- 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: 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 ethical oversight there is of healthy volunteers participating in human clinical trials of non-pharmaceutical substances at Inveresk research laboratories.
Answer
We understand that studies involving healthy volunteers participating in clinical trials of non-pharmaceutical substances at Inveresk research laboratories are ethically appraised by the Edinburgh Independent Ethics Committee.
- 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 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
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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 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
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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 regulation there is of healthy volunteers participating in human clinical trials of non-pharmaceutical substances at Inveresk research laboratories.
Answer
Such trials are regulated under UK health and safety law.
- 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 issues of commercial confidentiality prevent the disclosure to healthy volunteers participating in human clinical trials of non-pharmaceutical substances at Inveresk research laboratories of full information regarding their treatment.
Answer
The Scottish Executive is not in a position to comment on issues of commercial confidentiality in relation to a private company.
- 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 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
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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.