Year:    2010

Author:    von Kielmansegg, Sebastian Graf

Die Verwaltung, Vol. 43 (2010), Iss. 2 : pp. 195–216

Abstract

Biomedical research involving human beings is a practice regulated by law and subject to a preventive control mechanism. As part of this mechanism, each clinical trial and each principal investigator (Prüfarzt) have to be reviewed by an independent ethics committee. In particular, clinical trials on pharmaceuticals may not be started until the relevant ethics committee has issued a favourable opinion.

One of the legal problems arising in this context is how to deal with principal investigators who have violated the relevant legal rules on good clinical practice, e.g. by manipulating trial data. Does an ethics committee have the right (or even the duty) to object to a principal investigator because of such violations in earlier clinical trials, or to withdraw its favourable opinion because of violations in the course of an ongoing trial? Under German statutory law, an ethics committee is required only to consider the principal investigator's professional “qualification“ but not his “reliability“. Nevertheless, the principal investigator's readiness to comply with the rules on good clinical practice is legally relevant because the ethics committee can deny a favourable opinion when the legal requirements are in danger of not being fulfilled. Such danger can be assumed if there are serious, fact-based doubts about the principal investigator's readiness to comply with these requirements. Such doubts, in turn, can be based upon former violations while conducting clinical trials; in other words, former violations indicate a danger of further infringements. Yet, it depends on the circumstances of the individual case whether this danger is sufficiently substantial to regard the statutory requirements for the clinical trial and the principal investigator's participation as not being fulfilled. Moreover, a mere suspicion of former violations as such cannot establish a sufficient danger unless it is the subject of criminal proceedings.

Finally, even if these conditions are fulfilled, the principle of proportionality has to be respected; in particular, the principal investigator may only be rejected if it seems necessary for the prevention of further violations. Again, this depends on the circumstances of the individual case. Alternative means to be considered would be, for example, formal reprimands or intensified inspections and similar interventions by the competent state authorities and the sponsor of the clinical trial.