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Minutes of Meetings - June 2002 |
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MINUTES OF THE MEETING HELD ON 26 JUNE 2002 At the Home Office Present: Professor Banner (Chairman) Professor Atterwill Professor Broom Professor Bulfield Professor S Clark Dr Festing Mr Gregory Dr Jennings Dr Langley Professor Martin Professor McNeilly Mr McCracken Dr Morris Professor Purchase Professor Richardson Home Office Ms Hilary Jackson (Director, Home Office Community Policy Directorate) Home Office (AP&CU) Mr Cobley Mr Walsh Mr Wood Home Office (Inspectorate) Dr Richmond Dr Anderson Secretariat Mr West Ms Horrey Mr Brenner [Secretary's note: The order of discussion of items was changed to accommodate some members' time constraints, so item 11 (Primates report) was discussed after item 5. The items appear in these minutes in their original order. The following members had to leave the meeting during the lunch break: Professor Atterwill, Mr Gregory, Mr McCracken and Professor Richardson. They were therefore not present during the discussion of items 9, 10 and 12, but were present during the discussion of all other items, including item 11.] Item 1: Welcome / Apologies for Absence 1.1 Professor Banner welcomed members to the meeting. Apologies for absence from the meeting were accepted from the following APC members: Professor Anderson, Dr D Clark, Professor Dunbar, Professor Flecknell, Professor Holland and Dr Hubrecht and also from Ms Sara Bacon of the Secretariat. 1.2 Professor Banner welcomed Ms Hilary Jackson (Director of the Home Office's Community Policy Directorate) as an observer to the meeting. Ms Jackson advised committee members that the successor to Angela Eagle as Home Office Minister responsible for animal experimentation was Bob Ainsworth. She said that at a recent meeting Mr Ainsworth had expressed interest in the subject of animal experimentation and hoped to attend a future APC meeting. Action: Secretariat to liaise with Private Office 1.3 Professor Banner noted that this was the last APC meeting that Ms Horrey would attend, as her secondment to the Secretariat from the New Zealand Ministry of Agriculture and Forestry was soon to end. The committee thanked Ms Horrey for her work and wished her well for the future. Item 2: Minutes of the meeting held on 10 April 2002 2.1 The minutes from the previous meeting were approved subject to the following amendments:
Item 3: Matters Arising October 2001 Minutes, Paragraph 6.1 3.1 Professor Banner drew the committee's attention to INF(02)22 that described the proposed setting up of a Transgenic Animal Welfare Assessment Committee (TAWAC) to take forward work on the welfare of genetically modified animals. It was envisaged that the proposed committee would be managed by the MRC's Centre for Best Practice in Animal Research. Professor S Clark undertook to bring the proposals to the attention of the Farm Animal Welfare Council and noted that there might be a need to bring this to the attention of other groups which might be interested. Action: Professor S Clark 3.2 In response to a request from Professor Bulfield, the Secretariat undertook to liaise with him to correct some inaccuracies in the paper and to communicate the corrections to the new TAWAC secretariat. Action: Secretariat 3.3 Mr McCracken commented that the Home Office should not approve project licences unless applicants could show they were adopting best practice in transgenic animal welfare. April 2002 Minutes, Paragraph 3.10: Enforcement and Compliance 3.4 The earlier APC paper on CPS prosecution decisions had been traced, and was a later agenda item. Paragraph 3.14: Members' expenses 3.5 The Secretariat had prepared a short paper explaining the scope for claiming expenses in addition to travel expenses. Members were asked to contact the Secretariat if they had any outstanding questions. Paragraph 3.16:Design and statistical analysis of experiments 3.6 Dr Festing had prepared a paper that was a later agenda item. Item 4: Primates application 3.7 The agreed letter had been sent to Angela Eagle on 21 May 2002. [Secretary's note: the text of the Chairman's letter is attached as Annex A to these minutes.] The letter had asked for comments and clarification. The Home Office staff present confirmed that a reply would be available shortly. [Secretary's note: The reply is now available, and is attached to these minutes as Annex B.] Item 5: Microsurgery application 3.8 The Secretary confirmed that he had written to AP&CU on 23 April passing on the Committee's recommendation that the application be approved without additional conditions, "based on the information provided in the application form and the assumption that good clinical practice would be observed." 