Ethics in research

This page contains information on laws and guidelines concerning ethics in the research process. You will also find contact information to authorities with special responsibility for regulations in the field of research ethics.

Disclaimer: If the information in English is different from the Swedish version, it is the Swedish version that applies.

Good research practice

Adopting an ethical approach in the research process means that you, as a researcher, protect both the people who participate in the research and the knowledge that is being produced.

Good research and an ethical approach always go hand in hand. However, the ambition to achieve scientific progress must never take precedence over the principle of protecting the dignity of research participants – it is always most important to safeguard human dignity.

Ethical issues in research have been discussed for a long time in various research areas. The results of these discussions are summarized in different sets of rules – codices – which aim to clarify how researchers should act in an ethically correct manner. Codices in various research areas have contributed to increasing the awareness of ethical challenges in research.

The Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, is a central guideline adopted by the World Medical Association (WMA) in 1964. The rules and concepts in the Helsinki Declaration are also useful in research areas other than medicine. Therefore, the Helsinki Declaration has achieved a special position as a guideline for research ethics in general.

A codex is a collection of rules, but is not a legally binding document.

In Sweden, we also have legislation in the area of research ethics, such as the Ethical Review Act and the Animal Welfare Act.

Ethical Review

Certain types of research are required by law to undergo ethical review. An approved application for an ethical permit is required if you plan to conduct research that concerns sensitive information about people or if the research includes the processing of personal data.

The Ethical Review Act, Act (2003: 460) on ethical review of research on people, aims to protect the individual and the human dignity in research.

The law also contains regulations regarding consent when participating in research.

Anyone who participates in research (research participant) must be protected against the risk of being harmed physically, mentally or in terms of integrity. The public must be given insight into, and influence over, the ethical review. The legal security of both researchers and research participants must be safeguarded.

Research – definition
The Ethical Review Act defines research as:

"Scientific experimental or theoretical work or scientific studies through observation, if the work or studies are done to acquire new knowledge, and development work on a scientific basis".

Studies that are carried out only within the framework of higher education, at basic or advanced level, are in most cases not defined as research.

Entity principally responsible for the research – definition
A public authority or a physical or a legal person in whose organization the research will be carried out.

For example: university, municipality, region, or private company.

Research participant – definition
A living person who will be the subject of the research.

Research covered by the Ethical Review Act

The Ethical Review Act shall be applied to research conducted in Sweden, which:

  • includes the processing of sensitive personal data or data on criminal offence.
  • involves a physical intervention, on a living or a deceased person.
  • is performed according to a method that aims to affect the research participant physically or mentally.
  • concerns studies involving biological material taken from a living person which can be traced to that person.

Sensitive personal data
Research that processes any of the following sensitive personal data is covered by the Ethical Review Act:

  • ethnicity
  • political opinions
  • religious or philosophical beliefs
  • union membership
  • health
  • a person's sexual life or sexual orientation
  • genetic data
  • biometric data that uniquely identifies a person

To inform about, and obtain consent for, participation in research

In research involving humans, you as a researcher are obliged to provide information about the research and to obtain consent from each research participant.

If the research participant has not yet reached the age of 18, there are special requirements in the Ethical Review Act.

Research may only be carried out if the research participant has consented to the research that concerns him or her. A consent only applies if the research participant has received the following information about the research:

  • the overall plan for the research.
  • the purpose of the research.
  • the methods that will be used.
  • the consequences and risks that the research may entail.
  • the entity principally responsible for the research.
  • participation is voluntary.
  • the research participant has the right to discontinue his or her participation at any time.

A template, which can be used as a starting point for formulating information to research participants in your research project, is available on the Swedish Ethical Review Authority's website (in Swedish).

https://etikprovningsmyndigheten.se/for-forskare/sa-gar-det-till/

Ethical review – application

If you plan to conduct research on humans, human tissue, or to conduct research that involves collection of sensitive personal data, you must submit an application for ethical review. The application is submitted to, and assessed by, the Swedish Ethical Review Authority.

https://etikprovningsmyndigheten.se/

Application for ethical approval of animal experiments

If you are planning experiments with living mammals, birds, reptiles, amphibians, fish, cyclostomata, and in many cases even with embryos, you must apply for ethical approval. This is mandatory.

Applications are submitted via an e-service at the Swedish Board of Agriculture, Sweden's expert authority in the areas agriculture, fishery and rural areas.

Please note that the application has to be written in Swedish with the Swedish application documents.

https://djur.jordbruksverket.se/etjanster/etjanster/etjansterfordjuragareochdjurhalsopersonal/ansokanometisktgodkannandeavdjurforsok.4.37e9ac46144f41921cdc881.html

Register-based research – laws and ethics when using Swedish register data in research

There are a number of laws and ordinances that regulate the conditions on which a researcher may access register data, and how such data must be handled. These regulations are primarily intended to protect the personal integrity of the persons whose data are used, as well as ethical rules, including requirements for ethical review.

