I would like to open a discussion about how 'lack of written consent' and how this is managed in investigations.

Thanks Sophie.  @HelenH @Ed Marsden @Keith Bates @MartinL Any thoughts and experience around written consent or lack of it? Are there any guidelines or documents we can put on the hub around this?

 

Hi @Sophie Caswell Now that's an interesting question!

I'm assuming that you're raising the issue where you would expect there to be written consent? Clearly there are circumstances where verbal consent is appropriate. Maybe you're highlighting where there is a conflict in the views of the patient and the organisation as to whether there was consent at all?

This might be of interest to @Joanna Lloyd and @Amelia as they are lawyers and might be able to direct you to advice, case law etc

Helen

If the trust owns the data e.g. records, statements from staff etc it is usually not an issue, the questions is raised when a patient/family may have their own material e.g. video/audio/photograps on smartphones or other correspondence such as letters or emails etc.  Personaly I would always ensure I have written consent from them to use it.  This could be recorded in for example their witness statement saying that they consent to abc using the material for the purposes of the investigation, and what will happen to the material once the investigation is concluded.  I would not want want for example an aggrieved party who is not later happy with the investigation outcome to then be using a complaint to the information commissioners on the issue of consent or the retention of data (post) and written is provable where verbal may be a contentious point.  All information is subject to GDPR.

Section from Recital 42 GDPR " Where processing is based on the data subject’s consent, the controller should be able to demonstrate that the data subject has given consent to the processing operation.  In particular in the context of a written declaration on another matter, safeguards should ensure that the data subject is aware of the fact that and the extent to which consent is given"

Hi @Sophie E Caswell the following resources around consent may be helpful...
GMC - Consent: patients and doctors making decisions together (June 2008, currently under review)

Consent: The Montgomery Ruling (2015)