3.9 The discussion at the April meeting had been expanded to discuss applications in a broader sense. The new working group on applications, chaired by Professor Purchase, was due to meet immediately after the APC meeting. April 2002 APC Minutes - Item 10: paragraph 10.1 3.10 Mr McCracken commented on the Chairman's statement that requests for information by members should be made through the Chair rather than directly to the Secretariat. Mr McCracken felt this would be ineffective, and asked when this had been established. [Secretary's note: The Chairman wrote to members explaining the role of the APC Secretariat in 2000. (It was an APC Information paper (INF(00)3).) A copy is attached at Annex C. Paragraph 4 of the annex to that letter states that the Secretary is responsible to the Committee through the Chairman for the performance of its functions.] April 2002 APC Minutes - Item 10: paragraph 10.4 3.11 The Chairman confirmed that in the event he had not spoken to the Clerk of the House of Lords Select Committee, but that the Secretary had, in order to establish the likely publication date of the Select Committee's report, which was mid-July, before the Parliamentary recess. [Secretary's note: Certain matters arising were discussed later in the meeting under 'Any other business' Item 4: The Committee's Annual Report for 2001 (APC(02)21) 4.1 Professor Banner drew members' attention to the draft report and asked that any drafting comments be provided to the Secretariat in writing. The intention remained to submit the revised report to Parliament in October. 4.2 In general terms, Committee members suggested that draft report could be improved by removing general description and using more succinct summaries and proactive language. It was also suggested that the report could be altered to better showcase the APC's actual achievements during the year. 4.3 Mr McCracken commented specifically on paragraph 28 of the draft report. He suggested that the Minister's position on the reasons why an APC quality assurance panel had not been used to investigate the 'Uncaged' allegations should be distinguished from the Committee's position. In addition, he suggested that the APC did not see this investigation as merely routine. Other members said that such amendments did not reflect the Committee's agreed position. Professor Banner said that he did not wish to reopen the issue. He advised that the minutes of the February APC meeting would be checked and the annual report would be written to reflect the formally recorded opinions of the Committee. [Secretary's note: The relevant section from the ratified minutes of the February 2002 APC meeting is reproduced below:
4.4 Mr McCracken suggested that the reference to the APC weekend conference be amended to make it clear that this was an additional forum for discussion, and not an official APC meeting. 4.5 Another member suggested that paragraph 30 of the draft report should be amended to read 'We asked the two scientists for their permission for their paper (suitably anonymised) to be made publicly available on our website.' 4.6 Professor Banner advised that a revised report would be provided to the APC at its next meeting on 11 September. Action: Secretariat Item 5: Code of Practice for Scientific Advisory Committees: Implications for the APC (APC(02)22) 5.1 The Secretary described the background to the development by Cabinet Office of this code of practice. Two lessons learnt from the BSE crisis had been that scientific committees needed to embrace divergent opinions, and to strive to keep the public informed. The Secretary said that he had also added material about Freedom of Information to the paper. 5.2 The Chairman asked for the Committee's views on a publication scheme. He said that the Committee already published a lot of material, including minutes, reports and correspondence with Ministers. This could be widened to include APC papers, working drafts etc. However, disadvantages to publishing all papers were that publication of working papers might inhibit the Committee's discussions. A possible compromise would be for minutes of Committee meetings to be made fuller and more comprehensive by increased use of annexes and Secretary's notes. Some Committee members were in favour of a large proportion of background papers being made publicly available. Others however expressed reservations and felt that only 'fully formed' documents should be made available, with the consent of the author (where appropriate) and after due regard to sensitivity and confidentiality. There was also a need to limit the volume of material. 