Cami Gearhart Image

by Cami Gearhart

Letter from the CEO: Is it time to get rid of IRBs?

Letter from the CEO (Spring 2015)

Institution Bulletin vol 5, issue 2

Is it time to get rid of IRBs? In a recent New York Times editorial, Dr. Carl Elliott of the University of Minnesota describes IRB review as an “antiquated” and “inadequate” system that should be replaced by a “full-blown regulatory system.” Dr. Carl Schneider of the University of Michigan, whose book “The Censor’s Hand: The Misregulation of Human-Subject Research” was just released, states in an on-line interview that IRBs were fundamentally misconceived and “cannot be expected to make decisions well, for they lack the expertise, ethical principles, legal rules, effective procedures, and accountability essential to good regulation.”

This isn’t the first time IRBs have been criticized; complaints about IRBs have existed as long as IRBs themselves.  Nevertheless, these complaints should not be ignored. The nature of ethics review makes our programs especially vulnerable to lack of funding, overwork, and pressures from fellow academics. We should heed cries from the community that the system is not working.

At Quorum Review we strive to be part of the solution. If and when it makes sense for your institution to outsource some or all of your IRB review obligations, we are committed to supporting you with a high quality review, a strong regulatory team, and multiple quality control and compliance processes.

To help advance the work of your ethics board, today’s newsletter focuses on pediatric research. One article discusses assent by children, one provides tips for obtaining parental permission, and our new toolkit provides proposed template assent language. I hope you find these articles useful, and we look forward to an opportunity to work with you further!