bell hooks, Feminism Isfor Everybody, South End Press, Boston 2000, p 17.

introduction

When you prepare your project licence application, you must specify the required regulated procedures for the programme of work, the likely adverse effects that may occur as a result of the regulated procedures, and the humane end-points that will be applied. You must also explain what benefits are likely to accrue as a result of the project.

The harm–benefit analysis must be undertaken by the inspectorate, based on the information you provide, as part of the project evaluation process. inspectors provide advice to the Secretary of State based on the harm–benefit analysis of project licence applications. To do this we utilise a number of processes to ensure a consistent approach amongst inspectors: good communication, continued professional development, precedent cases, and utilising external views (e.g. the Animals in Science Committee (ASC), external expert reviews and other stakeholders). This Guidance explains how inspectors carry out the harm–benefit analysis and the main factors they take into consideration. it will be of particular interest to project licence applicants and to AWeRBs considering applications from a local perspective.

What is a harm–benefit analysis?

The likely harms that the animals will experience as a consequence of the project are assessed by analysing the information you provide in the project licence application. The extent to which you have applied the 3Rs (replacement, reduction and refinement) will be evaluated in considering whether the proposed harms are minimised in relation to the particular purpose of the requested animal use. We will advise you if we consider you have not adequately explained how the proposed harms are minimised as much as possible.

inspectors may also use additional information to assess the likely harms such as evidence from inspection of your work or that of others, the scientific literature and their own specialist knowledge of science, animal welfare, veterinary and human medicine. during this process the inspector will also confirm the severity categories of each

of your protocols by using the descriptors in Annex 8 of 2010/63/eU (see appendix g), other relevant guidance,

literature evidence, knowledge of similar work authorised under ASpA and their own professional judgement. The benefits that may result and the likelihood of their delivery are also assessed from the information you provide in the application. inspectors may seek further information either from you, from the scientific literature or from specialist knowledge within the inspectorate to understand the context and the value of those benefits.

Once the benefits have been clearly defined and understood, the likelihood of delivery of those benefits is considered. inspectors use criteria such as the proposed scientific methodology, the resources available to you and your track record with regard to publications and animal use, to determine how likely the benefits are to be delivered. Only once the harms, benefits and likelihood of delivery have been fully explored by the inspector, including the extent to which the effective implementation of the 3Rs has been addressed, is a judgement made as to whether the likely harms are justified by the likely benefits. This judgement is fundamental to the recommendation provided to

the Secretary of State with regard to granting or rejection of the applicationand reflects the scale and significance

The balance between harm and benefit may be further analysed throughout the life of the project for a number of reasons, and should be considered to be a continuous process. For example, unexpected adverse effects may increase the level of suffering during a project, and the inspectorate will need to reconsider the analysis.

On 1 January 2013, the recording of actual severity experienced by each animal became a legal requirement. This will facilitate continuous analysis of actual harm throughout and at the end of the project, providing a mechanism to review the predictions made at the beginning of the project. in addition, some categories of applications are subject to retrospective assessment, which in part involves reconsideration of actual harms and benefits. This will facilitate regular harm–benefit review which will inform our decisions regarding whether ongoing project authorities are still appropriate and whether new project applications have predicted harm appropriately.

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What information is taken into account?

The benefits that are weighed against the harms are the specific likely outcomes of the programme of work, and not the non-specific benefits of the area of research.

projects may both deliver direct and indirect benefits, and/or short-term and long-term benefits. inspectors weigh the importance of benefits by considering:

What will be the benefits of the work?

What data or product(s) may be acquired from the work? What scientific questions will be answered? What are the knowledge gaps that will be filled by the work?

Who and how many will benefit from the work?

For example, other researchers in the field or other fields, patients or clinicians.

How will they benefit – impact?

For example, further understanding of normal brain function, better diagnostic tools, better therapy or monitoring the success of therapy, improvements to quality of life, or knowledge to inform drug development.

When will the benefits be achieved?

For example, within the life of the project or in 20 years’ time.

Explaining benefits in the project application

it can be useful to address some or all of the following points in your application to provide detailed information about the benefits of your project:

1. Clarify the current state of knowledge on which your project intends to build.

2. explain the way in which the project will help to advance knowledge through filling a knowledge/ information gap.

3. Wherever possible, “increased knowledge” as the primary benefit should be linked to a more tangible strategic goal, even though any wider benefits may be much further in the future and less predictable. 4. explain why the benefits go beyond “it would be nice to know”.

5. Scale of improvement (for humans, animals or the environment); numbers; size and quality (need informed judgement – orphan drugs may be used in a few people but high impact on individuals) and

burden to society of the problem (both in basic and applied research).

6. Basic research driven by hypotheses needs to confirm that the hypothesis is scientifically sound and realistic.

7. in some areas of basic research expanding knowledge can be a suitable objective in its own right – but

should always be linked to dissemination of results, whether positive or negative (having regard to

intellectual property), and potential longer-term benefits.

Evaluating benefits

it is often more straightforward to judge the severity of harms to be applied than to place specific value on benefits. projects that directly benefit human health tend to be considered of high value but basic research is also a permissible purpose under ASpA and is not necessarily considered to be less valuable. The seriousness of a human disease and number of patients affected may be taken into account. However, if there are existing efficacious drugs for the disease in question already, the benefit may be considered to be lower. The benefits of regulatory testing can be difficult to determine beyond that of safety and efficacy, but there are legal requirements that these be conducted. it should be recognised that the value of particular benefits to society are dynamic and influenced by social factors and by health, economic and political issues. These will vary over time. Finally, the perceived value of a particular benefit is affected by an individual’s own personal values and will therefore vary amongst individuals. in order to avoid significant inconsistency of decision-making within the inspectorate, we use a number of mechanisms:

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● internal referral of specified cases;

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● inspector review panels;

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● regular discussion groups;

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● advice from the ASC;

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● external assessors.

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each protocol has a severity category applied but of itself does not provide sufficient information for the harm–

benefit analysis to be undertaken.

The key issues for consideration of harms include:

1. procedures being applied to animals:

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● frequency/duration of procedures;

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● likelihood of each adverse effect, percentage of animals predicted to be affected;

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● severity level and methodology to minimise severity;

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● monitoring regime; welfare assessment protocols;

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● humane end-points and triggers for interventions.

2. Species/strain/age of animals being used.

4. Fate of animals: ●

● death – intrinsic value of animal; “quality” of death impacts on animal’s experience and on severity;

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● criteria for re-use or rehoming.

5. Contingent harms – husbandry and care practices; transportation.

Consideration should also be given to the cumulative effects of techniques considered to be ‘lower than’ or ‘below threshold’ which when used in combination or on more than one occasion (multiple) may lead to a ‘higher’ or above ‘minimum threshold’ severity when repeated.