Consent in the 100,000 Genomes Project
This pages gives GMC staff the latest on consent materials, where to go for training and support, as well as download links for the patient information sheets and consent forms.
Download all the current materials
Download the PDF versions of the materials in A4. GMCs will need to insert their local logos and contact details before printing. Click on the placeholder box top right of page 1 > select ‘browse image’ > find and select your logo (make sure JPEG is selected in file type). On the last page, click ‘insert local contact details here’ > type > save.
Can be edited to include your logo and contact details. To replace the placeholder logo: right click on the logo > change picture > browse > select your JPEG logo. At the bottom of each information sheet and form there is a text box to type in local contact details.
A5 PDF Booklets
GMCs will need to add their logos and contact details.
- Download all rare disease and cancer A5 booklets. (zip folder)
Download the large print versions, compatible with screen readers. These are word documents where the font size and colour can be changed by GMCs. GMCs will need to add their contact details.
A version of the ‘R1 adults with rare disease’ information sheet and consent form will be available in ‘easy read’ format for use with individuals with learning disability. Expected to be available in March 2017.
We do not provide translated versions of the materials. GMCs should use their own translation or interpreter services to enable equitable access to the Project.
Updates – February 2017
The consent materials were updated in February 2017. Materials for adults, in both cancer and rare disease, were updated. Materials for children will be reviewed later in 2017.
New materials should be used wherever possible. However, there will be a transition period of a two months. The previous and the new versions will be both available and registration files using either versions can be submitted to Genomics England.
For OpenClinica users the new materials will be listed, together with the old ones from the end of February. For sites submitting data via XML, this will be dependent on your local development timescales for your data capture tools and technical documentation to support this will be available from 17th February. This is with the exception of the C6 and C8 forms which requires more substantial changes in the database so these will only be available to be registered on our systems (OpenClinica or via XML) from the end of March.
The transition period will end on 30th April 2017 and after that point only the new versions will be accepted.
The Protocol for the 100,000 Genomes Project committed us to an evaluation of the consent materials after 10,000 participants had been recruited, which was reached in 2016. We commissioned a National Service Evaluation to capture participant, consent takers’ and PPI groups views on the consent materials and process. The consent forms and information sheets were then revised to take into account the results from this and further feedback from GMCs.
- Improvements in readability and formatting. All materials have been independently proofread by the Plain English Campaign and have achieved the ‘Crystal Mark’ standard for clarity.
- Adults with rare disease or their family members now have the same PIS.
- Northern Ireland will shortly be recruiting participants using the same materials, which have been amended to take into account legal differences around loss of capacity in NI.
- At the request of GMCs, on the consent form, it is now possible for the participant to give the name of a person that they would want the GMC to try to inform of the participant’s results, should the participant become unable to receive them. This is optional.
- Where no personal consultee is available literature is provided for the use of nominated consultees, who could have a professional relationship to an adult who lacks capacity (England and Wales).
- Consultees can now use Opt In or Opt Out forms for Additional Findings for the person who has lost capacity (England and Wales).
- Consultees (in England and Wales) can now use Withdrawal forms.
- Participant literature has been provided to enrol deceased adults in the cancer arm of the project, in response to a change in eligibility criteria.
Which form should I use?
100,000 Genomes Project Information Line
You can signpost eligible potential participants to the information line with any questions they have about taking part in the Project. The information line can answer ad-hoc questions or people can book an appointment to go through the consent materials in detail. Note that it can’t offer individual or medical advice, or advise on eligibility.
Current participants and the public can also call the information line. 0800 389 8221, open from 9.00am to 5.00pm Monday to Friday.
Frequently asked questions
The consent conversation should be as short or as long as is required for informed consent. Consent is a process which does not end once the consent form is signed, but should be referred to over time in the natural course of routine interaction with Project participants. https://www.genomicseducation.hee.nhs.uk/courses/courses/consent-ethics/
Participants can decide if we should look for ‘additional findings’ in their genome. These are genomic changes that are known to cause rare, serious, life threatening conditions. These diseases can often can be prevented or reduced by NHS treatment if they are known about earlier. Additional findings currently looked for (including a list of the genes).
Genomics England only look for these changes if a participant wants us to. Participants can change their mind about receiving additional findings at any time using this form.
A participant who has lost mental capacity (to make their own decision about being part of the programme, at the time this decision is needed) must be withdrawn from the programme under the terms of the Mental Capacity Act in England and Wales, until and unless an appropriate personal or nominated consultee can be found to advise us on whether they would have been likely to want to remain in the programme.
If a suitable personal or nominated consultee can be found by the GMC clinician, the appropriate Consultee Declaration form should be completed and Genomics England should be notified.
In Northern Ireland it is considered that if a participant has consented then if they lose capacity, their consent remains valid under the common law.
As soon as the data has been processed it will be sent to the participant’s clinical team.
They will contact the participant when the NHS has confirmed the findings from Genomics England. In many cases, no clear answer will be found at first. The participants will be told if nothing has been found. Genomics England will keep looking and any new results will be given to the clinical team as soon as they are available. The main results will be reported first the additional findings will be reported some time later.