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Forms for the presentation of a new animal research project

Prior and express authorisation must be requested for the implementation of Type II projects and Type III projects, and for Type I projects with procedure/s included in any of the cases of article 34 of Decree 214/1997, of 30 July.

  • Application. Research staff do not have to complete the application. This is filled in by the CEEA at the time of processing the sending of the documentation online.
  • Descriptive report on an animal research project (ESU users have to fill the document with VHIR data / LAS users have to fill the document with VHIO data). Instructions project report.
  • Descriptive report on an animal research procedure (ESU users have to fill the document with VHIR data / LAS users have to fill the document with VHIO data). Instructions procedure report.
  • Non-technical summary (NTS). Instructions NTS.

Forms for the communication of a new Type I animal research project with procedure/s not included in cases of article 34 of Decree 2014/1997, of 30 July

These procedures do not require prior authorisation, they only need to be communicated.

Types of projects

The Department of Territory and Sustainability has established that the procedures must be linked to the corresponding project.

Project type definitions:

  • Type I: the following three circumstances occur simultaneously:
    • They are made to comply with legal or regulatory requirements, or for production or diagnostic purposes by established methods.
    • They only involve procedures classified as "non-recovery", "mild" or "moderate".
    • They do not use primates.
  • Type II: the following circumstances occur simultaneously:
    • They only involve procedures classified as "non-recovery", "mild" or "moderate".
    • They do not use primates.
    • According to RD 53/2013, “Type II projects that include procedures classified as“ moderate ”will be subject to retrospective evaluation when this has been established in the authorisation”.
  • Type III: all other projects. According to RD 53/2013, they include a mandatory retrospective assessment.

Submission of applications

Documentation will be emailed to the address ceea@vhir.org.

CEEA's secretariat will answer the research staff in order to confirm their receipt and report the assigned registration number.

The project will be in the pre-filter phase for a period of approximately 1 week. Once the relevant changes have been made, the pre-filtered version will be evaluated by CEEA member staff for a period of 2 weeks.

Resolution

The meeting will decide on the approval or rejection of the proposed projects, notifying the research staff of the result and requesting the necessary modifications if the evaluation is negative.

The CEEA will present the accepted project with all the pertinent documentation to the Department of Territory and Sustainability, which will assign the corresponding order number, expiration date for its execution and, if applicable, the request for the retrospective evaluation.

Project extension and modifications

According to "Order APA/349/2020, of 15 April, extending the authorisations of projects relating to the use of animals for scientific purposes granted under Royal Decree 53/2013, of 1 February, by which are set out the basic rules applicable to the protection of animals used for research and other scientific purposes, including teaching", the notification of an animal research project shall be valid for five years, renewable.

To modify or extend a project, the responsible researcher must resubmit the project to the CEEA before the expiry date. It is advisable to start the extension procedure 4 months before the expiry date.

In case of relevant modifications, a new authorisation will be required. Relevant modifications are those that:

  • Lead to an increase in the number of animals to be used in the case of protected species or the use of a new protected species.
  • Involve an increase in pain or suffering of the animal.
  • Are carried out in a different place than originally planned.
  • Require the release of the animal into the wild.
  • Involve any changes to the project that could have a negative impact on animal welfare.

Documentation to be sent in case of a request for extension or modification of the authorisation of a project: the same 4 forms as in the application for a new project.

Documentation to be sent in case of a request for extension or modification of a communicated project: the same 3 forms as in the communication of a new project.

Fees of the Department of Territory and Sustainability for processing

There may be two fees associated with this process:

The rate for a Report of the Animal Research Commission as a qualified body will be applied across the board: €114.40.

In addition, Type I and II projects that fall within one of the assumptions of article 34 of Decree 214/1997 and for Type III projects will have an additional fee:  €90. That is, a total of €208.

These fees will be borne by the staff responsible for the project. Once the payment has been made, the Department of Territory and Sustainability of the Generalitat de Catalunya will start the project evaluation procedures.

The VHIR’s Economic Management Unit is requesting that the official fees for animal research projects be an approved expenditure for state-funded projects.

Confirmation


Each year, the user centres must notify the Department of Territory and Sustainability of the Generalitat de Catalunya of the research projects carried out, indicating the title of the project, the assigned order number and the number of animals used in each of them.

These confirmations will be used to compile the statistical tables to be submitted annually to the European Union.
For more information you can visit the website Canal Empresa of the Generalitat de Catalunya.