FAQ - frequently asked questions on ethics and good research practise

I don’t conduct medical research. Do I still need to think about an ethics review?

Yes, the Ethical Review Act is not restricted to specific subject areas. However, medical research does more commonly require an ethics review. Even if you do not need an ethics review of your research, it is important to be aware of ethical issues, for example relating to risks.

I will be conducting research on or involving human subjects. What applies in my case?

As with other research, research conducted on or with human subjects must be carried out according to good research practice established on a collegiate basis. If you have not done research on or with human subjects before, then please collaborate with those experienced in that kind of research.

Please check whether an ethics approval from the Swedish Ethics Review Authority is required. It is important that you do this while planning the project. Please use this check list.

 If your planned research activities require ethics approval, the Swedish Ethics Review Authority must have decided to approve the research before you may commence the research activities.

Additional permits or approvals may be required if you, for example, plan to store human tissues during an extended time, expose people to radiation, test medical devices on human subjects, film in public spaces or pilot drones in populated areas.

Read more at the web page of the Swedish Ethics Review Authority

I need to use animals in my research. Is there anything I need to think about?

• Please note that for both ethical and legal reasons, animal experimentation should be replaced by other methods wherever possible.
• The number of animals must be kept as low as possible without compromising the scientific purpose.
• In Sweden, animal experiments are defined by the fact that they are conducted for scientific purposes, not by any risk of suffering they may entail.
• Research on animals in captivity must only be performed at an animal facility and within an operational framework approved by the Swedish Board of Agriculture. The principal investigator must also apply for an ethics approval concerning the animal experiments from the regional research animal ethics committee via the Swedish Board of Agriculture.
• Permission to carry out animal experiments is required if the test animals are live vertebrates or cephalopods. In the case of vertebrates, permission is required from the time the juveniles are able to feed or, in the case of mammalian foetuses, the last trimester of their normal development. Legislation also regulates experiments on animal embryos in earlier stages of their development if the experiments are likely to lead to suffering later in their development.
• The director of the laboratory animal facility where the experiments are to be conducted must approve the application prior to submission. The application is assessed by a regional animal experimentation ethics board.
• There are legally specified competence requirements for the person who plans and the person who conducts the animal experiments. Courses that meet the requirements can be found via this link.

What are sensitive personal data?

View KTH's internal page on GDPR. .

Do I have to get an insurance that covers harm of research persons?

KTH’s personal injury insurance from Kammarkollegiet/The Legal, Financial and Administrative Services Agency covers visitors in the event of an accident, as long as they are on KTH’s premises at the time. An obviously increased risk of harm also entails a legal obligation for an ethics review prior to project start-up.

My method may involve the collection of sensitive personal data, but this is not its intention. Should I apply for an ethics permit?

This is a grey area, and careful consideration is required in each case.

• Any project design whose purpose/thesis and method clearly strive to collect information that includes sensitive personal data must be subjected to an ethics review.
• A project design wherein neither the purpose/thesis nor the method entails the collection of sensitive personal data need not be subjected to an ethics review.
• A project design wherein the purpose is not to collect sensitive personal data but where the method is designed so that it is very likely to collect such data must typically be subjected to an ethics review. Example: To film how an identifiable person move around its home with the purpose to map how rooms are used.
• A project design wherein the purpose is not to collect sensitive personal data but where the method may collect such data does not usually require an ethics review. Example: To interview people about how they use their kitchen to conclude optimal placement of appliances.

My method involves studying children or a group that is dependent on me. Do I need an ethical permit?

From a legal standpoint, the same criteria apply to applying for ethical approval regardless of the group being studied. The criteria include no wording on dependent relationships, age or vulnerability.

Ethically speaking, careful consideration is required of the risks of including particularly vulnerable groups as research subjects. When considering this matter, keep in mind that research can also help vulnerable groups. The same applies when the research subjects are dependent on the researcher. If the research group lacks experience with such cases, advice should be sought from colleagues, the Ethics Committee of the Faculty Council and/or the Research Support Office.

I will apply to the Ethical Review Authority for a permit. Is there anything I should think of?

• The Ethical Review Authority application forms are available in English on the authority’s website and contain detailed instructions. Note that the application must be submitted in Swedish, using the Swedish forms. For further support, please contact RSO.

• If you integrate plans to manage risks of harm, dependency relationships and sensitive data with the rest of the project plan to begin with, you will save time at the point of applying to the Ethical Review Authority.
• Transparency and clarity are vital in the application. Vagueness could be perceived as an attempt at concealment.
• The information letter is the most common reason for the authority to request revisions. There is a template for the information letter on the authority’s website, so use it and imitate its neutral language.
• The slightest signs of pressuring participants into consent may delay the application process. An example of pressuring might be arguing for consent, being obsequious, or promoting the project to potential subjects or the Ethical Review Authority.

I am applying for research funding within mathematics. The application form includes a question on research ethics in my project. What should I write?

This kind of question is generally intended to make the researcher aware that the funding body deems research ethics important and expects the researcher to share this attitude. It is, therefore, important to answer this question, even for projects without risks or relationships relevant to research ethics.