UK Genome Wide Association Study (GWAS) project - draft website goes live, feedback sought on recruitment plan, and updates

Personally I see it as two things, rather than the one.

1. The patient volunteers for the study.

2. The patient also decides if they are happy to be contacted in the future about other studies.

I don't see it as any different, in principle, from my mother-in-laws GP putting her on a list, with her agreement, of potential participants in research for the serious condition that she is affected by.

And I would suspect that if a potential participant is put off by the question of agreeing to be contacted or not for future research, then they probably aren't going to do too well at filling in the CureME questionnaire to identify if they qualify for the study or not.

 

Yet how would it be possible to police that? And while I don't disagree with the principle, who decides which are harmful misconceptions and ineffective therapies?

 

But the volunteering is going to be dependent on the whole 'feel' of the request.
I think the situation is quite different from most other illnesses where sensitivities about being hassled by the wrong people are not in the forefront. Here they are sticking out like a sore thumbfyor a lot of people.

I also do not think that there is any particular value in this cohort for any other research. I think it would be a mistake to think that once this cohort is collected you can do much more. This is a unique situation where a very large sample is needed for the statistical reasons associated with GWAS. Any other study ought to use a better documented cohort derived on a population basis.

 

It wouldn't look good to try and prevent access to data on the basis that the requester believes in CBT/GET.

What could be done is to minimize the potential for abuse by avoiding collection of data via potentially problematic questionnaires. Avoid problematic questionnaires entirely (the kind about catastrophization and illness beliefs, the ones that are very subjective and not tied to how well you can do things in the real world, depression scales that can't distinguish between depression and other chronic illnesses and things like that).

Data that one cannot avoid collecting, like perhaps self-reported PEM could be collected with questions that are phrased to minimize potential for abuse. So not questions such as "do you agree that exercise can make your condition worse?" but more like "Have you observed a pattern of symptoms where your attempts to increase daily activities from a low baseline inevitably and quickly lead to a relapse?"

The recruitment material could also list what data exactly will be collected and who will be doing the analyses.

 

So, for the GWAS study the only questionnaires used will be the ones used by CureME as these are the ones needed to make a meaningful comparison.

The use of the CureME data probably makes significant reduction in costs and time, as it's already there, and therefore increases the chances of being funded.

 

With regard to further contact, it might be useful to understand how this will work.

Perhaps it would be helpful to understand more how this will work?

Will the list of participants be held securely and not be shared with other researchers? When requests for new research comes in then participants who have agreed with allowing further contact be contacted only by those who are responsible for maintaining the list? In other words new researchers only know about patients who have actively agreed to take part in their additional research.

Or
will the list of all participants with those who have agreed to contact for further research indicated be shared with other researchers?

Or
will only the list of participants who have agreed to contact by other researchers be shared?

 

Okay I missed the earlier part about the study using the CureME questionnaires. Which are listed here https://cureme.lshtm.ac.uk/researchers/431-2/

• Symptoms experienced
• Sociodemographic variables
• Family and individual health histories
• Potential risk factors (exposures)
• Medical Outcomes Survey Short Form (SF-36v2)
• General Health Questionnaire (GHQ-28)
• Epworth sleepiness score
• Fatigue scales assessing severity and disability
• Pain and fatigue analogue scale

 

It's certainly food for thought, but if we are going to have any research done, of any kind there will always be the risk that some pillock is going to twist things to their own ends. If we don't have any research....well, we'll never get anywhere.

As I now see it, thanks to @Andy's clarification this morning & separating out the future contact issue, the CureME questionnaires are the minimum we can do questionnaire-wise for cohort comparison. Someone feel free to correct me if I'm wrong. If that's what we're using then we've minimised our risk of having things twisted further down the line as best we can - this was my concern about having a shedload of subjective questionnaires.

Again, putting opt in/out of future research contact aside, you can choose whether or not to participate in any further research that require other questionnaires. If that ever even comes up.

As long as only anonymised data from the GWAS study is shared, even if some people took part in a later study by different researchers there is no way to link the data from individual participants between studies. Again someone please correct me if I'm wrong. Essentially, those studies would be separate from the GWAS.

 

@Andy, is there any more detail about the data sharing side of things we could go and look at beyond that paragraph.

