Many of the medical research studies that are planned and implemented involve various ethical issues and dilemmas. These may apply to aspects such as patient safety, animal experiments or the use of sensitive personal information.
Therefore various laws and regulations are in place to ensure that research is medically justified and that the risk of damage is minimised.
Sensitive personal information
Research involving data connected to people alive today is subject to particular rules and laws. If sensitive personal information is processed (such as ethnicity or sexual orientation) the research must undergo additional ethical review by an ethical review authority in Sweden, Etikprövningsmyndigheten.
Participating patients and volunteers - informed consent
In addition to any necessary approval for the research study as a whole to proceed, other types of permission are also often required. If the research is a patient or population study, consent from the participants will be required in most cases. This means that the participants must have been informed and must have understood the purpose of the study as well as any risks and benefits involved in participation, and they must have subsequently agreed to participate.
Researchers who need to conduct animal experiments require special permission; read more about this on the page about animal experiments.
Research on samples and register data
Research on human blood, tissue etc. normally requires ethical approval. This applies regardless of whether the material is from a living person or a deceased person. If the sample is to be stored in a biobank, the sample provider must have consented to this.
In case of major register studies based on previously collected personal data (which is available in quality registers and population registers, for example) it is not always a requirement that participants renew their consent to a researcher using the material. Such cases are usually dealt with through a simplified procedure in which information is disseminated via websites and daily media. The information is to contain details of how to proceed if one does not wish to be included in the study.
Good research practice
Good research practice means, among other things, that relevant legal regulations and ethical demands are fulfilled.
Since 2020 there is a certain legal act in Sweden on good research practice and research misconduct: The Act on Responsibility for Good Research Practice a nd the Examination of Research Misconduct
The act defines research misconduct as fabrication, falsification or plagiarism that is committed intentionally or through gross negligence when planning, conducting or reporting research.
Suspected research misconduct is investigated by The National Board for Assessment of Research Misconduct.
There are more actions which can interfere with good research practice than those defined as research misconduct in the legal act. Examples:
- providing incorrect information about a person’s contributions to research
- without permission including and using data in your research belonging to someone else
Notifications on these matters are to be handled by Lund University.
Ethical review authority
The Swedish ethical review authority, Etikprövningsmyndigheten, operates under the supervision of the Ministry of Education and Research. The authority processes applications for permission from Swedish universities and higher education institutions.
Etikprövningsmyndigheten was launched on 1 January 2019 and it replaces six regional ethic review boards which before has handled the applications.
The head office of Etikprövningsmyndigheten is situated in Uppsala.