Abstract
BackgroundWhile the development and evaluation of clinical ethics services in Norway has been recognized internationally, the country’s research ethics infrastructure at times may have been less well developed. In 2016, media interest in the controversial nature of some health services research and pilot studies highlighted gaps in the system with certain types of research having no clear mechanisms through which they may be given due independent consideration. It is not clear that new legislation, implemented in 2017, will address this problem.SummaryWe explore relevant law, committee scope, and the function of the system. We show that 1) Norwegian law provides for ethics assessment for all forms of health research; 2) regional RECs in Norway might not have always enforced this provision, considering some interventional health services research to be outside their remit; and 3) Norwegian law does not explicity provide for local/university RECs, meaning that, in practice, there may be no readily accessible mechanisms for the assessment of research that is excluded by regional RECs. This may include health services research, pilot studies, and undergraduate research. New 2017 legislation has no effect on this specifically but focuses on institutions regulating researcher activity. This may place researchers in the difficult situation of on one hand, needing to hold to recognized ethical standards, while on the other, not readily having access to independent committee scrutiny to facilitate consistent operation with these standards.ConclusionTo support researchers in Norway and to protect the public, it may be necessary either to widen the regional RECs’ remit or to make legislative alterations that permit and do not discourage the existence of local RECs.
Highlights
While the development and evaluation of clinical ethics services in Norway has been recognized internationally, the country’s research ethics infrastructure at times may have been less well developed
In 1964, during a period of heightened debate, the UK Royal College of Physicians published a statement recommending that all human research be subject to ethics review, and the World Medical Association adopted the Declaration of Helsinki [3, 4]
Since the 2008 Act came into force in 2009, the law has been explicit that all Norwegian medical and health research on human beings, using human biological material, or personal health data, must have prior approval from one of the seven regional medical and health RECs in Norway. The system, as it was instituted in 2009, continued unchanged and until new legislation in 2017, which followed several research ethics related scandals that cast the light of the media interest and public attention throughout 2016 onto specific research studies
Summary
We have argued that in HSR and some undergraduate health research in Norway, the a priori intent is to provide new knowledge of health and disease. Regional Norwegian RECs must consider such study protocols. The effect of regional RECs declining to consider these may breed confusion, difficulty in managing ethical issues, and could risk public harm. New legislation provides mechanisms for institutional management of researcher misconduct but does not address variable interpretations of the Health Research Act and the regional RECs’ remit. We suggest it should either be made clear that assessing protocols for pilot studies and other HSR should be within the regional REC remit; or changes in legislation are needed to permit the existence of local RECs that can provide independent scrutiny in-line with international standards. Endnote 1For this paper, we define LRECs as committees convened by institutions, such as universities and hospitals, that have a composition and independence that is consistent with the Declaration, and that may or may not be independent of a larger national ethics infrastructure
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