Mission creep: Is it leading IRBs astray?

How much oversight for QI activities?

Expert offers suggestions for handling issue

The problem of how to handle quality improvement (QI) projects resulted in a research project that explored the intersection between research and quality improvement and ethical oversight.

"When you engage in data-based improvement activities, which are keeping track of what is going on and changing an improvement, you use a lot of methods that look very much like research," says Mary Ann Baily, PhD, Associate for Ethics and Health Policy at The Hastings Center in Garrison, NY. Baily made a poster presentation titled "The Role of IRBs in Ethical Oversight of Quality Improvement Activities," at the 2005 Annual Human Research Protection Programs Conference, sponsored by the Public Responsibility In Medicine & Research.

QI activities may have elements in common with research, so there is uncertainty about whether they require IRB review, Baily says.

IRBs and research institutions could establish policies for deciding which activities are QI and which are human subjects research, requiring IRB review. One first step to establishing these policies is to define quality improvement, Baily says. "Quality improvement is systematic data-guided activities, designed to bring about immediate positive changes in the delivery of health care in particular settings and through a wide variety of methods."

QI might look like a type of practical problem-solving, an evidence-based management style, and the application of a theory-driven science of how to bring about organizational change, she adds. On the other hand, research could be defined as a systematic investigation, including research development, testing, and evaluation, that is designed to contribute to or develop generalizable knowledge, Baily says.

Participation in research is optional, whereas participation in QI is not completely optional, she adds.

The Hastings Center, with a grant from the Agency for Healthcare Research & Quality, convened a multidisciplinary group of experts to compare and contrast three kinds of closely related activities: clinical adaptation and innovation, quality improvement, and research. The group reviewed and analyzed the accepted ethical requirements for research, taking note of to what extent they applied to QI, and drew conclusions about the type of ethical review and oversight that made conceptual sense for QI, she says.

The key conclusion is that QI requires ethical oversight, but the differences between QI activities and research justify different ethical requirements for QI, Baily says. "While QI is data-guided and has methods that are not unlike research, it fundamentally is an integral part of normal health care operations to make health care work," she says.

The current IRB process is not well-suited to the structure of QI activities, Baily adds.

The problems with having IRBs review quality improvement projects is that the IRB process has high transactions costs and it does not fit the structure of many QI activities, Baily says. An institution that requires an IRB review of QI activities creates a disincentive for systematic monitoring and evaluation of change, Baily says.

Rather than sending QI activities to the IRB for review, it would be better to bring protection of human subjects of QI into the accountability system for clinical care, Baily notes. This can be done through the development of a QI oversight system that is an integral part of ethical oversight of clinical practice and which matches management and supervision appropriately to the ethically relevant characteristics of the QI activity.

"There is more flexibility in the human subjects protection system than is sometimes recognized in the field, and OHRP encourages IRBs to specialize in the kinds of research they mostly see," Baily explains.

Consent requirements should be different for QI activities. For instance, a consent to inclusion in minimal risk/harm QI activities could be part of the consent to treatment, Baily says.

In establishing ethical oversight for QI activities, it is wise for an institution to provide guidance on ethical requirements and to establish an accountability structure with internal QI accountability categories, Baily says.