- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
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Date lodged: Friday, 13 August 2004
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Current Status:
Answered by Malcolm Chisholm on 7 September 2004
To ask the Scottish Executive, further to the answer to question S2W-9588 by Malcolm Chisholm on 29 July 2004, whether the informed consent, with full information given about treatment, of healthy volunteers participating in human clinical trials of non-pharmaceutical substances at Inveresk research laboratories is required under UK health and safety regulations.
Answer
UK health and safety matters are reserved to Westminster.
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
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Date lodged: Friday, 13 August 2004
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Current Status:
Answered by Malcolm Chisholm on 7 September 2004
To ask the Scottish Executive, further to the answer to question S2W-9588 by Malcolm Chisholm on 29 July 2004, whether the controls to protect healthy volunteers participating in human clinical trials of non-pharmaceutical substances at Inveresk research laboratories are equivalent to those in England and Wales, such as those accepted or implemented by the (a) Health Protection Agency and (b) Health and Safety Laboratory.
Answer
I refer the member to the answer to question S2W-10010 on 7 September 2004. All answers to written parliamentary questions are 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: Friday, 13 August 2004
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Current Status:
Answered by Malcolm Chisholm on 7 September 2004
To ask the Scottish Executive, further to the answer to question S2W-9588 by Malcolm Chisholm on 29 July 2004, what information it has on how many times in each year since 1995 the Health and Safety Executive has visited Inveresk research laboratories, on which records relating to clinical trials of non-pharmaceutical substances on healthy volunteers were inspected on each occasion and on what monitoring has been carried out by the Health and Safety Executive of volunteers who have participated in clinical trials of non-pharmaceutical substances to assess long-term health effects.
Answer
I refer the member to the answer given to question S2W-10010 on 7 September 2004. All answers to written parliamentary questions are 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: Friday, 13 August 2004
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Current Status:
Answered by Malcolm Chisholm on 7 September 2004
To ask the Scottish Executive, further to the answer to question S2W-9592 by Malcolm Chisholm on 29 July 2004, who holds the information on who the members are of the Edinburgh Independent Ethics Committee for Medical Research.
Answer
This information is held by Inveresk Research Ltd.
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
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Date lodged: Friday, 13 August 2004
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Current Status:
Answered by Malcolm Chisholm on 7 September 2004
To ask the Scottish Executive, further to the answer to question S2W-9595 by Malcolm Chisholm on 29 July 2004, whether Schedule 2, or any other part of The Medicines for Human Use (Clinical Trials) Regulations, covers clinical trials of non-pharmaceutical substances on healthy volunteers.
Answer
The Medicines for Human Use (Clinical Trials) Regulations 2004 apply only to clinical trials of medicinal products. Substances falling outwith that definition would, therefore, not be in covered by the Regulations. The definition of “medicinal product” is set out in section 2 of the Regulations.
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
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Date lodged: Friday, 13 August 2004
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Current Status:
Answered by Malcolm Chisholm on 7 September 2004
To ask the Scottish Executive, further to the answer to question S2W-9594 by Malcolm Chisholm on 29 July 2004, what criteria under the Clinical Trials Directive (a) NHS and (b) non-NHS ethics committees have to fulfil before they can be given type (1) recognition by the United Kingdom Ethics Committee Authority.
Answer
The criteria applicable to all committees are set out in Regulation 7 of, and Schedule 2 to, The Medicines for Human Use (Clinical trials) Regulations 2004. Committees recognised solely for the purpose of Phase 1 trials, however, are not required to meet the provisions set out in Schedule 2 until 1 May 2005.
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
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Date lodged: Friday, 13 August 2004
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Current Status:
Answered by Malcolm Chisholm on 7 September 2004
To ask the Scottish Executive, further to the answer to question S2W-9588 by Malcolm Chisholm on 29 July 2004, which UK health and safety regulations apply to healthy volunteers participating in human clinical trials of non-pharmaceutical substances at Inveresk research laboratories.
Answer
The regulation of Health and Safety is a matter reserved to Westminster. However, I understand that trials of the kind carried out at Inveresk Laboratory are regulated under the Health and Safety at Work Act 1974 and the Control of Substances Hazardous to Health Regulations.
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
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Date lodged: Friday, 13 August 2004
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Current Status:
Answered by Malcolm Chisholm on 7 September 2004
To ask the Scottish Executive, further to the answers to questions S2W-9592 and S2W-9593 by Malcolm Chisholm on 29 July 2004, whether the (a) Ethics Committee Authority or (b) Central Office for Research Ethics Committees holds (i) the list of members of the Edinburgh Independent Ethics Committee for Medical Research and (ii) declarations of interests of those members.
Answer
This information has not been requested nor is it held by UK Ethics Committee Authority or Central Office Research Ethics Committees.
- Asked by: Mark Ruskell, MSP for Mid Scotland and Fife, Scottish Green Party
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Date lodged: Friday, 13 August 2004
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Current Status:
Answered by Malcolm Chisholm on 7 September 2004
To ask the Scottish Executive, further to the answers to questions S2W-9592 and S2W-9593 by Malcolm Chisholm on 29 July 2004, what information it has on when the (a) United Kingdom Ethics Committee Authority and (b) Central Office for Research Ethics Committees have requested from the Edinburgh Independent Ethics Committee for Medical Research (i) a list of their members and (ii) declarations of interests of those members.
Answer
I refer the member to the answer to question S2W–10016 on 7 September 2004. All answers to written parliamentary questions are 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: Friday, 13 August 2004
-
Current Status:
Answered by Malcolm Chisholm on 7 September 2004
To ask the Scottish Executive, further to the answer to question S2W-9594 by Malcolm Chisholm on 29 July 2004, whether the informed consent, with full information given about treatment, of healthy volunteers participating in human clinical trials of non-pharmaceutical substances is required under the Clinical Trials Directive.
Answer
The Clinical Trials Directive, which was transposed into UK law by The Medicines for Human Use (Clinical Trials) Regulations 2004, addresses clinical trials of medicinal products (that will include some non-pharmaceutical substances) and requires fully informed consent.
