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.
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?
FREEDOM OF INFORMATION
Subject: Clinical Trials Orion 4
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
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