Animal Care and Research Ethics Committee (ACREC)

An Application Submitted to the[A1]

National University of Ireland’s

Animal Care and Research Ethics Committee (ACREC)

Designated Contact Person:

......

Contact details:

Email: ......

Tel: ......

Address: ......

ACREC Filing ID:......

Application for a Project Authorisation under Scientific Animal Protection Legislation

For details on completing this application form, refer to the‘Guide to Project Applications under Scientific Animal Protection Legislation’.

SECTION A: proposed Authorisation holder (i.e. user)

Proposed authorisation holder (i.e. user):
Address 1:
Address 2:
Address 3:
Note: In the case of an academic setting, the user is usually the project manager. In the case of a commercial setting, the user is usually the commercial entity.

SECTION B: PROJECT MANAGER AND breeder/supplier/user ESTABLISHMENT DETAILS

B1: PROJECT MANAGER
Title:
First name:
Surname:
Address 1:
Address 2:
Address 3:
County:
E-mail:
Telephone:
Individual authorisation number:
If no current individual authorisation number exists, please state the date of application for an individual authorisation:
Provide the project authorisation number(s) and expiry date(s) of any HPRA project authorisations currently or previously held by the project manager:
Please append CV (setting out education, training, experienceand publication history). (A template CV is available on the HPRA website if you wish to use it.)

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B2: DEPUTY PROJECT MANAGER DETAILS (if applicable)
Title:
First name:
Surname:
Address 1:
Address 2:
Address 3:
County:
E-mail:
Telephone:
Individual authorisation number:
If no current individual authorisation number exists, please state the date of application for an individual authorisation:
Please append CV (setting out education, training, experience and publication history). (A template CV is available on the HPRA website if you wish to use it.)

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B3: USER ESTABLISHMENT DETAILS
USER ESTABLISHMENT NAME / USER ESTABLISHMENT AUTHORISATION NUMBER
Address where the project will be conducted:
In the case of a collaboration, list the user establishment authorisation number of each user establishment at which the applicant will participate in project work:
COLLABORATING USER ESTABLISHMENT NAME / COLLABORATING USER ESTABLISHMENT AUTHORISATION NUMBER
List any location other than the authorised user establishment(s) where procedures will be carried out and provide a scientific justification as to why each additional location is necessary.

Section C: Project information

Project title (≤ 500 characters):
1. Is this project being performed solely to satisfy regulatory requirements?
If ‘yes’, provide details in relation to the relevant statutory requirements and/or regulatory guidelines that will be fulfilled by completing the project: / Yes ☐No ☐
2. Is this project application solely for production or diagnostic purposes using recognised established methods(e.g. production of antibodies, serum-based medicinal products, other biological material)?
If ‘yes’, state the likely demands for the service or product in the lifetime of this proposed authorisation: / Yes ☐No ☐
3. Does this project involve any use of neuromuscular blocking agents (NMBAs)?
If ‘yes’, explain why the purposes of this project cannot be achieved without the use of such an agent: / Yes ☐No ☐
4. Has this project been approved by an ethics committee[A2]?
If ‘yes’, provide a copy of the ethical review application, approval documentation and any correspondence/documentation to/from the relevant ethics committee in which queries have been raised and addressed[A3].
If ‘no’, complete the ‘Fee Application Form for Scientific Animal Protection’, include the appropriate fee and provide a justification as to why an ethical review was not performed: / Yes ☐No ☐
5. State expected duration of project work (months):
6. State estimated start date of project work, while considering the HPRA timelines for project evaluation:
7. State the total number of animals per species to be used for this project:
SPECIES / NUMBER OF ANIMALS
Provide details of the individuals who will be performing procedures as part of this project. (Please note, if the project manager and/or deputy project manager(s) will be performing procedures they should also be listed here):
TITLE / FIRST NAME / SURNAME / INDIVIDUAL AUTHORISATION NUMBER / If no current individual authorisation number is held, state the date of application for an individual authorisation

