Monday, January 17, 2011

Response to Review of Ethics Approval for SMILE study of Lightning Process on Children with ME/CFS

by Jo Best on Monday, January 17, 2011:

Dear Mrs. Kirkbride,

Thank you for your email of 6th January. Please accept permission to
re-post this reply and consider the content to be in the public
domain, except for the personal details of the co-signatories to this
letter. I appreciate the NRES and SW REC review of this study
application. It was clear that the SW REC had already had to make
several suggestions and improvements to the original study proposal,
and I concur with the additional recommendations for the important
inclusion of the risks in the PIS.

However, I would like you to take account of the following points.

As someone with concerns about the human rights and safety of children
in general, and of children with sickness and disability in
particular, I am, as you would expect, disappointed by the SW REC's
decision to uphold its approval of this study. I feel sure you will
agree that this is a very serious issue, given that it concerns

However, it is clear from your comments that you do not
have a full understanding of the issues pertaining to research and
treatment of Myalgic Encephalomyelitis and the condition known as
Chronic Fatigue Syndrome. Read more>>

PS: Update 18.01.2011: Message from Jo Best and letter as pdf


Lilpink said...

If the NRES can continue to ignore this level of concern then their working practices must be brought into question. There are clear concerns about patient safety and vested interest which they have simply not addressed in the first instance or answered subsequent to earlier complaints.

I wonder what the next port of complaint is? Presumably there must be a Human Rights issue amongst the concerms expressed here? Who determines the ethical standards of the ethics committees? Surely thy can't be a law entirely to themselves?

Chris said...

It beggars belief that an unproven procedure - I can't call it a 'treatment' because I am not aware of anyone with ME who has been helped by LP - can be approved for a trial involving children. I can only deduce that those reponsible for giving this approval are not fully aware of what having ME entails and therefore how potentially dangerous LP could be on the health of those children involved. Very upsetting.


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