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Questions and answers

Parliamentary questions can be asked by any MSP to the Scottish Government or the Scottish Parliamentary Corporate Body. The questions provide a means for MSPs to get factual and statistical information.

Written questions must be answered within 10 working days (20 working days during recess)
Other questions such as Topical, Portfolio, General and First Minister's Question Times are taken in the Chamber

Urgent Questions aren't included in the Question and Answers search. There is a SPICe fact sheet listing Urgent and emergency questions.

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Question reference: S2W-09584

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 the disclosure to healthy volunteers participating in human clinical trials of non-pharmaceutical substances at Inveresk research laboratories of full information regarding their treatment.

Question reference: S2W-09594

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.

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.

Question reference: S2W-09588

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 regulation there is of healthy volunteers participating in human clinical trials of non-pharmaceutical substances at Inveresk research laboratories.

Question reference: S2W-09590

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 information is publicly available about the ethical oversight of healthy volunteers participating in human clinical trials of non-pharmaceutical substances at Inveresk research laboratories.

Question reference: S2W-09599

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 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.

Question reference: S2W-09598

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.

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).

Question reference: S2W-09591

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 information is publicly available about the regulation of healthy volunteers participating in human clinical trials of non-pharmaceutical substances at Inveresk research laboratories.

Question reference: S2W-09586

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.

Question reference: S2W-09583

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.

Question reference: S2W-09593

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.