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Table 3 Content examples by category

From: Research involving adults lacking capacity to consent: a content analysis of participant information sheets for consultees and legal representatives in England and Wales

Why the proxy is being approached
 We would like to invite your relative/friend to be part of a research study. We feel that he/she may not be able to decide for himself/herself whether to participate in this research. We would therefore like to ask your opinion as to whether or not you think he/she would want to be involved (personal consultee information sheet ID 214)
 We would like to invite one of your residents to take part in our research study. We feel that they are unable to decide for themselves whether to participate in this research. To help decide if he/she should join the study, we would like to ask your opinion about whether you think they would want to be involved (nominated consultee information sheet ID 218)
 We are asking you, as a [title of medical role] or [title of medical role], to consider whether you will be able to act as a professional legal representative to provide agreement for your patient to participate in the [name of trial]. The majority of patients who will be eligible for this trial, due to the severity of their injuries, will not have capacity to provide informed consent for enrolment into the trial (professional legal representative information sheet ID 306)
Basis for the decision
You are being asked to advise the researchers about this person’s wishes and feelings as to whether they themselves would have wished to join this research (personal consultee information sheet ID 105)
If you agree please read the information sheet carefully and give your opinion as to whether or not you think this patient would be willing to participate in this medical research (professional legal representative information sheet ID 311)
How the proxy might approach deciding
 Using what you know of the wishes and feelings of your relative/friend, please advise us on whether you feel he/she would have agreed to join the study, if he/she had been able to decide for him/herself. Please base your advice on your knowledge of your relative/friend and their past and present views or feelings, not on your own views of research in general or this project. You should try to seek the views of your relative/friend, if appropriate, and also the views of other family or friends in helping give this advice (personal consultee information sheet ID 213)
 If you have known them for some time, you may be aware of any views they may have about taking part in such a project or whether they have made an ‘Advance Decision’. If the potential participant has made an ‘Advance Decision’ this is important, as it shows that they have already made decisions for themselves (professional legal representative information sheet ID 105)
 Think about the broad aims of the research, the risks and benefits, and what taking part will mean for this person (combined personal and nominated consultee information sheet ID 203)
Practical instructions for the proxy
 If you are prepared to act as the consultee you will be provided with a copy of the participant information sheet and be given an opportunity to discuss the project with one of the researchers so that you can form an opinion as to the individual’s likely wishes/feelings with respect to the project. If, at the end of this process, you feel that the individual would like to take part in the project, you will be asked to sign a form to that effect (personal consultee information sheet ID 108)
 Please take time to read the following information carefully. Talk to others about the study if you wish. Ask us if there is anything that is not clear to you, or if you would like more information. Take time to decide whether or not you wish the patient to take part. If you do decide for them to take part, you will be given this information sheet to keep and be asked to sign a consent form (professional legal representative information sheet ID 316)
Withdrawal from the study
 If the resident does take part in the research, we will keep you fully informed during the study so you can let us know if you have any concerns or you think the resident no longer wishes to take part (nominated consultee information sheet ID 214)
 If you later decide that he/she no longer wishes to take part, please inform us and he/she will be withdrawn from the study. You do not need to give a reason and it will not affect the standard of care your relative receives (personal consultee information sheet ID 317)