- 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 what information is publicly available about the regulation of healthy volunteers participating in human clinical trials of non-pharmaceutical substances at Inveresk research laboratories.
Answer
Inveresk research laboratories is a private company. Any information should be sought from them.
- 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 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
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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 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
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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 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, 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
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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 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 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.
