Ethics
Delivering the NHS-embedded Generation Study
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
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.
About the Programme’s ethics working group
Working closely with the Ethics Lead, the group supports us in our aims of designing the Generation Study so that it has ethical considerations embedded into it.
The group supports us through advising us on critical ethical issues, and helping us to develop policies and positions for our research study – from inception to evaluation. It also takes deep dives into the ethical issues our Programme is tackling (e.g., consent), and collaborating with our Programme’s other working groups to ensure ethical consideration sits across all of the study’s workstreams.
The working group is chaired by Professor Dominic Wilkinson. Dominic is Professor of Medical Ethics and Director of Medical Ethics at the Oxford Uehiro Centre for Practical Ethics. He’s also a Consultant Neonatologist at the John Radcliffe Hospital. Before Dominic took up the post in July 2022, the working group was chaired by Professor Mike Parker.
Commissioned research
We also occasionally commission external organisations to conduct research as part of our evidence gathering and to support our deliberations.
Report on data governance for newborns by The PHG Foundation (coming soon)
A report on the regulation and governance of genomic data held over the course of newborns’ lifetime.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].
