IRBs – STREAM research

Help Wanted, Part 2

So, what are some of the intriguing ethical questions of Kolata’s August 2d article? Here is one: when researchers conduct studies and ethics committees review protocols, resource allocation is an important consideration. If, as Kolata alleges, mediocre trials siphon eligible patients away from good trials, then there is a case to be made that IRBs… Continue reading Help Wanted, Part 2

Red Tape: More IRB-bashing

Slow news day, I guess, at the New York Times. In today’s paper, American Enterprise Institute scholar Sally Satel laments that “federal ethics regulations” have become “so stringent and unwieldy that the ethics oversight system often impedes the kind of careful research we should be promoting.” And the paperwork, according to Satel, is driving up… Continue reading Red Tape: More IRB-bashing

Red Handed: An Independent Review of IRBs

A decade or so ago, the Government Accounting Office published a series of reports faulting human protections at VA hospitals, raising concerns about HHS oversight of human research, and urging continued vigilance in human research. After a seeming pendulum swing toward protections bashing (witness the outpouring of condemnation after OHRP sanctioned a team of researchers… Continue reading Red Handed: An Independent Review of IRBs

NOTES from the Underground

Surgical innovation has always been a problem for medical ethics. Surgeries are unregulated, and partly as a result, few are introduced to clinical practice having been validated in randomized controlled trials. Moreover, attempts at novel surgeries typically fly beneath the radar of ethical review, because they are viewed as innovative clinical practice rather than research.… Continue reading NOTES from the Underground