- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
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Date lodged: Tuesday, 06 July 2004
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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).
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
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Date lodged: Tuesday, 06 July 2004
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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
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Date lodged: Tuesday, 06 July 2004
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Current Status:
Answered by Malcolm Chisholm on 29 July 2004
To ask the Scottish Executive whether consideration of applications to carry out human clinical trials on healthy volunteers at Inveresk research laboratories should be considered by an ethical committee other than the Edinburgh Independent Ethics Committee for Medical Research.
Answer
Any committee recognised to cover the same type (type (i) recognition) and geographical area could be asked to consider applications for ethical review from Inveresk research laboratories.
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
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Date lodged: Tuesday, 06 July 2004
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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
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Date lodged: Tuesday, 06 July 2004
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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
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Date lodged: Tuesday, 06 July 2004
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Current Status:
Answered by Malcolm Chisholm on 29 July 2004
To ask the Scottish Executive what information is publicly available about the ethical oversight of healthy volunteers participating in human clinical trials of non-pharmaceutical substances at Inveresk research laboratories.
Answer
This information is not held centrally.
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
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Date lodged: Tuesday, 06 July 2004
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Current Status:
Answered by Malcolm Chisholm on 29 July 2004
To ask the Scottish Executive who the members are of the Edinburgh Independent Ethics Committee for Medical Research.
Answer
This information is not held centrally.
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
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Date lodged: Wednesday, 23 June 2004
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Current Status:
Answered by Allan Wilson on 21 July 2004
To ask the Scottish Executive when it expects to make commencement orders in respect of the Nature Conservation (Scotland) Act 2004 and which sections will come into force first.
Answer
As I made clear during parliamentary consideration of the act, commencement of this important legislation will not be unnecessarily delayed. My intention is that the act should be commenced later this year. It is likely that the provisions in part 3 of the act (Protection of Wildlife) will be the first to come into force.
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
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Date lodged: Tuesday, 22 June 2004
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Current Status:
Answered by Frank McAveety on 1 July 2004
To ask the Scottish Executive whether it will ensure that, in expanding the field sports sector of tourism, biodiversity and other land use interests are protected.
Answer
Scotland’s unrivalled natural beauty is one of the major assets that attracts visitors to choose Scotland as a holiday destination. The protection of these assets is therefore an essential element in our tourism strategy, and in the development of the tourism products that we offer our visitors.
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
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Date lodged: Wednesday, 23 June 2004
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Current Status:
Answered by Cathy Jamieson on 1 July 2004
To ask the Scottish Executive whether it anticipates any problems arising from the operation of the TETRA police telecommunication system.
Answer
The operation and maintenance of the Airwave network is a matter for the service provider O2. Scottish police forces and the Scottish Executive have been working closely with O2 with the aim of achieving a smooth migration from existing systems to Airwave.
In planning for the introduction of Airwave, Scottish forces have benefited from sharing information with those forces in England and Wales already using the service. This information has been used at both national and local levels to assist forces in preparing for Airwave.