The Research ethics committee

Individual researchers are responsible for their research. However, when people’s integrity or other sensitive data are involved, this personal accountability needs to be complemented with ethical vetting by an independent authority. A well-functioning ethical vetting system is also required to retain public confidence in research.

Application for Ethical Review

All research conducted at Karlstad University that may fall under the provisions of the Ethical Review Act must, prior to submitting an application to the Swedish Ethical Review Authority, either:

1. Be reported to the Research Ethics Committee for support with a comprehensive ethical assessment, or
    
2. Be sent directly to the authorized representative of the entity responsible for the research (Head of Department) by the responsible researcher. In this case, an advisory risk analysis regarding data protection and information security, prepared by the Data Protection Officer and the Information Security Manager, must always be attached.

The Research Ethics Committee

The Research Ethics Committee at Karlstad University is tasked with assisting the representative of the entity (Head of Department) and individual researchers in assessing whether research may fall under the Ethical Review Act, and with providing recommendations aimed at strengthening and ensuring the quality of applications submitted to the Swedish Ethical Review Authority.

The committee is also responsible for conducting risk analyses and providing advice to both the principal and the individual researcher regarding data protection and information security, including whether a data protection impact assessment needs to be carried out.

Responsibilities of the Research Ethics Committee

• Assessment According to the Ethical Review Act

  The committee assesses whether research projects, for which Karlstad University is the responsible entity, fall under the Ethical Review Act. The assessment, along with an advisory opinion, is submitted to the responsible researcher and the authorized representative.

  If the committee determines that the research project is subject to the Act, an application must be submitted to the Swedish Ethical Review Authority before the research begins. If the authorized representative does not agree with the committee’s assessment, the Vice-Chancellor will decide whether the application should still be submitted.

  Please note that even if the committee assesses that the project is not subject to the Act, it is still possible to voluntarily submit an application. The final preparation of the application is the responsibility of the authorized representative, in consultation with the responsible researcher.

• Review of Projects Not Covered by the Ethical Review Act

  The committee may also review research projects that do not require ethical approval under the Act, if requested by the responsible researcher or the authorized representative. Such a review results in an advisory opinion from the committee.

• Risk Analysis and Data Protection

  The committee, together with the Data Protection Officer and the Information Security Manager, conducts a risk analysis to assess how personal data is handled in research projects. This analysis includes determining whether a full Data Protection Impact Assessment under the General Data Protection Regulation (GDPR) needs to be carried out. The results of the assessment are submitted to the responsible researcher and the authorized representative of the principal, who then decides whether such impact assessment should be conducted.

  Templates and FAQ

  Karlstad University recommends that our researchers always use the university’s templates and FAQ as support when preparing information letters for research participants and applications to the Swedish Ethical Review Authority. The support documents are available on the Research Ethics Committee’s webpage. It is also always possible to contact the ethics advisor, the information security officer, and the data protection officer for assistance in this work.

• FAQ (in Swedish)

Submitting an application:

Head of Department is the authorized representative of the entity responsible for the research. Please note that the application should not be signed by the authorized representative when submitted to the local Research Ethics Committee. The application should only be signed if it is deemed to fall under the Ethical Review Act and is to be submitted to the Swedish Ethical Review Authority. 

Once you have completed the application online, save it as a PDF file and email it along with all attachments to registrator@kau.se. Depending on whether you wish to submit your ethics application to the Research Ethics Committee (FEK) or directly to the authorized representative (Head of Department), indicate “Etikansökan, FEK” or “Etikansökan, Prefekt” in the subject line.

You will receive confirmation of receipt from the committee secretary or alternatively from the DPO/CISO. If the project is considered to fall under the Ethical Review Act, the next step is to (after any revisions based on the committee’s advice) submit the application to the Swedish Ethical Review Authority for review.

The application form is available on the Swedish Ethical Review Authority´s website. 

• Swedish Ethical Review Authority

Remember to:

• Avoid including details that could reveal the identity of prospective participants.
• Discuss the application within your subject or research group before submission to obtain input from experienced researchers.
• Write the application in Swedish. If you need translation or language support, contact the English Department at translation@kau.se.
• Include all required documents and attachments, as the committee can only assess complete applications.
• You are welcome to include a short cover letter highlighting any aspects where you would like advice or that you consider problematic.

What happens after you have submitted your application?

The application is reviewed by the Research Ethics Committee. All members read the application before the meeting, and one member is responsible for presenting it.

After reviewing the application, the committee gives an advisory opinion. This is meant to guide the researcher and the authorised representative when preparing the application for the Swedish Ethical Review Authority. The committee also provides an opinion if it decides that the research does not fall under the Ethical Review Act.

If the project is considered to fall under the Ethical Review Act, the next step is to revise the application as needed and then submit it to the Swedish Ethical Review Authority. At this stage, the researcher must also complete a checklist, which is attached to the application and sent to the Head of Department to facilitate their handling of the matter.

• Checklist

When Will a Decision Be Issued by the Ethical Review Authority?

A decision regarding an initial application should be issued within 60 days. An application for amendment should be decided within 35 days. An email notification that a decision is available in Ethix will be sent within two weeks after the decision has been made.

Download the decision as a PDF and send it to the university registry. Contact details can be found in the right-hand column.

• Members and meetings