Are we absolutely sure of that now? If so that's good news, means that can be argued in next appeal when patient confidentiality is raised as an excuse.
But if that really is the case why has the issue of patients not wanting their anonymised data released been such a sticking point?
Something isn't adding up...
I think the problem is that neither the patient information sheet nor the consent form explained the distinction between personal data and anonymised data, leaving participants with the distinct impression that *no* data of any kind would be shared.
The Patient Information Sheet stated:
"Will you keep my details confidential?
Yes. All your details and all recordings will be kept strictly confidential and held in a locked filing cabinet or on a secure computer. People on our research team will only see your records if they need to for the research.
Your GP and any other doctors you are consulting will be told you are joining our study. And occasionally, other researchers will need to see your notes so they can audit the quality of our work. An audit might be run by one of the universities helping with our study or hospital regulatory authorities, or by one of the organisations funding our study.
The data and recordings we collect will be securely stored for 20 years after the end of the trial, for your protection and to follow good clinical practice (GCP). The same applies to other records gathered for our study, including your medical notes and the database holding the collected data for this trial.
Your name, address, and telephone number will be on only one database. This will be held securely at St Bartholomew’s Hospital, in London, and it will be used only to monitor recruitment. You will not be named in any published results from our study."
The consent form stated:
"I understand that any of my medical notes may be looked at by responsible individuals from either the trial or regulatory authorities where it is relevant to my taking part in research. I give permission for these individuals to have access to my records."
The PACE team seem to be taking the line that they can't release any data - even anonymised - because the participants only gave permission for it to be accessed by individuals involved directly with the trial.
(The reason that the participants gave only this limited permission is of course because that's all the trial investigators asked them for - it's almost as if they didn't want anyone else to be able to access the data, regardless of what the MRC guidance on data sharing might say...)
(And of course Kings College has publicly claimed that they *have* released data to independent investigators, so obviously this is less of a stumbling block than they claim it is when they're refusing FOI requests)
My understanding (which may be wrong) was that you don't need patient consent to release anonymised data, as it can't be considered personal data any longer (as participants aren't identifiable).