Human ethics application
Are you going to perform studies with research subjects, human tissue or sensitive personal information? If so, an ethics application is required.
The Act (2003: 460) on ethical review of research relating to humans (the "Ethics Review Act", EPL) contains provisions on ethical review of research on humans and biological material from humans. Ethics review is done by the Ethics Examination Authority. The authority is divided into six regions (Gothenburg, Linköping, Lund, Stockholm, Umeå and Uppsala).
The ethics review examines the extent to which research can be conducted with respect to human dignity. The research may only be approved if the research project's knowledge gains outweigh the risks it may entail. The ethics review authority places high demands on the quality of research and on the fact that the research participants in the project have understood and accepted the conditions for their participation.
Documentation on the application for human ethics
An important part of the application concerns the information to the participants in the study.
The information should include:
- The study background and the overall plan for the research
- The purpose of the research
- Information on samples and / or methods that will be used
- Any consequences or risks that research may entail
- The legal entity (forskningshuvudman)
- Voluntary participation, the right to quit at any time and the right to withdraw consent
- Description of data management, e.g. handling of personal data
- Sharing of samples and/or data, e.g. for collaborations
- Future research
- Contact information, eg responsible researcher and the controller for processing personal data (usually KI).
The application should also include the informed consent the participants are asked to sign. This, together with the information to the study participants, will be scrutinized by the Ethical Review Authority (EPM) to ensure that it is adequate and comprehensible.
They will also consider the evaluation of risks (e.g. physical or mental discomfort, complications/side effects, delay of effective treatment or how time-consuming it is for the study participants) and how the risks are minimized (e.g. readiness for complications, the competence of the people performing the study and how safe the environment is).
Applications for ethical approval are sent electronically to the EPM. If necessary, the decisions made by the EPM can be appealed to the Ethics Review Appeals Board (Överklagandenämnden för etikprövning (ÖNEP).