Consider informed consent issues with QI initiatives

More clarity is needed

A group of hospitals implements an inexpensive, evidence-based intervention to prevent costly, potentially fatal infections in acutely ill patients. Investigators monitor the results and find a significant improvement in infection rates that is sustained over time.

Doesn't this sound like a quality improvement "success story?" Unfortunately, government regulators shut the program down, claiming that the rights of patients and clinicians were violated.

The intervention was part of a hospital quality and safety initiative at Michigan hospital intensive care units. The program involved a five-step approach developed by a Johns Hopkins faculty member, including wearing sterile gloves and gowns prior to inserting intravenous lines.1

The study investigators used statistical methods to study the impact of the intervention on infection rates across all the ICUs. An infection control practitioner in each hospital provided the investigators with data from each ICU on the rate of infections at the beginning of the intervention, and periodically for up to 18 months after. Each of the participating hospitals used a quality improvement process, with teams working together to introduce best practices and make them routine.

In response to an anonymous complaint alleging that the research was conducted without prior approval by an institutional review board (IRB) and without the informed consent of the human subjects who participated (both patients and clinicians), the Department of Health and Human Services' Office for Human Research Protections (OHRP) investigated, and found the program was not exempt from the regulations.

Now, advocates are appealing to OHRP to rethink its policy. "We have confidence that OHRP will see that their original decision, while perhaps following the letter of the law, was formed in a vacuum — without regard for the fact that the program does not pose a threat to patients and is proven to save lives, easily and efficiently," says Karen Linscott, acting CEO of the Leapfrog Group. "A severe blow to patient safety will be dealt if decisions like this are upheld."

What is impact on QI?

There is "serious concern" over this incident among quality professionals, who are wondering about the implications for their own QI activities, says Joe McCannon, vice president at the Institute for Healthcare Improvement.

QI initiatives must be designed with ethical considerations in mind, and there are certain types of research that do need to be subjected to IRB review, with informed consent obtained.

"But there are other types of work, like the work that we do, with tactics such as checklists and other foolproofing techniques, that involve measuring and managing existing processes and trying to make them more reliable," says McCannon. "We are not introducing new medicines or technologies."

If new approaches are being tested, with different types of care assigned to different groups for research purposes, IRB review would likely be required.

"But the typical QI activity focuses on refining existing, established, evidence-based best practices and making sure those practices are done more reliably," says McCannon. "Those activities don't need to be subject to that type of review."

According to OHRP, if any hospital or ICU decides to implement the use of checklists or other measures only for the reason that it believes those measures will improve the quality of care provided, they may do so without consideration of the regulations for the protection of human research subjects. (To access the announcement, go to
ohrp. Click on "OHRP News" on the left and under "Recent Announcements" select "January 15, 2008.")

OHRP says the regulations do not apply when institutions are only implementing practices to improve the quality of care, but if institutions are planning research activities examining the effectiveness of interventions to improve the quality of care, then the regulatory protections do apply, to protect the rights and welfare of human research subjects.

"OHRP hopes to close this case in the near future," says Ivor A. Pritchard, MD, OHRP acting director. "We recognize that some people in the field are having difficulty determining when the regulations apply. We are working hard to develop ways to clarify when the regulations apply and when they do not."

Clearer guidelines are needed for human subjects review and informed consent is necessary, says McCannon. "The fact that OHRP has taken this action is making people stop and say, 'Let's try to be more clear about when stringent review of QI activities is necessary, and when in fact, it's not necessary and can freeze or slow down the pace of important work," he says.


  1. Pronovost P, Needham D, Berenholtz S, et al. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med 2006;355:2725-32).

[For more information, contact:

Joe McCannon, Vice President, Institute for Healthcare Improvement, 20 University Rd., 7th Floor, Cambridge, MA 02138. Phone: (617) 301-4800. E-mail:

A report on the Ethics of Using QI Methods to Improve Health Care Quality & Safety can be downloaded from the Hastings Center web site ( Click on "Publications," "Special Reports" and scroll down to the report title.]