Editorial: Should studies without ethical permission be published in JCN?

Authors


Late last year I chaired a symposium at an international conference at the University of Hull in Hull, UK on the ethics of conducting research with children. The conference was dedicated to this theme and the symposium was concerned with presenting different ethical positions on the involvement of children in research projects.

As a nurse researcher I take it for granted that ethical permission must be sought and obtained before conducting any study in our National Health Service. Since the advent of research governance in the UK (DoH 2001) this extends beyond patients to the inclusion of staff in surveys. However, this position may change following recent recommendations (DoH 2005). My contribution to the symposium was minimal due to my position as chair and also because my research takes place mainly at the other end of the age spectrum. I was surprised by the variety of views on the need to seek ethical permission; some of the contributions were from non-nurses. As an editor I ventured the view that we should not publish studies with vulnerable groups where ethical permission had not been obtained and I proceeded to outline my policy with papers in JCN. Essentially, my position is that all studies with patients should have ethical permission but I was prepared to consider studies involving staff that do not have such permission as the requirements were different across the world. I also pointed out that this was more or less standard across nursing journals. I thought that this was a relatively uncontroversial position and was not prepared for the reaction.

At one level I was questioned about who I was to be excluding any studies. Some of the contributors had described work with children where ethical permission and, indeed, parental consent had not been obtained for very practical reasons: the researchers did not have an ethical committee to approach and parental consent would have interfered significantly with the process of involving the children in the projects, thus jeopardising the research. Of course, the definition of children was also an issue extending beyond biological and legal grounds.

My definition of ‘vulnerable’ was also questioned, not that I had offered one. However, being forced to, I defined vulnerable people as those in our care as nurses and excluded members of the general public and staff. In the case of both groups it was my opinion that, while a full explanation of what being involved in a research project would entail was warranted and seeking consent was in order, these groups could simply refuse to participate or withdraw from studies without apparent prejudice. Where patients are concerned, while we assure them that there will be no prejudice if they do not participate, they may still feel under pressure to assent to inclusion in any study. It was pointed out to me that many members of the general public and healthcare staff may well include vulnerable people and what protection did they have? Naturally, staff may also feel under pressure to participate in research studies if the research is being conducted, for example, by a senior colleague.

Further problems were brought to my attention. For instance, in studies from Sweden it is common when explaining the ethical dimensions of a study that the authors cite the specific ethics committee and the serial number of the document giving permission. Presumably this is open to audit – although I have never felt moved to take this any further. In studies from the UK it is more common simply to state that ethical permission was obtained, perhaps referring, unspecifically, to a local research ethics committee. This is certainly not open to audit. In other cases, and from other countries, it is quite common for no mention of ethical permission to be made and I have to request that authors make a suitable statement prior to publication. But, without casting a shadow of doubt over any papers published in JCN, how can I be certain of the veracity of their statements? Finally, again outside Europe and North America, it is common for studies involving patients to have been approved by a university ethics committee and not by an independent body. Is such ethical scrutiny valid?

Therefore, I raise the above issues with the readership and authorship of JCN and I would welcome your views and, perhaps, a debate through this editorial page in the journal. Specifically:

  • •   Should it be any of my concern whether or not a study has sought and obtained ethical permission?
  • •   Should I be concerned at the type of ethical permission obtained in terms of its independence from the researcher?
  • •   Should I seek written evidence of ethical permission as part of the submission process?
  • •   Should I exclude certain types of study from the need to have ethical permission (clearly reviews and position papers already fall outside of this necessity)?
  • •   Should the ethical dimensions of any study be purely the responsibility of the submitting authors leaving them to conform to a general statement in our guidance for authors that it is expected that all studies published in the journal will have undergone ethical scrutiny?

The last thing any editor requires is more work and the last thing any researcher needs is another barrier to getting published. Nevertheless, JCN is a leading international journal for clinical nursing research and complacency about the standard of what we publish is not an option. I welcome criticism, comments and discussion of the issues raised above either privately or publicly from readers, authors and fellow editors.

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