What Does Consent Mean for Generation Genome?

Progress Educational Trust
Meeting Room 2, Nowgen Centre, 29 Grafton Street, Manchester M13 9WU
11 September 2017
This public event was organised by the Progress Educational Trust (PET) in partnership with Genomics England, the organisation established by the UK Government to deliver the 100,000 Genomes Project.
The event formed part of the Genomics Conversation, a programme of activities led by Genomics England which involves the public and stakeholders in discussions about key issues in genomic medicine.
Below, you can watch a film of the event produced by the education charity WORLDwrite. (If you cannot see the film below, click here to view it.)
You can also read a synopsis of the event proceedings, by Professor Becki Bennett, in PET's flagship publication BioNews.
Films of other events in the Genomics Conversation programme can be watched here and here.

The next three free-to-attend events in the Genomics Conversation programme will be:
'How Do We Make Genomics Everybody's Business?', in Manchester on the evening of Wednesday 5 September 2018.
'Whose Genome Is It Anyway? Big Data and Your DNA', in Edinburgh on the evening of Wednesday 10 October 2018.
'What Is the Value of Our Genomes - to Us, to Our Families, to the Future of Medicine?', in Cardiff on the evening of Thursday 15 November.
To book places at any of these events, please email sstarr@progress.org.uk
If tweeting about any of these events, please use the hashtag #PETgenomic

Consent - a conscious process of granting permission or approval - is one of the most important concepts in all of medicine, and plays a vital role when patients consent to receive particular treatments or undergo particular tests.
Consent is also vitally important when research participants consent to certain uses of the samples they provide, or to uses of the data generated by analysing these samples. Increasingly, such data may include the patient's whole genome sequence, which may in turn be linked to the patient's lifetime health and medical records.
Genomic medicine - an approach to medicine in which our genomic information plays a central role in understanding, preventing, diagnosing and treating disease - may require, or may result in, changes to the way we discuss and understand consent.
The new Generation Genome report from the UK's Chief Medical Officer calls for 'a short, simple, understandable and workable consent process for patients to choose how confidential genomic data about them is used'.
Another new report from the UK's National Data Guardian says work is needed 'to explore how the consent process might cover both direct and indirect care purposes as genetic and genomic medicine become a more routine part of care for a greater number of NHS patients'.
This public event saw consent discussed in relation to genomic medicine, the UK's 100,000 Genomes Project, the Chief Medical Officer and National Data Guardian reports, and wider developments. Questions explored included:
Is it possible to ensure that a consent process is thorough, meaningful and leaves the patient well-informed, without it becoming so detailed and onerous that it results in disproportionate burdens or impediments - for patients, clinicians and researchers alike?
What uses of genomic data - and what constraints on such uses - are reasonable and foreseeable, after a patient has consented to use of the data? In what circumstances would additional consent need to be sought from the patient? What scope exists for patients to change their mind, and what are the possible consequences - for them and for others - if they do so?
Where, when and how should consent be taken? It is common at present for consent to be taken using paper forms, during a face-to-face discussion in a hospital or clinic. But consent can also be taken electronically, and face-to-face discussions may not always be necessary or practical (for example, if additional consent is sought over the course of a long-term project).
What are the implications for consent, if clinical services and research projects are combined (as in the 100,000 Genomes Project)? Are such arrangements likely to become more common? To what extent could treatment become dependent on the genomic data of large numbers of patients, and draw upon this data in real time (rather than relying on intermittent research publications)?
What are the rules, regulations, standards and laws that govern consent, in the UK and internationally? How do they apply in cases of cross-border treatment, or cross-border research collaboration?
What legal, technical and professional assurances can be given about the security, identifiability and uses of genomic data? How can members of the lay public be expected to assess these assurances? Where can the public seek reliable advice on the matter, and to whom can they report any concerns or complaints about the use of their data?
Do we need to rethink the way consent relates to individuals and families? Our genomic data may have implications for our blood relatives, and vice versa. It is already the case in genomics that treatment and research can mean involving family members, and seeking their consent. But it is also technically possible to infer some facts about our relatives from our genomic data without their knowledge or consent.

Dr Tara Clancy
Consultant Genetic Counsellor and Honorary Senior Lecturer at the Manchester Centre for Genomic Medicine, and Member of the Nuffield Council on Bioethics
Jillian Hastings Ward
Chair of the Participant Panel for the 100,000 Genomes Project, and mother of a severely disabled child with an undiagnosed genetic condition
Professor Sue Hill
Chief Scientific Officer at NHS England, and Senior Responsible Officer for the NHS Genomics Programme
Anneke Lucassen
Professor of Clinical Genetics and Leader of the Clinical Ethics and Law research group at the University of Southampton, and Honorary Consultant in Clinical Genetics at the Wessex Clinical Genetics Service

Bill Newman
Professor of Translational Genomic Medicine at the University of Manchester, and Director of the Manchester Centre for Genomic Medicine

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