SECTION D: PROJECT PURPOSE

D1: PROJECT DETAILS
1. Describe the overall purpose and specific objectives of this project, setting out clearly the key scientific questions to be addressed (≤ 5000 characters):
2. Describe the current state of scientific knowledge for the work to be performed on this project, including, where relevant, anygoals you have already achieved under previous studies in the area (≤ 5000 characters):
3. How do the objectives of this project differ from the findings of previous studies in this area?(≤ 5000 characters):
4. Detail the expected scientific or educational benefit of the project,including who is likely to benefit, how and when they are likely to benefit, and why these benefits are worthwhile (≤ 5000 characters):
5. Describe how the results will be disseminated(≤ 5000 characters):
6. Describe the resources available (including staffing, experience of personnel and equipment and funding) for the project (≤ 5000 characters):
7. List the most relevant key references supporting the need for the project:
D2: PURPOSE OF THE PROJECT
Provide information on the proposed purpose(s) of this project, selecting the most relevantfrom the list below (Refer to the ‘Guide to Project Applications under Scientific Animal Protection Legislation’for the choice of sub-fields).
☐ Basic research - state sub-field(s)
☐ Translational and applied research - state sub-field(s)
☐ Regulatory use and routine production - state sub-field(s)
☐ Protection of the natural environment in the interests of the health or welfare of human beings or animals
☐ Preservation of species
☐ Higher education or training for the acquisition, maintenance or improvement of vocational skills
☐ Maintenance of colonies of established genetically altered animals, not used in other procedures
☐ Forensic inquiries

SECTION E: NON-TECHNICAL project SUMMARY

Provide a completed ‘Non-Technical Project Summary for a Project under Scientific Animal Protection Legislation’form in Word format, which is available onthe Scientific Animal Protection Guides and Forms section of

SECTION F: EXPERIMENTAL DESIGN

Using the table below, provide information on each of the procedures to be carried out as part of this project in chronological order.

The table can be expanded by copying and pasting sections as many times as required depending on the number of procedures to be conducted.

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Procedure number
Name of procedure
Description/details of procedure
Justification/relevance of procedure
Species
Life stage or age
Number of animals to be used
Duration of procedure
Frequency of procedure, including the total maximum number of times an individual animal will undergo the procedure
Proposed severity classification of procedure
List all potential adverse effects of the procedure including the likely incidence and in what percentage of animals it is expected: / List all procedure-specific humane endpoints, relatingdirectly to the adverse effects: / List details of pain relieving methods, including analgesia (if relevant):
If analgesia is not proposed, provide justification: / Provide details of anaesthesia (if relevant):
If anaesthesia is not proposed, provide justification: / List any additional refinements for this procedure:
Provide details on the fate of the animals at the end of the procedure(For example, will they continue on to another procedure or will they be euthanised?)
If the fate of the animals is euthanasia, state the method of euthanasia.
If this method is a not an approved method as per Annex IV to Directive 2010/63/EU, provide justification for the use of this method.
Procedure number
Name of procedure
Description/details of procedure
Justification/relevance of procedure
Species
Life stage or age
Number of animals to be used
Duration of procedure
Frequency of procedure, including the total maximum number of times an individual animal will undergo the procedure
Proposed severity classification of procedure
List all potential adverse effects of the procedure including the likely incidence and in what percentage of animals it is expected: / List all procedure-specific humane endpoints, relating directly to the adverse effects: / List details of pain relieving methods, including analgesia (if relevant):
If analgesia is not proposed, provide justification: / Provide details of anaesthesia (if relevant):
If anaesthesia is not proposed, provide justification: / List any additional refinements for this procedure:
Provide details on the fate of the animals at the end of the procedure (For example, will they continue on to another procedure or will they be euthanised?)
If the fate of the animals is euthanasia, state the method of euthanasia.
If this method is a not an approved method as per Annex IV to Directive 2010/63/EU, provide justification for the use of this method.
Procedure number
Name of procedure
Description/details of procedure
Justification/relevance of procedure
Species
Life stage or age
Number of animals to be used
Duration of procedure
Frequency of procedure, including the total maximum number of times an individual animal will undergo the procedure
Proposed severity classification of procedure
List all potential adverse effects of the procedure including the likely incidence and in what percentage of animals it is expected: / List all procedure-specific humane endpoints, relating directly to the adverse effects: / List details of pain relieving methods, including analgesia (if relevant):
If analgesia is not proposed, provide justification: / Provide details of anaesthesia (if relevant):
If anaesthesia is not proposed, provide justification: / List any additional refinements for this procedure:
Provide details on the fate of the animals at the end of the procedure(For example, will they continue on to another procedure or will they be euthanised?)
If the fate of the animals is euthanasia, state the method of euthanasia.
If this method is a not an approved method as per Annex IV to Directive 2010/63/EU, provide justification for the use of this method.

