Consent

Q. Can nurses take full informed consent?

A. Yes, as long as this is in line with local R&D policy and the PI has delegated this role to the nursing staff.

Q. What is the time limit for consent?

A. This should be taken sooner rather than later. It is recommended that this should be obtained as soon as the patient is back on the ward and stabilised particularly if they are involved in the sub studies. All patients should be fully consented prior to discharge or transfer to another hospital.

Q. If a patient is discharged from hospital prior to fully informed consent being obtained, what are the procedures for collecting this?

A. The patient may be contacted by a member of their direct clinical care team, but not the research nurse. It is recommended that a consent form is sent to them in the post along with an information sheet. A covering letter may be added to ask the patient to return the consent form or to contact the research nurse if they have any questions.

Alternatively the patient can be seen at their OPA and consent obtained then. The date on the consent from must coincide with the date that fully informed consent was obtained and not back dated.

Q. How can I collect data if a patient does not want to be followed up?

A. There are three scenarios that may apply;

1. A patient may be willing for their data to be used but does not want to be followed up on the telephone or attend clinic appointments. In that case the follow up can be gathered remotely using their NHS number, hospital records or through their GP. In this case the consent form would need to be fully signed and a note made locally not to follow up the patient.
2. A patient may be happy for the data already collected to be used, but no further data to be gathered. In this case a consent form would still need to be fully signed and an email should be sent to Matt Dodd and Steven Robertson in order to formally withdraw the patient.
3. A patient may wish to have all of their data removed, in which case there is no need for the patient to sign anything. The eCRF consent page should be marked as ‘No’ giving a reason and an email should be sent to Matt Dodd and Steven Robertson in order to formally withdraw the patient.