Reply from NRES – no further action – 14th April 2011

Our Correspondence with Director of National Research Ethics Service

From NRES Director –

Further to your email of 8th April, complaints must be managed within the policy timelines. I appreciate that this, as an ongoing study, may generate new issues outside what has currently been investigated but at this stage I consider all matters raised have been fully investigated.

Specifically, I was aware of the outstanding response, I reviewed the draft response and have given my approval for the reply to be sent. I do not believe NRES needs to take further action at this time.

Yours sincerely
Dr Janet Wisely
Director National Research Ethics Service
National Patient Safety Agency
4-8 Maple StreetLondon W1T 5HD
Tel: 020 7927 9898Fax: 020 7927 9899
queries@nres.npsa.nhs.uk
http://www.nres.npsa.nhs.uk
April 2011

From Patient Advocate 8th April 2011

Dear Dr. Wisely,

I refer to your response to my complaint of 7th April.

I accept that you may have dealt with some aspects of this particular issue internally during the course of your investigation, but I do not feel that it has been addressed satisfactorily as far as the public is concerned. It also seems that your investigation may have concluded prematurely – before Mrs. Kirkbride and Dr. Davies had completed their replies to responses to the REC review of their decision.

As you know, members of the public were given false information in the apology to Phil Parker and were asked to publicise it, as described in my letter to Mrs. Kirbride of 1st April, which I copied to you for your information. I was also given false information in Mrs. Kirkbride’s letter to me of 16th March, which you can also see from my letter of 1st April. No attempt has been made to correct this information or further apology made public. I realise you may have concluded, during the course of your investigation, that it had not been appropriate to issue a public apology to Phil Parker, but having made that mistake, it should be rectified.

I expect you will have noted from your investigation that the major objections to this study from the outset derive from this very problem of false, incomplete, misleading information, and unsubstantiated claims made publicly by members of the research team involved with the intervention arm of the study – which potential recruits were advised to read for themselves to help them decide whether to take part – and also made by the lead researcher, for example by stating she did not believe there to be risks to the participants, and by not declaring this to be a clinical trial, even though one of her stated aims was to assess the safety of this product, allegedly because around 250 children per year were already using it. No evidence was provided that this number of children are doing the LP and there cannot possibly be no risks declared to patients taking part in a study of a product that is being tested for its safety. A further misleading element of the study is that the LP is described by Phil Parker as a “non-medical tool”, yet claims have been made throughout that the research aims to evaluate treatments that may come into mainstream use in the NHS as a result of the full RCT that may follow from this pilot study.

It seems clear that this study was fraught with flaws from the outset. It can be seen from the documentation posted on the Bristol University website that the SW2REC had to make several suggestions for improvements prior to its original decision to grant approval. The study proposal was of poor quality and I believe that the REC did its best, with the information and assurances it was given by the lead researcher, to assist her in meeting the standard required for approval.

The difficulty, as I see it, has arisen by the REC subsequently failing to give sufficient weight to the new and very relevant information that was presented to them prior to and since their review. It is repeatedly stated throughout the notes on your investigation, that the REC may take new information into account in order to review a decision. I realise you may conclude that this was the case, and that the REC found in favour of the research team. In which case, it seems that the ethics service gives more weight to “thoughts, feelings, beliefs, opinions and views” of researchers than to facts, existing evidence that should inform the research proposal, and scientific quality.

This is not a full complaint. I will be writing to the Chief Executive as you advised and to the Ombudsman, but have not yet had time to fully digest the documents you kindly sent summarising your investigation, or the letter sent by Mrs Kirkbride in reply to our response to the minutes of the ethics committee review meeting.

In the meantime, I wanted to give you the opportunity to consider whether the NRES should take steps to rectify the false information given to the public and to consider whether you agree with Mrs.Kirkbride’s view that the information provided in a recent letter from Trading Standards that was forwarded to her, is not relevant to the ethical considerations of this study – i.e. that Phil Parker, member of the research team and designer of the Lightning Process, is currently the subject of Trading Standards and Advertising Standards Authority investigation for misleading and aggressive selling practices – as he is likely to comply with the law when advised by them to do so – otherwise of course, he risks prosecution, as stated in the letter by the TS investigating officer.

I am sure you will appreciate that it is our concern for the dignity, safety and well-being of the paediatric patients involved in this study that drives these requests to take such information into account. The letter from the Trading Standards Officer post-dates your investigation. I repeat that my concerns and complaints are in no way vexatious in intention and I have no vested interest in whether or not this study is completed.

Yours sincerely,

From NRES Director 7th April 2011 – 

Thank you for your email of 6th April. I can confirm that the matter of the error in the REC minutes, subsequent correction and apology were part of my original investigation as I considered in this investigation the complete set of correspondence and events with the study and management by NRES staff. It is therefore a matter that has been thoroughly and fully investigated by NRES through the NPSA Complaints Policy.

Yours sincerely

Dr Janet Wisely

Director National Research Ethics Service

National Patient Safety Agency

4-8 Maple Street London

W1T 5HD

From Patient Advocate 6th April 2011 – 

Dear Dr. Wisely,

Thank you for your letter of 5th April and the helpful attachments.

I believe that the REC concerned did not take the relevant new
information received regarding this piece of research into account for
its review and so I will be taking that matter further with the
relevant bodies, as you have advised.

In the meantime, you have not addressed my complaint against Mrs.
Kirkbride regarding the untruthful information she provided in her
public apology to Phil Parker, and which she requested the recipients
to publicise.

I would like you to note that I do appreciate the complexity and
volume of work that this matter has generated for Mrs. Kirkbride, and
that I note from the attachment that this was unprecedented in her
experience.  My complaint is in no way vexatious.

I am sure you will appreciate the seriousness of this complaint, which
I presume was not among the ‘matters that have already been thoroughly
and fully investigated under this complaints procedure’.

Your sincerely,

 

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