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 External link.
Information on research ethics in connection with medical research in the Declaration of Helsinki External link.
Application for ethical review and guidance for the design of a research plan, the Swedish Ethical Review Authority (in Swedish) External link.
Answers to frequently asked questions about the application, the Swedish Ethical Review Authority (in Swedish) External link.
Information on how data for study participants should be designed, the Ethical Review Authority (in Swedish) External link.
Information on fees for ethics review, the Swedish Ethical Review Authority (in Swedish) External link.
Generic templates for conducting clinical studies, Apotekarsocietet's section for Clinical Studies in collaboration with LIF and the Swedish Medical Products Agency (in Swedish) 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.
Information regarding rules for clinical studies in which study participants are exposed to ionizing radiation External link.
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.
Forms and instructions for biobank applications and contact information for, among others, biobank coordinators and RBC (in Swedish), Biobank Sweden's website External link.
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.
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 OrganizationExternal link. External link.
Requirements and guidelines, Declaration of HelsinkiExternal link. External link.
About publication requirements, International Committee of Medical Journal Editors (ICMJE)External link. External link.
Guidelines and further information on student registration, the Swedish Research Council 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.
About the product area: advanced therapy and joint links (in Swedish), Swedish Medical Products Agency’s website External link.
E-course: Introduction to advanced therapies (in Swedish), Swedish Academy of Pharamceutical Sciences website External link.