5.3 It was agreed that when induction packs were prepared for new members any updated or new material would also be provided to existing members. It was also noted that the Committee's strategic planning did not take place only at the APC weekend conference, but also took place during official APC meetings. Lastly it was noted that paragraph 64 of the paper - dealing with contacts with the media by the Committee and Members - should more closely reflect guidance on relations with the public contained in the Committee's Code of Conduct. 5.4 It was noted that the use on the website of hyperlinks could make information more accessible. The Secretariat was asked to explore the practicalities of placing a larger number of background and working papers on the APC website. The Secretariat was also encouraged to continue its attempts take a pragmatic approach to provision of information and to provide useful background material to illuminate the ratified minutes. It was likely that the availability of documents would need to be determined on a case-by-case basis. The Secretariat was asked to work up a possible modus operandi for discussion at a future meeting. Action: Secretariat Item 6: Cost/Benefit working group draft report APC(02)23 6.1 Professor Banner opened discussion on the working group's draft report. He said that it was still very much work in progress. He sought comments on the current draft and asked if there were any key points missing. He advised that the revised paper would be brought back to the APC for discussion at the September meeting. He invited members to provide the Secretariat with any detailed comments in writing. 6.2 During the discussion, the Secretariat took notes and undertook to forward them to Dr Jane Smith, the consultant assisting the working group. Action: Secretariat Item 7: Response to the letter from 'Genewatch' APC (02) 24 7.1 Upon receipt of a report and letter from Genewatch, Professor Banner had asked Professor Richardson to reconvene the Biotechnology working group to assess the report for the main Committee. APC(02)24 contained the working group's conclusions, which suggested that the report largely covered material which had already been addressed in the Committee's reports on Openness and Biotechnology. After general discussion it was agreed that the Chairman would reply to Genewatch referring to the Committee's views which had already been recorded in the Biotechnology report, and also advising that the issue of retrospective reviews was being considered by the cost/benefit committee. Action: Secretariat Item 8: BUAV allegations about non-human primate research at Cambridge University APC(02)25 8.1 The following committee members declared interests:
8.2 There was a short discussion as to who needed to declare interests and whether those interests should prevent them from participating in the ensuing discussion. Professor Banner noted that those with a direct personal or commercial interest should withdraw from discussion. Dr Langley volunteered to withdraw and her offer was accepted. She left the room during the discussion of this item. Home Office staff also offered to withdraw, but this offer was not accepted. It was agreed that having declared her interest, Professor Richardson should remain in the meeting. 8.3 The Committee agreed with Professor Banner's proposal to commission a small working group to assess the BUAV's allegations in the light of the BUAV report and the Home Office's response to it, in order to identify areas for further discussion by the Committee. The possible membership of the working group was discussed. Professor Banner agreed to circulate a proposed membership list and terms of reference of the working group after the meeting. Action: Professor Banner 8.4 A member asked why the Home Office's examination appeared to be restricted to an examination of the severity levels and compliance issues rather than a wider investigation of the full BUAV report. Home Office officials replied that as an initial step, Bob Ainsworth had asked the Chief Inspector for a report on the allocation of severity bands and severity limits in respect of the three project licences raised in the report, and for advice on the licensing decisions and on compliance with the licence authorities. The need for any further action would be considered when the Chief Inspector had submitted his report. Item 9: Improving experimental design and statistics APC (02)26 & APC (02)26A 9.1 Dr Festing's paper referred to the need for experimental animals to be used humanely, efficiently and economically so as to obtain the maximum amount of information at minimum cost to the animals. Experiments should be well designed so that high quality data were collected and