FAQ - frequently asked questions on ethics and good research practise
Here are the most frequently asked questions on research ethics and good research practice, along with their answers, listed.
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 involving human subjects must be carried out according to good research practice established on a collegiate basis. In some cases, one or more legally regulated permits are required. If a permit is required, it must be obtained before the project begins.
Research on human subjects requires a permit from the Swedish Ethical Review Authority if the research:
- Involves a physical intervention on a living or deceased person.
- Aims to physically or psychologically affect the research subject.
- Poses a risk of physical or psychological harm.
- Uses biological material from a living or deceased person that can be traced to the person in question.
- Entails the processing of sensitive personal data or personal data about legal offences.
For other types of research, see below.
- If research subjects are exposed to ionising radiation, information about this must be attached to the application submitted to the Swedish Ethical Review Authority. A basic rule about ionising radiation activities is that they require permission from the Swedish Radiation Safety Authority . Certain research activities need only be reported.
- The establishment of a biobank or the collection of samples for such a bank requires a decision from KTH in line with the delegation procedure. In research, a biobank refers to human biological material that can be traced to the individuals from whom the material was taken. Samples analysed within nine months of obtaining the sample and then immediately destroyed are excepted. Samples taken outside of Sweden are also excepted, even where the samples are used in Sweden.
- Clinical trials of medicinal products and medical technology may only be conducted with the permission of the Medical Products Agency and the Swedish Ethical Review Authority, and are subject to special regulations. We recommend engaging a consultant.
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.
- KTH does not have a permit to host a laboratory animal facility. Therefore, no permits can be issued for animal experiments on KTH’s premises. KTH-affiliated researchers who need to carry out animal experiments must make arrangements with a party that has a laboratory animal facility.
- 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.
- Permits for animal experiments are sought by the principal investigator (PI) for a group of similar animal experiments that are to be conducted for a specific scientific purpose. The application is submitted via the Swedish Board of Agriculture .
- 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.
- The applicant need not be the same person who performs the experiments. The applicant must be affiliated with the laboratory animal facility, but need not be employed there.
- 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?
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 wherein the 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 entail 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 can reasonably be assumed to still result in the collection of such data, should be subjected to an ethics review.
- In order to protect the research subject as well as the researcher’s own research career, the interpretation of what is reasonable should err towards carrying out an ethics review rather than refraining from doing so.
- Discuss the matter with your colleagues and remember that you are welcome to seek help from the Research Support Office (RSO).
- A relatively common situation is when an interviewee is very open about their sensitive personal data (such as their religion or state of health), even though the interview is not aimed at obtaining sensitive information and the researcher does not ask for it, even indirectly. In such instances, an ethics review is not required.
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 and/or RSO.
Conducting research on one’s own students can be ethically sensitive because students are dependent on teachers who decide their grades, for example. A primary problem is that their consent to participate in the research may not be genuine. Such a risk can, for example, be managed by having a person other than the teacher obtain the student’s consent and by ensuring that the research is not carried out in connection with teaching. Another way to deal with the dependency relationship is to engage the students as co-researchers or otherwise balance the power relationship.
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 where there are no risks or relationships relevant to research ethics.