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Delivering the NHS-embedded Generation Study

Newborn baby being kissed by mother and yawning

Embedding ethics

The Generation Study raises a complex set of ethical challenges. Through tackling these challenges head-on, we will ensure our study is trustworthy and ethically robust in its aims, governance, design, delivery, and evaluation.

We take the ethical complexity of the Generation Study seriously. We are learning from, and building on, experiences from other Genomics England programmes, including the 100,000 Genomes Project, to achieve our ambition of embedding ethics throughout our research study.

At Genomics England’s 2022 Research Summit, Arzoo Ahmed (Ethics Lead, Newborns (up to October 2022)) and Dr Natalie Banner (Director of Ethics) discussed the challenges that an embedded approach to ethics will support the Generation Study to address.

The ethical challenges and issues we’re focusing on

Consent process

Designing an ethical consent process for parents who will be asked to take part in the Generation Study

Hybrid clinical-research study

Navigating the complexities of our hybrid clinical-research study: it's both a study to generate evidence if whole genome sequencing can be used to screen newborns for rare genetic diseases, and a study to assess the feasibility of doing this within the NHS

Sharing pre-symptomatic findings

Identifying the potential benefits and harms of sharing screening research findings with families where babies are pre-symptomatic

Adequate support for families

Ensuring that we have established adequate support and follow-up for families who take part

Equitable and fair delivery

Determining how the Generation Study’s design and delivery can be carried out equitably and fairly, to facilitate participation from a diverse range of communities

Data governance policies

Establishing how data governance policies can support the ethical storage, access, use, and linkage of newborns’ data

Involving young people

Planning how and when young people should be brought into discussions about their data for our study

Ethics and engagement

This Programme has an extraordinary opportunity to innovate in ethics. Much of this innovation will be realised through our commitment to ensuring that ethics and engagement sit hand-in-glove throughout the Generation Study. This requires the ongoing involvement, engagement, and support of a diverse range of stakeholders and members of the public, including parents, healthcare professionals, and researchers. We are hugely grateful to all those who have supported this process so far.

We will shortly launch a new phase of engagement work with ethics at its heart, details of which will be posted on this website.

Ethics: how we work

The Programme has an ethics workstream led by a dedicated Ethics Lead, supported by the independent Newborn Genomes Programme ethics working group, which was established in February 2022. The team also receives ethics support and advice from Genomics England’s Ethics Advisory Committee, Participant Panel, and in-house ethics team.

Commissioned research

We also occasionally commission external organisations to conduct research as part of our evidence gathering and to support our deliberations.

Health Research Authority protocol approval

The protocol for the Newborn Genome Programme's Generation Study was approved by the Health Research Authority (HRA) in spring 2023, following a favourable opinion by the Cambridge Central research ethics committee (REC).

Applying to the HRA is a requirement for all research involving patients. If the HRA does not approve a study, it cannot proceed. A favourable opinion from a REC is integral to this approval.

Any questions?

For any questions about our ethics workstream, please contact [email protected].

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