A group of patient and social justice advocates plan to form an Alliance for Human Research Protection to provide oversight on clinical research from laypersons' point of view, says John H. Noble Jr., a founder and professor of social justice at the Catholic University of America. He lambastes Internal Review Boards (IRBs) designed to protect human subjects as agents of institutions "who are hustling the bucks" from industry and other sources. Noble says IRBs need to be "severed from research institutions" and provided adequate resources as part of the accepted overhead costs of conducting clinical trials.

Government commitment to patient protection "without the [funding] is just a sham," he says. Greg Koski, director of the federal Office of Human Research Protections (OHRP), which grants authority to the IRBs, acknowledges that concern over IRB members' financial ties to industry can be valid. "But I don't think it's fair to call [the system] a sham," he says. "While there are legitimate reasons to be concerned about conflicts, it's also fair to say institutions have an interest in making sure things are done right. We have to work toward ensuring that conflicts do not exist."

Koski says he welcomes the creation of any group that broadens public participation in and understanding of research oversight. Comprising lay people, researchers, and ethicists, the alliance would have no regulatory authority, but its founders aim to use public censure to help enforce legal guidelines.

Bob Roehr The Scientist 15[16]:20, Aug. 20, 2001
Copyright 2001, The Scientist, Inc. All rights reserved.