Read more at the Swedish Research Council's service:

https://www.registerforskning.se/en/

https://www.registerforskning.se/en/guide/law-and-ethics-when-using-swedish-register-data-in-research/

Misconduct in research

Law on misconduct in research
On January 1 2020 a new law, Act (2019: 504) on responsibility for good research practice and assessment of misconduct in research, was introduced. The law contains regulations on the responsibility of research principals and researchers with regard to good research practice. It also contains regulations on the procedure for assessing misconduct in research.

https://www.uhr.se/en/start/laws-and-regulations/Laws-and-regulations/act-on-responsibility-for-good-research-practice/

Misconduct in research – definition
The law defines misconduct in research as:
"A serious deviation from good research practice in the form of fabrication, falsification or plagiarism committed intentionally or through serious negligence in planning, conducting or reporting of research".

Assessment of misconduct in research
Misconduct in research is assessed by a special board, National Board for Assessment of Research Misconduct. The board investigates and decides in cases where there are suspicions of misconduct (website in Swedish).

https://oredlighetsprovning.se/

Assessment of other deviations from good research practice
Cases that do not concern misconduct according to law (2019: 504), but concern other deviations from good research practice are handled at the university. At Umeå University, the Legal Affairs Office is responsible for assessing such cases, and can also provide more information on these issues: 
universitetsjurist@umu.se

Reporting 
Reports regarding suspicion of deviation from good research practice is made to: 
registrator@umu.se

Cases concerning misconduct in research can also be reported directly to the National Board for Assessment of Research Misconduct.

Research data at Umeå University – handling, storage, publication, preservation

Data collected or generated in research must be managed, stored and preserved in a responsible manner.

Data management plan Swedish Research Council
For research projects funded by the Swedish Research Council, a data management plan is a requirement. A data management plan contains a description of how data will be managed both during and after the implementation of the research.
https://www.vr.se/english/applying-for-funding/requirements-terms-and-conditions/producing-a-data-management-plan.html

Data management plan Formas
For research projects funded by Formas, a data management plan is a requirement. Read more about Formas' requirements regarding research data:
https://formas.se/en/start-page/applying-for-funding/how-it-works/good-to-know-before-you-apply.html#h-Openaccesstoresearchresultsanddata

Research data policy at Umeå University
This policy describes responsibilities and provides guidance on how Umeå University is to manage and preserve research data during the entire course of a research project from the planning stage, during the project and after the end of the project.
https://www.umu.se/en/legal-framework/research/research-data-policy/

Management of research data at Umeå University
At Umeå University, the University Library provides practical guidance on research data management (RDM) before, during and after a research project. Read more about data management during the phases of a research project on UB's website.

Data management at the beginning of a research project: https://www.umu.se/en/library/research-data/beginning-of-research-project/

Data management during the course of the research project: https://www.umu.se/en/library/research-data/during-research-project/

Data management when the research project ends: https://www.umu.se/en/library/research-data/conclusion-of-research-project/

Researchers at Umeå University have access to a variety of resources related to data management. Read more about these on the University Library's website:
https://www.umu.se/en/library/research-data/organisation-and-contacts/

Research funders demand good practice in research

All research funders demand that research be carried out in accordance with applicable laws and regulations. Some research funders, such as the EU, make special demands. Below, you can read more about requirements from various research funders.

Research funding from the European Union – Ethics
For all activities funded by the European Union, ethics is an integral part of research from beginning to end, and ethical compliance is seen as pivotal to achieve real research excellence. There is clear need to make a thorough ethical evaluation from the conceptual stage of the proposal not only to respect the legal framework but also to enhance the quality of the research.

Ethical research conduct implies the application of fundamental ethical principles and legislation to scientific research in all possible domains of research.

Ethics review
In order to avoid funding of ethically problematic activities, some funding programmes require an ethics review procedure to clear the projects (e.g. Horizon Europe).

The details and the scope of the ethics review depend on each programme. Most programmes simply check whether projects raise ethics issues and, if so, whether these are adequately addressed. Some programmes, such as Horizon Europe, have a more elaborated review procedure which includes several steps depending on the complexity of the issues.

Read more in the online manual:
https://webgate.ec.europa.eu/funding-tenders-opportunities/display/OM/Special+procedures%3A+Ethics+review%2C+security+scrutiny%2C+Ownership+control+check

EU-grants: How to complete your ethics self-assessment
https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/common/guidance/how-to-complete-your-ethics-self-assessment_en.pdf

Swedish Research Council – conducting ethical research
https://www.vr.se/english/applying-for-funding/requirements-terms-and-conditions/conducting-ethical-research.html

Swedish Research Council for Health, Working Life and Welfare (Forte) – general terms and conditions for grants
See specifically section 3.3 Project leader's commitments.
https://forte.se/en/funding/apply-for-a-grant/general-terms-and-conditions-for-grants/

Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (Formas) – terms and conditions for grants
See specifically section 2.3 Responsibility for conducting the Project according to good research practice, Swedish law and applicable international regulations.
https://www.formas.se/en/start-page/applying-for-funding/terms-and-conditions-for-grants.html

Important links

Codices

Questions?

As an employee at Umeå University, you are welcome to contact us at the Research Support Office if you have questions concerning ethical issues in the research process.

E-mail rso@umu.se

Legal Affairs Office

At Umeå University, the Legal Affairs Office is responsible for assessing deviations from good research practice, and can also provide more information on such issues.

E-mail universitetsjurist@umu.se

Lena Holmberg
6/28/2021