Posted on February 14, 2011 at 4:16 PM
A German anesthetist, Joachim Boldt, has published over 350 peer-reviewed papers and is currently the target of a German medical board investigation for data manipulation, fabrication of data and failure to have human studies reviewed and approved by an ethics review board. This story began when the journal Anesthesia and Analgesia retracted a 2009 article authored by Boldt citing concerns of data manipulation. Now, after further investigation by a German medical review board, up to 90 of Boldt’s published articles are being considered for formal retraction.
Here’s more on the story from Retraction Watch: Unglaublich! Boldt investigation may lead to more than 90 retractions
Note: The Retraction Watch story refers to a joint letter posted to the websites of 11 major anesthesia journals, authored by their editors-in-chief regarding Boldt’s research, much of which was published in their 11 journals. Here is an excerpt from the letter that was included in the Retraction Watch story:
LÄK-RLP [the German medical board conducting the investigation] has reviewed 74 scientific articles describing clinical trials subject to the requirements of the German Medicinal Act. This includes the article by Professor Boldt recently retracted by Anesthesia & Analgesia and an article submitted by Professor Boldt to Anaesthesia but not published. By law these studies required IRB approval. Although the articles typically stated that IRB approval had been obtained, LÄK-RLP could not find evidence of approval for 68 of these articles.
The story on Retraction Watch notes that, in addition to these retractions, Boldt faces a fine of up to 100 000 Euros (approximately 140 000 Canadian dollars) and even jail time for conducting human research without ethics review board approval, a violation of German medical profession’s Code of Deontology (i.e., Code of Ethics).
The story notes that there is evidence that Dr. Boldt failed to obtain ethics review board approval for studies, forged signatures on copyright forms, fabricated data, fabricated clinical cases, and lied about the participation of co-authors. In fact, the claims and information suggest that Boldt’s 2009 now-retracted study never even took place at all. As a result of these claims, further investigation into Boldt’s other published research is taking place.
There are a plethora of ethical and practical problems with Boldt’s research, if even a few of the claims are found to be true. Certainly there are too many to discuss here. But what I did want to comment on is the burden placed on ethics review boards to “police” research, something most of us are loathe to do. As the story notes, upon submission to a scientific journal, researchers often are required to simply check a box to indicate that an institutional ethics review process took place. No one asks for confirmation of this. In this case, no one questioned the volume of research Boldt was producing. No one questioned the fact that Boldt was noting the use of albumin in his published studies when it hasn’t been used since 1999 in that institution. It seems no one asked for evidence or confirmation of some very basic science — something one would expect as part of a peer review process. The role of peer review, or scientific review is, to some degree, downplayed, with claims that scientists are too busy to do thorough reviews, can’t be expected to know everything in their discipline or that they certainly shouldn’t have to monitor their colleagues. Well, peer review is, in fact, about monitoring colleagues in a way that ensures the rigor and quality of information provided through research and science.
I know that I have had months in which I have been asked to do a number of scientific reviews of articles. I also know that I don’t sign up unless I know I can devote the time to doing a thorough review and not just “sign on the line” after reading it superficially or approving it for publication because it’s a smart friend or close colleague. There’s no clear evidence that those sorts of things happened in this case, but it is clear that, alongside other systemic problems, the process of scientific peer review failed miserably here.
Ethical research and ensuring ethical conduct in research shouldn’t be the sole responsibility of an ethics review board. Nor should concern with ethical research begin and end with the submission to an ethics review board. It should be an ongoing part of the entire research process, and a clear part of the research culture, embedded in professions, disciplines and institutions that fund, sponsor and publish research.