Vetting the ethics of research involving humans
Heading: Statute (2003:615) concerning the ethical vetting of research involving humans
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SFS number 2003:615
Ministry/authority: Ministry of Education and Cultural Affairs
Heading: Statute (2003:615) concerning the ethical vetting of research involving humans
Issued: 9 October 2003
Changes made: up to and including SFS 2008:351
Introductory provisions
Section 1
In this statute there are regulations issued in connection with the act concerning the ethical review of research involving humans (2003:460). The expressions and appellations used in that legislation have the same meaning in this statute. For ethical vetting in accordance with the law there are regional ethical review boards and the central ethical review board.
The application process
Section 2
When several responsible research bodies participate in the same project, only one of the responsible research bodies is to apply for ethical vetting. The application is to be submitted by the responsible research body that is mainly responsible for the research project in question.
Section 3
The catchment areas for the regional ethical review boards are listed in annex 1.An application concerning research to be carried out by a state university or a state college is to be vetted by the regional ethical review board in the catchment area to which the responsible research body belongs. An application concerning research to be carried out by someone other than the responsible research body is to be vetted by the regional ethical review board within whose catchment area the responsible research body resides. If the responsible research body is resident in a country other than Sweden, or if the place of residence has not been established, the application is to be vetted by the board within whose catchment area the research will primarily be carried out.An application concerning research that is to be carried out within the catchment areas of several regional ethical review boards is to be vetted by the board within whose catchment area the responsible research body that is mainly responsible for the research project resides. If a responsible research body is not resident within a catchment area, the application is to be vetted by the board within whose catchment area the research will primarily be carried out. Section 4The regional ethical review board that has vetted an original application is also to vet an application that concerns an alteration subsequent to an approval being granted. This applies even if the central review board was the one to vet the original application.
Advisory statements
Section 4 a
A regional ethical review board may issue advisory statements with respect to research concerning humans in those cases where the research is not covered by The Act concerning the Ethical Review of Research Involving Humans (2003:460). The board may also issue advisory statements with respect to work carried out as part of a programme of study at an institute of higher education at a basic or advanced level.Ordinance (2008:351)
Section 4 b
A request for an advisory statement is to be submitted to the regional ethical review board in the catchment area to which the responsible research body belongs, in accordance with this ordinance. The competent authority may also submit a request to another regional ethical review board.
Ordinance (2008:351)
Research that involves the donation of eggs
Section 4 c
If, in the course of its ethical review, an ethical review board decides to approve research that involves the donation of eggs, the board is to send a copy of the decision to the National Board of Health and Welfare.
Ordinance (2008:351)
Processing times for applications
Clinical trials of medicinal products
Section 5
In those cases where the application concerns the clinical examination of people to establish the traits of a pharmaceutical product (clinical trials of medicinal products), the regional ethical review board is to make its decisions within the times given in the table below. The time is calculated from the moment that a complete application is received by the proper regional ethical review board. The application concerns
Number of days
Pharmaceutical products for gene therapy: 90
or somatic cell therapy or pharmaceutical products that contain genetically modified organisms
in those cases where there are regulations requiring the board to consult another authority:180
Alteration according to section 4: 35
Xenogenic cell therapy: no time limit
Other clinical trials of medicinal products: 60
Section 6
One extension to the period of time stipulated in section 5 may be granted if the regional ethical review board requests additional information from the applicant. In such cases the number of days specified in section 5 is extended by the number of days that elapse from the time the information is requested until the time it has been received.
Section 7
The central ethical review board is to make its decision within the number of days specified in section 5 in cases concerning clinical trials of medicinal products that have been referred to it by a regional ethical review board in accordance with section 29 of the act concerning the ethical review of research involving humans (2003:460). This time is calculated from the moment that a complete application has been received by the correct regional ethical review board. The time needed by the central ethical review board may be extended in the manner described in section 6, unless such a procedure has already been invoked in the case by the board which referred the matter.
Other research
Section 8
When there is ethical vetting of other research than clinical trials of medicinal products, a regional ethical review board should make a decision within 60 days. When changes are made in accordance with section 4, the board should make a decision within 35 days.
