Initial application (grundansökan)

A new application for ethical review is known as an “initial” application (grundansökan). The Swedish Ethical Review Authority neither can nor may issue any advance ruling on the question of whether an ethical review is required. It falls on the entity responsible for the research to decide whether an initial application needs to be submitted. This relates to the rule that the entity responsible is obliged to ensure that, without ethical approval, research covered by the requirements of the Ethical Review Act is not conducted within the entity’s own activities.

Within the entity’s own organisation, there must therefore be knowledge of the applicable legislation. Furthermore, it is equally important to include ethical considerations in the planning of a research study as any other aspect.

Only when a complete application has been reviewed by the department involved can the Swedish Ethical Review Authority draw any firm conclusions about the research in question.

The first issue to consider is whether the study planned constitute research according to the definition of the term as described in Section 2 of the Ethical Review Act: that is, whether it involves scientific experiments or theoretical work or observational research studies, if the work or the study is conducted with the purpose to collect new knowledge, or if it is developmental work based on science. If the planned study does not meet the definition of Section 2 in the Act an ethical review is not needed.

However, if it indeed constitutes research, ethical review is required if the study

• involves physical intervention, on living and deceased persons alike
• is carried out with a method that aims to affect the research participant physically or mentally, or involves an obvious risk of harm to them in body or mind
• are performed on biological material from a living or deceased human being and can be traced back to that person
• involves processing of sensitive personal data or of personal data relating to criminal offences.

The Act applies only to research conducted in Sweden (Section 5). However, ethical review is also required when not all, but only parts of the research are to take place in Sweden. Only these parts, and not those to be conducted in any other country, can and must be examined by the Authority.

When you apply

If you are applying for ethical review, log in to the Ethix portal. This is where, as well as applying, you receive notifications, decisions and other messages related to your application.

The application must be made in Swedish. The application form in Ethix is designed so that you only need to provide details relevant to the particular research your application concerns.

In some cases, you need to send the application to other bodies:

The EU Clinical Trials Regulation 536/2014 (CTR) has been in force since 31 January 2022. According to the CTR, the sponsor must apply for review through the EU Clinical Trial Information System (CTIS) portal. Between 31 January 2022 and 31 January 2023, sponsors may choose to apply for authorisation for a clinical trial either in accordance with EU Directive 2001/20/EC or in accordance with the new EU CTR regulation. After 31 January 2023, all new clinical trials will have to be submitted via CTIS and processed according to the CTR.

The EU Regulation on Medical Devices 2017/745 and Regulation on Medical Devices for In Vitro Diagnostics 2017/746 have been in force since 26 May 2021 and 26 May 2022. They state that a sponsor must notify and apply for review of a medical device, and a medical device for in vitro diagnostics through the European database on medical devices (EUDAMED) portal. Until EUDAMED is fully functional, the documents must be sent to the Swedish Medical Products Agency.

Annexes to be attached

Besides the application form, annexes required for all projects are:

• A research plan intended for professionals, in Swedish or English.
• The PI’s CV, in Swedish or English.

You may also need to include the following annexes, which must all be in Swedish:

• If you intend to use advertising copy in your recruitment of research participants, the advertising material must always be attached to the application.
• The information to be given to the research participants when they are invited to take part, must always be attached to the application, and applicants may want to consider using the support templates provided by the Authority.
• If you are planning to use questionnaire surveys and forms, interview guides or interview questions in the project, these must also be attached.
• A list of variables should be attached to the application if data are to be requested from existing registers.

If the research project is a clinical trial, you must include the following annexes:

• A shared EU Clinical Trial Application (CTA) form may be attached but is no longer a required supporting document. It may be in Swedish or English.
• A summary of the protocol in Swedish (if the research plan and/or protocol are in English).
• An Investigator’s Brochure (IB) alternatively a package leaflet or a summary of product characteristics, which must be in Swedish or English.

In the first stage of the application, you will be able to make a series of preliminary choices that determine which questions you need to answer in the form. The questions are as follows, and your choices can be changed even if you have proceeded to the form:

• Will ionizing radiation be included in the research project?
• Will new biological material be collected, or material from one or more existing sample collections be used in the research project?
• Does the application relate to a clinical trial of a medical device or a performance study of a medical device for in vitro diagnostic? Please note that if the trial meets the criteria of the MDR or the IVDR, you need to submit your application to the Swedish Medical Products Agency (MPA). Read more on the MPA website.

Any other annexes that you believe the Authority must include in its assessment of the project can be attached.,

Time limits

Normally, the Ethical Review Authority should reach its decision within 60 days after an application is complete and the application fee has been received. For applications relating to clinical trials of medicinal products, decisions must be made within the following specific time limits.

If the application relates to drugs for gene therapy or somatic cell therapy, or drugs containing genetically modified organisms, the time limit is 90 days. In cases where regulations oblige the Swedish Ethical Review Authority to consult another government agency, a decision must be made within 180 days after the application is considered complete.

If the application relates to xenogeneic cell therapy, there is no time limit. For other new applications relating to clinical trials of medicinal products, the time limit is 60 days.

The Swedish Ethical Review Authority’s ruling

Your application can be approved, approved subject to conditions, refused or rejected. For the application to be approved, the Ethical Review Act’s established requirements for approval must be met. In the event of rejection, the application is not examined on its merits. If the research does not fall under the provisions of the Ethical Review Act, the Swedish Ethical Review Authority may, at the applicant’s request, issue an advisory opinion.

An approval expires if the research has not commenced within two years after the decision has gained legal effect.

Appeal

If a decision is not in favour of the applicant, the applicant may appeal to the Ethics Review Appeals Board. The appeal must be filed with the Swedish Ethical Review Authority within three weeks from the appellant receiving the decision. See the Ethics Review Appeals Board’s website.