If you are going to process special category data, or sensitive personal data, in a research project, you must have an ethical approval from the Swedish Ethical Review Authority. Sensitive personal data concern for instance:
- racial or ethnic origin
- political opinions
- religious or philosophical beliefs
- trade union membership
- a person’s health, sex life, or sexual orientation
- genetic data
- biometric data which uniquely identify a person.
An ethical approval is also needed if a research project:
- involves a physical intervention on a living or deceased person
- will be carried out in accordance with a methodology that aims to have a physical or psychological effect on the research participant
- poses a clear risk that the research participant could suffer physical or psychological harm from the research
- concerns studies of biological material that has been taken from a living or deceased person and may be traced back to that person
- will process personal data relating to criminal offences.
In most cases, if a person is going to participate in a research project, they must give consent for their participation, in accordance with The Act concerning the Ethical Review of Research Involving Humans (2003:460). Such consent is valid only if the research participant has been given adequate information about the research before consenting to it (“informed consent”). Their consent must always be documented.
The Ethical Review Act requires that research subjects are informed about for instance:
- the overall plan for and aim of the research
- which methods will be used
- possible consequences and risks that the research may entail
- who the principal investigator is
- that participation in the research project is voluntary
- that the research subject may at any time withdraw their participation.
In addition, there are the requirements of the general data protection regulation (GDPR), which are stipulated in for instance Article 13, that the data subject should have been provided in advance with information that clearly states:
- what personal data will be collected
- the purposes of the collection of the personal data
- how the data will be processed and stored
- the legal basis for the data processing.
Note: Remember that you cannot promise confidentiality to the research subjects! A privacy impact assessment shall be made every time someone requests access to the data. You cannot in advance say anything about who may be able to gain access to the research material. Instead, the Swedish Ethical Review Authority recommends to use phrases which express that no unauthorised persons will be able to gain access to the data.
Note: Consent to participating in the research is not connected to the legal basis for consent according to the General Data Protection Regulation. (See Research material with personal data.)
On the Swedish Ethical Review Authority website, you can read more about how you can write information about consent. (At present, the information is in Swedish only.)
In a research project that uses animal testing, it may be necessary to have an ethics approval from a regional ethical committee on animal experiments. The Swedish Board of Agriculture coordinates the applications to these committees. Ethical approval (information in Swedish) is needed for experiments on living mammals, birds, reptiles, anura, fish, and cyclostomes. In many cases, this includes embryos.