Many approve the research themselves

This article was first published in Norwegian on October 11, 2022.

More and more international funding sources, collaboration partners and publication channels are requiring approval for research on human subjects. This has led to frustration among researchers in Norway who find that their projects are not covered by the country’s current system for the assessment of research. 
 
The solution for many has been to draw inspiration from the US tradition of so-called institutional review boards (IRBs), which are separate bodies that have the authority to approve research at the relevant institution or faculty. 
 
In the last five to six years, at least six such bodies have been created in Norway (see fact box), and other institutions are considering following suit. Several stakeholders believe that this would strengthen the institutions’ efforts in research ethics.  

Complicated publishing process 

The Research Ethics Committee at the University of Oslo’s Department of Psychology was set up around 2015. According to the committee’s initiator, Anne Inger Helmen Borge, the requirement from journals for ethical approval was the catalyst. 
 
The current head of the committee, Silje Endresen Reme, notes that this is still one of the main reasons why researchers contact them. She has experienced first-hand that the road to international publication can be extra long and complicated without the right paperwork. 

The journals wondered why on earth I couldn’t refer to an ethical assessment. Silje Endresen Reme 

‘The journals wondered why on earth I couldn’t refer to an ethical assessment. So there’s been a lot of toing and froing, and I’ve had to ask the Regional Committees for Medical and Health Research Ethics to write a report on how the system works in Norway.’ 

Narrow interpretation of the law 

In the United States, most research involving human subjects requires a statutory assessment by an IRB prior to commencement. Consequently, almost all hospitals, universities and other institutions that conduct research on people have an IRB.

In Norway, the approval system for research projects is built around seven Regional Committees for Medical and Health Research Ethics (REK). These committees assess all research projects covered by the Norwegian Health Research Act. Decisions by REK can be appealed to the National Committee for Medical and Health Research (NEM). 
 
In addition, there are several advisory bodies, but these do not have the authority to approve or reject a project. 
 
In the last decade, Norwegian researchers, including Silje Endresen Reme, have expressed their frustration at much of the research on human subjects falling outside the REK’s remit. The criticism has mainly related to what they consider to be a narrow interpretation of the Health Research Act by REK. The Act targets medical and health research where the aim is to generate new knowledge about health and disease – but what exactly constitutes new knowledge, and what is health and disease? 
 
‘I have done a lot of research on work and mental health. Rather annoyingly, this has always fallen outside REK’s mandate. Even where a project has involved large volumes of health data and the examination of vulnerable hospital patients, our research has been rejected because its focus is on work’, says Reme. 

Risky research 

In 2014, Professor Jostein Hallén from the Norwegian School of Sport Sciences expressed concern that sports research had fallen into an ethical vacuum, and that REK would no longer even give it consideration. This served as a barrier to publication. Hallén called for new laws and new national committees for projects that were not encompassed by the existing research ethics committees. 
 
Then, in 2017, new legislation on research ethics came into effect. However, it was far from the solution Hallén had been hoping for.  
 
‘The law is unsatisfactory’, he says. 
 
The Research Ethics Act imposes requirements on institutions in relation to training in and awareness of recognised research ethics norms. Hallén sees this as a positive development, but thinks that the Act is otherwise far too focussed on dishonesty in research. He also thinks the new legislation provides insufficient guidance on the practical application of research ethics. 
 
He notes that, in contrast, the Health Research Act contains numerous important details and points of clarification for areas in which clarity is crucial, such as the sharing of data and the information provided to participants. 
 
‘This Act does not apply to us for the most part – but we comply with it nonetheless.’ 
 
Hallén explains that many of the Norwegian School of Sport Sciences’ projects concern physical activity in the context of health and disease, and often involve vulnerable groups. A sports researcher can, for example, take a muscle test and insert venous catheters in participants who will then cycle until they are exhausted.   
 
‘Some of what we do here can be much more of a strain, both mentally and physically, than the work of health research institutions’, the professor points out. 

Preventing serious non-compliance 

The Norwegian School of Sport Sciences dealt with the rejection by REK in the same way as the Department of Psychology in Oslo: by creating its own internal approval body. 
 
Hallén was initially sceptical about such a solution, partly because he feared that the ethical assessment would not be independent. Now, five years since its inception, he is pleased with the work of the committee. He himself has been a member of the committee and used it actively. 
 
The committee resolves the challenges of the criteria set by journals. But perhaps even more importantly, according to the professor: 
 
‘It serves as a double check for researchers, especially when it comes to how we inform the participants. How the participants are informed is one of the key aspects of ethics in research on people, coupled with the fact that they should not be exposed to unnecessary risk.’ 

Social inequality  

It is perhaps not surprising that such bodies are set up by research communities whose activities are almost, but not quite, covered by the Health Research Act and the Research Ethics Committees. However, they are also seen in other areas with a strong element of social research, such as economics. 
 
The Norwegian School of Economics (NHH) has such a committee, and its origins stem from a group of researchers seeking to find solutions to social inequality – namely the Center for Experimental Research on Fairness, Inequality and Rationality (FAIR). 
 
‘We are a centre for experimental research and as such have direct contact with study participants. It’s therefore particularly important for us to safeguard their integrity and interests’, explains Erik Øiolf Sørensen. 
 
Sørensen is a researcher at FAIR and was one of those who initiated the establishment of an IRB when the centre opened in 2017. 
 
