Vetting the ethics of research involving humans
The Statute (2007:1068)
The Swedish Code of Statutes (SFS) Please note that errors may occur in the wording of statutes. In most cases the annexes are included. However, given the technology currently in use, annexes consisting of images, maps and listings in many columns cannot be entered into the database. The text should therefore always be checked against the printed version.
Statute (2007:1068) containing instructions for the Central Ethical Review Board
SFS number: 2007:1068
Ministry/authority: Ministry of education and cultural affairs
Issued: 22 November 2007
Tasks
Section 1
The Central Ethical Review Board is to examine applications concerning the ethical vetting of research involving humans and is to exercise supervision in accordance with the Act concerning the Ethical Review of Research Involving Humans (2003:460). The board also has the task of vetting certain issues in accordance with the Biobanks in Medical Care Act (2002:297).
Management
Section 2
The Central Ethical Review Board is to be governed by a board.
Section 3
In sections 32 and 33 of the act concerning the ethical review of research involving humans (2003:460), there are regulations concerning the composition of the board and when the board is quorate.There are to be personal substitutes for all the members of the board. The Swedish Research Council is to propose members and substitutes who have suitable scientific qualifications and skills to the Swedish government.
Organization
Section 4
The chairman is to appoint one of the delegates to be the scientific secretary for a fixed period of time. The scientific secretary is to prepare the cases prior to the meetings of the board and contribute his or her scientific expertise.
Section 5
The Swedish Research Council is to provide premises and ensure that administrative matters, the presentation of cases and related matters are carried out on behalf of the Central Ethical Review Board.
The handling of cases
Section 6
Cases are decided after presentations have been made. The scientific secretary is the one who is to make such presentations to the board. Staff working for the Swedish Research Council who carry out duties specified in section 5 may also make presentations to the board.
Section 7
When ethical issues of a novel and fundamental character are being dealt with, all members should be present if possible.
Section 8
In section 33 paragraph three of the act concerning the ethical review of research involving humans (2003:460), there are regulations stating that the chairman may divulge certain information to a person who makes presentations to the board. A separate decision is required to enable this to be done.
Exceptions to the Swedish Authorities Act
Section 9
The following regulations in the Swedish Authorities Act (2007:515) are not applicable to the Central Ethical Review Board:Section 5 - concerning delegation.Section 14 - concerning the composition of a boardSections 15 and 16 - concerning quorum issuesSection 27 - concerning the right to represent the state in a court of law.