Overhauling patient protections

WASHINGTON - Public and political concerns about gene therapy trials are catalyzing the first wholesale revamping of federal protections for people who participate in biomedical experiments in two decades. But until the new rules, regulations and laws take shape, the impact on cost, time, patient recruitment and drop-out rates can only be guessed.

Shockwaves from the September 1999 death of a young man as a result of a gene therapy experiment at the University of Pennsylvania, and subsequent allegations by FDA that some academic researchers had put clinical trial subjects at risk, have reverberated in Congress, the White House, FDA and NIH. While scrutiny and oversight of gene therapy research already has been intensified, the expanding political and regulatory response will affect virtually all research involving human subjects...