‘We wanted to ensure a high ethical standard, in the same way that we try to maintain a high standard in relation to other methodological matters. The IRB application process is an opportunity to initiate discussions about what is good, right and necessary.’ 
 
Sørensen and his colleagues also find that more and more journals and international partners want to see references to an IRB assessment. 
 
‘It’s easier for us to satisfy such expectations now, but this was of secondary importance to us. I have also never heard of anyone being refused permission to publish due to the absence of a norm for IRBs at Norwegian institutions’, he points out. 

The work with the committee has given a boost in terms of the overall awareness of research ethics. Ingrid H.G. Østensen

Several sources that the Research Ethics Magazine has spoken to emphasise that this can be a positive development for research ethics in general. One such source is Ingrid H.G. Østensen, head of the secretariat for the Ethics Review Board at BI Norwegian Business School. 
 
‘The work with the committee has given a boost in terms of the overall awareness of research ethics’, she states. 

High demand 

Many committees are also experiencing a high demand. The Department of Psychology’s committee has received 24 applications this year to date. Other faculties and departments have also contacted them, but the committee has had to turn them away due to resource considerations. 
 
Tore Nilssen is research dean at the Faculty of Social Sciences, which the Department of Psychology is affiliated with. Nilssen is aware that several research groups at the faculty are interested in this topic. He himself is not convinced that everyone needs such a committee, and he certainly does not want to force it on anyone. 
 
‘I think the initiative must come from academia; from individual institutes or research communities. I’m too high up on the management side to make such a decision, but I can certainly facilitiate the outcome. We will try to start a discussion’, he says. 
 
At Western Norway University of Applied Sciences (HVL), a large project dealing with the organisation of research ethics is now underway. The project is a response to the criticism levelled at higher education institutions in 2021 by the Office of the Auditor General of Norway for having inadequate systems for safeguarding research ethics.  
 
Anne-Mette Somby, head of research ethics at HVL, notes that two faculties have already established their own research ethics committees. Whether all faculties at HVL should have an approval committee is a pertinent but as yet unanswered question. 
 
‘In the project, we want the faculties to have autonomy when it comes to finding solutions that are suitable for their academic environment’, she says. 
 
The School of Business Economics at the Norwegian University of Life Sciences is one of the institutions following developments and hoping that the university will soon appoint its own committee for the prior approval of research. 

Avoiding the red tape 

Lars Jacob Tynes Pedersen heads the committee at NHH. He believes it is important to stress that contacting the committee is voluntary. The extent of application processing also varies from project to project. 
 
‘This should not entail the unnecessary bureaucratisation we are seeing in the United States. It must be driven by demand, and not thrust down people’s throats.’ 
 
‘Do you think that, in the long term, such arrangements could lead to it becoming mandatory for institutions to have their own ethical approval committees?’ 
 
‘I would turn that on its head and say that it’s actually a result of trends we are seeing internationally, and to an extent nationally, with various requirements for explaining the handling of data and research ethics. These requirements exist regardless of what we choose to do. If anything, we are perhaps slightly ahead of the curve.’ 
 
Erik Øiolf Sørensen supports Pedersen’s view. 
 
‘I think it’s strange that it’s not even more widespread’, he says.  

Maintains call for new law 

Jostein Hallén at the Norwegian School of Sport Sciences does not want to leave the question to be settled by the individual institutions – he wants the authorities to remain involved. He would like to see a separate law which is almost an exact replica of the Health Research Act, but aimed at all research on human subjects. 
 
‘The legislation should stipulate that no institution can conduct research on people without first undergoing an independent ethical assessment’, he says. 
 
He is not quite clear on exactly what requirements should be set for the organisation of an ethical assessment. However, he is convinced that it will take very little to create a workable piece of legislation that does not trigger complaints about complicating the situation. 
 
‘On the contrary, it would be a law that could be used to raise awareness in the context of both teaching and research – and that would make Norway a better place for research participants’, he believes. 

No barrier in University and University Colleges Act 

According to the Ministry of Education and Research, the University and University Colleges Act allows higher education institutions to set up their own committees to safeguard research ethics. 
 
The Research Ethics Magazine put several questions to the Ministry, including in relation to knowledge about institutions setting up their own approval bodies and any response to this. We also asked whether the Ministry envisages alternative solutions. 
 
In an e-mail, the Ministry stated that researchers and research institutions have a statutory responsibility to ensure that all research is conducted in accordance with recognised research ethics norms. 
 
The Ministry added the following: ‘We also have academically independent ethics committees that advise and draw up guidelines for good research ethics. However, the University and University Colleges Act also provides for higher education institutions to set up their own committees to safeguard research ethics.’ The Ministry stipulates that this must take place within the legislative framework. 

Various possible solutions 

The National Committee for Research Ethics in the Social Sciences and the Humanities (NESH) and the National Committee for Research Ethics in Science and Technology (NENT) are two of the independent ethics committees referred to by the Ministry. The committees’ secretariat heads say that they regularly receive requests for approval of projects. 
 
‘But we can only advise, not grant approval’, points out Vidar Enebakk from NESH. 
 
Like the Ministry, the secretariat heads note that the research institutions have overall responsibility for ethics. There is therefore no national control function in these areas. 
 
‘The institutions themselves must devise procedures for dealing with this responsibility. Establishing an IRB could be one of several possible solutions’, says Thomas Østerhaug from NENT. 
 
Nevertheless, FEK recognises the need to assist the institutions and work on a guide that outlines the different ways in which the institutions can fulfill their responsibilities.