FAQ - Frequently asked questions on ethics and good research practise
I don’t conduct medical research. Do I still need to think about ethics reviews?
Yes, the Ethical Review Act is not bounded by subject. However, it is more common that medical research implies requirements for ethics review. Even if you do not need to ethically review your research, it is usually necessary to apply a research ethics perspective to your awareness of for example 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 collegiately established good research practice. 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 breaches of the law.
- 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 requires a permit from the Swedish Ethical Review Authority. The biobank must also be reported to the Health and Social Care Inspectorate ( you can dowload a form via this link ). In research, a biobank is human biological material that can be traced to the individuals from whom the material was taken. The exception is samples that are analysed within six months of sampling and then immediately destroyed. By definition, biobanks contain sensitive personal data and data protection must be adapted accordingly.
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.
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 experiments should primarily be replaced by other methods if possible. The number of animals must be kept as low as possible without compromising the scientific purpose.
- Please note that 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 have 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 arrange collaborations 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 fry themselves 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 parts 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 collection 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 manager of the laboratory animal facility where the experiments are to be conducted must approve the application prior to its 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 or conducts the animal experiments. Courses that meet the requirements can be found via this link .
- What are sensitive personal data?
- FAQ on data protection and personal data can be found via this link to KTH intranet pages on GDPR .
Do I have to get an insurance that covers harm of research persons?
That is recommended if the research pose an obviously increased risk of sudden and unintended harm of research persons. Such a risk also imply an obligation for ethics review before the research project starts. Appropriate insurance is special personal injury protection insurance through Kammarkollegiet, who will also require information on the specific project. An obviously increased risk for harm also entails a legal obligation for ethics review.
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. Obviously, 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 nor the method entail the collection of sensitive personal data is collected need not be subjected to 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 her/his research career, the interpretation of what is reasonable should err on the side of implementing 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 Research Support Office.
A not uncommon special case is that an interviewee is very open about their sensitive personal data (such as their religion or state of health), although the interview is not aimed at obtaining sensitive information and the researcher does not even ask for it 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 an ethics permit regardless of which group is being studied. However, special rules on informed consent apply when the research subjects are under the age of 18 or when the research subjects have a dependent relationship with the researcher. For further information, see paragraphs 14 and 18 of the Ethical Review Act (2003:460).
Ethically speaking, careful consideration is required of the risks of including particularly vulnerable groups (children or not) as research subjects. When weighing 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 Research Support.
Conducting research on one’s own students can be ethically sensitive because students are dependent on teachers who decide their grades. A primary problem is that there is a risk that their consent to participate in research is not 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 even out the power relationship.
How does one make an ethics assessment of one’s project?
Funding bodies or other involved parties often provide checklists that can help you get started. The ethical reflection is of course not explained although benefits, risks and dependencies are usually highlighted as important aspects to consider when making a research ethical assessment.
One necessary manoeuvre is to weigh likely benefits against the risk of harm. A risk of harm that exceeds the risk of harm to which the person in question would have been exposed without participating in the research normally requires informed consent. Such a risk must also be justified on the basis of the likely benefit of the project. New basic knowledge is, of course, beneficial. Never downplay a risk – show how you handle it. Where at all possible, risks must also be minimised or fully mitigated by specific measures. Risks can also be managed by, e.g., clarifying them for everyone involved or increasing the influence of research subjects on risk aspects. The research person shall be informed of the risk even if it is assessed that the countermeasures completely counteract it.
Also consider what relationships exist between researchers and research subjects. Conflicts of interest can interfere with the scientific process and pose ethical obstacles. For ethical and scientific reasons, research in which the research subjects are in a dependent relationship with the researcher are problematic. However, with careful project design it is possible to carry out such research, but it in such case it will be especially important to report this in publications. Dependencies arise, for example, if the research subjects are also the researcher’s students.
Risk and relationship analyses must be subjected to continuous plausibility assessments in order to be helpful. There may be research ethical problems that can be predicted, but which are not covered by either risk analysis or relationship analysis. Unforeseeable ethical problems can also arise during ongoing research. For this reason, constant vigilance and independent judgments are required in addition to good preparation and consideration of laws and scientific approach.
I will apply to the Ethical Review Authority for a permit. Is there anything I should think of?
- The Ethical Review Authority’s forms are available in English at their home page. They contain extensive instructions. Note that the application must be submitted in Swedish, by the forms in Swedish. For further support, please contact the Research Support Office.
- If you integrate plans to handle risks of harm, relations of dependency 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 is important in the application. Vagueness could be perceived as concealment.
- The information letter (missive) is the most common reason for the Authority to request revisions. There is a template on the home page of the Authority. Use it! Imitate its neutral language! Even small signs of pressuring participants into consent may delay the application process. That means: do not argue for a consent, do not be obsequious, do not promote the project.
I will apply for research funding within mathematics. The application form includes a question on research ethics in my project. What should I write?
By that kind of questions, the funder conveys that the researcher is expected to be ethically aware. It is, thus, important that a reply is offered, even for projects where there are no significant research-ethical risk or relation. Make sure that you have done an appropriate ethics assessement of your project (see this FAQ for hints for how to do that). Also, include the results or other possible consequences of your project in the assessment. Risks of minor harm or that oppressive relations arise or are intensified by indirect or far-fetched reasons by your project may be mentioned even in such cases where judicial action is not justified. That demonstrate that you have reflected upon the project.