Guide for KI staff on the testing and analysis of SARS-CoV-2 in relation to research
In response to questions concerning testing related to COVID-19, the KI management and the Resource Team for Ethics have produced a guide for five areas. The guide covers testing and analysis of SARS-CoV-2.
1. It is inappropriate to researchers to study their own personnel:
There are initiatives for research projects in which parts of the study population are themselves members of the research group or the equivalent. We find it inappropriate for many reasons for researchers to include people who are occupationally dependent on them. The most obvious reason is that it threatens to undermine the voluntary nature of participation if the invitation to participate comes from someone in a superior position. It also muddies the collegial relationships. There is nothing of course wrong with recruiting study participants from within KI for a KI-based project, but researchers ought to do so outside their own group.
2. It is inappropriate to inform study participants of the results of diagnostic tests as part of a research study:
It is imperative that the boundary between research work and healthcare work is maintained. To inform someone of their test results might necessitate continued advice and medical monitoring, which as a healthcare concern should normally be carried out by a health authority. There are two problems with the IgM testing of viral infection: non-accredited IgM tests have an inadequate specificity, and a positive test result can mean that the person might have a current/recent infection, which can have repercussions on society/the workplace. Again, this is a matter for the care provider to decide, not a KI-related research issue. If as part of a project a researcher wishes to examine a test’s effectiveness, it has not by definition been proven reliable. It is then inappropriate to feed back on the results at an individual level, since the correctness of the test comes with a high degree of uncertainty. To feed back on test results in general to participants is effectively to introduce screening for the condition in question, which is a healthcare project, and a major one at that. In 2014, the National Board of Health and Welfare introduced fixed criteria that need to be met for this.
3. Research must be kept separate from healthcare and employment-related objectives:
It goes without saying that KI seeks to make a constructive contribution to an extensive COVID-19 crisis in hospitals and in the community at large. We wish, however, to emphasise that the research objectives are kept separate from purely healthcare- and employment-related objectives (such as determining whether someone is immune, fit for work, etc). If the testing of a test analysis is done for research purposes, a procedure of coded samples, withholding of results, group-level analysis, etc. should be considered.
4. Tests done as research need the approval of the Swedish Ethical Review Authority (EPM):
Just like with all other such research, a project would need EPM approval. Normally, biobank procedures are also likely to be needed, these too with the required permit and, when relevant, permits from the Medical Products Agency or other such bodies depending on the nature of the project.