The Generation Study: How can participants withdraw?

Parents are informed when they give consent to the Generation Study that they can withdraw from the study at any time. They do not have to provide a reason for withdrawing. The withdrawal process and implications depend on when the participant chooses to withdraw.

Parents may change their mind about having a sample taken. If a participant wishes to withdraw before the sample is collected, they can inform their healthcare team at the hospital. The baby will not join the Generation Study.

If a participant wishes to withdraw after the sample is collected, they can contact Genomics England. The screening result will be returned to them, and if the baby has a suspected condition they will still be referred to an NHS specialist for follow-up testing.

If the participant’s data has already been stored in the National Genomic Research Library and is already involved in research, this cannot be stopped and the data cannot be deleted. However, Genomics England will make sure that no new research is begun, no further health data is collected and leftover samples are destroyed.

If a participant does not wish to withdraw fully, but does not want to have any further contact about the study, they can contact Genomics England. Their screening result will be returned to them, but no further contact about the study or requests for other research will be made. The mother’s antenatal data and the baby’s genome and health data will be retained for ongoing research.

While parents initially decide to take part in the study on behalf of their baby, it is important for children to be appropriately involved in discussions and decisions about their health and data as they grow older. Genomics England will contact participating children when they are around 16 years of age to ask whether they’d like to remain part of the study.

• Like any research study, participants of the Generation Study can withdraw at any time.
• If parents change their mind about having a sample taken, they can withdraw and their baby will no longer be part of the study.
• Participants can withdraw and ensure that no new research is conducted on their data or samples. Alternatively, they can unsubscribe and have no further contact from the study – although their data and samples will remain available for research.
• If a parent withdraws or unsubscribes before their screening result is returned, Genomics England will still contact them to share the result.

For clinicians

• Genomics Education Programme: CPI: Generation Study: Recruit, enrol and sample
• Genomics Education Programme: CPI: Generation Study: Return results and further care
• Genomics Education Programme: CPI: Generation Study: Sample, sequence and interpret

For study teams at recruitment sites, there are numerous education and training resources available.

Please note that some of these resources are hosted on the Generation Study workspace on the NHS Futures platform. If you have not already had an invitation to join, please contact the Genomics England service desk: generationstudy@genomicsengland.co.uk.

Content may evolve over time. Should you have any issues accessing the content, please contact the service desk.

For patients

• Genomics England: The Generation Study
• Genomics England: The Generation Study Participant Information Sheet
• Genomics England: The Generation Study translated participant information