If a potential participant is identified as lacking capacity to provide consent for themselves at the time a decision or action needs to be taken, doctors treating this patient may have decided that it was safe and suitable for the patient to take part in this study. The CoMiTED Research team have created a short video (please see below) to help describe how and why this happens.
Following this, if the patient is still not well enough to decide for themselves, reasonable steps will be taken to seek advice on their continuation in the study from a Personal Consultee (e.g. their partner, relative or friend), as per the Mental Capacity Act 2005. If reasonable steps to contact a Personal Consultee fail, then a Nominated Consultee (an independent person, e.g. a doctor not involved in the study) will be approached to advise the research team about the continued participation of the person who lacks capacity.
You (the Consultee) should first read the relevant invitation letter below. If preferred, you can download the invitation letter by clicking on the ‘Download’ option that is underneath each display. The first letter is for those who are giving advice on behalf of a participant who has not yet regained capacity following their initial admission to A&E. The second letter is for those who are giving advice on behalf of a participant who has, at some point previously, had capacity and given their consent to participate in the study but has since lost capacity following this.
1 Consultee Invitation Letter (Participant not regained capacity following Auto-enrolment)
2 Consultee Invitation Letter (Loss of capacity following Participant Consent)
If you are interested to know more, further information can be found in the Summary Participant Information Sheet and the Detailed Participant Information Sheet which can be viewed by clicking on the links or going to the Information For Patients page. This information is the same information which would have been provided to the patient upon admission to A&E if they had been well enough.
If there are any parts of the information that you do not understand, or if you would like further information, you can speak with a member of your local participating hospital research team. Alternatively, you can contact the CoMiTED Central Trial Team; see contact information, “here”.