Orion 4 (2)

Joe Whittaker made this Freedom of Information request to Bolton NHS Foundation Trust

This request has been closed to new correspondence. Contact us if you think it should be reopened.

The request was successful.

Dear Bolton NHS Foundation Trust,

Bolton NHS Foundation Trust is listed as a ORION 4 COORDINATING CENTRE
For clinical trials service Unit [in conjunction with Oxford University.

HPS-4
TIMI 65
ORION -4
Drug trails taking place under the lead of Dr Andrew Hutcheson [listed as Consultant Chemical pathologist Royal Bolton hospital]...

Q Was the Royal Bolton Foundation Trust paid for , or have had any benefit from this commercial arrangement, either financial/shares in the pharma company or otherwise? Please supply information.

Q Was Dr Andrew Hutcheson paid as an RBH employee for this work, as he had previously retired from his role; Or is he paid as a separate consultant working for an outside agency [ e.g Oxford University, or the pharma company heading the trails] which funder pays for his work/role?

Q Is the basis for the commercial arrangement, the initial and ongoing transfer of patients` medical records to a third party, and the work done by the Trust in carrying out the drugs trial?

Q How have patients been selected for inclusion in this drug trial, were such issues as co morbidities or allergies/suitability of patient considered?

Q Were selected patients informed [before being selected and sent appointments, if they were sent appointments] of the drugs trial in a clearly written letter, about what benefits or side effects they might experience if they wanted to become involved Before appointments were made ?

Q How is GDR/Data Protection Act 2018 complied with [for instance some patients will opt out of data sharing how is this managed?] Evidence of this please ?

Q Patients who had already opted out of data sharing to 3rd parties...how was their privacy protected?
Q What measures have you followed to stop data breachs? Evidence of this please.

Q was this project taken to Governors for consideration of whether the Hospital and or listed consultant should be involved in such a drugs trail prior to its implementation? Evidence of this please.

Q Who approved this Medical Research study in Royal Bolton Foundation Trust?

Yours faithfully,

Joe Whittaker

Freedom of Information, Bolton NHS Foundation Trust

1 Attachment

 

 

FREEDOM OF INFORMATION

 

 

REF:            2020-126

Subject:        Clinical Trials Orion 4

 

 

Dear Sir/Madam,

 

Thank you for your email dated 13^th February 2020 where you requested
information about Clinical Trials Orion 4.

The information you requested is enclosed.  

 

Please find information attached.

 

 

If you have any queries or concerns please do not hesitate to contact the
Freedom of Information Department. It would be helpful to quote the above
reference number in any future communication.

 

If you are unhappy with the service you have received in relation to your
request and wish to make a complaint or request a review of our decision,
you should write to The Chief Executive, Bolton NHS Foundation Trust, The
Royal Bolton Hospital, Minerva Road, Farnworth, Bolton. BL4 0JR.

 

If you are not content with the outcome of your complaint you may apply
directly to the Information Commissioner. Generally the Information
Commissioner cannot make a decision unless you have exhausted the
complaints procedure provided by Bolton NHS Foundation Trust. The
Information Commissioner can be contacted at The Information
Commissioner's Office, Wycliffe House, Water Lane, Wilmslow, Cheshire. SK9
5AF.

 

The information supplied to you continues to be protected by the Copyright
Design and Patents Act 1998. You are free to use it for your own purposes,
including any non-commercial research you are doing and for the purposes
of news reporting. Any other reuse, for example commercial publication
requires the permission of the Trust. You must ensure you gain the Trust
permission before reproducing any third party information.

 

 

Yours sincerely,

 

Information Governance Department

Informatics

IT Training Suite

N Block

Royal Bolton Hospital

' 01204 390861

8  [1][email address]

 

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