BurnA
Senior Member
- Messages
- 2,087
Next reply from AfME...
We cannot confirm if the patients informing us that their anonymous data should not be shared, were actually PACE trial participants or not, as they wish to remain anonymous.
-
Welcome to Phoenix Rising!
Created in 2008, Phoenix Rising is the largest and oldest forum dedicated to furthering the understanding of, and finding treatments for, complex chronic illnesses such as chronic fatigue syndrome (ME/CFS), fibromyalgia, long COVID, postural orthostatic tachycardia syndrome (POTS), mast cell activation syndrome (MCAS), and allied diseases.
To become a member, simply click the Register button at the top right.
Tell our charities: QMUL must release PACE data
- Thread starter ClarkEllis
- Start date
We cannot confirm if the patients informing us that their anonymous data should not be shared, were actually PACE trial participants or not, as they wish to remain anonymous.
- Messages
- 55
I thank AfME for keeping patients updated as this situation moves forward.
My view, that I will be expressing to AfME who I have been in communications with, is that some individual patient participants may well feel they did not give consent for such de-identified data to be released, and I understand they are upset in principle that the consent form they signed did not mention this. But actually by taking part in a trial under data protection laws as they are, that consent was never required for de-identified data to be released. It is normal for de-identified data to be released and it was always subject to potential release under FOI law. Without that it is difficult for trials to have much value. Release is safe because patients cannot be identified.
Indeed, the PACE authors have already released some of the de-identified data. Both in their published papers and to an outside research team who are currently writing a paper for publication. So the PACE authors themselves have already broken their agreement if we look at their agreement the way the PACE authors say they want it looked at. Have AfME made the patient partiiciapants aware that some IPD have already been released without consent being requested?
I sympathise with patient participants who may not feel they can trust the PACE authors anymore, and that may be part of the reason why they just want to say no, please keep things as they are. And if they have read any of the statements from QMUL it is likely they are under the false impression that the data release would lead to them being identified, but this is not true; the information commissioner has already rejected QMUL's asserions on this matter - still I could understand if a patient participant felt uncertain given the scaremongering QMUL have put about. And who knows what QMUL have said to them in private!
But as it is not true that patients can be identified from the de-identified data we're talking about here, that is why the reality is that patient consent is not required for the release of de-identified data (we're talking about things like numbers of steps taken, not names or postcodes).
Despite a small number of patient participants rightly feeling this process has been mismanaged by QMUL -- and I think QMUL should appologise to them for that mismanagement -- there is no actual risk to these individual patient participants who have raised these concerns and as there are tens of thousands of patients who want the data to be released, and so release would clearly still be in the interest of the vast majority of patients, AfME should clearly support that.
If you are a patient yourself (or even a patient participant from the trial), a carer, or advocate, and you want the data released, then I encourage you to contact AfME if you have not already done so..
My view, that I will be expressing to AfME who I have been in communications with, is that some individual patient participants may well feel they did not give consent for such de-identified data to be released, and I understand they are upset in principle that the consent form they signed did not mention this. But actually by taking part in a trial under data protection laws as they are, that consent was never required for de-identified data to be released. It is normal for de-identified data to be released and it was always subject to potential release under FOI law. Without that it is difficult for trials to have much value. Release is safe because patients cannot be identified.
Indeed, the PACE authors have already released some of the de-identified data. Both in their published papers and to an outside research team who are currently writing a paper for publication. So the PACE authors themselves have already broken their agreement if we look at their agreement the way the PACE authors say they want it looked at. Have AfME made the patient partiiciapants aware that some IPD have already been released without consent being requested?
I sympathise with patient participants who may not feel they can trust the PACE authors anymore, and that may be part of the reason why they just want to say no, please keep things as they are. And if they have read any of the statements from QMUL it is likely they are under the false impression that the data release would lead to them being identified, but this is not true; the information commissioner has already rejected QMUL's asserions on this matter - still I could understand if a patient participant felt uncertain given the scaremongering QMUL have put about. And who knows what QMUL have said to them in private!
But as it is not true that patients can be identified from the de-identified data we're talking about here, that is why the reality is that patient consent is not required for the release of de-identified data (we're talking about things like numbers of steps taken, not names or postcodes).
Despite a small number of patient participants rightly feeling this process has been mismanaged by QMUL -- and I think QMUL should appologise to them for that mismanagement -- there is no actual risk to these individual patient participants who have raised these concerns and as there are tens of thousands of patients who want the data to be released, and so release would clearly still be in the interest of the vast majority of patients, AfME should clearly support that.