subjected to a statistical analysis which extracted all useful information. Poor design might lead to the direct waste of the animals used as well as indirect waste of the animals used in trying to sort out unrepeatable results. Unfortunately, it was well documented that some experiments were poorly designed and incorrectly analysed. Dr Festing proposed that the APC should convene an informal meeting of all stakeholders with an interest in improving the design of animal experiments. The aim would be to develop a plan of action which might include ways of achieving better education of new and existing research scientists and the provision of statistical consultancy expertise, 9.2 Professor Banner opened discussion on the paper and thanked Dr Festing for preparing it. Some members endorsed the proposal, and one member had personal evidence of poor statistical design in a research proposal which had been presented to an ERP committee of which he was a member. Professor Martin noted that the proposal could be seen as placing an extra burden on scientists, and suggested that improvements in molecular biology were of equal importance to improvements in statistical design. Another member felt unease that the APC had not carried out substantive work on the issue before proposing a meeting with stakeholders, and agreed that there were other areas that might be equally deserving of the Committee's attention. Some members felt that the evaluation of statistical design should be covered by academics performing peer review. 9.3 It was agreed that Dr Festing's paper would be discussed by the Education and Training and Research and Alternatives subcommittees before further discussion at a future Committee meeting. Action: Secretariat Item 10: Enforcement and Compliance - CPS Prosecution Criteria (APC (02)27) 10.1 Professor Banner invited discussion on the CPS prosecution criteria. The Chief Inspector noted that Home Office liaison took place with CPS or the Police when there was a possibility of prosecution. 10.2 Dr Langley drew the Committee's attention to a recent 'Guardian' report (19 June) discussing anonymous reporting mechanisms to improve patient safety within the NHS. She thought some of those mechanisms might be transferable to organisations conducting experiments on animals. 10.3 The Committee agreed to note the paper. Item 11: Primates sub-committee report APC(02)28 11.1 APC (02) 28 was a revision of the paper discussed at the Committee's meeting of December 2001. Dr Jennings outlined the changes to the document. She advised that further information was being sought from the pharmaceutical industry and suggested that once the report had been agreed, the executive summary could be written and the document published. 11.2 Professor Banner thanked the working group for their efforts in developing this report. The Committee then considered each recommendation in turn and Dr Jennings noted amendments to the text accordingly. 11.3 It was agreed that Dr Jennings would co-ordinate the redraft taking into account the comments and produce an executive summary. This entire redrafted document would be circulated to members for comment, and the Chairman said he would aim to place it before Ministers prior to the Committee's next meeting on 11 September. Action: Dr Jennings / Professor Banner 11.4 Committee members were asked to provide any further written comments to Dr Jennings. Action: All Item 12: Any other business April 2002 APC Minutes -Item 7: Accommodation, Husbandry and Care working group 12.1 This working group had been appointed at the last meeting and had been conducting its business via e-mail. An update was provided in APC(02)29 which proposed an "ad hoc sub-committee". This group would immediately examine accommodation and husbandry policy issueSTIFY">12.3 At the April APC meeting Dr Langley had discussed statements made by Ms Angela Eagle in her evidence to the House of Lords Select Committee on Animal Experimentation regarding the difficulty of spending the APC research budget. The Chairman asked Professor Anderson, chair of RASC to write to Dr Langley. Action: Professor Anderson Schedule 1 working group 12.4 APC(02)30 contained a progress report from the Schedule 1 working group. Mr Gregory spoke to this document and advised that good progress had been made. The working group anticipated considering the results of a scientific literature review at its October meeting. After discussion the Secretariat was asked to check the propriety of tenders to carry out the literature search being sought from organisations with which APC members had significant contacts. Action: Secretariat Home Office recent events (APC(02)31) 12.5 Mr Walsh spoke to this item.
