In the May 1, 2008 issue of Nature, Alison Abbott reports on fraud allegations against Austrian researcher Hannes Strasser for performing an adult stem cell trial for urinary incontinence without having his protocol reviewed by an ethics committee.
According to the story, the volunteers paid approximately $17K U.S. to enter the study. They also were not told the procedure was investigational. The researchers might also have lied to their ethics committee, as well as Lancet (where they published the results). There also appear to be questions about whether the promising results obtained by Strasser are reproducible.
Of course, the allegations have yet to be proven. But the story will sound familiar to anyone that has followed the history of gene transfer- and indeed any cutting edge research area. The allegations highlight a key point I make in my book: part of what makes risk assessment at the medical frontier difficult has to do with the mercurial individuals and institutions– and the unstable relationships among various interested parties– that surround high-risk, high-payoff research. These “social” components of risk need to be par of the equation when policy makers, ethicists, and others evaluate the ethics of a study. (photocredit: DisneyKrazie 2007)