The purpose of the Ethical Review Act is to protect the individual person and ensure respect for human dignity in research. A review includes weighing risks against the benefits of new knowledge.
If there is any risk that any part of the research process could imply a risk for the research study participants, an ethical review should be conducted. The review must include a weighing of risks against the benefits of new knowledge. High demands should be placed on the quality of the research and it is essential that the research study participants have fully understood and accepted the terms and conditions of their participation.
Since it is in the interests of the general public that human dignity and respect for people’s integrity are protected, it is justifiable to give the general public insight into and influence over the ethical review of research. In the long term, legislation that guarantees that representatives from the general public are given the opportunity to participate in the ethical review process will strengthen the confidence the general public have in research.
The Council of Europe Convention
The protection of participants in medical research studies has been brought to the fore after Sweden signed the Council of Europe Convention on Human Rights and Biomedicine. The Convention sets out rules for how the ethical review of medical research is to be conducted. In order for Sweden to be able to ratify this convention, judicial regulation of the ethical review of research is needed. In addition, Swedish legislation must be adapted to the directive concerning good clinical practice when performing clinical trials of medicinal products for human use (2001/20/EC).
The Government’s Bill on Ethical Review can be found here: 2002/03:50 p. 28.
Areas in which ethical review is required
The Statute (2003:460) on the ethical review of research involving humans must be applied to research that includes the processing of:
- personal data of the kind described in Article 9.1 of the EU Data Protection Ordinance (sensitive personal data), or
personal data about infringements of the law including criminal offences, judgements in criminal cases, criminal procedure coercive measures, or administrative detentions. Statute (2018:1999).
In addition, the Statute must be applied to research that:
- Implies a physical intervention on a research study participant.
- Is conducted using a method that is intended to influence the study participant either physically or mentally, or which implies a blatant risk of physical or mental injury to the study participant.
- Is conducted on biological material that has been taken from a living person and which can be traced to that person.
- Implies a physical intervention on a deceased person, or
- Is conducted on biological material that has been taken from a deceased person for medical purposes and which can be traced to that person.
The Swedish Ethical Review Authority is permitted to provide an advisory statement regarding research involving humans even if the research in question does not come under Statute (2003:460) on the ethical review of research involving humans.
Laws and regulations
Applicable laws and regulations
- The Act on the Ethical Review of Research involving Humans (2003:460). Contains regulations governing the ethical review of research involving humans and biological material from humans and regulations about consent to such research.
- The Statue on the Ethical Review of Research involving Humans (2003:615). This ordinance contains regulations linked to the Act on Ethical Review of Research involving Humans.
- The Statue with instructions for the Swedish Ethical Review Authority (2018:1879)
- The Statue with instructions for the Ethics Review Appeals Board (2007:1068)
Other relevant legislation:
Act on Biobanks in Healthcare etc. (2002:297)
Statute (2018:1091) with additional provisions about ethical review that complement the EU Ordinance on clinical trials of medicinal products intended for humans
- The EU data protection ordinance - the European Parliament and the Council’s regulation (EU) 2016/679 of 27 April 2016, on the protection of natural persons with regard to the processing of personal data and the free movement of such data.
- Government Bill 2007/08:44 Certain ethical review issues etc.
- Government Bill 2017/18:45 A new organisation for the ethical review of research involving humans