Sweden’s redrawn research ethics law ‘a step in right direction’

A proposed redrawing of Sweden’s research ethics law has been welcomed as a “step in the right direction” by sector leaders, although a more comprehensive overhaul of the ethics review system may be required in the long run.

Following a year-long inquiry, investigator Ulrik von Essen submitted a memorandum advising changes to the current Ethics Review Act, which academics have criticised as overly complex and burdensome.

Should the revised law be implemented, researchers would no longer need to seek approval to use personal data on subjects who are aged over 18 and have given informed consent, providing that the research “poses only a minor risk to the individual’s health or safety or to an intrusion into an individual’s personal integrity”. Further, the use of data that has been made publicly available and is “not subject to confidentiality” will not require approval from the Ethical Review Authority.

Under the new law, the Ethics Review Appeals Board (Önep) would no longer be required to report any suspected violation of the Ethics Review Act to prosecutors, with the ability instead to issue criticism. Universities and research-performing institutions would take greater responsibility for ensuring compliance with the law by issuing guidelines, training their researchers and implementing screening processes.

Lars Behrenz, deputy vice-chancellor of Linnaeus University, said the response to the proposed law could be summarised as, “Nobody’s super happy, but nobody will be super angry either.”

“It’s a step in the right direction. It will be a bit easier to get ethical approval, but there’s still work to be done,” Dr Behrenz said.

Stefan Eriksson, executive officer of the ethics expert group at the Association of Swedish Higher Education Institutions (SUHF), said he “welcomed” the proposal, but added: “It doesn’t solve everything.”

While the new law would go some way towards lessening the burden on researchers, he said, it did not address the need among some academics, particularly those in fields like history, law or political science, to gather data immediately on unfolding events. At present, he said, “ethical approval takes 30 to 60 days. You can’t just see something and say, ‘Oh, this is interesting; I’m going to collect data as the situation unfolds.’”

The call for institutions to issue their own guidelines could be problematic, Dr Eriksson noted: “It leads to the possibility of there being differences between universities”. Careful coordination would be required to ensure consistency across the sector, he said; otherwise, researchers could select institutions based on the stringency of their requirements.

Jonas Åkerman, research integrity and ethics coordinator at Stockholm University, said he would like to see a “broader overview of the system in order to determine how it should be reformed, in order to best serve its purpose without unnecessarily inhibiting research”.

Under the proposed law, researchers or institutions determined to have violated the ethics act would not be able to appeal this decision, an aspect Dr Åkerman described as “very problematic”, particularly when concerning the critique of individual researchers. “Such decisions are equivalent to decisions on research misconduct in terms of possible consequences,” he said, citing as examples “damaged reputation, blocked funding [and] retracted papers”.

“It is obvious that the present system isn’t working very well,” Dr Åkerman said, calling the proposals “welcome”. However, “applying the exemptions will not be a trivial matter”, he said. “There is a risk that many researchers will end up finding the new system even more demanding that the old one.”

emily.dixon@timeshighereducation.com