Data
General information
1 § there should be regional ethics review boards with the task
examining applications for ethical review under the Act (SFS 2003:460)
If the ethical review of research involving humans.
The boards also has the task to examine certain matters under
Lagen (2002:297) om biobanks in health care, etc.
Advisory opinion
section 2 of the regional ethical review board may make Advisory
opinions on research involving humans in accordance with the
the provisions of the Regulation (2003:615) on the ethical review of
research involving humans. Regulation (2008:352).
3 repealed by Regulation (2008:352).
General information about the Organization
Regional ethics review boards
section 4 of the regional ethical review committees are:
Regional ethical review board in Gothenburg,
Regional ethical review board in Linköping,
Regional ethical review board in Lund,
Regional ethical review board in Stockholm,
Regional ethical review board in Umeå, and
Regional ethical review board in Uppsala.
The structure of the boards of
5 § a regional ethical review board consists of two or more
departments in accordance with the annex to this regulation. There are
provisions concerning the composition of the Chambers in section 25 of the Act
(2003:460) concerning the ethical review of research involving humans.
It should be personal replacement for all members of the
Board.
Management
6 § a regional ethical vetting Board is headed by the Chairmen of
the Board's departments (Management Board). The Board of management shall
perform the tasks under paragraph 3 and paragraph 4 of the 1-4
the Government agencies Ordinance (2007:515) arrives at the Agency's
management. The Board of management shall also decide on the
annual report, interim report and financial documents and other
decisions of major importance. Decisions in the cases provided for in 1,
2 § § this Regulation shall, however, be taken by a Department of the
Board.
The Government appoints a President to be
Chairman of the Board of management.
If a case is to be decided by the Board of management is so
urgent to board management does not have time to meet to
treat it, it may be decided by the President of the
Board management. Regulation (2008:352).
Organization
Members with academic expertise
section 7 of The University referred to in section 9 shall submit proposals to the
Government members and deputies with scientific
competence of the regional ethical review board
the University will carry out tasks in accordance with the same
provision. Before the proposal is submitted, each University shall consult
with higher education institutions in the respective Committee's catchment area according to
Annex I to the Regulation (2003:615) on the ethical review of
research involving humans.
Members representing the public interest
7 a of The counties listed below should submit proposals to the
Government members and alternates representing General
interests in the respective regional ethical review board. Before they
leave suggestions, they should consult with other county councils in the County that
included in the respective Committee's catchment area according to annex 1
to Regulation (2003:615) on the ethical review of research
relates to people.
Board Councils
Regional ethical review board in
Gothenburg, Västra Götaland
County Council
Regional ethical review board in
Linköping: Östergötlands läns
County Councils
Regional ethical review board in Lund, Skåne County Council
Regional ethical review board in
Stockholm, Stockholm County
County Councils
Regional ethical review board in Umeå, Västerbotten County
County Councils
Regional ethical review board in
Uppsala Uppsala County Council
Regulation (2008:352).
Scientific Secretary
section 8 for each Department appoints the Chairman, one of the members to
Scientific Secretary of Department of a certain
time.
The Scientific Secretary shall prepare cases before the
the Department's meetings and assist the Chairperson and
the Department otherwise with scientific excellence.
Kansligöromål, etc.
§ 9 the following universities to grant premises and responding to
kansligöromål, presentation of cases and thus
continuous tasks are carried out for each Committee.
Board University
Regional ethical review board in Göteborg Gothenburg
University
Regional ethical review board in Linköping Linköping
University
Regional ethical review board in Lund, Lund
University
Regional ethical review board in Stockholm Karolinska
Institute
Regional ethical review board in Umeå Umeå
University
Regional ethical review board in Uppsala Uppsala
University
Caseload management
Quorum
section 10 of the 26 and 27 of the Act (SFS 2003:460) concerning the ethical review of
research involving humans, there are rules about when
the boards of departments is a quorum.
Presentation
section 11 of the cases will be decided after the presentation. Member of the Board,
Deputy member of the Board or such staff at a University
who performs the tasks set out in section 9 may be the rapporteur in
Board.
Cases referred to in paragraph 6 of the third subparagraph shall be decided without
presentation. Decisions in such cases must be reported at the next
meeting of the Board of management.
Ethical issues of new and principled character
12 § When ethical issues of new and principled character is handled
should all directors be present.
Special expertise in certain cases
section 13 of the cases on review of research involving minors
or persons referred to in section 20 of the Act (SFS 2003:460) if
ethics review of research involving humans, the
examination within the Department be special skills or a
in particular, the opinion of an expert in the matter.
The particular qualifications referred to in the first subparagraph shall
1. in the case of departments that examine applications relating to medical
Research relate to competence in child medicine, psychiatry or
Geriatrics, and
2. in the case of departments that examine applications relating to other
Research relate to competence in such a research issue in
case.
The handing over of certain matters
section 14 of the surrender in accordance with the third paragraph of section 27 of the Act (SFS 2003:460)
If the ethical review of research involving humans should be in
special resolution. Decisions taken pursuant to such
decision must be reported at the next meeting.
15 repealed by Regulation (2008:352).
Exemptions from government regulation
section 16 of the following provisions of the Government agencies Ordinance (2007:515)
shall not apply to the regional ethical review boards:
section 2 of the Agency's management,
4 § 5 If the responsibilities,
§ 5 If the delegation,
section 14 if the Board's composition,
sections 15 and 16 for a quorum, and
section 27 for the right to represent the State in court.
section 17 was repealed by Regulation (2008:352).
Annex
This annex sets out which departments should be within the
regional ethical review boards. With medical research referred to
also, pharmacy, clinical psychology, dentistry and health sciences.
Regional ethical review board in Gothenburg
Two departments which examine applications relating to medical
Research
A Department that examines applications for other research
Regional ethical review board in Linköping
A Department that examines applications for medical
Research
A Department that examines applications for other research
Regional ethical review board in Lund
Two departments which examine applications relating to medical
Research
A Department that examines applications for other research
Regional ethical review board in Stockholm
Four departments which examine applications relating to medical
Research
A Department that examines applications for other research
Regional ethical review board in Umeå
A Department that examines applications for medical
Research
A Department that examines applications for other research
Regional ethical review board in Uppsala
Two departments which examine applications relating to medical
Research
A Department that examines applications for other research
