New written guidance on ethical review

The Ethical Review Authority hopes to provide answers the most important questions about the research ethics system in a new written guide. But it does not eliminate the scope for interpretations and uncertainty surrounding the Ethical Review Act.

The guidance is extensive. Its 147 pages take readers through the entire process, from planning a research project to applying for ethical approval, and describe the history of research ethics that led to the system that Sweden now has to protect research subjects.
“We have collected as much in it as possible so that will be a central source for people to refer to,” says Johan Modin, who is Director of the Ethical Review Authority. “But you don’t have to read  it from cover to cover. You can dip into it to find support and guidance when you need it.”

Johan Modin

Director of the Ethical Review Authority

The guide has a lot of focus on non-clinical research. Knowledge of the Ethical Review Act has proven to be more deficient in that area, which has led to highly-publicised cases in recent years and a debate about the law’s requirements.

Despite its scope, the guide, written by Ulf Görman, a professor emeritus of ethics at Lund University, aims to be easy to read and to bring clarity through concrete examples. “Our hope is that it will be of great use to researchers and entities responsible for research in their everyday work,” says Modin.

Leaves room for interpretation
Jonas Åkerman, coordinator for research ethics at Stockholm University, welcomes the guide and recommends researchers to read it. ”It provides an overview and more advanced reasoning that there may not be room for in other publication channels, and it may be important in helping people to understand how the system works and why,” he writes in an email to Universitetsläraren.

Jonas Åkerman

Coordinator for research ethics at Stockholm University

For those who, like himself, are already well versed in the research ethics system, the guidance contains no major new information or insights. Nor can it be expected to cover all issues at a detailed level, says Åkerman.

But it also means that much room for interpretation in practice is still left to researchers.
”It is difficult to know how confident a researcher might feel in assessments made on the basis of general descriptions or specific examples in the guide. For example, can you be confident that the supervisory authority would make the same assessment in a matter such as when an application regarding a change needs to be made?” he writes.

Just a support tool
What is the legal status of the guidance provided? Johan Modin says that it should be seen as a source of support and that it is not a legally binding document.

The guide is also a living document, which is intended to be updated as new questions or legal clarifications arise. One area that the guide does not address, for example, is artistic research, where there is great uncertainty and ignorance among researchers regarding the Ethical Review Act. The scope of the Act is also currently being investigated, which may lead to changes to the guidance.

Part of a larger information effort
In 2022, the Ethical Review Authority was given an assignment by the government to provide better information. In addition to the written guide, the authority has started producing online courses, held a webinar on personal data in research and launched a newsletter.

The guide can be downloaded from the Ethical Review Authority’s website, and the aim is for it to be translated into English in early 2024.

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