How we use data

Will my taking part be kept confidential?

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

This information will include your

  • Initials
  • NHS/CHI number
  • NHS/CHI number of your baby/babies
  • Name
  • Date of Birth
  • Ethnicity data
  • Contact details
  • Date you gave 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. Data with personal details (name, contact details) included will also be shared securely with members of the central study team at the Bristol Trials Centre to contact you before, during, and after your participation in the study. For example, this may be to arrange an interview as part of the information study or provide a summary of results to you at the end of the study.

We will also collect information from your medical records about your health and from your child’s neonatal records about your child’s health, which will be used for research purposes.

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 unique study identifier instead.  We will keep all information about you safe and secure. The information you provide to the research team will be treated as confidential and will only be used for the purpose of the study.

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no one can work out that you took part in the study. University Hospitals Bristol and Weston NHS Foundation Trust and The Bristol Trials Centre (BTC) at the University of Bristol are the joint data controllers for this study. This means they are responsible for looking after your information and using it properly.

For monitoring and auditing purposes, relevant sections of your medical records, your child’s medical records and data collected during the study may be looked at by individuals from the University of Bristol, from University Hospitals Bristol & Weston NHS Foundation Trust (as Sponsor), from regulatory authorities or from the NHS Trust, where it is relevant to you taking part in the study.

What will happen to my information once the study has finished?

Your local research team will keep identifiable paper records about your study participation, such as your consent form, for up to 25 years after the end of the study. These will be retained in a secure location. After 25 years, all identifiable records will be destroyed.

An anonymised final study dataset will be kept and stored on a secure server at the University of Bristol which, with your permission, may be shared with other researchers in the future.

Choices about how your information is used

You can stop taking part in any aspect of the study at any time without giving a reason, but we will keep information about you that we have already collected and include it in the study results. This makes the results more reliable.  If you choose to stop taking part in the study, we would like to continue collecting information about your health from your hospital records. You don’t need to do anything extra to help the study in this way.

If you do not want this to happen, tell us and we will stop.

To protect other participants having the same treatment as you, we will need to keep collecting information on any serious side effects you may have, even if you have said you did not want any more information to be collected about you.  We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.

If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study. Any future research that uses your data will be required to have approval from an independent ethics committee.

What will happen to the samples I give?

The blood samples that you provide to determine your eligibility for the study and  to monitor your liver function will be analysed by your local hospital laboratory and destroyed in line with their usual processes. (for non-mechanistic study sites)

Samples – mechanistic study sites 

The additional blood samples and vaginal swabs provided at Visits 2, 3 and 4 will be stored locally and then transferred to a laboratory at Imperial College London where they will be processed and analysed for the purposes of the study. No one will be able to identify you from any of the samples that you provide. They will be transferred and stored with a unique study identifier.

The stool samples that you provide will be sent in a return package via post directly to the laboratory at Imperial College London for processing. The instructions that we provide will include guidance not to include any identifiable information.

Imperial College London will analyse your samples to measure levels of certain bacteria and markers of inflammation in your blood, vaginal fluid and stool. They will also analyse the levels of fat molecules called lipids in your blood. The aim of this will be to see if Pravastatin works by changing vaginal and/or blood inflammatory profiles, vaginal and gut bacteria, and/or lipids in the blood.

Only authorised personnel will have access to these samples. The samples we are taking from you will not be used for diagnostic purposes and so cannot be used to inform your medical care.  You can request that any samples we have already collected are destroyed before analysis. We will make all reasonable attempts to do this, however sometimes this will not be possible. If your samples are analysed after you have requested them to be destroyed, this data will not be included in the statistical analysis.

What will happen to my audio-recording and interview data?

The audio-recordings of your conversations with the research team about recruitment to the study will be securely passed to the researchers at the University of Bristol. We will not put your name or any other personal information that might identify you on any recordings. The data will be labelled with a unique study identifier instead.

If you have consented to an interview, a qualitative researcher at the University of Bristol will use your contact details to get in touch with you to arrange the interview, which will be recorded.  The audio-recordings of your conversations and your interviews will be stored on a secure server at the University of Bristol for up to 25 years after the study has ended; at this point, it will be destroyed securely. Only the qualitative research team members working on the study will have access to this secure storage area.

Audio-recordings will be listened to by the qualitative researcher or other approved personnel and transcripts (written versions) of the conversations prepared by either an approved University of Bristol employee or a third-party transcribing service approved by University of Bristol.

These transcripts will not have your name or other personal details on. Any paper copies of transcripts or other study documentation will be stored securely (i.e. in a locked cabinet with restricted access) for at least 25 years after the study ends. Transcripts can be accessed by other researchers for approved research; however, all identifiable information will be removed before they are made available.

We may wish to use quotes and play parts of your audio-recordings (from interviews and appointments/meetings) as part of publications, teaching, and presentations at academic meetings. If we do use any of your data, all quotes will be anonymised and voices modified so that you cannot be recognised from any of the information we present. We may also use the data collected (including quotes) in our future research, teaching and publications looking at common issues across studies.

You will not be identified in any way, in any presentation, report or publication. 

What will happen to the study results?

The results will not be known until some time after the last participant has entered the study. During the course of the study we will ask you if you would like to receive a summary of the results after the research has finished. A summary of the study results will also be published on the study website which can be found here:  www.bristol.ac.uk/pioneer.

The overall results of the study will be published in medical journals and shared with other healthcare professionals interested in this area of research, for example at conferences.

We will make sure that no one can identify you from any study outputs.

Where you can find out more about how your information is used

You can find out more about how we use your information:

Further information

You can obtain general information on clinical research from the UK Clinical Research Collaboration (UKCRC), who produce a booklet called “Understanding Clinical Trials”.  This provides in-depth information on the design and conduct of clinical trials and aims to answer the questions of those considering taking part.  Electronic copies can be downloaded from the UKCRC website:

https://www.ukcrc.org/public-awareness-of-clinical-research/information-resources-on-clinical-research/

Printed copies can be requested by emailing:crncc.info@nihr.ac.uk

Or contacting:

UK Clinical Research Collaboration
Woburn House
20 Tavistock Square
London
WC1H 9HD

Tel: 020 7419 5494

General information about research can also be found at www.uhbristol.nhs.uk/research-innovation