FAQ's about Research Ethics

Research Ethics and good research practice

1. What is research ethics?

Research ethics concerns ethical aspects of research. Exactly what is included can be discussed, but obvious areas are good research practice and research misconduct, ethical aspects regarding the handling of people and animals involved in research, the presentation of research results, the consequences of the research and the researcher's responsibility. Values and attitudes within individual research groups to these issues are of course also of research ethical relevance. A central question in research ethics is how to balance the research interest (the interest in conducting research with the aim of generating new knowledge) against the interest in protecting research subjects and laboratory animals and possible risks at the societal level.

If you have questions about research ethics, you are welcome to ask them to researchethicsadvice@ki.se. 

2. What does “good research practice” mean?

“Good research practice” refers to the practice of following ethical requirements for research when conducting research. This generally also includes not violating relevant legislation (although in principle one can imagine unethical legislation, which would imply a conflict between ethics and law). The Swedish Research Council’s booklet Good Research Practice (2017, page 10) lists the following examples: tell the truth about your research; consciously review and present the basic premises of your studies; openly present methods and results; openly disclose commercial interests and other commitments; don’t steal research results from others; keep your research in good order (through documentation and filing); Strive to conduct your research without harming people, animals, or the environment; Be fair in your assessment of other people’s research.

Link to the Swedish Research Council’s Good Research Practice.

3. What support is available at Karolinska Institutet on research ethics issues?

At Karolinska Institutet, there are opportunities for support in various forms. The website Ethics at KI collects information for the whole of KI about ethics, including research ethics. Researchers can turn to KI’s scientific representative, to the Research Support Office and to KI’s teachers and researchers in medical ethics, the latter either via personal email or through the function email researchethicsadvice@ki.se.

Scientific misconduct and other deviations from good research practice

4. What is meant by "scientific misconduct"?

Anyone who intentionally presents inaccurate or misleading descriptions of the research process or its results is engaging in scientific misconduct. A research publication can be misleading even if it does not report any false or distorted results (no one has made up, deleted, or changed any measurement points), namely if a skewed selection of results is made, for example that certain measurement series or experiments are selected from everything that has been done (so-called cherry-picking) while others are omitted, in order to be able to show a certain result.

A circumstance that to some extent complicates the discussion of this issue is that “scientific misconduct” is often used as a legal term, for example in the United States, and then its meaning has been stipulated to include FFP – fabrication, falsification, and plagiarism – despite the fact that it is conceivable that scientific misconduct in common parlance encompasses much more than that, such as cheating with authorship, intentionally untrue claims about hypothesis testing, and the application of method fishing (for example in statistical analysis) without being open about it. 

5. Are all deviations from good research practice scientific misconduct?

No. There are two ways to deviate from good research practice: either by being ignorant about the fact that you are deviating from good research practice – because you have not fully understood instructions and expectations, because you have been careless, or have thought incorrectly – or by deviating consciously and intentionally. Those who intentionally deviate from good research practice engage in scientific misconduct, while those who do not do so intentionally are unskilled or careless in their research, often referred to as “sloppy science”. 

6. What should you do if you suspect that a colleague is engaging in scientific misconduct?

Feel free to find out more and discuss with colleagues you trust before deciding whether it is reasonable to proceed with a report. Perhaps there is information that puts the matter in a different light and makes it seem less likely that it is actually a question of scientific misconduct – or that, on the contrary, strengthens the view that it may be. You can also contact KI’s scientific representative or KI’s doctoral student representative to tell them what you have noticed and ask for advice. These conversations are confidential – what you discuss will not be made public. Contact information can be found on KI’s website. Anyone who deems that there are sufficient grounds to make a report of suspected scientific misconduct can report either to Karolinska Institutet or directly to the Swedish National Board for Assessment of Research Misconduct (Npof).

7. How can individual researchers report suspected scientific misconduct or other deviations from good research practice?

