/

•             our leaflet available from www.hra.nhs.uk/patientdataandresearch

•             by asking one of the research team

•             by sending an email to prencog@ed.ac.uk or

•             by ringing us on 0131 242 1665 or 07443274839

This study will be written up as publications in scientific journals and presented at scientific meetings.

You will not be identifiable from any published results.

Results of the study will be made available to you.  A parent advisory group will advise on the best ways to do this and will work with an artist to develop ways of communicating the results.   We will share the results through newsletters, e-mail, the study website [website under production] and information days or events.

This study has been organised and sponsored by the University of Edinburgh and NHS Lothian. 

The study is being funded by the UK Research and Innovation (UKRI) Medical Research Council (MRC).

The study proposal has been reviewed by the UK Research and Innovation (UKRI) Medical Research Council (MRC).

The Adult Preemie Advocacy Network were involved in the design of the project.  The Network and our parental advisory group have co-designed this information sheet and other study materials. 

All research in the NHS is looked at by an independent group of people called a Research Ethics Committee. A favourable ethical opinion has been obtained from South East Scotland REC 02. NHS Management Approval has also been given.