Minutes of the Scottish Ethics Implementation Group: Thursday 28Th September 2006, Victoria

MINUTES OF THE SCOTTISH ETHICS IMPLEMENTATION GROUP: THURSDAY 28TH SEPTEMBER 2006, VICTORIA QUAY, EDINBURGH

Present:

Mr Mike Stevens (Chair)- Chief Scientist Office

Ms Joyce Clearie -NHS Lothian

Dr Ellie Dow-NHS Tayside

Mr Nicholas Grier-Lothian LREC

Dr Alison Hinds-Chief Scientist Office

Professor Bob Hunter-NHS Greater Glasgow

Dr Peter Hutchison-Dumfries & Galloway LREC

Dr Julie Kelly-NHS Grampian

Professor Ken Lees-MREC

Mr Gus MacConnachie-NHS Tayside

Mrs Moira Nolan-Chief Scientist Office

Mr Malcolm Pringle-Chief Scientist Office

Mr Peter Reith-NHS Lothian

Mrs Margaret Thomson-Highland LREC

Apologies

1.Professor Nigel Webster, Mrs Jillian Evans, Dr Derek Cox.

SEIG Membership(SEIG(1)06)

2.Mike Stevens welcomed the Membership and invited those present to introduce themselves.

3.It was noted that the Membership had been established to ensure continuity with the membership of theGroup’s forerunner, the Scottish Ethics Advisory Group (SEAG), appropriate REC/NHS expertise and geographical representation. The membership was duly agreed.

SEIG Remit & Handling of Papers(SEIG(2)06)

4.The Membership were invited to consider the remit of the Group and in so doing indicated that they were content.

5.It was noted that the general presumption was that all papers could be made available after individual meetings of the Group.This would allow the Membership the opportunity to identify sensitive information justifying a more restricted approach. It was also agreed that the Minutes of meetings would be posted on the Chief Scientist Office website. The Membership agreed this approach.

Review of NHS RECs (SEIG(3)06)

6.Mrs Nolan spoke to the Paper and highlightedthe SEAG support for closer integration between ethics and R&D. It was noted that nationally, the UK Clinical Research Collaboration were looking at closer integration between ethics and R&D. Mrs Nolan noted that NHS Greater Glasgow and Clydewas moving towards achieving this and that it had been established within NHS Tayside for some time. With regards to other NHS Board areas the position was less clear.

Development of UK Issues(SEIG(4)06)

7.Dr Hinds spoke to the Paper identifying that the National Patient Safety Agency had published the Implementation Plan for Englandduring August.

8.It was noted that a revision of the Governance Arrangements for Research Ethics Committees (GAfREC) was planned and that there would be a public consultation on this document across the UK early in the new year.SEIG saw itself as a stakeholder group in terms of the review.

9.The fact that there is no structure for the ethical consideration of social care research in Scotlandwas raised. It was noted that since this matter was being addressed in England,an appropriate reference to social care research in England would feature in the proposed revisionof GAfREC. It was suggested that the absence of a social care researchethics system has an impact on the work of the NHS REC chairs, in that they may be called upon to consider whether social care applications are appropriate for consideration by NHS RECs. While this topic falls outwith the ambit of the SEIG, CSO nonetheless undertook to raise this issue with social care colleagues within the Executive.

10.In terms of REC capacity, Peter Reith suggested that the introduction of human tissue legislation might result in an increase in the work of RECs because cases previously not submitted for ethical review were being discovered. However this view was not shared by the R&D Directors, who felt that any such cases would have been identified at the time of the incidents which led to the human tissue legislation. It was noted that the Health Department proposed to issue an HDL on the implications of the human tissue legislation in Scotland later in the year.

11.Members noted that the national principles accepted by SEAG included the removal of the distinction between MRECs and LRECs. This was seen as consistent with the decision of the UK Ethics Committee Authority to remove the distinction between Type II and Type III RECs (recognised for the purposes of the Clinical Trial Regulations) at a future date. While it was recognised that MREC A and B were both busy, it was also noted that that Scotlandhad a disproportionate number of MRECs compared to England. While MREC A is a requirement of the adults with incapacity legislation and must remain as a distinct REC for that purpose, the future of MREC B needed to be considered alongside the other UK MRECs. An additional factor impacting on MREC B is the fact that it was currently carrying two vacancies and that four of the members’appointments expire on 31 March 2007, none of whom can be reappointed. The Group agreed to discuss this matter further when the UK position is clearer and after discussions had taken place with the MRECs.

Scottish Implementation Issues (SEIG(5)06)

12.Dr Hinds spoke to the paper and highlighted that the appointment of Scientific Officers was a key component of the establishment of the four Ethics Management Centres.As such, to facilitate the early move to the new structures, the Chief Scientist Office had indicated that it was prepared to offer funding for new posts for the first year.