The report can be sent directly to the Swedish National Board for Assessment of Research Misconduct (Npof). It can also be addressed to the president of KI. Once the president has submitted the matter to the Council for the Investigation of Deviations from Good Scientific Practice at KI, the Council conducts an initial review to determine whether the matter should be handed over to Npof, investigated further by the Council, or handled in some other way. If the initial review shows that the case concerns suspected scientific misconduct, the case is handed over to Npof following a decision by the president. Other deviations from good research practice are handled locally by the Council. The report can be made anonymously. 

For more information about Npof. For more information about the Council for the Investigation of Deviations from Good Scientific Practice at KI.

8. How does Karolinska Institutet handle suspicions of scientific misconduct and other deviations from good research practice?

This is what the Council for the Investigation of Deviations from Good Scientific Practice at KI writes: “Cases of suspected scientific misconduct are examined under a separate system by the National Board for Assessment of Research Misconduct. Cases of other deviations from good research practice are examined by KI’s internal Council for the Examination of Deviations from Good Scientific
Practice. Decisions on such cases are pronounced by the president.” The Council assists in determining whether incoming cases should be handed over to Npof or investigated locally at KI. For the cases locally investigated, the Council prepares a written reasoned statement as a basis for the decision to be made by the KI president.

9. What is Karolinska Institutet doing to reduce deviations from good research practice?

Karolinska Institutet works in various ways to avoid research fraud and other deviations from good research practice and to make its employees, affiliates, and students aware of these issues through: (1) information on KI’s websites, via workshops, seminars, etc.; (2) teaching on research ethics at undergraduate programmes, master’s programmes, for doctoral students, and for doctoral supervisors; (3) advising researchers to help them avoid missteps, for example in relation to ethical review and other research regulation. The advice is also intended to provide answers to research ethics questions in general and to specific questions of an ethical rather than legal nature. Relevant links:

Information and links on the web: 
Ethics at KI
Scientific Representative
Research Support Office
Advice from the medical ethicists at LIME

10. What does the Board for Assessment of Research Misconduct (Npof) do?

Npof is a Swedish authority tasked with investigating suspected scientific misconduct, which is defined as “a serious deviation from good research practice in the form of fabrication, falsification or plagiarism that is committed intentionally or through gross negligence when planning, conducting or reporting research”. The following can be read at the Npof website: “The Board for Assessment of Research Misconduct (Npof) was established on 1 January 2020 as a government agency under the Ministry of Education and Research. Our task is to examine whether misconduct in research has taken place in accordance with the Act (2019:504) on responsibility for good research practice and the examination of misconduct in research.” Npof’s vision: “Swedish research must be recognised as reliable. Every researcher must therefore comply with good research practice, and allegations or suspicions of misconduct must be investigated in a legally secure, transparent and clear manner.” 

Read more.

11. What is fabrication in research?

Definitions of fabrication vary slightly. However, the basic idea is well captured by the definition given by the Board for Assessment of Research Misconduct: “Fabrication: making up results and recording them as if they were real.” The fact that a scientific article contains fictitious results is a serious form of scientific misconduct. From an ethical perspective, it is difficult to see that extensive fabrication of results in a paper can ever be a minor deviation from good research practice.

12. What is falsification in the context of research ethics?

The Board for Assessment of Research Misconduct (Npof) gives the following definition of “falsification”: “manipulating research materials, equipment or processes or changing, omitting or suppressing data or results without justification.” A common example of what falls under falsification is that research has actually been done, unlike what applies to fabrication, but the research has been distorted in one way or another. This can apply to research results as well as research processes and the analysis of results.

It should be noted that even though Npof provides a standard definition of “falsification”, the Swedish legislation treats the concept in a way that deviates from established international research ethics practice. In research ethics, a clear distinction is made between intentionally misleading (which is fraudulent behaviour) and deviating from established scientific practice out of ignorance. The latter is often called “sloppy science”, while “falsification” is reserved for cases where the researcher is presenting results in an intentionally misleading way. This distinction is not maintained in Swedish law. In other words, you can be convicted for falsification without having been intentionally misleading (gross negligence is sufficient).

