Age of consent
We consider 16 years of age to be adult.
There is no statute in England, Wales or Northern Ireland governing a child’s right to consent to take part in research other than a Clinical Trial of an Investigational Medicinal Product (CTIMP), that is consent for non-CTIMPs.
As a consequence, our practice follows common law, which presumes competency around 16 years of age (using “Gillick competence”). It is normally good practice to involve the family even if the young person appears competent. For children under 16 it is our common practice that the wishes of the child are taken into account although the documentation is signed by a parent/guardian.
Children participants of the BioResource will be asked to consent for themselves once they are over 16 years old and they will be free to decide if they want to do so or not.
Read the National Health Service Health Research Authority guidance notes.
The BioResource includes many cohorts (projects) so the paperwork our participants see may be tailored to the cohort they are invited through, for example IBD, STRIDES, COVID-19, Rare Diseases)
Adult participant or adult relative
Paperwork for adult (16 years of age or greater): Participant Information Leaflet (PIL)* and Consent Form (CF).
Paperwork: parental or guardian's Patient Information Leaflet (PIL) and Consent Form (CF). Children under 16 must have parental consent: the consent of one parent is sufficient. Foster or other carers (e.g. social workers) use the same Parent/Guardian for Child documents.
Adults (more than 16 years of age) lacking capacity
Paperwork: Consultee Information Leaflet (PIL) and Consultee Declaration Form
COVID-19 adults patients (more than 16 years of age): additional options for consenting
If a patient with COVID-19 has the capacity to consent but is unable to sign for themselves, a witness can sign on their behalf on the Witness Statement of the form.
Sometimes patients with COVID-19 lack capacity to consent due to the infection or treatment and this may be temporary. A Consultee (relative or friend) can sign the Consultee Declaration option of the form to consent for the patient to join the COVID-19 BioResource. Once the participant re-gains capacity they will be asked to consent for themselves to continue being in the study.
* The PIL may also be called Patient Information Sheet (PIS)
Participants agree to:
- provide written consent
- provide a biological sample
- provide access to health records/medical notes
- be willing to be contacted again and invited for further studies
To be complete, a consent form must
- have all boxes completed and all options chosen
- have the participant’s name
- have the participant's date of birth, if this is asked
- be signed and dated by the participant
- have the receiving officer's signature and date
A parent/guardian for a child, or a personal consultee for an adult may be approached via phone initially to consent for their child or adult relative/friend to join the study if they are not able to be together with patient. If they agree, the verbal consent will be documented and will be followed up by asking for the written consent. The study team will send a copy of the verbal consent to the parent/guardian or consultee by email or other means (e.g. by post), together with the PIL and Consent Form for them to complete and return.
Postal/ Email Consents with Errors
If the consent received by post or email has errors or omissions, it must either
- be corrected via email or phone with the participant
amendments must be signed and dated by the receiving officer stating agreement with the participant and a new copy sent to the participant for their records
- be returned to the participant for correction and resubmission