Sweden - RECs and Medical Research

History

The original ethical review system of research in Sweden was initiated in the late 1960's. Committees were established by Faculties of Medicine and a nationwide system was then developed in co-operation with the Swedish Medical Research Council and the Ethical Delegation of the Swedish Society of Medicine. This REC system was not formally regulated and although it was voluntary in principle, in practice there was good coverage of biomedical research on humans.

As of January 1st, 2004, there is a new system of ethical review based on statutory law. Under the Act (2003:460) on Ethics Review of Research Involving Humans, the approval of a board for ethics review is a mandatory legal requirement for certain types of research.This is notably the case for research involving physical interventions, psychological manipulations, use of human biological material and research on sensitive personal data in cases where the informed consent of the data subject is not obtained. However ethics approval is not required for research involving the processing of sensitive data with the consent of the data subject.

This reform has created a new organisation of 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. Each board has at least 2 separate departments: one for reviewing medical research and another for non-medical research, as the new system of ethical review covers both types of research.

The Central Board reviews certain types of research that fall under Sections 34-35 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.

Summary of Swedish RECs

Type of REC	Regional boards for research ethics.	National Board for Research Ethics
Where situated?	6 university regions - Gothenburg. Linköping, Lund, Stockholm, Umeå & Uppsala	Stockholm
Who applies to them?	Researchers	Researchers, regional boards
Formal/Informal	Formal	Formal
National/Regional	Regional	National
Laws Involved (see below)	Act (2003:460) on Ethics Review of Research Act (2002:297) on Biobanks in Health Care Ordinances: 2003:515, 616 & 617 Government Bill: 2002/03: 50	Act (2003:460) on Ethics Review of Research Act (2002:297) on Biobanks in Health Care Ordinances: 2003:515, 616 & 617 Government Bill: 2002/03: 50
Guidance Involved	Declaration of Helsinki	-
Membership requirements	A Chairperson who must be or have been a judge 15 Members appointed by the Government out of whom 5 shall represent public interests and the others shall have a scientific expertise	A Chairperson who must be or have been a judge 6 Members out of whom 4 are scientific experts and 2 represent public interests.
Responsible/accountable to whom?	Considered to be independent agencies, both financially and operationally	More Independent in relation to the Universities. The Parliamentary Ombudsmen can supervise and criticise them.
Mission	Review certain type of scientific research and scientifically based development projects (carried out in Sweden). Research involving processing of certain types of personal data without consent. Research involving physical interventions, physical or psychological manipulations or studies on biological material from identifiable humans.	reviews and appeals
Approval or Advisory powers	An approval is a prerequisite for the type of research concerned	Approval

Not submitting research or failing to follow review

Section 38 of the Act on Ethics Review sets out that intentional breaches of the requirement for ethical approval and intentional breaches of the conditions laid down in such an approval are criminal offences sanctioned by a fine or imprisonment of up to 6 months. Negligence and petty cases are not criminalized.

Which body, if not the REC itself takes this action, and how do they proceed?

The Central Board has supervisory duties and powers but only to the extent that such supervision is not already the responsiblity of any other supervisory body, for example the National Board of Health and Welfare, the Medicinal Products Agency or the Data Inspection Board.

Impact of Directive 2001/20 EC

Modifications concerning clinical trials where minors and incapacitated adults are involved; single opinion for multi-centres trials; time frame for ethics review; particular expertise in the RECs.

Legal action that can be taken against RECs

The new Central Board for Ethics Review can overrule the decision of the regional boards for ethics review that reject research projects. The regional boards exercise public power and consequently they may be penally liable for breach of duty in case of intention or negligence. (Chapter 20, Section 1 of the Penal Code). Sanction: fine and Imprisonment up to 2 years.

Links section

Laws and Guidance

Act (2003:460) on Ethics Review of Research Involving Humans- in Swedish
Ordinance (2003:615) on Ethics Review of Research Involving Humans supplements the Act on Ethics Review
Ordinance (2003:616) with Instruction for Regional Boards for Ethics Review
Ordinance (2003:617) with Instruction for the Central Board for Ethics Review
Medical Product Act (1992:859)
Medical Products Agency's provisions and guidance (LVFS 1996:17) on the clinical trials of medicinal products English translation: www.mpa.se
Act (2002:297) on Biobanks in Health Care
Ordinance (2002:746) on Biobanks in Health Care.
National Board of Health & Welfare provisions and general advice (SOSFS 2002: 11) on biobanks in Health Care: www.sos.se
Research ethics guidelines for using biobanks. Adopted by the Swedish Medical Research Council (MFR) in June 1999, (Dnr 1999-570)
CODEX The Swedish Research Council's gateway to various research ethics and professional guidelines

Organisations and Ethics Committees:

Papers

E.Rynning, "Etisk granskning av medicinska humanforskningsprojekt - lagstiftning behövs!" (Ethical review of biomedical research involving humans - a call for legislation! ) Läkartidningen 1997:1771-1774
E.Rynning, "Biobankerna - hög tid för bankinspektion?" (The biobanks - high time for inspection?) Förvaltningsrättslig tidskrift 1998, pp. 303-333.
E.Rynning, "The Regulation of Neonatal Research in Sweden." European Neonatal Research - Consent, ethics committees and law [eds. Mason, S. & Megone, C.] Ashgate Publishing 2001, pp. 167-183.
E. Rynning, "Public law aspects on the use of biobank samples - privacy versus the interests of research." Biobanks as Resources for Health [eds. Hansson, M & Levin, M] Research Program Ethics in Biomedicine, Uppsala University 2003, pp. 91-128.
E. Rynning, "Patientuppgifter som forskningsresurs - om integritetsskydd och intresseavvägningar" (Patient data as resources for research - on privacy rights and the balancing of interests) Förvaltningsrättslig tidskrift 2003, pp. 95-126.
E. Rynning, "Offentligrättslig reglering av biobankerna - en utmaning för lagstiftaren" (Regulating the biobanks - a challenge to legislators) Biobanksrätt [ed. Wolk, S] Studentlitteratur, Lund 2003, pp. 49-176.
U. von Essen, "Etikprövning av biobanks- och registerforskning" (Ethics review of research on biobank samples and data) Förvaltningsrättslig tidskrift 2002 pp. 351-
U. von Essen, "Biobanksforskning - forskares möjligheter att få tillgång till vävnadsmaterial och personuppgifter" (Biobank research - the possibilities for researchers of getting access to human tissue and personal data) Förvaltningsrättslig tidskrift 2003 pp. 197-
U. von Essen, "Focusing on personal integrity violation - legal guidelines for ethical practice" Biobanks as Resources for Health [eds. Hansson, M & Levin, M] Research Program Ethics in Biomedicine, Uppsala University 2003, pp.129-148
U. von Essen, "Biobanks- och registerforskning - etikprövning och materialtillgång" (Biobank and data research - ethics review and access) Biobanksrätt [ed. Wolk, S] Studentlitteratur, Lund 2003, pp. 177-234.

See the REC bibliography section for more links and papers