13. What is plagiarism?

This concept has given rise to a fairly extensive research ethical discussion, and the way in which “plagiarism” is defined varies somewhat. The Board for Assessment of Research Misconduct provides the following definition of plagiarism in a research context: “Plagiarism: The researcher uses other people’ texts, ideas or works without giving due credit to the original source.” For those more versed in medical research, it might have been more helpful to say that plagiarism includes ideas, results, text, and images/graphs/tables/illustrations.

14. What deviations from good research practice must Karolinska Institutet deal with?

The Board for Assessment of Research Misconduct (Npof) has the task of investigating suspected misconduct in research, more specifically “a serious deviation from good research practice in the form of fabrication, falsification or plagiarism committed intentionally or through gross negligence in the planning, implementation or reporting of research”. KI shall examine suspected deviations from good research practice that fall outside this range but still damage or risk damaging the integrity of the research process, research or researchers, and that are committed intentionally or through gross negligence in the planning, execution, or reporting of research. 

When assessing other deviations from good research practice, the starting point must be the relevant national and international rules and guidelines that were in force at the time of the research in question or its reporting, such as the European Code of Research Integrity from ALLEA, the Vancouver Rules, and the Code of Ethics for Professional Review from the Committee on Publication Ethics (COPE). See:

• ALLEA, The European Code of Conduct for Research Integrity, revised 2023
• The Vancouver Rules
• COPE

15. Where can I learn a bit more about good research practice, research misconduct and the like?

The Swedish Research Council publishes the booklet Good Research Practice, which provides a certain overview of research ethics issues. A large number of research ethics rules and guidelines are collected on Codex.

16. Does KI have any training in research ethics other than what is available in the various educational programmes and doctoral education?

There is a certain element of research ethics in the supervisor training, which is mandatory for those who want to become principal supervisors for doctoral students. In addition to this, there is a web-based education, developed jointly by the medical faculties in Sweden, open to all researchers with a PhD (contact Annelie Jonsson). 

Authorship in research

17. Why is it important how authorship is handled in research?

How decisions are made about which researchers to include as co-authors of scientific articles is important in several ways. For the individual researcher, publications are of great importance for their own career, at least if they choose to remain in academia. In a fierce competitive situation, it matters a great deal to those involved whether the distribution of co-authorship is fair or not, i.e. whether it reflects actual research contributions or whether it can rather be explained on some other basis. The question of fairness can be said to concern whether everyone gets the scientific merits they deserve. 

The handling of authorship on articles is also a matter of transparency in research. Just as openness and transparency about research require an accurate description of the methods used, a complete transparent description of a study requires that it is clear who contributed and in what way. Both authorship management and contributorship management are important for this.

18. What are the central ideas behind the best-known criteria for authorship, the so-called Vancouver Rules, developed by the International Committee of Medical Journal Editors (ICMJE)?

There is a lot of discussion about the details, but the cornerstones of these authorship criteria are that you should (1) have made a sufficiently large contribution to the research work, (2) have written the first draft or contributed to a critical revision of the manuscript (at some stage), (3) have approved the final version, and (4) be prepared to shoulder the responsibility as a co-author of the article in question. The guidelines do not provide an answer to exactly how large a research contribution is sufficient to qualify as co-author, nor how to weigh different research efforts against each other. On the other hand, they are clear about which aspects do not have any direct relevance to the question of who should be listed as an author, such as who contributed to the funding of the research or who had a certain formal role in relation to the study (such as supervisor of a doctoral student or postdoc or as head of the research group or division). For more information, see ICMJE.

19. ICMJE’s authorship criteria are described as recommendations – so you don't have to follow them if you don't want to?

The authorship criteria do not have independent legal status. It is not a matter of legislation. Therefore, there are no legal sanctions that emanate directly from them. Rather, they express an idea of what is ethically correct handling of co-authorship in research: to handle authorship in research in this way is right, to handle it in any other way is wrong. At least, that’s the idea.

