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Eurecnet - National Information: Sweden
National Information: Sweden
Introduction and historical overview
It was in the late 1960s that research ethics review committees were first established in Sweden. The first committe was created at the Karolinska Institute, others followed shortly after at the other medical faculties in Sweden. The ethical review system was voluntary and developed according to the declaration of Helsinki. A major reason for their introduction was the strong demand by international granting bodies, especially the NIH, to create such research review systems in order to provide grants. In the early 1970’s, the Medical Research Council (MRC) decided to form a working group to harmonize the procedures of the different regional research ethics committees (REC). The MRC working group for research ethics, involving representatives from each of the 10 existing RECs, had developed a common application form and written guidelines for the regional RECs. There was no formal appeal body but cases that RECs had identified as problematic were discussed in this central working group that also arranged yearly seminars for all members of the RECs. Despite these attempts to harmonize the membership as well as the working procedures, the RECs developed a somewhat different composition varying from ten to fifteen members, of whom two to five were lay persons while the others were skilled scientists. The scientific representatives were appointed by the local university and should be skilled researchers such as professors or associate professors. The scientists constituted the majority of the committees in all except one committee, where scientists and lay persons were equal in number. The chairman was a scientist in all but one of the committees. Lay persons were generally nominated by the county councils. Each of the committee members had a deputy member. The scientists should represent a broad expertise and normally a clinical pharmacologist, a pediatrician and psychiatrist were members or deputy members in each REC.
In the MRC working group, the chair was a member of the MRC steering committee (a researcher) and except for representatives from the RECs, different authorities, such as the Medical Product agency, the Board of health and welfare and the Swedish medical association, were represented. A lawyer and a professor in medical ethics were members as well. In the local RECs lawyers and/or philosophers could be appointed as “lay people” whereas the scientists were medical scientists.
This system was working well and becoming more and more harmonized over the years due to the MRC working group activities. As a result of different debates on new medical research, such as the use of biobanks or stem cell research, as well as debates on longitudinal projects in the social sciences, a call for a legal system was raised in the parliament; this call was accelerated after Sweden signed the European Convention on Ethics and Biomedicine and the directive (2001/20/EC) on clinical trials. The present legal system for ethics in research with humans thus started January 1, 2004 as described below.
Present system of local research ethics committees; content and institutional affiliation
The Swedish ethical review act, issued 5 June, 2003 (SFS no 2003:460), was implemented in January 2004 and concerns research involving humans and biological material from identifiable persons in medical as well as other research areas such as psychology, sociology etc.
For details on the ethical review act and the application form, see: www.epn.se.
The Swedish ethical review act was revised in 2008 (SFS 2008:192).
According to this act, research ethics review is mandatory in research involving interventions using methods intended to physically or mentally influence the person participating in the research. It is also mandatory in cases where there is an obvious risk that the subject of the research may be affected physically or mentally, even if unintentionally. The act also involves research on biological material taken from living or dead identifiable persons as well as sensitive personal data obtained from registers or questionnaires/interviews.
In other kinds of research with humans, the researcher could optionally apply at/for the REC for an ethics review and advice. In this case, the decision would not be legally binding. This rule was introduced since both grant giving bodies and international journals often demand ethics review in all projects involving humans. The law also details some of the requisites for, e.g., research with incompetent persons, children or informed consent procedures. In principle, the law adheres closely to the European Council’s Convention on Human Rights and Biomedicine and the EC directive for clinical trials (see below).
Organisation
The regional research ethics boards are independent bodies responsible to the ministry of education. All of the six large universities in Sweden have a regional research ethics board which, in regions comprising larger universities, may involve one to four different units for medical research review and always one separate unit for review of non-medical research with humans. The regional committees have their own administration and economy although they are located close to or within the university building. They may get administrative help from the university but the internal work of the ethics boards is entirely independent from the university and they have their own internal organization.
Members
Each unit involves ten skilled scientists and five lay persons, each of them having a deputy member. The chair is always an experienced judge and the experts in the medical units (scientific member or deputy member) should cover psychiatry, pediatrics, clinical pharmacology when possible. The other scientists/deputies should represent a broad expertise. All board members and deputy members are appointed by the ministry of education but the local universities will nominate the scientific members and the local county council for the lay persons. Overall, there are 16 units covered by the six regional boards, thus involving 480 individual members/deputies plus 32 judges chair/deputy chair. The central board (see below) adds to this 12 members/deputies and 2 judges. Therefore, 526 people are involved altogether, dealing with approximately 45 000 applications per year including those for advisory review.
