The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2012) Sweden

Transcription

1 The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe Sweden Question 1: What laws or regulations apply to an application for conducting a clinical trial in Sweden? Act on Ethics Review of Research Involving Humans (2003:460) Act on Personal Data (1998:204), revised Act on Patient Data (2008:355), revised 2009:525. Act on Biological Tissue Banking (2002: 297). Drug Act (1992:859), revised 2011:19. Question 2: Which government, legal or authoritative body or bodies is or are responsible for the establishment and/or accreditation of (research) ethics committees for IMPs, and for their supervision and quality? Are there different (research) ethics committees reviewing other projects? Under the above Act on Ethics Review of Research Involving Humans, the approval of an EC, called a Board for Ethics Review is a mandatory legal requirement for research involving physical interventions, psychological manipulations, use of human biological material and research on sensitive personal data in cases whether or not the informed consent of the data subject is obtained. There is also a Central Board that reviews certain types of research that fall under Sections of the Act on Ethics Review, receives applications from regional Boards when they cannot reach a unanimous decision and considers appeals from researchers concerning regional board decisions. Question 3: What is the process for achieving clinical trial authorisation from the competent authority in Sweden? Application is made to the Medical Products Agency (Lakemedelsverket) using a form that can be downloaded from its website ( An English translation is available.

2 Question 4: What is the process for obtaining ethical review of a clinical trial protocol by a competent (research) ethics committee in Sweden? Application is made to the relevant EC (Board for Ethics Review) using a form that is available on the website An English translation is available. Question 5: Is there a single organisation to which to apply for ethical review of a clinical trial for an investigational medicinal product, regardless of whether this is for a single site or multiple sites? Yes, one of the six Regional Boards (see Question 9). Question 6: What is the website for the organisation that issues guidelines on the ethical review of a clinical trial for an investigational medicinal product? The website of the Medical Products Agency is at Question 7: Is there a procedural interaction between the national or local competent authority and the (research) ethics committee during the approval process? No. Question 8: Does the application to the REC and to the competent authority have to be submitted in parallel, or, if not, in which order? This is up to the discretion of the applicant, as there is nothing stated in laws or regulations. Question 9: How many (research) ethics committees are there in Sweden? There are six independent Regional Boards for Research Ethics Review, each chaired by a judge, as well as a Central (National) Board for research ethics review. The regional boards are situated in Gothenburg, Linköping, Lund, Umeå, Uppsala and at the Karolinska Institute in Stockholm. Most boards have one committee reviewing both medical and non-medical research; however, Gothenburg has two separate committees: one for reviewing medical research and one for non-medical research. And Stockholm (the Karolinska) has five committees, four reviewing medical research and one reviewing non medical research. The national (central) EC (for appeal) is located in Stockholm.

3 Question 10: How are RECs funded in Sweden? Do they charge fees? If yes, what is their scale of fees? They are funded by fees ranging from 2,000 SEK (approximately 200 ) for an amendment to 16,000 SEK (approximately 1,600 ) for pharmaceutical trials, or multicentre studies. Question 11: Who is responsible for submitting the request for ethical review to the competent (research) ethics committee for single-site and for multi-site clinical trials? The legal body where the investigator is an employee. Typically this could be a university institution or hospital department. It can also be a commercial body, e.g. sponsor. Sponsor has a right to communicate directly with the EC. Question 12: How is a single opinion achieved for multi-site studies? A decision from any Regional Boards for Research Ethics Review will form that single opinion (only one Board needs to review any clinical trial for an investigational medicinal product; which one depends on the location of the Chief Investigator). Question 13: How many members serve on a REC? A Chairperson who must be or have been a judge and 15 Members appointed by the Government out of whom 5 shall represent public interests and the others shall have a scientific expertise. Appointed deputies are permitted. Question 14: How many members constitute a quorum? A REC is able to make decisions when the chairman and at least 8 persons are present. Of those at least 5 persons must be researchers, and at least two must be laymen. Question 15: How are REC members appointed? By the Universities (experts) and political parties (laymen). The Government appoints the chairman (judge). Question 16: How is the independence of members ensured? There is a specific law with details, under which everyone in a governmental body must declare conflicts of interest (when they occur). Question 17: How are conflicts of interest of REC members avoided? By declaring in advance any conflict of interest. See Question 16.

