Age of consent
Although there is no statute governing a child’s right to consent to take part in research with non-CTIMPs (Clinical Trial of an Investigational Medicinal Product) the BioResource considers 16yrs as adult. This follows common law which presumes competency around 16yrs (using “Gillick competence”). It is normally good practice to involve the family even if the young person appears competent.
| ADULT PARTICIPANT OR ADULT RELATIVE | Paperwork for adult (16+) PIL and consent form. |
| CHILDREN | Paperwork – parental PIL and consent form. Under 16s need parental consent. One parent is sufficient. Foster or other carers (e.g. social workers) may prefer to use consultee documents. |
| ADULTS (16+) LACKING CAPACITY | Paperwork – Consultee PIL and consent form. |
Participants agree to provide:
- written consent
- biological sample
- access to health records/medical notes
- be willing to be contacted again & invited for further studies
Consent Form
A complete consent forms needs:
| 1. All the boxes completed, options chosen. 2. The participants name and is 3. Signed and dated correctly by participant. 4. Receiving consent signature and date. |
Postal/Email Consents with Errors
If the consent received by post/email has errors/omissions –
Either correct via email/phone with participant. Note amendments and sign changes. Or return to participant for amendment.