13.Dr Kelly confirmed that NHS Grampian wascurrently in discussion with NHS Highland surrounding a collaborative working arrangement. The main areas being considered currently arethe difficulties inrunning a service over such a large geographical area.

14.There was some discussionon the role of the Scientific Officer.Peter Reith indicated that NHS Lothian did not favour this post as having managerial control over those running the service; they saw the post’s role largely restricted to the provision of scientific advice to the RECs. He pointed out that the SEAG report did not state this explicitly. A further concern of Lothian was the availability of a person with sufficient experience to carry out the proposed task and manage the service, although this was not perceived as a problem by those managing the service in other parts of the country.

15.It was clarified that the role of the scientific officer was not to undertake scientific review of the research proposalsor to give expert advice to the researchers on their proposals, as seemed to be envisaged in Lothian, but to make decisions on and give advice on the handling of the application for ethical review purposes. This required scientific and ethics experience. It was recognised that the term “scientific officer” may be partly to blame, since it referred to only one part of the proposed role. It was agreed that an alternative was required, perhapsScientific Advisor and Manager (SAM).

16.Mrs Nolan pointed out that paragraph 35 of the SEAG report envisaged a much wider role for the scientific officer than providing advice to the REC chair, and there was concern from the other centres thatthe Scottish ethics service could not operate effectively unless common structures were adopted. It was also stressed that one of the aims of SEAG was to establish an ethics service in its own right; this would not be achieved by adding scientific advice to RECs through existing structures. The group therefore agreed that it was important for the full ambit of ethics service activities, including the operation of the REC service, to be managed by the scientific officer in all parts of Scotland. Peter agreed to feed the group’s view back to his colleagues.

17.Professor Hunter confirmed that NHS Greater Glasgow and Clydehad had a series of discussions involving the DPH, R&D, CSO, and Oliver Blatchford (Public Health Consultant) and had proposed the structure for the new ethics service within Greater Glasgow. Accountability for the operational running of the service will rest with R&D,although R&D will have no function in the decisions of the Ethics Committees. Early discussions are taking place with Lanarkshire and Ayrshire and Arranregarding collaboration and the Scientific Officer post would be advertised.

18.Dr Hutchison confirmed that NHS Dumfries & Galloway currently had close ties with both NHS Lothian and Greater Glasgow. As such, they were awaiting the outcome of the discussions those areas were having with “outlying” Boards before considering which to align to.

19.Mr MacConnachieconfirmed that NHS Tayside was well advanced in its discussions with Fife and ForthValley to establish the “Central Scotland Ethics Service”. He anticipated that a central allocation system supporting three committees across the region would be in place byspring 2007. The anticipated workload of the three committees would be 7/8 projects per committee meeting, resulting in an enhanced role for the current administrator.

20.Mr Reith confirmed that little progress had been made in Lothian to establish links with neighbouring NHS Boards with a view to integration within a Lothian ethics management service.

21.The Chair reiterated that it was the desire of the Scottish Ministers that that the four ethics management centres be established and that Scientific Officers be appointed. In terms of taking the issue forward, and to ensure the consistency of approach previously discussed, it was agreed that a generic job description for the post of Scientific Officerwould be useful. Professor Hunter agreed to share the job description prepared for the Greater Glasgow post and Mr MacConnachie and Dr Kelly agreed to share the relevant details of their posts.

Expedited Review

22.Dr Hinds spoke to the issue referring to the approach adopted by England and the alternative approach favoured by SEAG. In discussion it was recognised that there was a need to set out clearly how the proposed arrangement might work in practice within the parameters previously set by SEAG. It was therefore agreed to establish a Working Group to tease out the detail. Membership of that Group comprises: Mrs Nolan; Dr Kelly; Mr MacConnachie and Mr Reith. Action: The Group to report to the next SEIG meeting with proposed operational procedures.

Adults with Incapacity

23.Members were advised that the Scottish Executive Health Department intended to amend the research provisions of the Adults with Incapacity (Scotland) Act 2000 to address cross border anomalies that had arisen between Scotland and the remainder of the UK in the way research involving adults with incapacity is conducted. It was noted that the issue was one for discussion at the forthcoming MREC training day and that Mr Stevens and Mrs Nolan had agreed to attend.

Implementation Timetable

24.The membership agreed that the core factors upon which the success or otherwise of the revision to the ethics structure throughout Scotland was:

1. the establishment of the four ethics management centres;
2. the recruitment of Scientific Officers and;
3. the successful outcome of negotiations between the management centres and neighbouring NHS Boards.

Date of Next Meeting

25.The date of the next meeting was agreed as Thursday 16 November 2006and that the Agenda for that meeting would include:

• the implementation plans for the four management centres
• a further paper on AWI
• the recommendations of the Group established to consider expedited review
• a possible draft revision of GAfREC.

Chief Scientist Office

October 2006