Here's how the Johns Hopkins and OHRP controversy unfolded
One complaint set it in motion
It all began when investigators published a study that had good news for the infection control industry.
Investigators at Johns Hopkins University (JHU) of Baltimore, MD, studied a quality improvement project that used an infection control checklist at 67 Michigan hospitals. The study was funded by a grant from the Agency for Healthcare Research and Quality. The goal was to reduce catheter-related infections in intensive care units.1,2
JHU investigators wanted to build on past literature regarding the successful use of routine infection control practices to reduce infections among hospitalized patients.
For example, each of the items on the checklist was based on infection control literature, showing efficacy, and they included such simple procedures as having clinicians routinely wash their hands.1,2
The research ultimately showed that the checklist was a simple way to dramatically reduce catheter-related infections.1,2
Someone who had read about the study's results in a 2006 issue of New England Journal of Medicine complained to OHRP that investigators had not sought IRB review.
This set in motion the OHRP investigation, ultimately resulting in confusion among the hospitals where follow-up data still were being collected. JHU investigators found that their follow-up data collection was put on hold until OHRP was convinced that all necessary human subjects protection measures had been taken.
Then on Dec. 30, 2007, The New York Times published an op-ed story by Atul Gawande in which he chastised OHRP for its "bizarre and dangerous" decision to shut down the QI program at Michigan hospitals.
OHRP responded to The New York Times article on Jan. 15, 2008, with an e-mail statement, saying that the agency had not prohibited Michigan hospitals from implementing the infection control checklist for QI purposes.
"At the same time, if institutions are planning research activities examining the effectiveness of interventions to improve the quality of care, then the regulatory protections are important to protect the rights and welfare of human research subjects," OHRP officials wrote in the e-mail statement.
OHRP sent separate letters to JHU and the Michigan Health & Hospital Association of Lansing, MI, on Feb. 14.
In the letter to MHHA executive director Brian Peters, OHRP Director Kristina C. Borror, PhD, writes that OHRP acknowledges that no federal funds support the continuation of the quality improvement research initiative at the Michigan hospitals.
Borror also says that the Michigan hospitals do not need to obtain IRB approval because the research activities no longer involve human subjects and because there is no federal funding involved.
"If you still wish that IRB review and approval be obtained before continuing these activities, we note your desire to go above and beyond the regulatory requirements in this case," Borror writes.
In the letter to Daniel E. Ford, MD, MPH, vice dean for clinical investigation at JHU, Borror notes that the principal investigator of the QI study was granted IRB approval on Jan. 4, 2008.
"However, as noted above, the activities no longer involve human subjects research," Borror writes. "Therefore, it is not a regulatory requirement for you to obtain IRB review and approval for these activities before continuing with data analysis."
On Feb. 21, 2008, the New England Journal of Medicine published two editorials about the controversy.2,3
The first opinion piece says that OHRP is wrong about needing informed consent for quality improvement research. The writers state that it is justifiable from both ethical and regulatory perspectives to waive informed consent for low-risk research when soliciting IC is not practical.2
The second editorial makes the case that by adding bureaucratic complexity to QI research, OHRP is exposing patients to more harm than benefit.3
References
- Pronovost P, Needham D, Berenholtz S, et al. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med 2006;355:2725-2732.
- Miller FG, Emanuel EJ. Quality-improvement research and informed consent. N Engl J Med 2008;358:765-767.
- Baily MA. Harming through protection? N Engl J Med 2008;358:768-769.
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