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Select the predictedoverall severity that the animals in this project may experience, taking into account all the procedures they will undergo, the potentially cumulative nature of multiple procedures and the contingent harms to the animals?

☐Mild

☐ Moderate

☐Severe

☐ Non-recovery

Provide clarifying information if relevant:

Please append, as a separate document, the project protocol(s), giving specific details for each procedure (if not captured above) and indicating the flow of procedures for each group of animals. The steps involved should be clearly numbered (from beginning to end) in schematic or illustrative form e.g. a flow chart and should correspond with the table above[A5].

Project Protocol[A6]

[A7]

SECTION G: ANIMAL INFORMATION

G1: APPLICATION OF METHODS TO REPLACE, REDUCE AND REFINE THE USE OF ANIMALS
REPLACEMENT
1. Provide the reasons why the objectives of this project are not achievable through the use of alternative methods to animal testing (≤ 5000 characters):
2. List the sources consulted to track possible alternatives and indicate how recently the consultation was performed(≤ 5000 characters):
REDUCTION
3. Provide justification on the number of animals to be used in this project, specifying the principles of experimental design used to calculate the sample group size, including reference to the statistical analysis performed (≤ 5000 characters):
4. Has an experienced biostatistician been consulted?
Yes ☐ No ☐
If yes, provide details of their level of involvement:
If no, please comment:
REFINEMENT
5. Explain the choice of species and strain/breed, and why they are the most refined for the procedures chosen (≤ 5000 characters):
6. Explain the choice of procedures and how they are the most refined for this particular project (≤ 5000 characters):
7. Provide details of policies in place to minimise animal suffering throughout the project, including the implementation of humane endpoints (≤ 5000 characters):
8. Provide details about how the welfare of the animals will be monitored throughout the project, including the frequency and duration of the monitoring:
If score sheets will be used, these should be included with this application.
9. Provide details about the housing, husbandry and care conditions for the animals (≤ 5000 characters):
10. Will environmental enrichment be provided?
Yes ☐No ☐
If yes, provide details:
If no, provide justification:
If no, provide details of additional refinements in place:
11. Will the animals be group/pair housed?
Yes ☐No ☐
If yes, provide details:
If animals are not group/pair housed, refer to the ‘Guide to Project Applications under Scientific Animal Protection Legislation’ to determine if individual housing should be entered as a procedure under section F.
G2: ANIMALS TO BE USED
1. If the species to be used in this project is a species listed in Annex I to Directive 2010/63/EU, have these animals been bred specifically for use in scientific procedures:
Yes ☐ No ☐ Not applicable (not an Annex I species)☐
If ‘no’ please provide scientific justification for the reasons the animals were not specifically bred for use in procedures?
2. Have the animals to be used in this project been taken from the wild?
Yes ☐No ☐
If ‘yes’ please provide scientific justification for the reasons a wild animal is required?
3. Are the animals to be used in this project stray or feral animals of a domestic species?
Yes ☐ No ☐
If ‘yes’ please provide scientific justification for the reasons a stray or feral animal of a domestic species is required?
4. Are the animals to be used in this project an endangered species?
Yes ☐No ☐
If ‘yes’ please provide scientific justification for the reasons an endangered species is required?

G3: INFORMATION ON ANIMAL SPECIES

Provide information on the species of animal(s) to be used in this project in the table below.

The tables can be replicated by copying and pasting as many times as required depending on the number of species/strains/breeds requested for use.

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Species
Life stage or age
Strain/breed
Genetic status / ☐ Not genetically altered
☐ Genetically altered without a harmful phenotype
☐Genetically altered with a harmful phenotype
☐Animals used for the creation of a new genetically altered line / strain
Details of the genetic alteration (if relevant)
Name of supplier establishment (from where animals originate)
Authorisation number of above supplier establishment
Country of origin*
Have these particular animals been previously used in a project (i.e. will this be a ‘reuse’ of these animals)? / Yes ☐No ☐
If yes, specify the actual severity of the previous procedure(s)?
If yes, has the animal’s general state of health and well-being been fully restored?
If yes, is the reuse in accordance with veterinary advice, taking into account the life-time experience of each animal?
Number of animals to be used
Species
Life stage or age
Strain/breed
Genetic status / ☐ Not genetically altered
☐Genetically altered without a harmful phenotype
☐ Genetically altered with a harmful phenotype
☐Animals used for the creation of a new genetically altered line / strain
Details of the genetic alteration (if relevant)
Name of supplier establishment (from where animals originate)
Authorisation number of above supplier establishment
Country of origin*
Have these particular animals been previously used in a project (i.e. will this be a ‘reuse’ of these animals)? / Yes ☐ No ☐
If yes, specify the actual severity of the previous procedure(s)?
If yes, has the animal’s general state of health and well-being been fully restored?
If yes, is the reuse in accordance with veterinary advice, taking into account the life-time experience of each animal?
Number of animals to be used

