Reply from NRES re: apology to Phil Parker – 16th March 2011

Letter from National Research Ethics Service 16th March 2011 –

Please find below response to your further queries.

1. It was never the intention that Alastair Gibson would provide research interventions and no change has been made since initial submission.

We do not hold this information, please refer to the research team.

2. NRES did receive the correct information. The name was given incorrectly in the summary document provided to the SW2 REC. Therefore, the REC was given incorrect information.

3. As previously advised, NRES will respond to the previous correspondence. However due to its length and other correspondence received about this study it will take us some time to respond fully.

BW

Joan Kirkbride
Head of Operations, England
National Research Ethics Service (NRES), National Patient Safety Agency

(End)

The above was in reply to  our letter of 7th March 2011 – 

Dear Joan,

Thank-you for your reply to my letter regarding your public apology to
Phil Parker.

1.  Thank-you for confirming that Alastair Gibson will not be
providing any research intervention with the children.  I assume this
change has been made in response to the concerns raised by members of
the public about the ASA ruling against him.

Can you please confirm which LP traders will be providing research
intervention with the children.

2.  You say in your letter that SW 2REC was provided with incorrect
information, and that you will not, therefore, issue a further public
apology for making that mistake.

Please would you acknowledge to me though, that SW 2 REC did also
receive the correct information about that matter, as this is a fact
and therefore indisputable, otherwise it looks as though NRES is being
somewhat economical with the truth.

3.  Would you please clarify whether you and Dr. Davies are still
considering your reply to the points raised in our response in January
to your letter of 6th January covering the minutes of the Ethics
committee review meeting.

Kind regards,

(End)

The above was in reply to this letter from NRES of 4th March 2011 – 

Thank you for your further correspondence on this matter. NRES is sensitive to the fact that this study has caused great concern to some within the ME community and NRES has received extensive correspondence on the study and the intervention itself. Relevant information has been placed on the web-site at
http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smile.html

by the study team. NRES has, as described in standard operating procedures 9.86
http://www.nres.npsa.nhs.uk/news-and-publications/publications/standard-operating-procedures

referred the matter back to the ethics committee who originally approved the study. The committee discussed the application again at their meeting on 2 December 2010 and confirmed the favourable opinion on the study.

The role of the research ethics service is to consider the ethical aspects of research applications and approval from an ethics committee is one part of the approval process required within research governance in the UK. The actual decisions to approve applications lie with the research ethics committees which operate within the NRES. Unless new information is brought to our attention then our procedures for considering and approving the application are exhausted at this stage.

The application form which details the involvement of parties in the study is available on the University of Bristol website but I would confirm that Mr Gibson is not providing any research intervention with the children.

NRES does not intend to issue any further apology and the statement provided is correct that the SW 2 REC was provided with incorrect information.

I would though like to take opportunity to assure you that all information received by NRES will continue to be assessed and if there is new or additional information brought to our attention of relevance to the ethical decision made by the ethics committee on the research application then standard operating procedures would apply as per section 9.86.  It is felt that the other matters raised in your correspondence are outside the remit of the REC>

Kind regards.

Joan Kirkbride
Head of Operations, England
National Research Ethics Service (NRES), National Patient Safety Agency

(End)

The above was in reply to our letter of 8th February 2011 – https://frownatsmile.wordpress.com/2011/02/08/letter-to-ethics-service-re-nres-apology-to-phil-parker/

Our 8th February 2011 letter was in reply to this letter from NRES of 4th February 2011 – https://frownatsmile.wordpress.com/2011/02/04/apology-by-ethics-service-to-phil-parker-for-error-in-minutes-4th-feb-2011/

Advertisements
This entry was posted in National Research Ethics Service (NRES) and tagged , , , , . Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s