Title of the project

Duration of project

(in months)

Key Words (maximum of 5) (1)

Purpose of project  (2)

(multiple choices possible)

Objectives and predicted benefits of the project

Describe the objectives of the project (for example, addressing certain scientific unknowns, or scientific or clinical needs).

What are the potential benefits likely to derive from this project? Explain how science could be advanced, or humans, animals or environment may ultimately benefit from the project. Where applicable, differentiate between short-term benefits (within the duration of the project) and long-term benefits (which may accrue after the project is finished).

Predicted harms

In what procedures will the animals typically be used (for example, injections, surgical procedures)? Indicate the number and duration of these procedures.

What are the expected impacts/adverse effects on the animals, for example pain, weight loss, inactivity/reduced mobility, stress, abnormal behaviour, and the duration of those effects?

What species and numbers of animals are expected to be used? What are the expected severities and the numbers of animals in each severity category (per species)?

Species  (4)

Estimated total numbers

Estimated numbers per severity

Non-recovery

Mild

Moderate

Severe

What will happen to the animals kept alive at the end of the procedure? (5) ,  (6)

Estimated number to be reused

Estimated number to be returned to habitat/husbandry system

Estimated number to be rehomed

Please provide reasons for the planned fate of the animals after the procedure.

Application of the Three Rs

1. Replacement

State which non-animal alternatives are available in this field and why they cannot be used for the purposes of the project.

2. Reduction

Explain how the numbers of animals for this project were determined. Describe steps that have been taken to reduce the number of animals to be used, and principles used to design studies. Where applicable, describe practices that will be used throughout the project to minimise the number of animals used consistent with scientific objectives. Those practices may include e.g. pilot studies, computer modelling, sharing of tissue and reuse.

3. Refinement

Give examples of the specific measures (e.g., increased monitoring, post-operative care, pain management, training of animals) to be taken, in relation to the procedures, to minimise welfare costs (harms) to the animals. Describe the mechanisms to take up emerging refinement techniques during the lifetime of the project.

Explain the choice of species and the related life stages.

Project selected for Retrospective Assessment  (7)

Deadline

Contains severe procedures

Uses non-human primates

Other reason

Title (as per Non-technical Project Summary)

Reason for Retrospective Assessment  (8)

Using non-human primates

Contains ‘severe’procedures

Other reason

Explain ‘Other reason’

Achievement of objectives

Explain briefly whether, and to what extent, the objectives set out in the authorised project have been achieved. Provide reasons if objectives have not been attained.

Have there been any other significant findings?

What benefits have resulted from the work to date, and are further benefits expected?

Have the results of this project been disseminated, including where hypotheses are not proven? If so, describe how. If not, indicate how and when results are expected to be publicised.

Harms

Species  (9)

Total numbers of animals used

Numbers of animals per actual severity

Non-recovery

Mild

Moderate

Severe

How do numbers of animals used and actual severities compare with those estimated? Where the actual numbers are higher than the estimated numbers, please provide an explanation. Where the actual numbers are lower, please provide an explanation unless that difference is a result of Reduction or Refinement?

How does the fate of animals kept alive at the end of the study compare with the estimated fate? Please provide an explanation.

Any elements that may contribute to further implementation of the Three Rs:

1. Replacement

With the knowledge obtained from this project, have any new approaches that could replace some or all of the use of animals in similar projects been identified/developed (including the development/validation of new in vitro or in silico techniques)?

2. Reduction

With the knowledge obtained from this project, could the experimental design be improved to enable any further reduction of the use of animals, and if so, how?

Provide an explanation where numbers of animals used were lower than those originally estimated.

3. Refinement

Provide an explanation where the actual severities were lower than those originally estimated.

With the new knowledge obtained from this project, are the animal models used still the most appropriate? Please specify per species/model, where appropriate.

List any novel refinements introduced during the project to reduce harm to the animals or to improve their welfare.

What are the potential opportunities for further refinement in the future, for example, emerging technologies, techniques, improved welfare assessment methods, earlier endpoints, housing/husbandry measures?

4. Other

How are the findings for further implementation of the Three Rs disseminated?

Additional comments