* If animal(s) are sourced outside of the Republic of Ireland, please provide a certificate confirming authorisation and registration of the supplier establishment (as required under Directive 2010/63/EU) where animal(s) were bred/supplied in the country of origin.

SECTION H: DECLARATION AND UNDERTAKING

The declaration and undertaking below should be signed by or on behalf of the applicant i.e. by the project manager (designated pursuant to Regulation 47 of S.I. No. 543 of 2012), who is responsible for the overall implementation of the project and its compliance with the project authorisation and the compliance officer (designated pursuant to Regulation 44 of S.I. No. 543 of 2012) responsible for ensuringcompliance with the provisions of S.I. No. 543 of 2012 at the establishment.
I hereby declare that:
-I have been designated by the user to make this application on the user’s behalf
-The information contained in this application is true and correct.
I hereby undertake that in the event of the project authorisation being granted:
-To ensure fulfilment of the obligations arising by virtue of the terms and conditions of the project authorisation.
-To ensure fulfilment of the requirements of S.I. No. 543 of 2012, including:
-To submit an application for an amendment if any substantial changes to the project are required.
-To ensure that the project manager has a valid individual authorisation.
-To ensure that, if appointed, the deputy project manager has a valid individual authorisation for the purpose of project management.
-To ensure that all persons carrying out procedures under this project have a valid individual authorisation.
-To ensure that all persons performing euthanasia under this project have a valid individual authorisation.
-To ensure the methods of euthanasia performed are in accordance with Annex IV of Directive 2010/63/EU unless an exemption is granted by the HPRA.
-To report any project deviations that have an adverse effect on animal health or welfare, and to report any changes to a severity classification that have an adverse effect on animal health or welfare to the designated veterinarian and/or the animal welfare body at the establishment.
-To keep written records of all animals used under this project authorisation for a minimum of 3 years, and to make all written records or project documentation available to the HPRA upon request or as part of an inspection.
-To provide the user establishment with an end of project report for the finished project to be made available to the HPRA upon request.
-To fulfil all reporting requirements including annual statistical returns to the HPRA.
-To provide updates (if any) to the non-technical project summary (where relevant) to the HPRA, which will be made publically available by the HPRA.
-To comply with the requirements of S.I. No. 543 of 2012 for the care and accommodation of animals.
Signature of project manager:______
Print/type name:
Date:
COMPLIANCE OFFICER SIGNATURE (user establishment)
The declaration below should be signed by the compliance officer (designated pursuant to Regulation 44 of S.I. No. 543 of 2012 as amended) responsible for ensuringcompliance with the provisions of S.I. No. 543 of 2012 at the relevant user establishment.
I hereby declare that:
-The applicant is affiliated to the primary user establishment referred to in Section B3.
-I understand that if the applicant fails to uphold his/her responsibilities under S.I. No. 543 of 2012, in the user establishment or additional locations for which I am compliance officer,this may have implications for the continued authorisation of the user establishment.
Signature of compliance officer:______
(on behalf of breeder/supplier/user)
Print/type name:
Date:
COMPLIANCE OFFICER SIGNATURE (collaborating USER ESTABLISHMENT, where relevant)
The declaration below should be signed by the compliance officer (designated pursuant to Regulation 44 of S.I. No. 543 of 2012 as amended) responsible for ensuring compliance with the provisions of S.I. No. 543 of 2012 at the relevant user establishment.
I hereby declare that:
-The applicant is affiliated to the user establishment referred to in section B3.
-I understand that if the applicant fails to uphold his/her responsibilities under S.I. No. 543 of 2012 in the user establishment or additional locations for which I am compliance officer, this may have implications for the continued authorisation of the user establishment.
Signature of compliance officer: ______
(on behalf of breeder/supplier/user)
Print/type name:
Date:

CHECKLIST