What do international ethics guidelines say in terms of the scope of medical research ethics?
BACKGROUND
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. 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.


METHODS
We 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.


RESULTS
We 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.


CONCLUSIONS
There 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.
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Huispost Str. 6.131, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. r_bernabe@yahoo.com.
Rosemarie D L C
RD
Bernabe
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Huispost Str. 6.131, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
Ghislaine J M W
GJ
van Thiel
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Huispost Str. 6.131, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
Johannes J M
JJ
van Delden
D026688:Bioethical Issues; D001675:Bioethics; D035843:Biomedical Research / Q000941:ethics*; D032921:Consensus; D032984:Ethics, Research; D017408:Guidelines as Topic; D006801:Humans; D038622:Internationality
Comparison of guidelines; Ethics guidelines; Research ethics