Publication of ethically suspect research: should it occur?

In this issue of International Journal for Quality in Health Care, a prospective, observational study has been published that confirms frequent error in drug administration, a now well-recognized risk to patient safety [1–3]. As a peer-reviewer, I suggested rejection of this manuscript for publication on ethical grounds as it raises a series of ethical concerns including (i) lack of oversight by a Research Ethics Board (REB) or equivalent; (ii) lack of a written informed consent procedure; and (iii) the lack of intervention by the observers when potential harms to patients were identified. These concerns raise further issues. Which jurisdictional standards should apply in the assessment of research for publication? What are the consequences of rejecting a manuscript? What are the potential benefits to publishing ethically suspect work? Research ethics oversight Many national and international standards guide the ethical conduct of human research [4–6]. All of these statements promulgate respect for the person, with a prohibition to using participants as a means to an end, and an obligation to recognize participant's autonomy through free and informed consent. These guidelines all require an independent assessment by a REB or equivalent (e.g. Article 13 Declaration of Helsinki) [4]. It would appear that failure to comply with ethical regulations frequently occurs because of 'innocent' oversight in study design by otherwise well-intentioned researchers. It is precisely for this reason that REB reviews must focus their evaluative efforts on both the science and the ethics procedures of the proposed project. It is recognized that countries may operationalize the application of the tenets of the Declaration of Helsinki to account for geopolitical and cultural context , in respecting the local needs of research participants. This study was approved by the French National Committee on Informatics Technology and Freedom (commission nationale de l'informatique et des libertés). This committee does not appear to satisfy the requirements for a properly constituted REB committee as detailed in the French Huriet-Serusclat Law (Article 1123–6) governing biomedical research. This is a serious oversight. The Declaration of Helsinki recommends to editors that 'Reports of experimentation not in accordance with the principals laid down in this declaration should not be accepted for publication'. However, the stringency with which these guidelines are adhered to have been shown to vary [7,8]. The International Committee of Medical Journal Editors (ICMJE) recommends research be conducted in accordance with the Helsinki Declaration, but do not then go on to explicitly …