Application
When the research plan is ready, you should apply for approval from the Ethical Review Authority and, in many cases, also from the Medical Products Agency.
- Applying for an ethical review
- Research projects in which study participants are irradiated
- Application for access to biobank samples
- Finding out what applies for handling of personal data
- Register your study before the start of the study
- Agreement on the conduct of clinical studies
- Keep in mind
- Specific rules for medicines and medical devices
- Links and related information
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, guidance for application and information about how to write the information for study participants.
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, information on fees for ethics review can be found on the authority's website.
If your study needs to be approved by the Swedish Medical Products Agency, the process for ethical review has been affected by new EU regulations for both clinical trial on medicinal products and medical devices. Find out what applies to your study in the sections "Special rules for medicines and medical devices" further down the page.
Information about the Ethical Review Act, the Swedish Ethical Review Authority
External link.
Research projects in which study participants are irradiated
There are special regulations for medical exposure to ionizing radiation, such as X-ray examinations. These become applicable in clinical studies where participants are exposed to ionizing radiation.
Application for access to biobank samples
In order to conduct research on samples covered by the Biobanks Act, an approved biobank application is required. Human biological samples that are taken in health care and are traceable to the individual sample donor are covered by the Biobanks Act. Biobank samples are taken for care, diagnostics and treatment or for clinical research and can be anything from fluids such as blood, serum, plasma and saliva to stool samples and tissue samples such as biopsies, tumors and organs.
Approval from the Swedish Ethics Review Authority is always required when biological samples are taken for research, regardless of whether they are covered by the Biobanks Act or not. If you are unsure whether samples in the study are covered by the Biobanks Act, you can contact the region's biobank coordinator or a Regional Biobank Center (RBC) for advice.
The biobank application is sent to the region's biobank coordinator or to an RBC for review and approval. You can also get advice in connection with the biobank application or to get tips when designing research person information and the parts of the application for ethical review that are about tests.
New EU regulations for clinical trials on medicinal products and medical devices also affect the process for applying for biobanks. Read more under the sections "Specific rules for medicines and medical devices" further down the page.
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 Authority for Privacy Protection's website External link.
Register your study before the start of the study
The fact that it is easy to find information about clinical studies is important from both an ethical and a scientific perspective. In research on humans, studies must be registered before they begin and results reported so that both researchers and the general public can follow what the research leads to. These are requirements and guidelines set by the World Health Organization (WHO) and the Declaration of Helsinki. Many scientific journals in the medical field have also introduced study registration as a publication requirement. In addition, some healthcare regions have their own requirements for registration.
Requirements and guidelines, World Health Organization External link.
Requirements and guidelines, Declaration of Helsinki External link.
Agreement on the conduct of clinical studies
In Sweden, healthcare, universities, colleges and the pharmaceutical industry are working together to develop the conditions for conducting clinical studies.
The agreement sets out the conditions for the collaboration, which includes clinical trials of medicinal products and clinical trials of medical devices in Sweden.
Keep in mind
- Is the application to the Ethical Review Authority correctly filled in?
- Is approval from the Swedish Medical Products Agency is also required.
- Does the study need approval from the radiation protection committee?
- Is the establishment of a biobank necessary?
Specific rules for medicines and medical devices
There are specific rules to follow for clinical studies involving medicinal products or medical devices.
Please note that as of January 31, 2022, a new EU-wide regulation on clinical trials of medicinal products for human use, 536/2014, also known as the Clinical Trials Regulation (CTR), will apply. More information is available on the website of the Swedish Medical Products Agency. External link.
Application for approval of medicinal product trial
Clinical studies investigating medicinal products may fall under the definition of clinical trials of medicinal products, in which case a specific approval is required. This can apply to studies conducted on new medicinal products under development, but also to studies on medicinal products already approved for sale. The purpose can be both commercial and academic.
