- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
-
Date lodged: Tuesday, 06 July 2004
-
Current Status:
Answered by Malcolm Chisholm on 29 July 2004
To ask the Scottish Executive whether healthy volunteers participating in human clinical trials of non-pharmaceutical substances at Inveresk research laboratories give their informed consent for the trials and whether issues of commercial confidentiality prevent disclosure of information to such volunteers and affect their ability to give informed consent.
Answer
This information is not held centrally.
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
-
Date lodged: Tuesday, 06 July 2004
-
Current Status:
Answered by Malcolm Chisholm on 29 July 2004
To ask the Scottish Executive, for each clinical trial of non-pharmaceutical substances involving human volunteers approved or reviewed by the Edinburgh Independent Ethics Committee for Medical Research at Inveresk, what substance was involved, how many volunteers participated and what the trial entailed.
Answer
The Edinburgh Independent Ethics Committee is a private committee. The information requested is not held centrally.
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
-
Date lodged: Tuesday, 06 July 2004
-
Current Status:
Answered by Malcolm Chisholm on 29 July 2004
To ask the Scottish Executive whether issues of commercial confidentiality prevent ethical oversight and regulation of healthy volunteers participating in human clinical trials of non-pharmaceutical substances at Inveresk research laboratories.
Answer
I refer the member to the answer given to question S2W-9588 answered 29 July 2004 which is available on the Parliament’s website, the search facility for which can be found at
http://www.scottish.parliament.uk/webapp/search_wa.
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
-
Date lodged: Tuesday, 06 July 2004
-
Current Status:
Answered by Malcolm Chisholm on 29 July 2004
To ask the Scottish Executive what criteria the Edinburgh Independent Ethics Committee for Medical Research was required to meet in order to receive recognition from the United Kingdom Ethics Committee Authority and what information it has on whether these criteria were applied to all ethics committees so recognised.
Answer
Before the implementation of the Clinical Trials Directive, studies in healthy volunteers did not require regulatory approval. The Edinburgh Independent Ethics Committee was awarded type (i) recognition by UKECA. This recognition covers the committee to review Phase 1 trials in healthy volunteers.
As with most committees recognised to review Phase 1 trials, this is not an NHS committee and therefore is not subject to NHS governance arrangements.
For an interim period, non NHS committees reviewing trials in healthy volunteers are exempt from the detailed requirements laid down in the regulations. They have until 1 May 2005 to comply with these requirements.
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
-
Date lodged: Tuesday, 06 July 2004
-
Current Status:
Answered by Malcolm Chisholm on 29 July 2004
To ask the Scottish Executive whether a register of interests of the members of the Edinburgh Independent Ethics Committee for Medical Research is available and, if not, whether it will be made available.
Answer
This information is not held centrally.
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
-
Date lodged: Tuesday, 06 July 2004
-
Current Status:
Answered by Malcolm Chisholm on 29 July 2004
To ask the Scottish Executive what procedures are in place to oversee and control the activities of independent private sector ethics committees, including the Edinburgh Independent Ethics Committee for Medical Research.
Answer
Although currently recognised on an interim basis, independent ethics committees, including the Edinburgh Independent Ethics Committee will require to meet Schedule 2 of The Medicines for Human Use (Clinical Trials) Regulations 2004 (S. I. 2004, No. 1031), by 1 May 2005. Failure to do so would make further recognition unlikely.
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
-
Date lodged: Tuesday, 06 July 2004
-
Current Status:
Answered by Malcolm Chisholm on 29 July 2004
To ask the Scottish Executive what provisions there are to ensure that the activities of independent private sector ethics committees, including the Edinburgh Independent Ethics Committee for Medical Research, are regulated.
Answer
From 1 May 2005, all committees awarded type (i) recognition to review clinical trials in healthy volunteers will be required to comply with the conditions set out in The Medicines for Human Use (Clinical Trials) Regulations 2004 (S. I. 2004 No. 1031).
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
-
Date lodged: Tuesday, 06 July 2004
-
Current Status:
Answered by Malcolm Chisholm on 29 July 2004
To ask the Scottish Executive whether healthy volunteers participating in human clinical trials of non-pharmaceutical substances at Inveresk research laboratories receive full information regarding their treatment.
Answer
Such information is not available to the Scottish Executive. Inveresk is a private company.
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
-
Date lodged: Tuesday, 06 July 2004
-
Current Status:
Answered by Malcolm Chisholm on 29 July 2004
To ask the Scottish Executive what provisions there are to ensure that the activities of independent private sector ethics committees, including the Edinburgh Independent Ethics Committee for Medical Research, are made public.
Answer
From 1 May 2005, when committees reviewing trials in healthy volunteers are required to comply with the conditions in The Medicines for Human Use (Clinical Trials) Regulations 2004 (S. I. 2004, No. 1031), the committees will be required to produce a report on the committee’s activities in relation to clinical trials of medicines, by financial year.
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
-
Date lodged: Tuesday, 06 July 2004
-
Current Status:
Answered by Malcolm Chisholm on 29 July 2004
To ask the Scottish Executive whether there is any conflict of interest in respect of consideration of applications to carry out human clinical trials on healthy volunteers at Inveresk research laboratories by the Edinburgh Independent Ethics Committee for Medical Research.
Answer
Schedule 2 of the Regulations requires ethics committees to make standing orders and to adopt standard operating procedures, subject to approval by the United Kingdom Ethics Committee Authority. Standard operating procedures would normally include issues such as conduct of meetings, membership requirements includingdeclaration of interest and conflict of interest.
I refer to my replies to S2W-9594 and S2W-9595 given on 29 July in which I stated that the Edinburgh Independent Ethics Committee have until 1 May 2005 to comply with Schedule 2 of The Medicines for Human Use (Clinical trials) Regulations 2004 (S. I. 2004, No. 1031).
