Ethical review in Directive 2010/63 an overview of project evaluation and the role of animal ethics committees. Maggy Jennings, RSPCA Belgrade, 2012

Transcription

1 Ethical review in Directive 2010/63 an overview of project evaluation and the role of animal ethics committees Maggy Jennings, RSPCA Belgrade, 2012

2 Overview of presentation Importance of ethical review Ethical review in the directive Project evaluation Animal Welfare Bodies (AWBs) and Animal Ethics Committees (AECs) National Committees Examples of AEC/AWB activities More general discussion points on harm/benefit assessments

3 Ethical review two aspects (i) Justification: whether animals are used Harm/benefit analysis The expected benefits to humans, animals or the environment of the proposed project involving live animals should be weighed against the likely harms done to the animals......and opportunities should be sought to maximise benefits and minimise harms

4 Ethical review two aspects (ii) Practical issues: how animals are used Research must be carried out in a humane manner with no unnecessary duplication The 3Rs must be implemented at the research planning stage and throughout the project All aspects of animal use must be considered supply, housing and care, transport, handling, restraint, identification, procedures, humane endpoints, euthanasia

5 Why is ethical review important? Required by legislation Helps address wider social and political concerns Helps ensure good animal welfare and good quality science raises standards Required by some research funders Expected by some scientific journals Included in the Corporate Social Responsibility policies of multi-national companies

6 2007 report sets a precedent All uses of animals for regulated procedures as defined in pan-european regulations should be subject to comprehensive ethical review. This includes all animals that come under the EU Directive, all studies required by legislation, and also the use of animals for additional purposes listed in the European Convention - that is animal use for education and training, basic scientific research and forensic enquiries. This should involve a wide enough range of expertise and perspectives to facilitate comprehensive and detailed review of the factors relevant to ethical evaluation. Gilles Demers et al,

7 Ethical review and Directive 2010/63

8 Ethics in the Directive Recitals Animals have intrinsic value which must be respected. There are also the ethical concerns of the general public From an ethical standpoint there should be an upper limit on pain, suffering and distress Articles A harm-benefit assessment is required as part of project evaluation taking into account ethical considerations Annexes Training includes ethics in relation to human-animal relationships, intrinsic value of life and arguments for and against the use of animals

9 Project evaluation Article 36 Projects must be evaluated and authorised in advance by the competent authority Article 59.1 Each Member State to designate one or more Competent Authorities May designate bodies other than public authorities if they have the expertise and infrastructure and are free of conflicts of interests

10 The evaluation must consider. Article 38.2 Objectives (scientific benefits or educational value) Compliance with 3Rs Assessment of severity (non-recovery, mild, moderate, severe: Annex VIII) Harm/benefit analysis taking into account ethical considerations Whether and when retrospective assessment of the project is necessary

11 Information required (Annex VI) Relevance and justification for use of: animals species, origin, numbers, life stages procedures 3Rs methods Use of anaesthesia, analgesia, other pain relief Reduction, avoidance, alleviation of suffering from birth to death Use of humane endpoints Experimental design & observations of animals to minimise suffering Re-use & its effects Severity classification Avoidance of duplication Housing & care Methods of killing Competence of staff

12 Transparency of the process Article 38.4 The project evaluation process shall be: transparent performed in an impartial manner and may integrate the opinion of independent parties

13 Retrospective review of projects Article 39 All projects using primates and projects with procedures classified as severe shall undergo retrospective review Retrospective review evaluates: Whether the objectives were achieved The actual harms (numbers, species, severity) Contributions to the 3Rs This is good practice for all projects! (see LASA guidelines at:

14 Project evaluation: key aims Aim to ensure that: A robust system is in place that will allow an honest description and critical assessment of the harms and benefits and application of the 3Rs in all projects Those responsible for making decisions on weighing harms and benefits and authorisation of projects have the right knowledge, expertise and skills and are able to balance science and welfare Independent views are incorporated and that authorisation is done in a transparent manner

