What does consent mean?

Hi, I’m Tina Nesbitt, Parent Rep for the North West. I recently attended an event in Manchester about consent as it relates to genomic medicine and the 100,000 Genomes Project.

On 11 September I attended a very interesting event in Manchester called ‘what does consent mean for Generation Genome?’ It all came about because of the ‘Generation Genome’ report, published in July 2017, from the UK’s Chief Medical Officer which calls for ‘a short, simple, understandable and workable consent process for patients to choose how confidential genomic data about them is used’.

Another report from the UK’s national data guardian says that 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 from 2018’. There were a number of experts talking about consent including our very own SWAN UK member Jillian Hastings Ward, who is also the chair of the Patient Participation Panel for the 100,000 Genomes Project.

The event saw our experts discuss contrasting perspectives of consent and whether it is possible to ensure that the process is thorough, meaningful and leaves the patient well informed without becoming so detailed and onerous that it results in disproportionate burdens or impediments – for patients, clinicians and researchers alike.

If you have been enrolled in the 100,000 Genomes Project or the DDD (Deciphering Developmental Disorders) Study, you may remember the extraordinary amount of information that your genetic counsellor took you through, and that you ‘must’ agree to the sharing of your, albeit anonymised, data in order to take full advantage of the results and findings of the study.

So was this consent a ‘free choice’ if you had to agree for your data to be available for others to use?

The expectation is that any data obtained from future genomic studies will be subjected to the same terms and conditions as in previous studies such as the DDD and 100,000 Genomes Project.

But, what are the rules, regulations, standards and laws that govern consent, in the UK and internationally? How would 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 and uses of genomic data? 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 genetic 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 genetic data without their knowledge or consent.

Even though the likes of Professor Anneke Lucassen, an expert in clinical ethics and Professor Sue Hill, Chief Scientific Officer at NHS England were involved in the debate, I think that there were more questions raised than answered.

Certainly there will be more debates on the topic especially when the media takes hold of it so be ready to give your learned opinions as parents of children with genetic conditions!

Email Tina: [email protected] uk. Find out more about Tina and our Parent Reps by visiting the team page on our website: undiagnosed.org.uk/our-team

Join our Community Of Families