If you are a patient yourself (or even a patient participant from the trial), a carer, or advocate, and you want the data released, then I encourage you to contact AfME if you have not already done so..
Last edited:
Bob
Senior Member
- Messages
- 16,455
- Location
- England (south coast)
Yep, I absolutely agree with your interpretation. The consent agreement applies to medical notes.
Bob
Senior Member
- Messages
- 16,455
- Location
- England (south coast)
Yes, it requires a bit of interpretation, doesn't it. It's difficult to articulate all the information in a single tweet! I took ages to write that tweet! Hope others will have interpreted it the way it was meant.Sorry, I see that was actually the point you made to LS: it was the reference to 'data sharing' that threw me. Jumped to conclusions. Not for the first time, won't be the last.
- Messages
- 171
- Location
- London
This document addresses expectations for open sharing of anonymized data sets of MRC funded trials, thereby through the act of patients consenting to take part in such a trial surely they would be subject to these rules:
http://www.mrc.ac.uk/publications/b...rch-data-from-population-and-patient-studies/
Only specific consent from the patient would likely be required in the instance that the data being shared was not anonymized and personally identifiable.
http://www.mrc.ac.uk/publications/b...rch-data-from-population-and-patient-studies/
Only specific consent from the patient would likely be required in the instance that the data being shared was not anonymized and personally identifiable.
What utter nonsense.
Keela Too said:
That's James Coyne's Belfast talk:
http://sallyjustme.blogspot.co.uk/2016/02/professor-coyne-how-can-we-thank-you.html
So AfME are listening to Coyne...
- Messages
- 55
That's encouraging. Quite a good effort to fly there so good on Clare Ogden for doing so.
Snowdrop
Rebel without a biscuit
- Messages
- 2,933
haven't read pg's 3/4 here but I know that there are patients that support AfME despite knowing their stance on the issue.
Not at all surprised at AfME's response. Would very much like to know what interests these patients feel are being served by supporting AfME.
Of course they will remain anonymous.
Not at all surprised at AfME's response. Would very much like to know what interests these patients feel are being served by supporting AfME.
Of course they will remain anonymous.
Snowdrop
Rebel without a biscuit
- Messages
- 2,933
AfME's statement/response to query is a not on point. It's meaningless.
The question is: who is still supporting them and why?
Snowdrop
Rebel without a biscuit
- Messages
- 2,933
If QMUL are forced to release data I would start to worry that they have a contingency in place whereby once data is given out somehow private details released to make it look like the people making request are to blame. Sounds paranoid. Until it doesn't.
At least if private details were released the patients involved would have legal recourse no? then they would benefit from a legal settlement.
At least if private details were released the patients involved would have legal recourse no? then they would benefit from a legal settlement.
I would expect and hope that any (adequately anonymised) data about me collected in a trial would be available to other researchers.
That's one of the main reasons for collecting and storing data, so that all researchers have access to it (at least some time later).
If the data is not available for other researchers to reanalyse and try to replicate, then it is worth nothing.
This is what any PACE patients need to understand. If their (adequately anonymised) data is not available to other researchers, independent of the PACE team, then we will never be able to find out if the claims from PACE are correct.
That's one of the main reasons for collecting and storing data, so that all researchers have access to it (at least some time later).
If the data is not available for other researchers to reanalyse and try to replicate, then it is worth nothing.
This is what any PACE patients need to understand. If their (adequately anonymised) data is not available to other researchers, independent of the PACE team, then we will never be able to find out if the claims from PACE are correct.
BurnA
Senior Member
- Messages
- 2,087
Maybe they were spying on him......
I doubt it! If they wanted to spy on him they could have saved themselves a plane ticket and waited for the YouTube footage.
I hope that what it really means is that some people in AfME understand the issues and might be in a position to try to persuade/educate the others.
In that case, likely they can't confirm that they are even patients - and if they are just people who have phoned them up to say this, they may well not be...
BurnA
Senior Member
- Messages
- 2,087
I just want to point out my comment was made tongue in cheek ..... It had no basis other than to suggest how ridiculous this situation is. Aplogies if anyone interpreted this as an actual comment, sometimes sarcasm doesn't work well in text.
Ah...sorry!
All too plausible...how would AfME know if the people who contacted them were trial participants or not?