15 Role of the Animal Welfare Body Article 26 Each breeder, user and supplier must set up an animal welfare body the AWB operates at the institute level Article 27: Tasks of the AWB 1. Advise staff on animal welfare (in relation to supply, housing, care and use) 2. Advise staff and keep them up to date on the 3Rs 3. Review internal operational procedures 4. Follow the development and outcome of projects 5. Advise on rehoming schemes

16 Membership of the AWB Article 26.2 The AWB shall include at least: The person responsible for the care and welfare of animals and in the case of a user, a scientific member The AWB shall also receive input from the designated veterinarian This is much less than recommended for ethical review and for dealing with the practical aspects of animal use

17 How do AWBs compare with AECs around the world? Ethics committees well established in some countries (e.g. Canada, Australia/NZ, USA, Sweden, Switzerland ) and EU Member States; just starting in others May be at institute, regional or national level Some have a regulatory role and carry out project authorisation Some carry out review of projects from a local perspective in addition to authorisation by the competent authority Local institute AECs cover practical tasks 1-5 Most have a wider membership with more emphasis on public involvement

18 Summary comparison of AWBs and ECs An ideal ethics committee Animal welfare body Ethics in the title with broader ethical review as a function No Project review/ethical evaluation No Ongoing review of projects Yes Retrospective review of projects Possibly Advice on animal welfare and 3Rs Yes Advice on housing, care, euthanasia Yes Operational issues Yes Training issues No Rehoming Many members: scientists, care staff, vets, community (lay), welfare Few members: a scientist, an animal care person, plus vet input

19 Institutional AWB: Key aims Define the scope and terms of reference of the AWB consider how it will implement its 5 tasks and what members it will need to be effective Include members with a wider range of skills and perspectives than the basic minimum If there is a good AEC with a broader remit and wider membership then retain this - incorporate the AWB into the AEC rather than replacing the AEC Further develop the operation of AECs/AWBs e.g. through guidelines, web resources, development of training for members

20 Two useful resources Click to edit Master text styles Second level Third level Fourth level Fifth level

21 and National Committees - roles membership Article 49: Each Member State shall establish a National Committee for the protection of animals used for scientific purposes to: Advise the CA and AWBs on acquisition, breeding, accommodation, care, and use of animals and ensure sharing of best practice Exchange information on operation of AWBs and project evaluation and share best practice within the EU No details of membership

22 NCPASP: key aims Define the scope and terms of reference of the committee Ensure a balance between members with scientific and animal welfare interests Think about how and what to communicate between AWBs/AECs internally and between your NC and those in other Member States Decide how to make judgements on what best practice is Develop an informative and interactive public face For an example, see

23 Some examples of institutional AEC/AWB activities

24 RSPCA/LASA guidelines Includes Ten Top Tips Click to edit Master text Second level Third level Plus FELASA report Fourth level Fifth level

25 An ideal institutional AEC/AWB can.. Review projects prior to authorisation Carry out ongoing and retrospective review Help assess actual severity Promote the development and application of all 3Rs Ensure high standards of animal housing and care Ensure all staff get the training they need Provide a forum for discussion of any issue relating to animal use Help with transparency and accountability regarding animal use Develop a culture of care

26 Project review A good AEC/AWB will: Devote sufficient time to reviewing individual projects Make a real effort to understand harms; carefully and critically review harms and benefits Take account of expert input on welfare, 3Rs etc Be prepared to be challenging about harms, benefits and the 3Rs Ask for regular reports of progress Ensure lessons learnt from retrospective review are applied in future Encourage open discussion, ensuring all views are heard Make the process efficient in time and resources

27 3Rs activities Provide a focal point for advice including 3Rs input to project development Review validity of specific animal models Review and refine procedures e.g. that cause severe suffering Develop welfare assessment protocols Challenge preconceptions about how things have always been done Review over-breeding and wastage Set up project or species based 3Rs groups. Develop global initiatives and oversight Disseminate 3Rs information newsletters, alerts, websites, 3Rs days, 3Rs prizes