This much can be said as that the criteria are reasonable if you think that you should be able to use scientific publications as a reasonably accurate (if far from perfect) measure of academic achievements – it does not make sense to compare academic achievements through publications if some are included in the author lists of publications because they have made a substantial research contribution while others are included on all sorts of other grounds, without having contributed in any significant way to the research presented.

Karolinska Institutet’s Council for the Investigation of Deviations from Good Scientific Practice uses these authorship criteria when assessing deviations from good research practice relating to academic authorship.

20. What does the order of authors say about the co-authors’ contributions to the research presented?

There is no consistent general answer to this question. There are different practices in different research traditions and several different practices at Karolinska Institutet alone. Of course, this does not preclude the existence of a clear and consistent practice within a given group or in a given context. However, different practices in different research groups and research areas make it difficult to compare between different research groups and research areas. 

In many fields of research in the humanities and social sciences, the order of authors says nothing about the relative contributions of different co-authors or the role they have had in the project. Alphabetical order is applied sorted by surname. In medical research, it has long been common practice that the order of authors should reflect the relative contributions of the various co-authors. In many contexts, certain roles in the collaboration are also assigned specific places in the order of authors (for example, that PI is last or second to last regardless of effort). This latter practice can be questioned based on the idea that authorship, including the order of authorship, should be handled on the basis of actual contributions to the article in question rather than reflecting power relations and formal roles of responsibility – if a certain position is worth more than others, it should, based on an idea of merit, be awarded to the person who has made a more valuable contribution to the work in question.

21. Do you have to be able to take responsibility for all the content in an article in order to be properly listed as a co-author?

The short answer first: no, such a demand is not reasonable. 

It is important that researchers realize that co-authorship of scientific articles is not only a right for the diligent, but also entails a responsibility for the work presented. The question is how far this responsibility should extend. Of course, a minimum is that everyone takes responsibility for their own specific contribution and is ready to report how the work has been done, what decisions have been made during the course of the work and what the raw data looks like, how analyses have been made, etc. if anyone asks. But many argue that this is not enough. Some would argue that everyone is to be held accountable for everyone else’s contributions as well (Npof leans towards that view in a decision in January 2024). In collaborations that require different specialist knowledge in terms of methods and analyses, it does not seem very reasonable that each co-author should be able to take responsibility for everything that everyone else has done. This expertise is simply not available to all participants in such a collaboration, even if all researchers are competent in their respective fields. Such a requirement would even risk leading to authorless articles in this type of collaboration (if the participating researchers are honest about their limitations). That would hardly be better. It is reasonable for researchers, in the absence of reasons to do the opposite, to trust each other and each other’s expertise. But we must not be naïve either. Cheating, shortcuts, selective reporting of results and exaggerations of their importance occur in the research community. It is hard to say what constitutes a reasonable degree of trust.

Ethical review of research

22. What research needs to be ethically reviewed?

In Sweden, there are requirements for ethical review for both human and animal research. While the Animal Welfare Act regulates the ethical review of research on animals, the ethical review of research involving humans is regulated by the Ethical Review Act. In order to know whether your own research needs to be ethically reviewed, you need to familiarise yourself with the conditions for ethical review of research on animals and humans. It is the researcher’s responsibility to find out what laws and regulations apply in the countries in which the researcher intends to conduct research. 

Research on humans.

23. What are the requirements for ethical review of research on humans?

A lot of research involving people may be conducted without ethical review (such as interviews, questionnaires, and document studies that do not contain sensitive personal data) and a lot of research involving humans requires permission from the Swedish Ethical Review Authority (EPM). You simply must find out what applies to your own research. Research needs ethical approval if it (1) involves physical interventions, such as drug trials (which also require approval from the Swedish Medical Products Agency) or the collection of blood samples or biopsies, (2) is done on biological material that can be traced to a human being, (3) involves obvious risks to the research participant, or (4) processes sensitive personal data. An important ethical assessment criterion for research that requires approval from the EPM is the balance between the benefits of the research project and the risks to the research subjects.

