FOI requests: South West SHA and National Research Ethics Service

Freedom of Information requests: South West Strategic Health Authority and National Research Ethics Service

Shortlink: http://wp.me/p5foE-30c

In July, I submitted a request for information under the Freedom of Information Act to the South West Strategic Health Authority in connection with the status of the application for research ethics approval for the controversial RNHRD NHS FT Bath/University of Bristol Lightning Process pilot study in children 8 to 18 years of age.

I received the response:

“The South West Strategic Health Authority does not hold information on individual research projects or details of individual ethics approvals.

“Under Section 16 of the Act, the South West Strategic Health Authority has a duty to provide advice and assistance to you. The information you require may be held by the National Research Ethics Service. The website is available at the following address: http://www.nres.npsa.nhs.uk .”

On 3 August, I therefore redirected the request for information to the National Research Ethics Service (NRES). This is due for fulfilment on or before 31 August.

National Research Ethics Service (NRES) foi@npsa.nhs.uk

03 August 2010

Information requested by: [Full name and street address redacted]

I should be pleased if an acknowledgement of receipt of this request for information could be issued, together with any reference number assigned to this request.

If the information being requested is not held I should be grateful if this could be confirmed at your earliest convenience.

I request the following information under the Act in relation to the following research study:

Royal National Hospital for Rheumatic Diseases NHS Foundation Trust and the University of Bristol

Funders: £164,000 awarded by Linbury Trust and the Ashden Trust

Lead researcher: Dr Esther Crawley, Consultant Paediatrician, Royal National Hospital for Rheumatic Diseases, Bath, Senior Lecturer, University of Bristol.

Study:

Pilot project to investigate how to recruit to a randomised controlled trial looking at the Phil Parker Lightning Process and specialist medical care in CFS/ME in children. Project to incorporate study on health economic cost of CFS/ME in children.

Ethics Approval:

1] Any reference numbers attached to the application for ethics approval:

2] Names of Research Ethics Committee(s) responsible for reviewing application:

Status of application for ethics approval:

3] Date application received:

Has a Research Ethics Committee already met to consider this application?

On what date did this meeting take place?

Was an unfavourable ethical opinion or a favourable ethical opinion given?

If an unfavourable opinion, has the applicant re-submitted, submitted modifications or appealed, and on what date were these received?

Were any clarifications requested?

Was a modified application submitted to a different REC and if so, which REC?

If an appeal was submitted was the application reviewed by a different REC and if so, which REC?

What was the outcome of any re-submission, modification or appeal and on what date was the Principal Investigator/lead researcher/applicant notified of the outcome?

If a favourable opinion, on what date was the Principal Investigator/lead researcher/applicant notified ?

If the application has yet to be considered, which Research Ethics Committee is responsible for considering this application and on what date is the committee expected to meet to consider the application?

By what date is the Principal Investigator/lead researcher/applicant expected to be notified of the opinion?

Please provide copies of applications for research ethics approval for the study, including any accompanying documentation that forms part of the application, for example, questionnaires, interview protocol.

Please provide copies of any ethical opinions already handed down, with any requests for resubmissions, modifications, requests for clarifications.

[Ends]

Related information:

 FOI request 16 May 2010 to University of Bristol, fulfilled 17 June

REC Application flowchart

 REC Application Researcher Training Pack

Background to this issue

ME Association and The Young ME Sufferers Trust joint Press Release, 4 August 10

Archive for all Lightning Process posts on ME agenda

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