Guidance on ethical review

Ethical review is a central part of the research process. Here you will find guidance on how to prepare for ethical review with a focus on data management, information about the ethical review process and links to further guidance and supporting materials.

Tips for applying for ethical review

Clearly state which data will be handled

In the application for ethical review, submitted via Ethix, questions posed by the Swedish Ethical Review Authority relevant to the research project should be answered. These include, among other things:

• which data sources are intended to be used
• why these data are needed to address the project's). research questions
• which data items will be requested (when requesting existing register data, a list of variables is required).

The data specification described in the ethical review application must correspond to the specification submitted when requesting the disclosure of data from the data holder. Some data holders have specific requirements for data requests, which may be useful to check before submitting the application for ethical review. If the data holder cannot confirm that all requested data have been approved by the Swedish Ethical Review Authority, an amendment application may be required. This may delay the start of the project and incur additional costs.

Before submitting an application for ethical review, it is therefore important to first engage in dialogue with the data holders from whom the data will later be requested. This will facilitate the work ahead. If the description of the data in the application to the Swedish Ethical Review Authority and the order for data from the data holder are carefully prepared and consistent, the risk of delays and the need to submit an amendment application at a later stage is reduced.

Justify the data to be used

If the research requires data containing personal identity numbers this must be justified and clearly described in the application. The disclosure of data containing personal identity numbers is strictly regulated and requires the Swedish Ethical Review Authority to assess such personal data handling as ethically acceptable.

If the study includes linkage of data from different sources or if data is to be combined with new data collections, this must be described in the application.

Indicate if the research requires disclosure at several points in time

If the project plans to apply for data disclosure on several occasions, for example when a code key needs to be stored with a register-keeping agency, this must be stated in the application.

This may be relevant for research projects that follow up data over time and therefore need annual updates of data for a specific population.

The correct research principal must apply

Data disclosure normally only takes place after a request from an authorised representative of the research principal (or research principals) specified in the approved ethical review application. This means that the same research principal who applies for ethical review must also order the data.

An approved application for ethical review does not entitle the applicant to receive data. The data holder always conducts an independent assessment before disclosing data.

Changes after ethical review approval

If details in the research plan have changed after ethical approval, an application for amendment may need to be submitted.

The Swedish Ethical Review Authority's decision

The Swedish Ethical Review Authority may:

• approve,
• approve with conditions,
• reject or
• dismiss an application.

Approval means that the research described in the application is acceptable from an ethical perspective.

Approval from the Swedish Ethical Review Authority does not mean that the research may be carried out if it is in with other legislation or if other permits are not in place.

A rejection of an application from the Swedish Ethical Review Authority can be appealed to the Ethics Review Appeals Board (ÖNEP).

Validity period for ethical approval

Ethical approval expires if the research has not started within two years of the decision gaining legal force.

If a researcher has obtained ethical review approval and wishes to use the same data in a new study or for new research questions that are not covered by the approval, a new review or an application for amendment is required.

Ethics Review Appeals Board

The Ethics Review Appeals Board (ÖNEP) handles appeals and is responsible for supervising compliance with the Ethical Review Act.

ÖNEP can, for example, carry out inspections by collecting documentation from researchers and research principals. Inquiries can be initiated by ÖNEP itself or after a report of a violation. If there is reason to suspect a violation of the Ethical Review Act, ÖNEP must report this to the public prosecutor.

Guidance and support material

The Swedish Ethical Review Authority has produced guidance on ethical review. It describes important aspects of research planning and contains detailed information on risk analysis and examples of measures that can protect research subjects. The material helps to answer key questions such as:

• What is important to consider when planning research?
• When should an application for ethical review be made?
• How should an application for ethical review be made?
• What is important to consider after a decision has been made?

The guidelines are available in Swedish and English and can be downloaded from the agency's website. Answers to frequently asked questions about ethical review are also published there but only available in Swedish.

The website also contains support templates for researchers, including information for research subjects and consent forms, including those for future research on samples.