Update on ethics approval for the Dr Esther Crawley led RNHRD NHS FT Bath/University of Bristol Lightning Process pilot study for children aged 8 to 18
For background to this issue see ME agenda 5 July report:
For joint ME charity opposition statement and press release see:
I was advised by the University of Bristol Director of Legal Services on 17 August that
“The Information Rights Officer has been assured by the leader of this project that the information requested will be published on the University’s website by the end of this month. The published information will include the research protocol and related material, including information about the ethics approval process.”
“May I therefore suggest that you await publication of the information and then come back to the Information Rights Officer if there are any aspects of your original request which you consider have not been fulfilled through publication.”
On 26 August, I was advised by the University’s Information Rights Officer that:
“The study is at the final stage of the ethics proposal. The information will be published regardless.”
On 3 August, I had submitted a request for information to the National Research Ethics Service (NRES) under the Freedom of Information Act around the application for ethics approval and application timeline.
This was fulfilled yesterday, 27 August.
I received the following responses provided by the FOI Manager, NHS South West. Responses are highlighted in blue:
27 August 2010
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.
1] Any reference numbers attached to the application for ethics approval: 10/H0206/32
2] Names of Research Ethics Committee(s) responsible for reviewing application: [A South West region Research Ethics Committee is identified]
Status of application for ethics approval:
3] Date application received: 14 June 2010
Has a Research Ethics Committee already met to consider this application? Yes
On what date did this meeting take place? 08 July 2010
Was an unfavourable ethical opinion or a favourable ethical opinion given? A decision is awaited on the ethical opinion.
If an unfavourable opinion, has the applicant re-submitted, submitted modifications or appealed, and on what date were these received? Not applicable
Were any clarifications requested? This information is exempt under Section 22 of the Act (information intended for future publication) as it will be published by the University of Bristol in the foreseeable future.
Was a modified application submitted to a different REC and if so, which REC? No
If an appeal was submitted was the application reviewed by a different REC and if so, which REC? Not applicable
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? Not applicable
If a favourable opinion, on what date was the Principal Investigator/lead researcher/applicant notified? Not applicable
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? Not applicable
By what date is the Principal Investigator/lead researcher/applicant expected to be notified of the opinion? This date is not yet known.
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.
This information is exempted under Section 22 (information intended for future publication) as the University of Bristol plans to publish this information in the foreseeable future.
I am advised that I have the right to complain about this response by reference to the complaints procedure of the South West Strategic Health Authority in which case I should write to the Chief Executive at NHS South West, South West House, Blackbrook Park Avenue, Taunton, Somerset TA1 2PX. That if I remain dissatisfied with the decision of the Authority following my complaint, I may write to the Information Commissioner, whose address is:
Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF.