The Generation Study: Recruiting participants

The Generation Study aims to recruit 100,000 newborn babies to help us understand whether we can improve how we diagnose and treat rare genetic conditions. This includes screening newborns for over 200 rare, early-onset and treatable genetic conditions and enabling wider research around genomics and health.

The Generation Study is running in NHS trusts across England.

Sites have been chosen according to a broad range of factors, including:

• birth volumes;
• geographical location;
• the diversity of people who access the hospital; and
• metrics around maternity and research department performance (which will help develop an understanding of the factors that may impact delivery of genomic newborn sequencing).

Most women giving birth at a participating NHS site will be eligible to join the study. Participants must:

• be booked for delivery in a participating NHS site;
• be over 16 years old;
• have an NHS number and be registered with a GP in England;
• have a singleton pregnancy (that is, not twins, triplets or beyond); and
• be expected to have parental responsibility for the baby (that is, not a surrogate, planning to give the baby up for adoption or serving a custodial sentence).

Any participant who meets the eligibility criteria can be invited to participate in the Generation Study during their pregnancy. Parents might first learn about the study:

• by seeing a poster, leaflet or video in their hospital;
• through social media;
• via SMS message;
• by receiving a letter or phone call from a member of the study research team; or
• in person from their midwife or obstetrician or a member of the study team.

Sites have flexibility to define their recruitment approach, but are expected to:

• ensure that women are made aware of the study as their pregnancies progress;
• signpost them to additional resources like the study website or the Participant Information Sheet; and
• answer questions and facilitate conversations about participation.

Potential participants can also register their interest on the study website.

If someone wishes to participate in the Generation Study, they will need to sign up with a member of the study team at their hospital site, who will then register them as a participant before their baby is born. For more information, see The Generation Study: How do participants provide consent and how is it recorded?

The Generation Study aims to recruit a diverse range of individuals – recognising that diversity includes a range of factors, including ancestry, ethnicity, culture and socioeconomic status – with the aim of generating a more diverse genomic dataset and more equitable participation in future genomic research. For example, people of African and Asian ancestry are currently under-represented in genomic datasets. Understanding the influence of ethnicity, culture, religion and ethical perspectives on people’s decisions to take part in genomic research is an important part of study staff training.

Genomics England works with the NHS on a range of approaches to promote equitable access to the study. They include:

• using user research with a diverse range of parents and healthcare professionals to co-design the recruitment journey and study materials;
• engaging with different communities, particularly those who are currently under-represented in genomic research, to identify needs and develop trust;
• ensuring that materials are written accessibly, and are available in different languages;
• providing funding to recruiting sites for interpreter services; and
• offering reimbursement for travel to the initial NHS consultation after a ‘condition suspected’ result is identified.

Throughout the recruitment process, it should be emphasised that the purpose of the Generation Study is research, that participation in it is optional and that it is completely separate to standard NHS care.

The Generation Study does not replace any genomic testing that should be undertaken in the case of a known or suspected history of a genetic condition in a pregnancy or wider family. The study is also different to standard screening like the NHS newborn blood spot test, which looks for nine rare but serious conditions and is recommended for all babies.

• The Generation Study is recruiting in a range of NHS trusts across England.
• Parents are eligible if they are over 16 years old, have an NHS number and are registered with a GP in England, have a singleton pregnancy and are expected to have parental responsibility for their baby.
• Participants might find out about the study from places like hospital posters and social media, or from their midwife or obstetrician.
• A variety of approaches are available to promote equitable access to participation, particularly for communities that are typically under-represented in genomic research.
• This is a research study in which participation is optional. It is separate to standard NHS care.

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