It is easier to apply for authorisation for a clinical study if thorough preparations have been made and there is a well worked out and detailed research plan. Once the research plan is completed, you must apply for authorisation from the Ethical Review Authority and in many cases also from the Medical Products Agency.
Applying for an ethical review
If you are planning to carry out research on living and/or deceased persons, on biological material from humans, or research that involves handling sensitive personal data, you must apply for and have your research ethically reviewed and approved by the Ethical Review Authority. In order to formulate your application as well as possible, it is important to know the starting points for the ethical review.
According to the Act Concerning the Ethical Review of Research Involving Humans (SFS 2003:460), research may only be approved if:
- it can be conducted with respect for human dignity
- human rights and fundamental freedoms have been taken into account, at the same time as consideration has been paid to the interest in the development of new knowledge through research
- the well-being of humans has been considered and given priority ahead of the needs of society and science
- the risks it may entail to the health, safety and personal integrity of participants are outweighed by the scientific value
- it is to be conducted by, or under the supervision of, a researcher who possesses the necessary scientific competence
You can read more about research ethics in medical research in the Declaration of Helsinki.
Application for ethical review is done via the Ethical Review Authority's website. On the website you can also find answers to commonly asked questions (in Swedish), guidance for application (in Swedish) and information about how to write the information for study participants (in Swedish).
An ethical review is carried out only once the application is complete, which means that the form has been filled in correctly, the fee has been paid and all information requested has been submitted. The administration time for the Ethical Review Authority is approximately 60 days. The cost of applying for an ethical review is currently between 5 000 SEK and 16 000 SEK. If the study also needs to be approved by the Medical Products Agency, the documents required for that application shall also be sent (in the same version) to the Ethical Review Authority. The same applies for applications to change the study, that is to say the same document, in the same version, shall be sent to both public agencies. You can read more about this in the sections on “Special rules for medical technology products” and “Special rules for medicines”.
SKR, the Swedish Association of Local Authorities and Regions, and LIF, the Swedish Association of the Pharmaceutical Industry, have developed generic templates for resource certificates and CVs that may be used in the application.
Applying for authorisation from a radiation protection committee
In medical, dental or biomedical research projects where the participants are irradiated, the study shall be approved by a radiation protection committee. For multi-centre studies, it is sufficient for the project to be assessed by one radiation protection committee. Other participating hospitals then only need to ensure that they can live up to the dose restriction set.
Setting up a biobank or getting access to biobank samples
To be allowed to conduct research using samples covered by Swedish biobank legislation, a biobank agreement is needed. The legislation covers human biology samples taken within health and medical care that are traceable to individual sample providers.
Biobank samples are taken for healthcare, diagnostics or treatment purposes, or for clinical research, and can consist of anything from fluids such as blood, serum, plasma and saliva, to faeces samples and tissue samples, such as biopsies, tumours and organs.
The legislation does not cover samples that are intended for research, analysed within 6 months of the sampling occasion and destroyed straight after the analysis. This exception applies for studies approved by the Swedish Ethical Review Authority after 1 January 2019, but does not apply if samples are collected for a biobank or used for any purpose other than that they were taken for. Approval from the Swedish Ethical Review Authority is always required when biological samples are collected for research, whether or not they are covered by the biobank legislation. If you are unsure whether samples in a study are covered by the biobank legislation, please contact the region’s biobank coordinator or a regional biobank centre for advice.
If samples are sent for analysis, a Material Transfer Agreement (MTA) is required. An agreement shall be in place whether or not samples are covered by the biobank legislation, but may be part of another agreement with corresponding content, for example between a sponsor and a central laboratory.
The biobank application shall be sent to the region’s biobank coordinator or to a regional biobank centre for review and approval. You can also contact these for advice in conjunction with a biobank application, or for tips on how to design the research subject information and the parts of the ethical review concerned with biological samples. The university hospitals also have centres for collaboration between universities and regions that can provide targeted support to research.
The Biobank Sweden website has up-to-date information about biobanking and links to current resources for biobank services. It also has a Biobank Guide, as well as forms and instructions for biobank applications.
Finding out what applies for handling of personal data
The General Data Protection Regulation (EU) 2016/679 regulates whether and how personal data may be handled for research purposes. The legal entity that handles the personal data in its operation and who decides on what data is to be handled, and what the data shall be used for is responsible for the handling of personal data (personal data controller).
Before starting your clinical study, you should find out what applies for handling of personal data within your organisation. If there is a personal data officer, this is a suitable person to contact.
Information about the handling of personal data is available on the Swedish Data Protection Authority’s website.
Registering your study before the study begins
Clinical medicine studies must be registered in a publicly accessible database before the study begins (clinical trials on medical devices should be registred according to the GCP-standard ISO 14155:2020). All applications for medicine studies to the Medical Products Agency are also registered with the European study database EudraCT. The European Medicines Agency (EMA) is responsible for EudraCT. In USA, the Federal Drug Association (FDA) has the equivalent requirements for registration and result reporting of medicine studies, and there the studies are registered in the database clinicaltrials.gov .
