From publication ethics to big-time research ethics scandal in Germany (Now with addendum)

Today, the eminent Retraction Watch blog reports about a scandal of mind boggling proportions in biomedical research, where German medical researcher Joachim Boldt has been found to have in various ways severely misconducted his research projects, and now faces the possible retraction of over 90 articles. Yes, ninety! I will not elaborate the publication ethical implications of this scandal or the rather grave research fraud underlying it, as this is done nicely by Retraction Watch themselves, with the aid of apt comments by Udo Schuklenk at his Ethx Blog.

However, the case has some really serious implications regarding how research ethical review works (or, rather, not works) in the Germany otherwise known for its Weberian tradition of to-the-letter rule of law. This since quite a number of the retractions are based on that Boldt has apparently conducted a great number of clinical studies and trials without the required research ethical approval or oversight. For you laypeople, this means that he has performed medical experiments with uncertain consequences on people (several or most of which most likely patients) without any sort of external review of risks and benefits, informed consent and all those things one imagines that Germany of all countries, for evident historical reasons, would be very, very, very picky about.

Apparently, judging by this joint statement by the German medical board overseeing the case, despite required by law to have a so-called internal review board (IRB) approval for the studies underlying 98 articles by Boldt, such approval has not been in place. This cannot but imply (almost a too weak word to use for signaling the strength of the inference here) that the German system for research ethical review is in a mess so bad that it would need to be thoroughly revised from the root up. For, what this means is that, evidently, there is no control whatsoever (such as submission of a signed IRB protocol documenting the approval) in the German health care or medical research system of whether or not researchers who claim to have such approval really have it (and, believing Udo Schuklenk, most journals seem to apply a similar slack practice). Even worse, it may even be the case that the question of approval is not even asked. German authorities have their work cut out for themselves, indeed.

Addendum on 2011-02-05:
Having spent this "morning after" browsing for good publications and presentations on German research ethics regulation, I have found one by Deutsch that is five years old. An easy-to-read, though incomplete, overview is found at the Privireal website and a very fresh work through is found in this report from the European Forum for Good Clinical Practice (EFGCP). From these, it appears that while made mandatory by law, the German research ethical review process is, in all practical respects, an internal affair for universities and/or clinics with use of the Helsinki Declaration as only guide. Moreover, since there apparently is no appeal process, it would seem that there are no sentences attached to the regulation. In other words, Boldt cannot be punished. This is a way of organising the activity that is pretty common, although not in my own country (where there is an elaborate and detailed law, independent review boards run as sections of a central public agency, opportunity for appeal, as well as specified sentences for non-compliance). Now, one lesson to learn from the Boldt case is that the whole idea of having research ethical review organised as an internal university business is a misnomer – conflating actual ethics review and oversight with the age-old practice of academic peer review. Adding a law that mandates (as in Germany) such peer review does not help much, if no sentences and clear and fair processes statutes are attached. That is, what German authorities should seriously consider is to break off the research ethics review organisation entirely from the academic and health care organisation – thereby creating the evident need for statutes requiring university, hospital and clinic heads to give the go ahead to clinical research only after having been presented with a research ethical review protocol that OK's the study. In view of the Boldt case, this would seem to be the minimum of required changes needed to be implemented rather rapidly.