Also, I would like to say, I appreciate you have been extremely patient, have worked really hard and, not least, are ill yourself. This is really important research made more complicated with all the added baggage. Thank you very much for your crucial efforts in making this a possibility.

 

Option two would be unlawful unless all participants gave permission for their contact details to be shared, which won't happen, so option two can't happen.

It would have to be either option one or option 3, with explicit participant consent.

I think the GLAD study does it in the way described in option one. I will try to find out.

EDTA: It looks like for the GLAD study, participants who consent to being recontacted, are only recontactable by the GLAD study research team and NIHR BioResource (where the samples are stored). Their contact details are kept only by the GLAD team and not passed on to other researchers. Patients are not asked to give permission to pass their contact details on to other researchers.

But they are asked to give permission for their anonymised data to by passed on to other researchers:

'Access to your anonymised data and saliva sample may be made available to other scientists under strict and confidential legal data-sharing agreements. All requests for access to use the data will be reviewed by the Glad Study, and/or NIHR BioResource Steering Committee. Any data released to other researchers will be anonymised using your unique ID number, and will contain no personal information'.

 

I think the research team curating the data would have the right to screen applications for quality. I am pretty sure that's what the CURE ME team do. So if a crappy BPS study was proposed and wanted data, even if it had ethical approval I think the GWAS team would have the right to decline to share the data if they felt the study proposed was of poor methodological quality or theoretical rigour.

 

(Bolding mine)

This being the GLAD study and so not necessarily how the ME GWAS will do things, but I wouldn't be happy with if my saliva sample was shared.

 

I am a participant with the ME Biobank and I am intending to volunteer to participate in the GWAS study.

I am happy for my anonymised data to be used by other researchers for any ethically approved research – even if that means that my anonymised data will be shared with researchers I do not support. The principle of open data is far more important.

I would also be happy to be contacted by the GWAS study researchers or the Biobank team to ask if I would like to take part in any other research studies which they support, provided that I am given assurance that I will have the option to opt out of receiving all such communications at any time of my choosing thereafter.

However, I do not want to be contacted by any other researchers, or for any other researchers to have access to my contact details.

I hope the consent form will allow patients to give these permissions.

Like Invisible Woman, I am only speaking for myself but I would be surprised if this was not a common view.

 

Could it be an option to have an additional choice of being open or not to psychological/BPS research? So basically: no contact, contact only for biomedical research, contact for any type of research.

Frankly, I would personally choose not to even share data with any psychological research, to restrict it only to serious research, if it were possible. I'm tired of all the wasted resources on the same nonsense in a loop for decades. I wouldn't do it systematically but as a personal option.

We have to think of ME patients who do not tightly follow the process and may be wary of participating with something funded by the MRC specifically because they'd assume it would be yet another wasted BPS nonsense. They will not necessarily know whether this is a genuine project, who is behind it, and I think this would be the key to reassuring many that this is an actual legitimate medical research project, despite being an ME project funded by the MRC.

A sort of spam filter...

 

I'd assume that this is how it would be done, that any such contact would be through the intermediary of the GWAS process, that no contacts would be shared directly with anyone?

 

I think opting in strictly for biomedical research would accomplish that. Not that it guarantees quality but at least it systematically filters out all the worst nonsense, while also sending a message (though it's a message that's been sent thousands of times but whatever).

 

I'm not sure about that. They don't know what they're doing, their involvement is just a waste of resources. HIV deniers aren't participating in AIDS research either. They already whine about being disliked so who cares what they think, they will whine anyway.

 

I agree. I've been very positive about this study, but when it dawned on me that BPS people (mentioning no names but we know who we mean) might be able to get their hands on my saliva sample & contact details, it makes me feel like I don't want to participate OR recommend that anyone participate either. It's only because I'm on S4 & I know that i'll be able to clarify exactly what "sharing" i'm going to be signing up to when the time comes, that I still think i'll take part.

Initially i'd thought that 'permission to be contacted' for future research etc meant the same team for biomed research, but of course others will want it too wont they. It makes me extremely nervous & I think it's crucial to explain precisely what is meant by 'data' when the word is used.... does it mean name address etc & saliva samples? does it mean anonymised samples? does it mean just contact info? does it mean just the anonymised data once it's all processed & the study finished so it can be looked at independently - like we wanted to for PACE data? or what exactly?

This. Thanks so much @Andy

Indeed!

Precisely

again... this