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 Agency 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 Agency. 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 application system Prisma. On the Ethical Review Agency's website there are 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 Agency 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 Agency. 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”.
SKL, 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
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 (SFS 2002:297) 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 the process of using application templates, designing 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, RBC. The Biobank Sweden website has a Biobank Guide and links to current resources for biobank services. The university hospitals also have 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 Biobank Sweden website.
If biobank samples are to be used in your clinical study, the biobank should be contacted early on in the planning. The biobank coordinator and the Regional Biobank Centre can help you with advice in conjunction with planning, application templates, design of patient information and the biobank sections of the ethical review application.
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
All clinical medicine studies must be registered in a publicly accessible database before the study begins. 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.
SKL 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.
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.
Specific rules for medicines or medical devices
There are specific rules to attend to if your study needs a permit from the Medical Product Agency.
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 Agency 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, 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 (in Swedish) to the application.
If the Ethical Review Agency 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
Does the study need to be notified to the Medical Products Agency?
Some clinical studies that involve medical devices need a permit from the Medical Products Agency. More information is available in the sections with specific rules for studies involving medical devices under the Idea and Planning tabs.
Some documents in the applications to an ethical review board and the Medical Products Agency shall be “mirrored”, such as the clinical trial plan (CTP). This means that these public authorities must approve the same version of these documents.
When a clinical study involving medical devices needs to be notified to the Medical Products Agency, the agency recommends that it follows “good clinical practice”. For medical devices, there is a harmonised standard, ISO 14155. More information on good clinical practice and ISO 14155 can be found under the Idea and Planning tabs.
Detailed application instructions are available on the Medical Products Agency’s website. Application form and mandatory appendices shall be submitted electronically.
The appendices to the application are defined in the application form; in some cases it is recommended that they are designed according to ISO 14155. The standard includes required headings and contents for a number of documents. Among other things, the documents shall show that the trialled device is ready for a clinical study, that is to say the product fulfils the significant requirements in addition to the aspects covered by the study.
One of the appendices – “Declaration of conformity” – must be issued by the manufacturer. For a trial device, this means that the document must be designed according to Item 2.2 of Appendix 8 (Swedish Medical Product Agency’s regulations 2003:11 on medical devices). This is a confirmation that the device in question corresponds to the significant requirements (Appendix 1 of the Medical Products Agency’s Regulation LVFS 2003:11, or alternatively Annex 1 of the Medical Devices Directive), in addition to the aspects that constitute the purpose of the trials and that, in consideration of these aspects, all precautions have been taken to protect the health and safety of patients, users and other persons. Please note that his document is a different declaration of conformity than the one produced by the manufacturer for CE marking.
The Medical Products Agency then assesses whether the application is complete, and invoices an application fee. If the application is complete, the first administrative stage starts. This takes around one month, and thereafter the Medical Products Agency may ask for answers to a number of questions, and ask for additional information or changes. The application then goes through a second administrative stage, and is approved or rejected after no more than 60 days.
Corresponding requirements also apply in other countries – that is to say, a permit for the study must be applied for to the ethical review body of the country in question, and possibly to the country’s “authorised authority”. In addition, there are also other notifications, registrations and applications, just as in Sweden.