The Swedish ethical review only covers the part of the research that takes place in Sweden. Data collection abroad requires compliance with the requirements of the country where the data collection takes place. If data is analysed in Sweden, ethical review is also required in Sweden for what is done in Sweden (provided that the law is applicable to that research). 

For more detailed information about ethical review, see the Swedish Ethical Review Authority’s website. You can also ask questions to researchethicsadvice@ki.se.

24. Is it possible to appeal against the decision of the Swedish Ethical Review Authority? 

Yes. If the researchers do not get their application approved by the Ethical Review Authority, the decision can be appealed to the Ethics Review Appeals Board (Önep).

For questions regarding appeals against the decisions of the Ethical Review Authority.

25. Is it possible to conduct an ethical review of research afterwards if you failed to carry out an ethical review before the research began? 

No. A central point of ethical review is to prevent unacceptable research. This presupposes that the ethical review takes place first and that the research begins only after the researchers have received the approval from the Ethical Review Authority (EPM). Far from all research needs to be ethically reviewed, but even for an advisory opinion for research that does not need to be ethically reviewed, the research must have been assessed by the EPM before it begins. 

26. Do I need ethical review even if my research only concerns health data and I am only interested in results at an aggregated level? 

What matters is not at what level the data is analysed, but what kind of data the researchers have access to and use. Permission from the Swedish Ethical Review Authority (EPM) is required to conduct research that involves the processing of sensitive personal data. Personal data is information that can be directly or indirectly traced back to a natural person who is alive, for example via name, IP address, code key, or collected background data. What constitutes sensitive personal data according to the Ethical Review Act is legally defined. What is considered sensitive personal data is listed in the EU’s General Data Protection Regulation: information about health, sex life, sexual orientation, ethnic origin, race, political opinions, religious beliefs, philosophical beliefs, genetic data and biometric data. In the Ethical Review Act, information linked to a person relating to offences involving criminal offences, criminal convictions, coercive measures, or administrative detention is also considered sensitive personal data. It makes no difference to the Ethical Review Act whether or not the researchers themselves can link data to a person. It is enough if someone can do this, such as the source from which the data was obtained, such as a quality register or Statistics Sweden.

For more information, see:

• The Swedish Ethical Review Authority’s website
• The Integrity Protection Authority (IMY)

27. What about ethical review for research on biological material from humans?

A rule of thumb is that you need a permit to conduct research on biological material taken from humans, if someone can trace this material back to a human. If the biological material cannot be traced back to individuals, ethical review is not required for the research.

For more information, see Biobank Sweden’s website
See also the website of the Swedish Ethical Review Authority

28. Ethical review of animal experiments

Ethical review of animal experiments varies between different countries. There are even different views about what should be counted as “animals” in these contexts. In Sweden, approval by an animal ethics committee is required before animal experiments can be carried out. Animal experiments have been regulated by law in Sweden since 1979. The Animal Welfare Act (2028:1192) is the law that regulates animal experiments. For more information, see:

• The Swedish Board of Agriculture’s websites
• Find facts about animal experiments in research and information about the ethics of using animals in research. (All in Swedish.) 
• A large number of research ethics rules and guidelines, including on research on animals, are collected on Codex

Research data

29. Who owns research data generated through research at KI?

Research data in the form of raw data and documentation that is generated in a research project or that is part of a research project belongs to KI and is not the private property of the individual researcher or research group, neither during the ongoing project nor when it has been completed. This applies even if the project has been financed by external funds. However, as a general rule, intellectual property (IP) rights created in research belong to the researcher. The researcher’s ownership of IP may be affected by collaboration and commissioned research.  Sometimes raw data consists of personal data, and in many cases the client does not have a legal basis for accessing personal data (even though they are financing the project) but instead has access to and ownership of the results. But then there may be several – both individuals and organisations – who have the right to access data. As a researcher, you can get permission to take data (usually a copy) with you, for example, when you leave KI and go to another university. See also Research Support Office.

