To safeguard research subjects, Swedish legislation states that research projects that involve humans, human tissue or sensitive personal data must undergo ethical review before research can begin. You also need to follow good research practice, not fabricate research data or unlawfully copy someone else's research.
Katrine Riklund, Pro-Vice-Chancellor, Umeå University
Photo: Mattias Pettersson
For a few years, the Council for Good Research Practice (REDA) has been one of Umeå University's key councils consisting of representatives from all faculties and the Umeå School of Education; and I've had the pleasure of leading it. At the University, we also have recently updated procedures to support good research practice and handling of suspected deviations. REDA convenes four times per year to proactively take measures to increase knowledge in this area within Umeå University. On the agenda, the Council will discuss with the University's directors of doctoral education how to improve doctoral education to emphasise the importance of research ethics and good research practice.
On a national scale, Sweden has had the Ethical Review Act since 2003, which intends to protect the individual and safeguard human dignity in research. In later years, many researchers, particularly in humanities and social sciences, have been criticising the Etichal Review Act, not least because the act requires ethical review for public material containing personal data. Even the Ethics Review Appeals Board is criticising the act since the Board must press charges against each suspected violation against the law, regardless of its dignity.
This is one of many questions discussed in the Association of Swedish Higher Education Institutions' (SUHF) expert committee on research ethics. The expert committee works towards nuanced discussions of mistakes, wrongdoings and cheating, and how to create the right conditions for taking responsibility in helping others to act correctly. We have also developed a guide for universities to prevent, handle and follow up suspected deviations from good research practice, which has recently been revised. And in addition to that, we are following what the National Board for Assessment of Research Misconduct (NPOF) is doing, and are analysing the consequences of the system. We also follow the work of the Swedish Ethical Review Authority and the Ethics Review Appeals Board.
As a consequence of the discussions held in spring 2023, and the criticism flowing from many directions against the Ethical Review Act, the act will now be reviewed by the appointed investigator Ulrik von Essen, Justice of the Swedish Supreme Administrative Court. He has been tasked with looking into two aspects of the law: if some research that includes sensitive personal data should be exempt from the legal ramifications; and if the section stipulating that each suspected deviation must be reported for prosecution should be revised. The investigation will be reported on 30 September 2024 at the latest.
What's unfortunate is that the review is limited to these two questions only. The key aspect, the interests of research subjects, has been left out from the review completely, and the investigation seems merely to be satisfying the dissatisfied researchers. Ethical review safeguards individuals and the General Data Protection Regulation safeguards sensitive personal data. Both parts are important, but they are fundamentally very dissimilar.