Thursday January 8, 2009
"Checklists Controversy"

Dr. Richard Savel and colleagues are publishing an important paper (in next month's Critical Care Medicine journal) on the controversial topic of projects that have components of both Quality Improvement (QI) and Human-subjects research (HuSR).

Background of controversy: Dr. Peter Pronovost and his group at Johns Hopkins have been at the forefront in the academic analysis of the use of checklists in the ICU in an attempt to improve outcomes. In an analogous—albeit much larger—study, this same group worked with the Michigan Health and Hospital Association to implement checklists in ICUs throughout that entire state (the Keystone Project). Despite a couple of articles in media espousing the use of checklists in the ICU, the Office for Human Research Protections (OHRP) announced the termination of any further data collection involving the Michigan Keystone Project. OHRP claimed that by not obtaining explicit Informed consent (IC) from each patient and provider involved in the project, the Hopkins researchers had violated fundamental scientific and ethical research regulations.

What is an institution to do when a project has components of both QI and HuRS? Dr. Savel's group has made the following 3 middle-ground recommendations:

1) OHRP must develop new ways to help institutions streamline the approval process of QI/HuSR by designing and developing structured criteria as to what constitutes “impracticability” of protocols without waivers of consent and “minimal risk” to the subjects, as well as providing some guidance for multicenter QI/HuSR projects like Keystone (including an explicit policy for central IRB approval of such projects).

2) More institutions should have formal processes within their IRBs to rapidly and safely evaluate QI/HuSR, with the goal of improving patient safety, making the approval process less onerous and more efficient, while at all times protecting the rights of the individual patient.

3) Hospitals too small to have their own IRBs should be allowed to use IRBs from predetermined designated nearby regional centers of excellence.

Richard H. Savel MD, FCCM is an Asssociate professor of Clinical Medicine, Albert Einstein College of Medicine [in application] and Medical co-director, surgical intensive care unit at Montefiore Medical Center in NYC.

He is also SCCM's associate editor for podcasting and podcast host.


Source:

Critical care checklists, the Keystone Project, and the Office for Human Research Protections: A case for streamlining the approval process in quality-improvement research - Crit Care Med 2009 Vol. 37, No. 2, - Feb. 2009