Ethical application for 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 (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, below AWO) is responsible for questions concering laboratory animal ethics at Comparative Medicine, Karolinska Institutet. For questions concerning laboratory animal ethical applications and licenses: email@example.com.
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.
Below is a general overview for a laboratory animal ethical application at CM's facilities (KM-Annexet, KM-Biomedicum, KM-C, KM-Wallenberg, KM-Fragraeus).
- The principal investigator must be connected to the correct establishment license in the e-service. This can be done by the AWO 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 name and email address, put ALURES in the subject line, to firstname.lastname@example.org.
- The principal investigator must initiate the ethical application in the e-service. Thereafter the principal investigator can connect other persons who can then work on the application. Please contact the AWO if you have this request since such persons must also be connected to the establishment license.
- To facilitate the writing process, plan and make a draft over your study prior to working in the e-service. It is recommended to discuss more complex applications with the AWO at an early stage of the application process.
- Consultation according to SJVFS 2019:9 saknr L150: The planning of the application must occur in consultation with AWO, veterinarian and representative from animal facility/ies involved in the study. When you have written your application in the e-service and the non-technical summary in ALURES*, you download the applications as PDF files and submit them to the AWO that coordinates the consultation. This can occur via email, phone, or a meeting.
- Do not submit the non-technical summary to the animal ethics committee before the AWO has seen it.
- Do not forget to add the id-number for the non-technical summary obtained from ALURES to your application in the e-service.
- Revise your application/non-technical summary according to the advice you have received from the consultation. For more complex applications, the consultation process may need to be repeated. If you as principal investigator does not consult with the AWO and veterinarian prior to submission of the laboratory animal ethical application, the establishment license holder may deny you to perform experiments at the CM animal facilities.
- After the last revision and approval from the AWO, the principal investigator can submit the application and the non-technical summary to the animal ethics committee via the e-service and ALURES respectively. This occurs in two steps at CM:
1) the principal investigator submits the application in the e-service and the AWO review and approve the application for submission to the animal ethics committee
2) the principal investigator can then go into the e-service and send the application to the animal ethics committee. The non-technical summary is submitted by the principal investigator via ALLURES.
- An application fee must be paid to the Swedish Board of Agriculture. You pay the fee at the Swedish Board of Agriculture’s web store. You will receive an order number when you place the order which you must add to the application in the e-service. The invoice does not have to be paid at the time you submit your application to the animal ethical committee.
- The Stockholm animal ethics committee, once the application has reached them, sends out an information email to the principal investigator. The mail is usually sent within 2 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 the application was sent, should check the status of the application in the e-services. There can 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 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 your application can be delayed or rejected if you do not answer the work group´s request in time.
Decision concerning your application will be sent to you ca 1-3 weeks after the animal ethics committee plenary meeting. You will be contacted by the work group with further questions and complementary information if your application has been deferred.
- If you are unable to obtain a Swedish BankID, you can contact the Swedish Board of Agriculture and apply for an exemption.
- Please contact the AWO if you are planning to include animal facilities not included in the establishment license at CM eg AKM/KERIC and Stockholm University.
After approval of your animal ethical application
You need to take the actions below once the approval of your new animal ethics license has granted:
- Carefully read through the entire decision since there may be conditions set by the animal ethics committee. You have the opportunity to appeal conditions to the Central Laboratory Animal Ethics Committee (CDFN). This must be done within three weeks of the receipt of the decision.
Please note that any additional correspondence with the local animal ethics committee (e.g. questions and answers) is part of the decision and must be attached when appealing to CDFN..
You must submit to a retroactive evaluation if the animal ethics license is of a "severe" level of severity. This is done after that the animal ethics license has expired and is coordinated by the CDFN. Retroactive evaluation may be requested by the animal ethics committee also for ethics licenses with a "lower" level of severity.
- Archive the animal ethics license according to KI's policy document for archiving. Your department can help with this.
At CM animal facilities, a second consultation meeting is recommended prior to or in connection with project start under an animal ethics license, obligatory for all animal licenses deemed severe. The AWO 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.
The decision of the 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.
Addendums to valid animal ethics licenses
An approved animal ethics license may need to be altered or complemented via an addendum. An addendum is done in SJV's e-service, the non-technical summary in ALURES following consultation with AWO as described above. For tips, advice, veterinarian plans etc, please login to 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). Also addendums without risk 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.