For guidance on whether your planned medicinal product trial is subject to approval, a guide is published on the Swedish Medical Products Agency's website.
Clinical trial of a medicinal product CTR
Applications under EU Regulation 536/2014 are submitted via the EU portal CTIS (Clinical Trials Information System). Both the Swedish Medical Products Agency and the Ethical Review Authority will then have access to the application. The application will be coordinated and the applicant will receive only one decision that applies to both authorities.
Clinical Studies Sweden has developed templates and supporting documents to support the application.
Templates and supporting documents External link.
Does your clinical trial of a medicinal product include biobank samples
If your clinical trial of a medicinal product involves biobank samples, an approved biobank applicationis required. According to the new application procedure, the biobank application should be submitted to kliniskaprovningar@biobanksverige.se in parallel with the submission of the clinical trial application in CTIS.
Biobank application according to the new EU regulation, Biobank Sweden website. External link.
If you choose to apply under the old EU Directive during the transition period, 31 January 2022 - 31 January 2023, a different procedure applies.
Medical devices, EU regulation MDR
Notification and application to the Swedish Medical Products Agency
Most medical device clinical trials must be notified or applied for to the Swedish Medical Products Agency. In most cases, the Swedish Medical Products Agency coordinates the review with the Ethical Review Authority. This means that it is the sponsor who submits application documents to be reviewed by the Ethical Review Authority when these are attached to the notification or application sent to the Swedish Medical Products Agency. Read more in the section Planning on the website
It is only clinical trials of CE-marked medical devices, where the study participants are not subjected to additional invasive or strenuous procedures that are not coordinated as above. In this case, it is still the entity responsible for research who applies for the ethical review directly to the Ethical Review Authority via the Ethix application portal.
What should be submitted to the Medical Products Agency and the Ethical Review Authority?
Whether it is an application or a notification, the requirements for the documentation to be submitted for review are the same. The dossier consists of an application form and mandatory annexes submitted electronically. Mandatory annexes to the application are defined in each authority's application form (see links below).
Annexes such as the investigator's brochure, written information to be provided to study participants and the clinical investigation plan are recommended to be designed in accordance with ISO 14155:2020, read more in the Planning section. The annexes should demonstrate, among other things, that the investigational device is ready for a medical device clinical trial, i.e., that the device meets the general safety and performance requirements apart from the aspects covered by the study.
What happens to my notification or application?
Depending on the authorisation procedure applied, the authorities' review will be different in scope and timeframe. The most extensive review procedure takes 45 days after a valid application is received.
For clinical trials of medical devices notified to the Swedish Medical Products Agency, the Ethical Review Authority makes a decision within 30 days (no further decision from the Swedish Medical Products Agency will be obtained).
For clinical trials of medical devices applied to the Swedish Medical Products Agency, and when the product is:
- invasive in Class IIa or IIb or a product in Class III, the Swedish Medical Products Agency and the Ethical Review Authority will make a coordinated decision within 45 days.
- Class I or a non-invasive product in Class IIa or IIb, a validation decision from the Swedish Medical Products Agency must be waited for and then the Ethical Review Authority will make a decision within 40 days.
If the trial will be conducted in several countries, there will be the possibility of a coordinated authorisation procedure within the EU. The coordinated authorisation procedure is being implemented in the EU.
Does your clinical trial of a medical device include biobank samples?
If your clinical trial involves biobank samples, an approved biobank applicationis required.
The Regional Biobank Centre is also part of the coordinated process to facilitate the establishment of the Biobank Agreement. A Biobank Application must always be submitted to the Regional Biobank Centre at the same time as the clinical trial application is sent to the Swedish Medical Products Agency.
Application procedure for medical devices, Biobank Sweden website External link.
In vitro diagnostic regulation for medical devices, EU IVDR
The new IVD legislation introduces the requirement to apply for approval from or notification to the Swedish Medical Products Agency for certain types of clinical performance studies of in vitro diagnostic products. Please read more in the section Planning .
