Guidelines on ethical principles for human research outside Sweden

The purpose of these guidelines is to ensure that research conducted abroad matches the ethical standards that apply to research conducted in Sweden as well as to protect individuals and safeguard respect for human dignity.

  • Diary number: 1-429/2022
  • Decision date:
  • Validity period: Until further notice
  • Decision: President
  • Document type: Guidelines
  • Handled by department/unit: Juridiska avdelningen
  • Preparation with: The ethics council and the vice president

Summary of the guidelines

Since Karolinska Institutet (KI) is a collaborative and global university, a good deal of research is conducted outside Sweden. Such research is not always subject to the rules in Sweden concerning the protection of humans and the wider community. Many countries have rules that correspond to those in force in Sweden, but others, if they have any at all, have rules that do not live up to what is considered an acceptable ethical standard in Sweden. KI’s research must be ethically defensible. 

Researcher ethics concern the researcher’s responsibilities and relationship towards his/her research, the scientific community and society in general. The Act on responsibility for good research practice and the examination of research misconduct stipulates that it is the responsibility of the researcher to comply with good research practice in his/her research and that the entity responsible for research has the overarching responsibility that the research is conducted in accordance with good research practice. 

Research ethics, on the other hand, concerns respecting and protecting participants and others involved in a scientific study. A very important aspect of research ethics concerns the treatment of the individuals taking part in a study, whereby they shall be protected from injury or violation to the greatest extent possible. 

KI’s ethical rules for international collaboration1 , both at departmental and individual level, require that an ethical review board or an equivalent local body approve the project before it is carried out. The Act concerning the ethical review of research involving humans, biological material from humans and sensitive personal data provides that such research may only be conducted if it has been ethically reviewed and subsequently approved. However, this law is only applicable to research conducted in Sweden. As regards research on animals, ethical guidelines are in place for international collaborations involving animal research in a third country.