Project Summary
The Ethics of Improving Health Care Quality & Safety
September 2002 – September 2006
Lead Investigators Mary Ann Baily, Bruce Jennings (Center for Humans and Nature)
Project Consultants: Joanne Lynn (The RAND Corporation), Melissa Bottrell (National Center for Ethics in Health Care of the Veterans Health Administration)
Funder: Agency for Healthcare Research and Quality
Purpose
To study the ethical issues raised by the use of quality improvement methods in health care, in order to build a consensus on how to manage QI activities so that valuable improvements can be achieved while at the same time patients affected by QI activities are adequately protected from harm.
Products
The Ethics of Using QI Methods to Improve Health Care Quality and Safety, by M.A. Baily. M. Bottrell, J. Lynn, B. Jennings. A special report to the Hastings Center Report 36:4, July/August 2006, S1-S40.
Health Care Quality Improvement: Ethical and Regulatory Issues, ed. B. Jennings, M.A. Baily, M. Bottrell, J. Lynn (Garrison, N.Y.: January, 2007). A volume of papers commissioned for the project.
“The Ethics of Using Quality Improvement Methods in Health Care” by Joanne Lynn, MD; Mary Ann Baily, PhD; Melissa Bottrell, PhD, MPH; Bruce Jennings, MA; and others. Annals of Internal Medicine, May 2007, Vol. 146, No. (9), 666-673.
Key Issues
One effective way to bring about urgently needed improvements in the quality of American health care is through the methods of QI, a term that refers to a broad range of systematic, data-guided activities designed to bring about immediate improvements in health care delivery in particular settings.
QI raises ethical issues because attempts to improve quality may inadvertently cause harm, waste scarce resources, or affect some patients unfairly.
Ethical issues also arise because some activities using QI methods are being considered research that comes under ethical and regulatory requirements governing human subjects research, including review by institutional review boards (IRBs). Evaluating QI activities under research regulations can cause substantial delays, costs, and conflicts.
Uncertainty about the requirements for ethical conduct of QI and the relationship of QI to the federal research regulations is serving as a disincentive for engaging in QI.
Lessons and Findings
QI requires oversight to ensure that it is conducted ethically.
Significant differences between QI and research justify somewhat different ethical requirements for QI and a different approach to oversight.
QI is an integral part of normal health care operations, closely linked to the actual implementation of change in the setting in which it occurs, whereas research is a distinct knowledge-seeking enterprise.
Participation in research is optional, whereas patients and health care providers have a responsibility to participate in QI, provided specific requirements for ethical conduct of QI are met.
The current IRB process is ill suited to the structure of QI activities.
Managing the quality of care (and the quality of QI) is a core professional and management function. Therefore, rather than “exporting” QI to the IRB-based human subjects protection system, protection of human participants in QI should be "imported" into a transformed system of accountability for clinical care.
A QI oversight system should be an integral part of ethical oversight of clinical practice and appropriately calibrate supervision to the context and ethically relevant characteristics of the QI activity.
Through demonstration projects, organizations engaged in QI should cooperate to develop models of internal management of QI that include policies and practices designed to ensure that QI is conducted ethically.
Procedures for ensuring that health care organizations are held accountable for having such internal policies and practices should be incorporated into the overall system of accountability for the quality and safety of health care.
Some (but not most) QI activities involving human participants are also research activities that require IRB review under current human subjects protection regulations.
To accommodate these "overlap activities," the existing flexibility in the research regulations should be used to develop specialized IRBs with review processes adjusted to match QI requirements.
Identifying the QI activities that fall into this overlap category is currently a major source of confusion.
Publication does not distinguish QI from research because QI can produce insights that are useful to others and should be shared through publication and other means (just as case examples, success stories, and cautionary tales produce insights and are published without being research).
QI practitioners and members of the research ethics community should work together in consultation with OHRP to develop practical rules for identifying the overlap activities that require IRB review.
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Last Updated: 10 May 2007