Clinical performance studies that are notifiable to the Swedish Medical Products Agency are those studies that involve:
- treatment-guiding diagnostics using remaining sample material
- that a CE marked diagnostic device is studied within the scope of its intended purpose, but the study involves additional invasive or strenuous procedures for the subject.
Clinical performance studies that require an application to the Swedish Medical Products Agency are such studies that involve:
- an intervention study of clinical performance
- that surgically invasive sampling is performed and where the procedure is done solely for the purposes of the study
- that additional invasive procedures are performed or other risks to subjects exist, even if these are not related to the sampling procedure
- treatment-guiding diagnostics where samples/materials are taken specifically for the study.
These types of performance studies must be notified or applied for to the Swedish Medical Products Agency, which coordinates the review with the Ethical Review Authority. This means that application documents to be reviewed by the Ethical Review Authority are attached to the notification or application sent to the Swedish Medical Products Agency.
However, it will still be possible to conduct many performance studies without either notification or application to the Swedish Medical Products Agency. For these an ethical review must be applied for to the Ethical Review Authority via the Ethix application portal.
What should be submitted to the Medical Products Agency and the Ethical Review Authority?
Whether it is an application or a notification, the requirements for the documentation to be submitted for review are the same and are set out in Chapter I of Annex XIV of the IVDR. The application form and mandatory annexes are submitted electronically.
Annexes such as the investigator's brochure, written information to be provided to study participants and the clinical performance study protocol are recommended to be designed in accordance with ISO 20916:2019, please read more in the Planning section. The annexes should demonstrate, among other things, that the investigational device is ready for a medical device clinical trial, i.e., that the device meets the general safety and performance requirements apart from the aspects covered by the study.
What happens to my notification or application?
Depending on the authorisation procedure applied, the authorities' review will be different in scope and timeframe. The most extensive review procedure takes 45 days after a valid application is received.
For clinical performance studies notified to the Swedish Medical Products Agency, the Ethical Review Authority makes a decision within 30 days (no further decision from the Swedish Medical Products Agency is obtained).
For applications of clinical performance studies to the Swedish Medical Products Agency, the Swedish Medical Products Agency and the Ethical Review Authority make a coordinated decision within 45 days.
Information on the review and approval procedures of the Ethical Review Authority. External link.
Does your clinical trial of a medical device include biobank samples?
If your clinical trial involves biobank samples, an approved biobank applicationis required. The Regional Biobank Centre is also part of the coordinated process to facilitate the establishment of the Biobank Agreement. A Biobank Application must always be submitted to the Regional Biobank Centre at the same time as the clinical trial application is sent to the Swedish Medical Products Agency.
Application procedure for medical devices, Biobank Sweden website External link.
Links and related information
More information on the Ethical Review Act External link.
More information on the Helsinki Declaration External link.
Ethical review - how it works External link.
The Ethical Review Authority's guidance on the design of the research plan External link.
Information from the Ethical Review Authority on documentation for study participants External link.
Information on ethical review fees External link.
More information on studies where participants are receiving radiation External link.
Data protection, website of the Swedish Authority for Privacy Protection External link.
Clinicaltrials.gov External link.
Joint agreement between SKR and LIF External link.
Links - medical technology
Information review and approval procedures on the Planning page External link.
Application procedure for medical devices, Biobank Sweden website External link.
Links - medicines
More information on transitional rules on the Swedish Medical Products Agency website External link.
Biobank application according to the new EU regulation, Biobank Sweden website. External link.
ATMP (Advanced therapy medicinal products)
Advanced therapy medicinal products (ATMP) are human medicines, based on genes, tissues or human cells. They offer ground-breaking new opportunities for the treatment of diseases and injuries. More information about advanced therapy:
For guide/templates and regulatory guide, ATMP project website External link.
Classifications, regulatory information, European Medicines Agency website External link.
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