12.6 Committee members asked the Home Office for more detailed information about the datasharing concordat. Home Office officials agreed to report further on the review of the datasharing concordat at a future meeting. Action: AP&CU Taking forward "Uncaged" issues (APC(02)32) 12.7 Professor Banner undertook to write to "Uncaged" outlining the work undertaken by the APC in relation to this issue and what actions remained. Action: Secretariat 12.8 Dr Jennings reported that the RSPCA had posted its report into the "Uncaged" allegations on the RSPCA website. It was also available on the Novartis website. New Orleans congress on Alternatives 12.9 Dr Festing said that he would be attending this conference and agreed to provide the committee with brief informal feedback at its next meeting. Action: Dr Festing Parkinson's disease research 12.10 Dr Langley referred to an article in "Nature" about experiments on non-human primates. [Secretary's note: The relevant paragraph of the article reads:
12.11 Dr Langley asked if the work referred to in the article had indeed been stopped and if it was the work conducted under the licence application which the APC had examined some time ago. The Chief Inspector said he was not aware of any ongoing licensed work on non-human primates being halted in the way described in the article, and he had not identified the researcher to whom the article referred. Item 13: Date of next meeting 13.1 Professor Banner advised that the next meeting of the APC would take place on 11 September. 13.2 The meeting ended at 14.12. APC Secretariat 10 July 2002 ANNEX A ROOM 978, 50 QUEEN ANNE'S GATE LONDON SW1H 9AT 020 7273 2915 or 2770 From the Chairman Reverend Professor Michael Banner MA DPhil Angela Eagle MP Parliamentary Under-Secretary of State Home Office 50 Queen Anne's Gate London SW1H 9AT
Dear Ms Eagle PRIMATES APPLICATION 40/2382: ADVICE OF THE ANIMAL PROCEDURES COMMITTEE (APC) The Home Office referred this application to the APC for advice, as it involves the use of non-human primates in procedures of substantial severity. As a first step the Committee formulated several questions about the application, and it was grateful to the applicant for replying comprehensively to them. We then discussed this application at our meeting on 10 April, and I am writing to present the Committee's advice. I apologise for the delay. 2. At the meeting on 10 April the Committee found the application difficult to assess. However, it recommended by a majority vote of 11 to 4 that the application should be allowed on the basis that reassurances are obtained on the particular concerns set out below. The Committee's particular concerns 3. The Committee was reassured to hear about the high level of support, including substantial involvement by the Animal (Scientific Procedures) Inspectorate, which will be available during the treatment, but they would like to have more information about the welfare assessments which will be used. What quantitative assessments of welfare are used? As well as aspects of the animals' physical welfare, how are psychological aspects to be measured and monitored during the MPTP treatment stage? We would also have expected more information on the expected harms to the animals' welfare and on the specification and identification of endpoints. Could the evaluation and alleviation of psychological and physical stress be shown by means of tables, noting endpoints, harms and how they would be alleviated? Such tables were used in two recent applications referred to the Committee involving research into Chronic Obstructive Pulmonary Disorder. We suggest that the applicant should use such tables. A comparison of actual with predicted harms through the life of the project will not only help monitor the animals, but will also be useful for any similar future projects. The Committee's general concerns 4. The Committee had other, more general concerns, and we will be discussing these further in our Cost/Benefit working group. The Committee considered that although the benefits of the project were explained well, the description of the costs to the animals, and how these would be alleviated was less clear. Although standard operating procedures were submitted, they covered technical matters rather than welfare matters, and did not cover all the proposed procedures. The Committee considered that it would have been difficult to carry out a fully informed cost/benefit assessment. We would also have found it helpful to have more information about the establishment's standards of husbandry, and staff knowledge of primate behaviour, although we recognised that the applicant and the Inspectorate might have this information. The Committee considered that, from the material supplied, an assessment of the costs and benefits would have been particularly difficult for the lay person. A clear, comprehensive but (as far as possible) non-technical explanation of costs and benefits would, we believe be essential to enable lay members of the Ethical Review Process to make informed and considered decisions both at the initial assessment stage and at periodic reviews. 5. I should also like to receive clarification on one other aspect of this application which caused some concern. We presume that, as is normal practice, where a substance is used on the animals which does not have full toxicological data, there will be careful dose escalation from very low dose levels in order to minimise unpleasant side effects. 