Item: Requirements to acquire approval from an ethics committee for Sweden

Subject:

Administrative data

Topic

  • Ethical approval

Description

Sensitive personal data may only be processed for research purposes if approved by an ethics committee, due to the Ethical Review Act. This statute came into force in 2004, and contains regulations concerning the ethical vetting of research concerning humans and biological material from humans (cf. Section 3-6). In 2008, the legislation was extended to include “all research that comprises treatment of so-called sensitive personal information [to be] subject to an ethical review, whether or not the data subjects have explicitly given their consent” (Central Ethical Review Board, 2008).

Ethical vetting is shared between six regional boards. These are independent authorities, divided into two or more sections. At least one section in each locality is to vet cases within the field of medical science (medicine, pharmacology, odontology, the science of health care and clinical psychology), while one section is to vet matters concerning other research. The secretariats of the regional boards are situated at the Universities of Gothenburg, Linköping, Lund, Umeå and Uppsala as well as at the Karolinska Institut in Stockholm.

Although the research ethics committee may thus authorize the processing of sensitive data in a certain research project, it should be remembered that the committee does not have the power to grant the researchers initial access to the information in question. (See Regulations for access to confidential data)

 

Relevant links:

Central Ethical Review Board

http://www.epn.se

 

Relevant legislation

The Ethical Review Act

http://www.epn.se/media/45159/the_etical_review_act.pdf

 

 

References:

Central Ethical Review Board [online]. Available at: <http://www.epn.se/en/start/startpage/>. [Accessed 25. February 2014].

Concerning changes made to the Act (2003:460) concerning the Ethical Review of Research Involving Humans (the ethical review act) etc, 2008. Central Ethical Review Board [pdf] Available at: <http://www.epn.se/media/37337/letter_080526__rev.pdf>. [Accessed 4. March 2014].The Ethical Review Act, 2003. The Act concerning the Ethical Review of Research Involving Humans [pdf] Available at: <http://www.epn.se/media/45159/the_etical_review_act.pdf>. [Accessed 25. February 2014].