4 Question 18: What backgrounds and/or qualifications of members are actively sought? Particular expertise sought includes the following: Relevant methodological and ethical expertise in clinical, non-clinical, qualitative and other research methodologies in the health and social sciences fields. Each REC must include expertise in geriatric, psychiatric and paediatric diseases. Generally a clinical pharmacologist is deemed necessary due to the amount of pharma applications. Lay members are recruited from the local political parties that are running the county council (which is taxing its population and paying for hospitals and medical care in the region). Question 19: How do RECs obtain specialist expertise? See Question 18. All experts are clinical specialists with at least scientific dissertation on top (MD, PhD.). For certain areas there are requests for specific representation. These include a paediatrician in cases when children are involved, a psychiatrist when such patients are involved, and a geriatrician when projects in the elderly are at stake. For specific needs a written statement from an external expert may be asked for. Question 20: What are the training requirements for members of RECs? There is an initial training provided by the Central Board. There is also a program at each Regional Board for Research Ethics Review, which is usually 1-4 days training per person per year. Question 21: What training programmes are available for REC members in Sweden? Regional Boards for Research Ethics Review have a budget including this. There are also annual meetings when all Regional Boards for Research Ethics Review meet and discuss new regulations and difficult cases. Question 22: What are the timelines for the assessment of singleand multi-site studies? The only timeline, for single site and multi-site studies, is 60 days from the acknowledgement of the application. It is however in real life much faster, usually approximately 30 days for both EC and CA.

5 Question 23: How are substantial amendments submitted during the review process dealt with? They are handled separately and charged accordingly. If not too late in the review process, they may actually be considered in the vetting of the original application. Question 24: How does a REC assess the suitability of investigators and of sites? For the investigator a CV, showing therapeutic expertise and scientific knowledge, is submitted. For the site a certification of the resources allocated is required from Head of Department. Question 25: How are the requirements for (research) ethics committees to review the contractual or financial arrangements in clinical trials for both investigators and hospitals handled? They are included in the application and reviewed during the process. Question 26: How are the requirements for (research) ethics committees to review the compensation arrangements for study subjects handled? They are included in the application and reviewed during the process. Question 27: Is there an ongoing quality assurance process (e.g. audits, inspections, internal SOP) for (research) ethics committees in Sweden? No. Question 28: Is there an appeal mechanism? Yes. To the Central (national) EC in Stockholm. Question 29: How do RECs deal with SUSAR reports and Annual Safety Reports? They are filed. Question 30: How are substantial amendments defined? As in guidelines to the Directive 2001/20/EC, and also laid out on the CA web ( In short the sponsor must define when an amendment is substantial.

6 Question 31: What are the indemnity insurance requirements for research projects? There must be one available. Question 32: What are the indemnity insurance requirements for (research) ethics committee members themselves? There are none. Question 33: How is informed consent obtained from vulnerable subjects who are potentially to be involved in a clinical trial? From the subject if possible, and otherwise from the relatives (proxy). Question 34: How do RECs assess the progress and outcome of research projects that they have approved? They do not. Question 35: How does the REC ensure reception of the Annual Safety Report and the Summary of the Final Report of a research project that it has approved? They do not. They file any reports that are sent to them. Question 36: Do national regulations in Sweden allow research on healthy volunteer children (subjects under 16)? Yes. Question 37: Do national regulations in Sweden allow payment, (other than expenses), to children taking part in research? Yes, for non-drug research it is allowed, typically a ticket to a cinema or equivalent value (app. 10). For drug research it is prohibited. Question 38: Do RECs invite or allow a) applicants or b) observers to attend committee meetings? Yes to both a) and b) REC allows applicants and observers to attend committee meetings, but they have to sign a confidentiality paper. REC can invite an applicant if necessary for the understanding of the proposal.

7 Question 39: Are the minutes of (research) ethics committee meetings made public? The minutes are not actively made public but can be obtained after a judgement made by the Chairman. Question 40: Is there any scope for Chairman s actions in between meetings? Yes, the Chairman could make decisions on minor trivial/ formal matters between meetings. Question 41: Do (research) ethics committees ever appoint subcommittees for any specific purpose? No, but sometimes it may be necessary to get consultations from experts for technical expertise to acquire optimal understanding of a specific study. Question 42: Is there a national policy on the registration of clinical trials before they start? Not beyond EudraCT. Question 43: If the answer to Question 42 is yes, do (research) ethics committees have any role to play in reviewing such registration? No Question 44: If the answer to Question 42 is yes, is this register of clinical trials made available to the public? N/A Question 45: With regard to Clinical Trial Insurance, do research ethics committees in Sweden work to a set template of requirements? Not beyond what is defined in the Act. Question 46: If the answer to Q45 is yes, how are these requirements a) Decided upon? b) Cross referenced to statutory requirements? c) Updated? By Law. EFGCP April 2012