Procedure
The application is to be completed according to a standardized form (see: http://www.epn.se/media/2070/etikprovning_blktt.doc) and the research institute/industry or another legal body responsible for the research is also formally responsible for the application and for the payment of the fee.
Catchment areas for the regional ethical review boards are defined and an application should be vetted by the regional ethic review board in the catchment area to which the responsible research body belongs (see www.epn.se). In case of multicenter studies, only one REC will review the application. The application should be submitted by the responsible research body mainly responsible for the research project in question (PI).
The boards in each unit meet once a month and should make decisions as rapidly as possible and in accordance with of the EC directive for clinical trials. Usually, this time schedule also applies to other research projects than clinical trials.
Although consensus is aimed for, a majority voting could determine a final decision. A regional board can make a decision when the chairman and at least eight other members are present. Of the other members, at least five should have scientific qualifications. In a case such as this, the majority voting will decide. If at least three members of a regional board find the application controversial, they have the possibility of transferring the case to the central research board (see below) for decision.
The Central ethical review board
Besides making decisions on controversial issues delivered by a REC, the central board is an appeal body for researchers who want to complain about a decision made by a regional board. The central board also has the responsibility to supervise the researchers’ adherence to the research ethics law. However, this is only the case when supervision is not already the task of the medical project agency (in cases of clinical trials) or the Swedish board of health and welfare (if the study concerns patients in the health care system). The central research ethics board involves four highly skilled researchers representing both the medical field as well as other fields of human science. In addition, there are two lay people on the board and it is chaired by high court judge. Each member, including the chair, has a deputy member. The members are appointed by the ministry of education. The scientists on the board are suggested to the ministry of education by the research council, whereas the lay people are nominated from county councils or other sources. The scientific secretary will prepare a summary of the application and present the ethical issues at the meeting but all members receive the complete application forms at least one week before the meeting and they should have prepared all cases before attending the meeting. The decisions of the central board are a yes or a no but they may be a yes with clear conditions. The decisions of the central board are of a final and policy making nature. All decisions from the central board are delivered to all regional boards and to the different units.
All decisions from regional and central boards are publicly available. In cases where the judge decides that no other laws, such as the law on privacy, would hinder that parts of the application must be kept secret, anyone should be able to get access to the decisions and the applications. In mid 2009, the central ethical review board will also take on the task of reviewing accusations for dishonesty or fraud in research.
The role of the Research council
The research council is authorized by the education ministry to give provisions for the procedures of the research vetting including changes in the application forms. The research council is responsible for education of the research ethics board members. For these purposes the council has instituted an advisory group including scientific secretaries and/or judges from each of the central and regional research boards in Sweden.
Both the regional and the central research review boards have a common web site – www.epn.se – where relevant information including related links to laws and other regulations can be found in Swedish and in English. Changes in guidelines or regulations are published there as well as interesting and potentially policymaking decisions from the central review board (in Swedish only).
Legal situation on the implementation of the directive 2001-20-EC and other associate legislation
Clinical trials
As stated above, the Swedish law from January 2004 is based on and adheres to the directive 2001/20/EC. For clinical trials, a separate application should be sent for permission by the Medical Products Agency and this application could be handled parallelly with the application to the REC.
Biobanks involving identifiable human tissue
Sweden has issued a separate biobank law (2002/297) for collecting and saving biological samples taken for diagnostic procedures within the health care system. For saving and storing such material collected for clinical purposes, informed consent is mandatory. In cases where such samples shall be used for research purposes, a research ethics review is mandatory and the REC must decide whether a new informed consent is necessary.
Register studies
According to the Swedish data protection law (1998:204), the research ethics review board should decide, in cases where personal data stored are to be used for research purposes. A separate application to the Swedish data inspection board should, however, be submitted for review when the research involves the processing of personal data concerning genetic traits that have been revealed as a result of a genetic examination.
Research involving radiation
In cases of research involving radiation, approval should also be obtained from the local hospital radiation protection committee.
For research including animals, there is a separate law included in the animal welfare act (1988:534).
Contact / Addresses
Contact addresses of the regional and central ethical boards are to be found under this link: www.epn.se.
Responsible for this information is EUREC partner Gisela Dahlquist, e-mail gisela.dahlquist@pediatri.umu.se, scientific secretary, Central ethical research board.
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