Ethical application for using laboratory animals
In Sweden, animal experiments must be evaluated and approved by a regional ethical committee. An experiment cannot begin until an ethical committee has approved it. It is the research group leader/project director who can apply for ethical evaluation of animal experiments.
At Comparative Medicine's (CM) laboratory animal facilities, a research group leader can apply and hold a laboratory animal ethics license. Hereinafter, this person is referred to as the principal investigator.
At Comparative Medicine's (CM) laboratory animal facilities, a research group leader can apply and hold a laboratory animal ethics license. Hereinafter, this person is referred to as the principal investigator (PI).
Prior a principal investigator can initiate a laboratory animal study, the planned study must be approved by a laboratory animal ethics committee (SFS 2018: 1192 Animal Welfare Act, Chapter 7, Section 9). The principal investigator applies for a laboratory animal ethical review via the e-service “Ansökan om etiskt godkännande av djurförsök” provided by the Swedish Board of Agriculture. All addendums that must be submitted to the laboratory animal ethics committee are also done via this e-service.
The non-technical summary (Populärvetenskapliga sammanfattningen, PVS) for a laboratory animal ethics application or an addendum is done separately in ALURES, an EU-based platform.
Please note! The laboratory animal ethical application and the non-technical summary (NTS) must be written in Swedish.
If you are not already a user of CMs animal facilities
Please contact the relevant animal facility to discuss the possibilities of using that facility for your studies.
You log in to the e-service using an Swedish BankId and to ALURES via you chosen login method.
How to apply – step by step
The Named Animal Welfare Officer (NAWCO) is responsible for questions concering laboratory animal ethics at Comparative Medicine, Karolinska Institutet. For questions concerning laboratory animal ethical applications and licenses: firstname.lastname@example.org
Function B or corresponding competence is required to apply and hold a laboratory animal ethics license. The principal investigator must submit the Function B certificate to the Named Officer for Training and Competence (NTCO) before any laboratory animal ethical application can be considered: NTCO@km.ki.se
General overview for a laboratory animal ethical application
This applies to KM-Annexet, KM-Biomedicum, KM-C, KM-Wallenberg and KM-Fragraeus.
- The principal investigator must be connected to the correct establishment license in the e-service. This is done by the NACWO after that the Function B competence has been validated by the NTCO. The principal investigator must also be registered at the EU-platform DECLARE/ALURES. This is done by the Swedish board of Agriculture, please send your full name and e-mail address with "ALURES" in the subject line to email@example.com
- The principal investigator must initiate the ethical application in the e-service. Please contact the NACWO if additional persons should be added to the application since such persons must be connected to the establishment license.
- It is recommended to carefully plan the application prior the principal investigator add the application to the e-service. It may be motivated to discuss more complex applications with the NACWO at an early stage.
- Consultation according to SJVFS 2019:9 saknr L150: The planning of the application must occur in consultation with NACWO, veterinarian and representative from animal facility/ies involved in the study. The principal investigator downloads PDF-files of the application in e-tjänsten and the non-technical summary in ALURES and submit them to the NACWO. NACWO coordinates the consultation which can occur via via email, phone, or a meeting.
NOTE! Do not submit the non-technical summary to the animal ethics committee before the NACWO has seen it. Remeber to add the id-number (NTS-id) for the non-technical summary obtained from ALURES to the application in the e-service.
- The prinicipal investigator revises the application and/or non-technical summary in e-service/Alures according to the recommendations from the consultation. For more complex applications, the consultation process may need to be repeated. If the principal investigator does not consult with prior to submission of the application to the laboratory animal ethics committee, the establishment license holder may deny the principal investigator to perform experiments at the CM animal facilities.
- After the last revision, the principal investigator can submit the application and the non-technical summary to the laboratory animal ethics committee via e-service/Alures. This occurs in three steps: A) The principal investigator submits the application in the e-service and the NACWO reviews and approves the application for submission to the laboratory animal ethics committee. B) The principal investigator goes into the e-service and sends the application to the committee. C) The non-technical summary is submitted by the principal investigator via ALURES.
- An application fee must be paid to the Swedish Board of Agriculture. The prinicipal investigator pays the fee at the Swedish Board of Agriculture’s web store. The principal investigator will receive an order that must be added to the application in the e-service.
- The Stockholm laboratory animal ethics committee, once the application has reached them, sends out an information email to the principal investigator. The mail is usually sent within three weeks after arrival, and contains general information and, when applicable, remarks specific to the application.
An applicant who has not received such an e-mail, even though three weeks have passed since submission, should check the status of the application in the e-services. There may be a problem due to a technical issue or the application may not have been completed. Contact the Swedish board of Agriculture if there are problems with the e-service.
- The laboratory animal ethics committee has 40 working days to handle your application provided that the application is complete. The application is reviewed by a working group that will, if necessary, contact the principal investigator with required complementary information and questions. A decision on an application can be delayed or rejected if the principal investigator do not answer the work group´s request in time.
The decision on the application will be sent to the principal investigator ca 1-3 weeks after the laboratory animal ethics committee plenary meeting. The principal investigator will be contacted by the working group with further questions and complementary information if the application has been deferred.
- The principal investigator can apply for an exemption from the Swedish Board of Agriculture if the principal investigator lacks a Swedish BankID.
- Please contact the NACWO if facilities, e.g. AKM/KERIC, Stockholm University, not included in the KM estabalishment license will be added to the application.
- The decision off the laboratory animal ethics license can be requested as a public document according to Swedish legislation. The non-techinical summary is published anonymously in DECLARE/ALURES within six months after the decision.
After approval of your laboratory animal ethical application
The principal investigator needs to take below actions once the approval of the new animal ethics license has been received:
1. Control the decision
Carefully read through the entire decision since there may be conditions or changes in severity levels set by the laboratory animal ethics committee. The principal investigator can appeal to the Central Laboratory Animal Ethics Committee (CDFN). This must be done within three weeks of the receipt of the decision.
Please note that the questions and answers usually is part of the decision.
The principal investigator must submit to a retroactive evaluation if the laboratory animal ethics license is classified as "severe" ("avsevärd svårhetsgrad"). This is done after the laboratory animal ethics license has expired and is coordinated by the CDFN. Retroactive evaluation may be requested by the laboratory animal ethics committee also for ethics licenses with other severity levels.
The principal investigator must archive the laboratory animal ethics license according to the KI's policy document for archiving.
3. Second consultation
prior to or in connection with project start under a laboratory animal ethics license, obligatory for all licenses deemed severe. The NACWO coordinates the meeting where veterinarian, animal technician and principal investigator´s research group are included.
This post-approval meeting can be short and concise but may also require follow-up meetings and the purpose is to facilitate communication and that all required documents eg project plan/s, risk assessments etc are in place. For more information: KM Facilities.
Addendums to valid laboratory animal ethics licenses
An approved laboratory animal ethics license may addendums with time. An addendum is done in SJV's e-service, the non-technical summary in ALURES following consultation with NACWO as described above. For tips, advice, veterinarian plans etc, please login at KM Facilities
All administrative changes, as change of principal investigator or addition of a CM animal facility is done via the local Animal Welfare Body (AWB). Addendums without any risks of negative effects on animal welfare can be submitted to the AWB. You find more information and the application form at the Animal welfare body.