Referral of a case
Section 9
When a case is referred in accordance with section 29 of the act concerning the ethical review of research involving humans (2003:460), the regional ethical review board is to include a statement. The statement is to contain an account of the different opinions for and against an approval, that were expressed when the board met. In those cases where the board procured more information concerning the matter, this information is to be included in the statement.
Entitlement to fees
Section 10
A regional ethical review board is entitled to levy fees for vetting a case in accordance with the act concerning the ethical review of research involving humans (2003:460). With respect to such fees the regulations in sections 11‑14 of the ordinance act (1992:191) should be implemented.A regional ethical review board is entitled to levy fees for such advisory statements described in 4 a §. With respect to such fees the regulations in section 11 – 13 §§ of the ordinance act (1992:191) should be implemented. Ordinance (2008:351)
Section 11
Fees in accordance with section 10 are divided into categories depending on what type of application is to be vetted. The fees are set out in annex 2 of this statute.
Directives
Section 12
The Swedish Research Council may issue directives concerning exemptions to the requirement that approval should be granted during the course of the ethical vetting of research or the treatment of personal data in accordance with the act concerning the ethical review of research involving humans (2003:460) if it is clear that the research does not involve any noteworthy risk to the health or safety of an individual or any intrusion with respect to an individual's personal integrity.The Swedish Research Council may issue additional directives concerning the implementation not only of the act concerning the ethical review of research involving humans (2003:460), but also of this statute.
Appeals
Section 13
There is no appeal against an advisory statement made in accordance with section 4 a
Decisions with respect to application fees in matters concerning advisory statements in accordance with section 4 a may be appealed against to the Central Ethical Review Board.
Ordinance (2008:351)
Transitional provisions
2003:615
- This statute comes into force on 1 January 2004
- The regulations in sections 5‑7 are not to be applied to applications submitted prior to 1 May 2004 .
Annex 1
This annex lists the geographical catchment areas for the regional ethical review boards. The annex also lists catchment areas state universities and university colleges. For universities and colleges with any other principal there are regulations in section 3 paragraph 2.
The regional ethical review board in Gothenburg
Counties
Västra Götaland county
Universities and colleges
The University of Gothenburg
Borås University College
Skövde University College University West
The regional ethical review board in Linköping
Counties
Östergötland County
Jönköping County
Kalmar County
Kronoberg County
Gotland County
Universities and colleges
The University of Linköping
Växjö University College
Gotland University College
Kalmar University College
The regional ethical review board in Lund
Counties
Blekinge County
Scania County
Halland County
Universities and colleges
The University of Lund
Blekinge Institute of Technology
Halmstad University College
Kristianstad University College
Malmö University College
The regional ethical review board in Stockholm
Counties
Stockholm County
Södermanland County
Universities and colleges
Stockholm University
Karolinska Institut
The Royal Institute of Technology
The University College of Dance
The University College of Film, Radio, Television and Theatre
The Swedish National Defence College
The Swedish School of Sport and Health Sciences
The University College of Arts, Crafts and Design
The Royal University College of Fine Arts
The Royal College of Music
The University College of Opera
Södertörn University College
The National Academy of Mime and Acting
The regional ethical review board in Umeå
Counties
Västernorrland County
Jämtland County
Norrbotten County
Västerbotten County
Universities and colleges
Umeå University
Luleå University of Technology
Mid Sweden University College
The regional ethical review board in Uppsala
Counties
Uppsala County
Värmland County
Örebro County
Västmanland County
Dalarna County
Gävleborg County
Universities and colleges
Uppsala University
Karlstad University
Örebro University
College Dalarna
University College Gävle
University College Mälardalen
University College The Swedish University of Agricultural Sciences
Ordinance (2007:1474)
Annex 2
In this annex is listed the fees for reviewing an application for ethical vetting.
Application width | Fee |
concerns research in which only one responsible research body participates | 5,000 Kronor |
concerns research in which more than one responsible research body participates | 16,000 Kronor |
concerns research in which more than one responsible research body participates, but in which all the researchers or subjects of research according to section 4 of the ethical review act concerning research involving humans (2003:460) have an immediate link to only one of the responsible research bodies | 5,000 Kronor |
only involves processing personal data | 5,000 Kronor |
concerns research involving clinical trials of medicinal products
| 16,000 Kronor |
concerns changes in accordance with section 4 | 2,000 Kronor |