In collaborations with the business community, there must also be agreements that regulate what applies. In all types of collaborations, KI usually wants to have the right to use data for research – this is typically a requirement in the agreements. See also Research Support Office. 

30. Is it possible for an individual researcher to own a database that has been built up as part of research activities at KI?

No, if the database has been built up as part of research activities at KI, you cannot own the database as an individual researcher. Raw data and analytics data are owned by the university.

31. Who owns research biobanks? Can you own a biobank as an individual researcher?

No, it is the organisation responsible for the biobank (KI in the case of KI Biobank, Region Stockholm in the case of the Stockholm Medical Biobank) that owns the biobank. All biobanks are in a national register. 

32. How does Karolinska Institutet recommend that researchers store their data?

Karolinska Institutet provides various services for storing data and sharing files. Use these in the first place. On the link you will find all systems approved by KI. If you want to use other systems, you must first check with Infosec. When storing data containing personal data in external systems, a data processing agreement is required.

33. What equipment can be used for interviews, from the point of view of data security?

From a data security point of view, how to store data after the interview (see answer above) is a bigger issue than how to collect data, but the latter is also important. Traditional recording equipment such as tape recorders, dictaphones, and video cameras are fine. But it is also possible to record interviews over Zoom or Teams with KI computers (send a request to infosec@ki.se if you want to use any other program of the type Zoom/Teams than these). Since KI is not able to require, introduce, or verify any security measures on private mobile phones, these should not be used for the recording of privacy-sensitive information.

34. Is it a research ethical requirement that research data is made available to other researchers?

A lot of research funders now make this demand. In that case, it is a condition for being awarded research funding. Exactly how the data will be made available may then still be an open question, unless the funder specifies its requirement. From a research ethics perspective, there are several advantages with making data available to others. For example, it will be possible for more people to conduct research on collected data. This reduces the risk of the collected data being under researched, i.e. that the resource is poorly utilized. Another great advantage (some would say the main one) is that it will be possible for researchers to control each other to a greater extent. Over time, it is conceivable that this is something that strengthens the quality of research. There are also conceivable disadvantages: If researchers are forced to share data immediately after their first publication, there is a risk that more resourceful research groups will take over and do all the other studies that the data-collecting researchers had planned to do before they find the time to do them themselves. That seems unfair and not very reasonable. There may also be reservations about how data is shared. Good data protection remains an important aspect of research ethics – data sharing must not mean that sensitive personal data is leaked to third parties. In addition, questions remain about informed consent. There are also confidentiality regulations to consider.

Research abroad

35. Does research that takes place outside Sweden need to be ethically reviewed?

Different countries have different regulations. Researchers must comply with the regulations that exist in the country where they are researching. Researchers who collect data abroad and carry out the analysis in Sweden must have Swedish ethical approval for what is done in Sweden if it falls under the Ethical Review Act. This is the case, for example, if the analysis involves the processing of sensitive personal data. If the code key remains in another country, the researchers in Sweden are considered to be handling sensitive personal data even if they themselves do not have the opportunity to identify individuals.

Karolinska Institutet has adopted its own guidelines for human research conducted abroad.

36. If interviews take place via Zoom or Teams, with the researchers in Sweden and the interviewees abroad, where is the research considered to take place?

If the interviewees share sensitive personal data, this data is considered to be processed in Sweden if the researcher is located in Sweden, which means that an ethical review permit is required for this. What applies in the other countries concerned to this type of research needs to be found out and complied with.

37. If a researcher in Sweden, over the internet, gains access to a database containing sensitive personal data stationed in another country, does the data processing take place in Sweden, in the other country, or in both countries?

From a Swedish ethical review perspective, sensitive personal data is handled in Sweden, even if only pseudonymised or anonymised data is later transferred to a Swedish server or online service. What applies in the country where the database is located is something you need to find out and comply with. 

Research ethics guidelines and important links

A large number of research ethics rules and guidelines are collected in Codex. Here you find, among other things, the Belmont Report, COPE’s guidelines and advice, the Declaration of Helsinki, and the Nuremberg Code.