There are a number of advantages of registering a study. WHO lists the following:
- registering clinical studies is a prerequisite for enabling health and medical care to make well-informed decisions that take into account all available knowledge
- it counteracts only some results being reported
- unnecessary repetition of research can be avoided when researchers and funding bodies have the chance of finding information about similar or identical studies that have already been carried out
- it makes it easier to understand where there are knowledge gaps
- recruitment of study participants can be quicker if researchers and healthcare personnel can find information on ongoing studies more quickly
- collaboration within clinical research becomes more efficient if researchers can find information about the studies that are in progress
- research quality increases if reviewers can identify at an early stage studies where the study design can be improved
Many respected scientific journals require studies to be registered in order for the results to be approved for publication, and in practice there is thus often a registration requirement even for studies that are not medicine studies.
At clinicaltrials.gov, you can register your study even if it is not a medicine study.
SKR and LIF – agreements and templates for clinical studies
In Sweden, collaboration has long been in place between health and medical care, universities, HEIs and the pharmaceutical industry in relation to the development of new medicines and follow-up after their introduction to medical care.
SKR, the Association of Swedish Local Authorities and Regions, and LIF, the Swedish Association of the Pharmaceutical Industry, have a joint agreement (in Swedish) on the implementation of clinical therapy studies and observation studies in Sweden.
The Swedish Pharmaceutical Society’s clinical trials section has produced generic study templates (in Swedish) together with LIF and the Medical Products Agency, which can be used for the implementation of clinical studies.
Specific rules for medicines or medical devices
There are special rules to comply with regarding clinical studies with medicines or medical devices.
Specific rules for medicines
Applying for authorisation for a medicine study
The purpose of clinical studies involving the investigation of a new medicine may be to discover or verify clinical and pharmacological effects, to identify any side-effects and/or to study its absorption, distribution, metabolism and excretion. If your planned medicine study is a therapy study, then authorisation from the Medical Products Agency is always required. If your planned study is an observation study without any experimental features, then only approval from the Etichal Review Authority is required.
For guidance whether your planned study requires authorisation, you can use the Medical Products Agency’s test .
The European database for clinical medicine studies, EudraCT, constitutes a register of all medicine studies carried out within the EU, and each study is identified by means of a unique number, an “EudraCT number”. This number is downloaded via EudraCT’s website and is the first step in an application to the Medical Products Agency. Once the EudraCT number has been downloaded, an electronic application form can be created at the Medical Products Agency. The application to the Medical Products Agency shall be supplemented with appendices, among them a study protocol, product information and a list of studies in progress with the same substance and safety evaluation. The Medical Products Agency’s website has a step by step guide to the application.
If the Ethical Review Authority has reached a decision on the study in question, the decision shall accompany the application. If not, the sponsor shall make sure the decision is sent to the Medical Products Agency as soon as possible. The decision must have been received by the Medical Products Agency no later than 15 days after the sponsor has received the decision.
Specific rules for medical devices
New rules apply from 26 May 2021 - but some are delayed (preliminary) until 15 July 2021. Updates regarding the rules from 15 July will be published early autumn.
Notification to the Swedish Medical Products Agency
Some clinical investigations of medical devices must be notified or applied to the Swedish Medical Products Agency. Find out more under the page Planning on this website.
What must be submitted to the Swedish Medical Products Agency and the Swedish Ethical Review Authority?
Different levels of authorization procedures are applied, but regardless of which procedure is applied, the requirements for the documentation that must be submitted to the Swedish Medical Products Agency are the same.
Registration form and detailed instructions for registration are available on the Swedish Medical Products Agency's website. Registration form and mandatory attachments are submitted electronically. The appendices to the application are defined in the application form. In some cases it is recommended that they be designed in accordance with ISO 14155: 2020, read more under the section Planning. The appendices must, among other things, show that the test product is ready for a medical technical clinical trial, ie that the product meets the general requirements for safety and performance apart from the aspects covered by the study.
One of the appendices- "Declaration of conformity" - must be issued by the manufacturer. Note that this document is a different declaration of conformity than the one made by the manufacturer regarding the CE marking. You can find a template on the Swedish Medical Products Agency's website. The appendix is a confirmation that the product in question complies with the general requirements, apart from the aspects that constitute the purpose of the examinations and that, taking into account these aspects, all precautions have been taken to protect the health and safety of the patient, users and others. All medical technical clinical trials also require a separate application to the Swedish Ethical Review Authority. Certain application documents, such as the clinical trial plan, must be sent to both the Swedish Ethical Review Authority and the Swedish Medical Products Agency. For these documents, it should be ensured that the authorities have the same version of the documents on which to base their decisions.
What happens to my application?
The scope of the Swedish Medical Products Agency's review and how long it takes to receive a response to your application depends on which permit procedure is applied.
In case the trial is to take place in several countries, there will be possibile to have a coordinated permit procedure within the EU. The coordinated procedure is being implemented in the EU. To investigate the possibility of a coordinated procedure, contact the Swedish Medical Products Agency.