Trial By Error: Bristol Investigating Crawley Papers

And given the potential coercion, possibly tacit, not really consent at all.

That is my feeling. I find it hard to believe this was simple oversight. This is hardly an isolated case!

 

To play Devil's Advocate it is perhaps less clear cut in community provision, when evaluating new service provision, what is service evaluation and what is research. When working in the NHS we would at times provide trial service provision in new venues, either Social Service or Education. This would usually be aimed at evaluating staffing levels required for ongoing service to that group. This was done in discussion with the management structures of both Health and Education/Social Services, but was not seen as research requiring ethical aproval.

However this still involved our normal refferal systems. We would explain to the relevant staff what we were able to offer, and then they with the patient/client and/or their parents/guardians, as relevant, would initiate refferal in the normal way. So it was in a sense no different to our normal provision, just a new venue.

In @dave30th 's Virology Blog he indicates that Prof Crawley has tried to use this argument, claiming that these assessments by herself in conjunction with the school attendance officers were no different to usual school nurse clinics. However I would argue there is a qualitative difference in what she was doing.

Here what was being introduced by Prof Crawley was a new trial screening service being used to test a research hypothesis that this different way of working would identify significant numbers of missed children with ME/CFS. All children classified as have school attendance issues were screened, even though at the start there were no identified health issues and many would likely have no health issues at all.

I can understand there are times when it can be confusing establishing what is service evaluation and what is research, but feel undoubtedly here with the ethical complexity and that the Bath service presumably does not normally provide blanket screening it is primarily research and undoubtedly required independent ethical evaluation.

However even if it can be admitted there is a degree of confusion between what is service evaluation and what is research, this can not justify using a letter dating several years earlier, that refered to radically different circumstances, to completely avoid any ethical consideration.

(It is a while since I have read the study and can't remember if there were any children with health issues other than 'CFS' identified. If none were, is this surprising? When my cousin headed up a specialist unit for non school attenders, I was always surprised by the variety issues she had to deal with. Given Prof Crawley still uses the [discredited] Oxford definition of CFS could some children with other issues have been misdiagnosed as ME/CFS.)

 

The very fact that she interviewed anyone in person automatically makes it research that should never have been published without ethical review.

 

The answer to this, in my experience is Yes!
Conversely, many of the students in my specialist Pupil Referral Unit who were wrongly labeled as"phobic" or "refusers" or "anorexic" actually had ME.

 

As @dave30th points out (many times more than should every have been necessary), if a study (not sure if 'study' is the right word here) includes:

• Hypotheses
• Generalizable conclusions
• Data collected from individuals known to the investigator

... then it cannot be deemed a service evaluation.

So I was just interested in understanding this a bit better.

1. A service is something already established and ongoing. Somewhere in the past it likely arose as the results of past research projects, which would of course have required their own ethics approvals. One established as a service, then whatever ethics approvals were ever needed to get it there, have been done. So long as further assessments of the service do nothing whatsoever outside the scope of that service, then it seems fine it is deemed a service evaluation. Doesn't need further ethics approvals.
2. If you do a study that uses the facilities an existing service provides, piggybacking off of it in effect, but your study strays outside the scope of that service, then it is not solely an evaluation of that service, and therefore there will be aspects never covered by any ethics approval.
3. If you have a hypothesis, then it's implicit you cannot be evaluating what already is - by definition you are not confining the study to the service you are piggybacking on.
4. If you have generalisable conclusions, then by definition you are not confining to within the scope of the existing service, but extrapolating outside of that, with all manner of potential implications that have never had any ethics approval.
5. If the individuals are known to the investigator, then presumably that raises all manner of ethical issues in its own right, be it bias, risk of coercion, whatever.

 

More or less, yes. I suppose some cases might be borderline. Not the school absence study. You also can't use an opinion about pediatric studies to exempt adult studies. I mean, the adult study might be service evaluation on its own. But not because of a pediatric REC opinion.

 

Where is the condition stated regarding individuals not being known to the investigators? I found a table that lists the other things, but could not see that constraint.

 

An important difference being that this is in the US. The UK seems far more committed to covering problems up.

 

Absolutely right. Having lived in those two countries for many years each, I can say that my takeaway has been that in the US, when those in charge find they've been doing something wrong, they like to take action to fix it and do better, which both puts themselves in a good light and helps others. Here in the UK, they prefer to ignore/deny and not respond (and as we've seen with ME, even smear those who point out the problem) rather than better themselves/help others.