6. The APC would be grateful for the Home Office's comments on the particular concerns set out in paragraph 3 and for your clarification about dose escalation. Yours sincerely MICHAEL BANNER Annex B Text of a letter from Bob Ainsworth MP to Reverend Professor Michael Banner 26 June 2002 PROJECT LICENCE APPLICATION PPL 40/2382: ADVICE OF THE ANIMAL PROCEDURES COMMITTEE Thank you for your letter of 21 May, in which you set out the Committee's advice on an application for a project licence involving the use of non-human primates in procedures of substantial severity (PPL 40/2382). I am grateful for the care that the Committee has taken in considering this application and have noted the Committee's majority recommendation that it should be approved. As to the concerns of the Committee about specific aspects of the application, you will wish to know that the applicant has agreed to revise the text describing the physiological and behavioural adverse effects of the experimental procedures, their incidence and proposed methods of prevention or control, and to use a table format. As to the concern that the experimental drugs in the project should be used in such a way as to minimise their unpleasant side effects. This is indeed the normal expectation in any programme of work and is the normal practice. However, there are circumstances where dose escalation studies are not necessary, because the minimum effective dose required to produce satisfactory results is already published in the scientific literature or is known from previous studies at the establishment. In the light of the above, I have concluded that the application should be granted. I have also noted the Committee's more general comment that it found it difficult from the material presented on the form of application to draw informed conclusions about the potential benefits and likely welfare costs of the work and that it intends to discuss this further in its cost/benefit working group. I am aware that the Committee has been conducting a review of the cost benefit assessment and look forward to receiving its report in due course. Yours sincerely BOB AINSWORTH ANNEX C To all members of the Committee 6 January 2000 THE SECRETARIAT In the interests of avoiding any confusion I thought it would be helpful to write briefly to members about the role of the Animal Procedures Committee's Secretariat. Although their role involves paper-handling, arranging meetings, and other day to day tasks they are also there to support me and members in the development & execution of the Committee's work. In particular they are expected to ensure that the Committee receives adequate advice and guidance, making use of their expert knowledge of Home Office policy and administration and of developments in the Department and in Government generally. I am grateful for the efficient and effective way in which they carry out this work. It is the job of the Secretariat to offer this advice and it is also the responsibility of members to treat it seriously. An important part of their function is to ensure that the Committee's published documents are readily comprehensible to a wide range of readers, cover all the necessary issues in relation to their subject matter, and take account of the current state of play in whatever debate they are contributing to. The attached document will, I hope, serve to clarify the position. MICHAEL BANNER ANIMAL PROCEDURES COMMITTEE The role of the secretariat The Secretariat of the Animal Procedures Committee (APC) consists of its Secretary and (currently) two other people. Members of the Secretariat are employed by the Home Office as part of its Animals, Byelaws & Coroners Unit (ABCU). They are effectively seconded to the Animals Procedures Committee, although they also have accountabilities to the Head of ABCU (see para 5 below). 2. The role of the Secretariat is to support the APC and be its executive arm. Their tasks include drafting reports and papers for approval by the Committee and/or its sub-Committees and working groups;
3. The Secretariat are also responsible for providing the Chairman and members with advice as to the conduct of Committee business and the options before it. They may offer their advice and interpretation without being specifically asked for it. 4. The Secretary is responsible to the Committee - through its Chairman - for the performance of these functions. Other members of the secretariat are responsible to the Secretary. In carrying out work on behalf of a sub-Committee or working group, the Secretariat remain responsible to the Chairman of the APC, but through the chair of that particular sub-Committee or group. The Secretary of the APC is responsible to the Head of Home Office ABCU for managing those parts of ABCU's budget which are used to support the Committee; the expenditure of the Home Office's funds for animal procedures research, on advice from the APC and its Research and Alternatives sub-Committee; fair management and the completion of staff reports on members of the Secretariat and other internal personnel issues.
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