The 100,000 Genomes Project is based on participant consent. This means that before taking part, information, risks and benefits are discussed between a potential participant and their healthcare team. People are free to decide if they want to take part or not.
Genomics England is following legal and regulatory standards to seek consent of potential participants. The Project has ethical approval from the Health Research Authority (East of England – Cambridge South) Research Ethics Committee (REC).
For healthcare professionals taking consent for the Project, Health Education England (HEE) have developed a specific training course.
Potential participants are also given written information about the project. This highlights key issues or risks from joining the project.
How, where and when do people give consent
Consent is usually taken in a routine medical appointment. This is normally a face-to-face discussion in a hospital or clinic.
We know that for some people this is not practical and so alternative arrangements can be made by their Genomic Medicine Centre.
Potential participants are also given information to read about the Project. Potential participants are given as much time as they need to consider whether they want to join or not.
What do participants agree to?
To take part in the Project, people must agree to:
- Whole genome sequencing (WGS), and related analysis of their samples.
- Receive any results from their genome that are relevant to the condition that led them to take part.
- Their lifetime health and medical records being linked to their genome sequence.
- Approved third parties accessing their pseudonymised information and samples. These could be commercial (for-profit) companies. It also includes people outside the UK.
- Be contacted again by their healthcare team and Genomics England. This would usually be to invite participants to take part in further studies. These might include relevant drug trials, or social research to do with participating in the Project.
They can choose to agree to:
- Receive feedback on additional findings. These are changes in the genome that cause serious, life-threatening but treatable conditions.
- Receive feedback on conditions that may affect future children (carrier status).
Other important points that participants are asked to consider:
- For patients who need treatments quickly (e.g. for cancer), the results will not usually be back in time to affect their care.
- We may not find anything relevant from the genome analysis.
- Data security, privacy and access is appropriately restricted and monitored.
- How to withdraw from the Project.
- In the future, donated samples and information may analysed using new tests, that don’t exist yet.
Doctors will identify children (under 16) who are eligible to take part.
The doctor, or other healthcare professional, will talk to the child and his or her parents about taking part.
The Project will be explained to the child to help them understand what is involved. The child can ask questions and express their opinions or concerns. The healthcare professional will seek the agreement of the child. But, it is the parents who decide whether a child should take part.
We have information sheets for children and young people about the Project.
When a child who is enrolled in the Project reaches 16 they will be asked to give their own consent as an adult to remain in the Project. Like any other potential participant, they do not have to take part and can withdraw at any time.
Young people over 16 can make their own decision about whether they want to participate.
A clinician may decide that a young person (under 16) is ‘Gillick competent’. This means they have a good understanding and awareness of their situation. These young people can give their own consent. All young people giving their own consent are encouraged to involve their parents or guardians in the discussion.