Abstract
BackgroundIn research ethics, the most basic question would always be, “which is an ethical issue, which is not?” Interestingly, depending on which ethics guideline we consult, we may have various answers to this question. Though we already have several international ethics guidelines for biomedical research involving human participants, ironically, we do not have a harmonized document which tells us what these various guidelines say and shows us the areas of consensus (or lack thereof). In this manuscript, we attempted to do just that.MethodsWe extracted the imperatives from five internationally-known ethics guidelines and took note where the imperatives came from. In doing so, we gathered data on how many guidelines support a specific imperative.ResultsWe found that there is no consensus on the majority of the imperatives and that in only 8.2 % of the imperatives were there at least moderate consensus (i.e., consensus of at least 3 of the 5 ethics guidelines). Of the 12 clusters (Basic Principles; Research Collaboration; Social Value; Scientific Validity; Participant Selection; Favorable Benefit/Risk Ratio; Independent Review; Informed Consent; Respect for Participants; Publication and Registration; Regulatory Sanctions; and Justified Research on the Vulnerable Population), Informed Consent has the highest level of consensus and Research Collaboration and Regulatory Sanctions have the least.ConclusionThere was a lack of consensus in the majority of imperatives from the five internationally-known ethics guidelines. This may be partly explained by the differences among the guidelines in terms of their levels of specification as well as conceptual/ideological differences.Electronic supplementary materialThe online version of this article (doi:10.1186/s12910-016-0106-4) contains supplementary material, which is available to authorized users.
Highlights
In research ethics, the most basic question would always be, “which is an ethical issue, which is not?” Interestingly, depending on which ethics guideline we consult, we may have various answers to this question
Apart from categorizing the imperatives, we took note where the imperatives came from, and we gathered the data on how many guidelines support a specific imperative, i.e., if there is a strong consensus among the guidelines (SC; 5/5, 4/5), moderate consensus (MC; 3/5), weak consensus (WC; 2/5), no consensus (NC; 1/5), or if it is a non-guideline-based imperative (NGI; 0/5 [in the case of benchmarks in the Emanuel et al framework that do not correspond to any of the imperatives from any of the guidelines])
The stated differences expounded above in terms of level of detail, intended audience, and actual conceptual/ ideological differences among the guidelines are unavoidable limitations of this manuscript. In this manuscript, we have provided a comprehensive view of what the various international ethics guidelines for research involving human participants say
Summary
The most basic question would always be, “which is an ethical issue, which is not?” Interestingly, depending on which ethics guideline we consult, we may have various answers to this question. Though we already have several international ethics guidelines for biomedical research involving human participants, ironically, we do not have a harmonized document which tells us what these various guidelines say and shows us the areas of consensus (or lack thereof). In this manuscript, we attempted to do just that. The basic question is always, “which is an ethical issue and which is not?” It is interesting that though existing internationally-known ethics guidelines on human research somehow help, we cannot help but share Hussein and Upshur’s observations, “There are many structural similarities to these varied guidelines, but, more importantly, there is considerable variability and lack of harmonization across the globe” [1]. We gain a comprehensive picture, we get a glimpse of the work that needs to be done in reaching a consensus in research ethics
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