28 Housing, care, humane killing Provide a central point for problem solving and review: housing and enrichment exercise and play for e.g. dogs, rabbits, rats identification procedures transport and acclimatisation noise and/or light levels the use of CO2 for humane (??) killing the sharing of tissues Create a system for incorporating new knowledge on animal behaviour and welfare needs

29 Education and Training Ensure there is a good system of education and training, supervision and assessment of competence in place so that: all training needs are identified and met supervision requirements are fulfilled there is a robust system for assessing competence CPD is provided training and competence records are reliable there are sufficient trainers, supervisors and assessors available staff know who to go to with questions

30 Developing an efficient AWB Ensure the AWB has authority and support from senior staff Be clear about the aims and objectives Focus on constructive discussion not complex paperwork Ensure all staff understand what the AWB/AEC is for, how it operates and what is expected of them Develop good communications between the committee and other staff Appoint members who are confident to put forward their views and challenge the status quo Implement decisions in a timely manner Re-evaluate its aims, activities and processes at regular intervals

31 Better selection and training of members Key competencies Knowledge, understanding and expertise in: animal husbandry, care and welfare each of the 3Rs education and training ethical issues and discussion individual techniques public opinion and perspectives relevant scientific fields statistics welfare assessment and humane end-points Personal qualities open-minded, fair and impartial prepared to listen and respond to differing views and not be unnecessarily defensive prepared to think outside the box and have the confidence to challenge the status quo having realistic expectations of what can be achieved the time and commitment to take an active role and do the role justice

32 The importance of a lay perspective Someone with no stake in the work Provides a different perspective Can stimulate improvements by asking simple questions or challenging traditional assumptions Can ask questions staff may feel unwilling to ask in front of others Provides a measure of public input

33 More general discussion of weighing harms and benefits

34 How do we make decisions? Harm/benefit analysis The expected benefits to humans, animals or the environment of the proposed project involving live animals should be weighed against the likely harms done to the animals... and opportunities should be sought to maximise benefits and minimise harms

35 How do we make decisions? There is no set formula and a spectrum of views! A matter of opinion and judgment which depends on: 1. The nature and likelihood of the benefit 2. The value placed on animal life may depend on species, numbers 3. The nature and level of suffering 4. Controversy around particular procedures 5. The fate of the animals

36 1. The nature of the benefit What criteria do we use to justify using animals? In basic research is all knowledge equally valuable? Are all health benefits equally valuable - does the nature and severity of a medical condition make a difference? What about using animals to develop cures for hangovers, or in space research? Are all chemical products essential? Does an economic benefit justify animal use?

37 2. The value of animals Are all animals equal? Primates are intelligent animals occupying extensive home ranges. They have complex behaviours and social nteractions. They can undoubtedly experience pain and distress. It is very difficult to satisfy their physical and behavioural needs in a aboratory environment. but the same can be said of pigs or rats And what about fish?

38 How do we make our decisions? Is it just perceived intelligence? Does the size of the animal make a difference, or what they look like, or how they behave towards us? =?

39 Small animals are not always small! and large animals are not always large!

40 3. The nature and level of suffering Does the level of harm it is acceptable to cause depend on the type of benefit expected? Are there harms that you think cannot be justified for any purpose? How well do you think we assess pain, suffering and distress in animals? Would you inflict severe suffering on any animal? Directive sets limits on severe pain, suffering or distress that is likely to be long-lasting and cannot be ameliorated. How would you interpret this?

41 4. The fate of the animal Is death a harm in itself? Are the ethical issues the same if animals are killed for tissues, or if experiments are carried out under anaesthesia and the animal is not allowed to recover? Does it make a difference if animals are: Killed Re-used Rehomed Released

42 5. Controversial procedures People can be concerned about certain procedures regardless of benefit and even if they cause no more suffering than others Interference with the brain or special senses Genetic modification where plant genes are put in to animals Putting human germ cells into non-human animals Xenotransplantation

43 Information on ethical review together with a range of documents for download that have been designed as resources for members of ethics committees Includes links to other relevant information

44 Thank you!