Ethical approval, laws and publication of caring science in the Nordic countries

Abstract

Over the past decades, all countries that have a developed structure of scientific research within health care have established human research ethics review systems. There are great variations between the comprehensive centralised government-based systems, for example, in New Zealand and the Nordic countries, and more localised systems, for example, in Australia and the USA. In all of the Nordic countries and also internationally, we have laws guiding the process of approval of scientific research and regulating the work of the research ethics committees. These laws have been in use for some years now and are affecting the practice of ethical approval of research studies. In short, problems arise when the laws of the respective countries state that certain studies must be reviewed by the review boards, while such a review is not mandatory for other studies. The aim of this editorial is to highlight some problems concerning ethical approval and publication of research findings within caring science. To some extent, it is a reflection on the difference between teleological and deontological ethics, or what Ricoeur 1 refers to as ethics and morality. He argues that ethics is the aim of an accomplished life, while morality is the articulation of this aim in norms. Or put differently, ethics constitutes what is good, while morality is that which imposes itself as obligatory, and as such, ethics has primacy over morality. As pointed out by Ricoeur and so many others both before and after him, a rule is always at risk of starting to work against its own purpose. The praxis that has come out of the judicial regulation of the ethical approval of research, we argue, is to some extent contradictory. It is now rather common that authors submitting a manuscript of an empirical study (involving participants) argue that ethical approval is not necessary according to the law and that they therefore not have submitted the study to an ethical committee. At the same time, the authors argue that they have followed the Declaration of Helsinki 2. One problem here is whether the review board itself has made the conclusion that the study does not need ethical approval according to the law, or if the authors themselves have made this assumption. If the authors themselves have made this assumption, it is clear that the law becomes an obstacle to its own intention. Furthermore, it does not seem logical to claim that the Declaration of Helsinki is followed, as it clearly says that ‘The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins’ 2. Researchers are here in a dilemma that resembles the ‘catch 22’. The Declaration of Helsinki says that the study protocol must be reviewed by an ethical committee, but the law in the country in which the study is carried out says it is not necessary, and in the worst case, scenario the ethics committee will not review it. If the researchers then carry on with the study not reviewed by an ethical committee, they will not be able to publish according to the COPE guidelines 3 and the Declaration of Helsinki which states that ‘Reports of research not in accordance with the principles of this Declaration should not be accepted for publication’ 2. However, caring science research is clearly not medical research, and as such, it does not automatically fall within the scope of the Declaration of Helsinki. This is true, but do we not all as researchers within the field of health care have the same obligation to protect the research subjects from harm? We as editors think we do, and furthermore, we want to follow the COPE guidelines that demand ethical approval 3. How, then, can we get out of this ‘catch 22’ situation? The problem is of course not the Declaration of Helsinki, but rather the national laws that do not require nonmedical research within health care to be reviewed by a research ethics committee. This has led to a practice where the committees sometimes refuse to review the protocol with the argument that this is not their mission according to the law. This is in our opinion a rather confusing situation where the intention of the ethical code is to some extent contradicted by the law. It is even more confusing as different ethical committees make different decisions. It is not uncommon when reading a journal that one study is approved and the other is not approved by a research ethics committee, even if the studies are similar. One way for researchers to get out of this dilemma is to get a review of the research protocol by another research ethics committee that is not appointed under the law. A French study 4 reports similar problems with medical research in France, where some medical research is not reviewed under the law but when submitted to an international journal, the editor demands ethical approval according to the Declaration of Helsinki and the COPE guidelines. The solution that the authors suggest is to refer studies that the ‘legal’ ethics committee will not take on for review to a scholarly ethics committee other than that acting under the law, that is, a university hospital ethics committee or a research ethics committee connected to a university education programme. It is vital to stress that ethical approval alone is no guarantee for good research ethical practice – the judgment of the researchers and the research community will always be of utmost significance. The Scandinavian Journal of Caring Sciences aims to maintain a high ethical standard, and this effort relies on the authors, the referees and of course on the editors of the journal. As a help in this joint effort the publisher, Wiley Blackwell has issued best practice guidelines on publication ethics 5 which rely on the Declaration of Helsinki and the COPE guidelines. According to the recent review of the journal by COPE, we have made ‘Ethical approval’ a mandatory heading (see author guidelines) in research studies reporting on empirical research. This was carried out to make the process of ethical approval more transparent both to referees and readers.