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 board and in many cases also from the Medical Products Agency.
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 a regional ethical review board. 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, research may only be approved if:
An application of ethical review (pdf, 74 kB) shall be made on a special form available from the website of the ethical review boards. There you can also find guidelines for application (pdf, 174 kB).
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 an ethical review board is approximately 60 days. The cost of applying for an ethical review is currently between 5 000 SEK and 16 000 SEK.
SKL, the Swedish Association of Local Authorities and Regions, and LIF, the Swedish Association of the Pharmaceutical Industry, have developed generic templates (in Swedish) for resource certificates and CVs that may be used in the application.
In medical, dental or biomedical research projects where the participants are irradiated, the study shall be approved by a radiation protection committee. The application shall be sent to the radiation protection committee in the same region as the decision-making regional ethical review board. 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. The main application form (doc, 28 kB, in Swedish) can be found on the website of the ethical review boards. The website also has forms relating to:
Biobank samples cover all areas from liquids, such as blood, serum, plasma and saliva, to faeces samples and tissue samples, such as biopsies, tumours and excised organs. The Biobanks in Medical Care Act applies for human tissue or cell samples if they are saved for longer than two months, except when the sample has been used for research, when it is a biobank sample irrespective of the storage period. It must always be possible to trace a biobank sample back to the sample provider, and it must always be stored in a biobank.
Advice in conjunction with planning a research study and the process of using application templates, design of patient information and the biobank sections of the ethical review application is offered in several locations in Sweden, both by biobank coordinators and the regional biobank centre. The Swedish National Biobank Board’s website has links to current resources for biobank services. The university hospitals also has centres for collaboration between universities and county councils/regions that can provide targeted support to research.
A biobank application is required in order to use biobank samples in research. Information, guidelines and checklists are available on the website of the Swedish National Biobank Board.
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 an ethical review board is required.
For guidance whether your planned study requires authorisation, you can use the Medical Products Agency’s test (pdf, 154 kB, in Swedish).
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, a “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 guid (in Swedish) to the application.
If the ethical review board 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.
For clinical studies involving a medical device, the procedure is different. Clinical studies involving non-CE-marked medical devices or medical devices that are CE-marked for other use than that intended in the study shall be registered by the Medical Products Agency. A clinical study of medical products within the CE-marked indication do not have to be registered.
The application shall be sent to the Medical Products Agency in electronic format. Detailed instructions are available on the Medical Products Agency’s website. The application shall be supplemented with appendices.
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.
SKL, the Association of Swedish Local Authorities and Regions, and LIF, the Swedish Association of the Pharmaceutical Industry, have a joint agreemen (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.
Office for Clinical Studies
Östra Hamngatan 26
SE-411 09 Göteborg
Phone: +46 (0)31 757 41 75
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