Consent in the 100,000 Genomes Project

This pages gives GMC staff the latest consent materials, where to go for training and support, as well as download links for the patient information sheets and consent forms.

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Cancer programme-specific guidance

  • The person taking informed consent is responsible for making sure that the potential participant has a clear understanding of the risks and benefits of taking part and what they are being asked to take part in. This information is included in the Participant Information Sheets which form the basis of the discussion between the potential participant and the healthcare professional.
  • Detailed consent is required to agree to the research aspects of the 100,000 Genomes Project; sharing of anonymised data with partners in industry and to state opinions on how a patient’s germline findings should be handled. There are also diagnostic outcomes from involvement in the project and these are now considered a standard of care for cancer diagnosis.

Which form(s) should I use?

Start here (* means an answer is required to proceed):

View the full flow chart in a single image (opens in a new tab)


Downloads: current materials

Information & Consent documents
Participant Information Sheets and Consent Forms

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.

  1. To replace the placeholder logo: right click on the logo > change picture > browse > select your JPEG logo.
  2. At the bottom of each information sheet and form there is a text box to type in local contact details.

GMCs will need to add their logos and contact details.

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.

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.

The consent video is available in Polish, Gujarati, Bengali, Urdu and Punjabi and you can view them here.

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.

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/

Yes; but consent is a process. A record is needed of the information that has been given to the potential participant and a record that the participant has consented. The Project has ethical approval for receiving consent by post or other non face–to-face means:

In exceptional cases, some potential participants may be offered the opportunity to give consent to be part of the Project via the return of their completed consent forms to the recruiting clinician or appropriate alternative in the post/via emailed document.
A telephone discussion with a suitably trained person will be offered to them as part of this, to take place at a time suited to the potential participant. This route to seeking consent will only be used where the clinical team has reason to think that seeking postal consent is an appropriate method for the individual concerned and that consent could not be sought face-to-face.

– 11.1.5 Giving consent by post or email. Page 79, Genomics England Protocol – PDF

In the Project the dialogue between the recruiting clinician and the participant is recorded through the consent form, with the participant signing to say they have received sufficient information and have agreed to take part in the project and the recruiting clinician also signing.

These two signatures do not have to be contemporaneous, but do have to be on the same form. For example the information and opportunity for a conversation will probably precede the participant actually signing and returning a consent form by post. The emphasis is on the communication and the willing voluntary agreement of the participant.

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.

Main results will be returned to people throughout 2017 and 2018.

More information

Further Consent Information

Download forms, booklets and presentations for adult and child participants in the Project.

Promoting the Project

Download flyers, posters and leaflets to promote the Project.

Training

Free online courses & guides including on consent.

For participants

Information for participants – what issues are there to consider when taking part? 

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