Leader, CEIR – Center for Research on Infection Control Measures, National Institute of Public Health and Professor II, OsloMet – metropolitan university
Is the mandatory consent requirement of the Health Research Act more harmful than beneficial?
This is a discussion post. Opinions in the text are the responsibility of the writer.
The results of one of the most impressive research projects of the last year clearly shows that masks reduce the spread of infections. This is an important and useful investigation, but it would be illegal to conduct it in Norway.
The use of masks has been the subject of debate since the beginning of the pandemic. Some studies have shown that bandages can prevent the spread of infection outside the health service as well. But it is not known how big the effect is and what type of mouthpiece works best.
In the new study, researchers from the United States and Bangladesh randomly divided 300 villages into two groups. In one group, they made a massive effort to increase the use of bandages, including through free distribution to all households. In the other group, they did nothing.
And they succeeded: by observing people on the streets and in meeting places, they found that the use of masks was almost three times higher where masks had been promoted (43 percent versus 13 percent).
Did more use of face masks lead to less infection?
The tension was probably great when the researchers, a couple of months later, investigated the appearance of covid-19 in the two groups.
The difference was not very big, but it was clear:
The proportion of residents with antibodies to COVID-19 was almost 10% lower in the group with high use of bandages (0.69% vs 0.76%). Along the same lines, they also made sure to compare cloth bandages with surgical bandages. The surgical ones clearly worked better.
This study is one of the few examples of a research-based assessment of infection control measures during the pandemic around the world. The consequence of the lack of controlled trials is that we know almost as little about the effects of infection control measures now as when the crown came to the country.
A crucial obstacle
We have made several attempts to carry out evaluations of the effects of infection control measures in Norway, but they have rarely been successful. The requirement of the Health Research Law that The written consent of absolutely all participants must be obtained. it has been a crucial obstacle.
If we were to carry out the bandage study in Norway, we would have to have obtained the prior consent of each of the 300,000 inhabitants of the 300 villages. That would not be practically possible. Fortunately, the ethics committees of the United States and Bangladesh did not consider it necessary.
Although it is an important principle that participants in medical research must consent, it is wrong when the same principle is blindly applied to research on social measures. It is scary when infection control measures with uncertain effect can be implemented at the national level without a single consent, while it is illegal to introduce measures in half of the country’s municipalities if the purpose is to know if they work.
We need a public debate on the Health Research Law and whether their inalienable requirement of consent is more harmful than beneficial to the population.
Conflicts of interest: The author has never liked wearing a mask and has been skeptical about the usefulness – until now. He has also attempted several studies of the effects of infection control measures in Norway, largely without success.