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.
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 Data Protection Authority’s website External link, opens in new window..
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.
Agreement on conducting clinical studies
In Sweden, healthcare, universities, colleges and the pharmaceutical industry collaborate with the aim of developing the conditions for conducting clinical studies.
The agreement reached sets out the conditions for the collaboration, which includes clinical trials on medicinal products and on medical devices, in Sweden.
Specific rules for medicinal products or medical devices
There are special rules to comply with regarding clinical studies with medicinal products or medical devices.
Specific rules for medicinal products
Applying for authorisation for clinical trials on medicinal products
Clinical trials where medicinal products are studied can be covered by the definition of clinical trials, and special permission is required. This can apply to both studies that are performed on new medicinal products under development, but also studies on medicinal products that are already approved for sale. The purpose can be both commercial and academic.
For guidance on whether your planned clinical trial is subject to authorisation, a guide has been published on the Swedish Medical Products Agency's website.
Apply according to old or new regulations
On 31 January 2022, a new EU regulation on clinical trials on medicinal products apply. During a transitional period, it will be possible to apply for and carry out studies both in accordance with the old EU Directive 2001/20 / EC with associated national legislation and in accordance with the new EU Regulation EU 536/2014 (also called Clinical Trials Regulation, CTR).
For clinical trials on medicinal products conducted in accordance with national legislation and EU Directive 2001/20 / EC
It will be possible to apply according to the old regulations until 31 January 2023. In that case, an application must be sent to the Swedish Ethics Review Authority via their own system Ethix and a separate application must be sent to the Swedish Medical Products Agency. You'll get two separate decisions from these two authorities.
For clinical trials on medicinal products conducted in accordance with EU Regulation EU 536/2014
If an application is to be made in accordance with the new regulations, the application must be submitted via the EU portal CTIS (Clinical Trials Information System). Both the Swedish Medical Products Agency and the Swedish Ethical Review Authority will then have access to this application. Coordination takes place and the applicant will only receive one decision that applies to both authorities.
Includes your clinical trial on medicinal products biobank samples
If your clinical trial on medicinal products includes biobank samples, an approved biobank application is required. According to the new application routine, the biobank application must be sent to firstname.lastname@example.org in parallel with the application being sent to CTIS.
If you during the transition period, 31 January 2022 - 31 January 2023, choose to apply according to the old EU directive, another routine applies.
Specific rules for medical devices
New rules apply within the EU from 26 May 2021, additional rules apply in Sweden from 15 July 2021.
Notification and application to the Swedish Medical Products Agency
Clinical investigations of medical devices must be notified or applied to the Swedish Medical Products Agency which coordinates the review with the Swedish Ethics Review Authority. This means that application documents that are to be examined by the Swedish Ethical Review Authority are attached to the notification or application that is sent to the Swedish Medical Products Agency. Find out more under the page Planning on this website. External link.
What must be submitted to the Swedish Medical Products Agency and the Swedish Ethical Review Authority?
Whether it is an application or notification the requirements for the documentation to be submitted for review are the same. Application form and mandatory appendices are submitted electronically. The mandatory appendices to the application form are defined in each authority's application form (see links below).
Appendices such as trial handbook, written information to be provided to study participants and the clinical trial plan is recommended to 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.
What happens to my notification or application?
Depending on which permit procedure is applied, the authorities' review will be differently extensive and run according to different deadlines. The most comprehensive review procedure takes 45 days after a valid application is received.
For medical technical clinical trials that have been reported to the Swedish Medical Products Agency, the Swedish Ethical Review Authority makes a decision within 30 days (no further decision is received from the Swedish Medical Products Agency).
For medical technical clinical trials applied for to the Medical Products Agency, and the product is:
- invasive in class IIa or IIb or a product in class III, the Swedish Medical Products Agency and the Swedish Ethical Review Authority make a coordinated decision within 45 days
- class I or non-invasive product in class IIa or IIb, a validation notice from the Swedish Medical Products Agency must be awaited and thereafter the Swedish Ethical Review Authority makes a decision within 40 days.
If the trial will 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.