In general, quality improvement programs should be considered "an intrinsic part of good clinical care" and carried out under separate, less stringent rules and consent guidelines than those governing human subject research projects that require patient consent and institutional review board, or IRB, oversight, according to a nine-page article, "The Ethics of Using Quality Improvement Methods in Health Care" published online today on the Web site of the Annals of Internal Medicine.
The article is a summary of work that began in 2003 when the not-for-profit Hastings Center, Garrison, N.Y., convened a group of healthcare experts to discuss the ethical issues involved in quality-improvement efforts. The sessions led to the publication last summer of a 40-page report on the topic.
Research for the report and today's article was performed under a grant from the federal Agency for Healthcare Research and Quality at HHS. The Hastings Center publishes two journals on healthcare policy and oversees research in bioethics involving care and decisionmaking at the end of life, emerging technologies and public health.
The quality improvement ethics project addressed three questions:
- What is quality improvement and what is its role in healthcare?
- What ethical requirements should quality improvement activities meet?
- What arrangements are needed to ensure ethical conduct of quality improvement?
The definition of quality improvement stated in the article is fairly straightforward: "The group defined QI as systematic, data-guided activities designed to bring about immediate improvements in healthcare deliver in particular groups."
Less obvious is the conclusion that the group reached that ethical behavior in quality improvement is a swinging door that obliges patients as well as clinicians to participate in QI programs. As an extension of that obligation, specific patient consent need not be obtained for providers to use patient information for routine quality improvement analysis, the authors said.
The researchers wrote that: "Because QI activities are, and should be, part of normal healthcare operations, patients also have a responsibility to participate in quality improvement, which often requires direct cooperation (for example, permitting collection and use of data about their medical conditions, treatment and outcomes).
"A patient who will not be involved in QI constrains the efforts of that care system to improve itself and thereby jeopardizes the very benefits sought. The interest of patients in receiving reliable high-quality healthcare depends on all patients cooperating with QI activities. Hence, the responsibility to cooperate need not turn on whether the particular patient directly benefits from a particular QI activity (although this is often the case); rather, it is justified ethically by the benefits each patient receives because all are cooperating in the overall QI enterprise. Reaping the benefits of the QI enterprise without participation would be unfair."
But, the authors conclude, patient participation in quality improvement efforts should be contingent upon their being "kept safe from harm and from violations of their rights. For example, patients should be able to count on the confidentiality of their personal health information and on the opportunity to choose whether to participate in a QI activity that exposes them to more than minimal incremental risk (measured relative to the risks of medical care)."
The authors, however, make a marked distinction between quality improvement and research.
"The ethical responsibility to cooperate with QI activities contrasts with the fundamental ethical claim that research is voluntary," they wrote. "Healthcare organizations have no ethical responsibility to do research, and every person is entitled to choose whether to be a research subject. Research ethics springs from society's conclusion that the interests of researchers often conflict with those of subjects and that research is conceptually distinct from healthcare delivery. A person's decision to be a subject in research must be voluntary and fully informed to prevent exploitation. To ensure that researchers meet their ethical obligations to human subjects, representatives of the relevant community (IRBs) should review the design, sample, informed consent process and risk-benefit relationship of most research projects involving human subjects. In contrast, QI generally aligns with patients' interests, presents lower risks than continuing with usual care (and certainly less risk than making the same changes without collecting data to monitor its impact), demands the participation of all to be effective, arises from a responsibility of professionals and patients alike, and has no history of ethics scandals. It is appropriate, therefore, that the ethical management of QI should be accomplished through processes and social arrangements that differ substantially from those designed to protect human research subjects."
Routine consent by patients for "minimal-risk QI activities" should be incorporated in the patient's consent to receive treatment, the authors note. Patients should be specifically asked for informed consent for a QI program "if the activity imposes more than minimal risk," they wrote.
The authors conclude a formal IRB structure is both unnecessary and too unwieldy for regular quality improvement efforts. Instead, they opted for "social arrangements" that now hold healthcare professionals responsible for quality of care "should also ensure that they meet requirements for the ethical conduct of QI."
Ethical rules unclear
The authors note that while identifying a QI project is fairly straightforward under their definition, deciding which projects also are covered by HHS' "common rule" protections for human subjects research, "is more challenging."
"Currently, the ethical rules for QI are not clear, and the situation is confusing," the authors said.
At the same time, when pressed for guidance, the Office for Human Research Protections at HHS has "repeatedly interpreted the category of research as inclusively as possible," forcing many QI project directors, out of self-defense, if nothing else, to default to IRB protocols.
To alleviate the restriction that forces many QI projects into the IRB environment, the authors proposed the category of research under the common rule to be "interpreted to comprise activities that are designed to increase enduring knowledge about the nature and function of human beings and their environment," criteria that most QI projects, which are of local scope and impact, would not meet.
The authors also called on the OHRP to encourage organizations to "develop new models of internal management and supervision of QI and of QI-human subjects research overlap projects."
Deborah Peel, a psychiatrist and the founder of the Patient Privacy Rights Foundation in Austin, Texas, disagrees with the basic premise that patients' disclosures under QI is benign, or that consent should be a foregone conclusion, or obtained in the manner outlined in the article, along with consent to treat, which Peel deemed coercive.
"The tone is in no way persuasive; it is essentially a demand," she said. From a privacy standpoint, "quality improvement is actually more dangerous than research," Peel said. "At least researchers have some kind of inculcation of having to explain what they are doing to obtain consent. But here's the thing; it's very simple. Nobody, in the vast majority of situations, should be able to get records without consent. That's just it. Everybody has to make their case. There is nothing in the AMA code of medical ethics that says that people doing quality improvement should be able to look at people's records without their consent. Just like legitimate researchers, just like a new physician, anyone who wants to look at your records should ask you. If you think they are important issues, then I'm sure you would say yes.
"I don't think Americans know virtually anything at all about quality improvement," Peel said. "What this proves is the fact that there is going to be a nonending parade of people who think they have a very good reason to access your medical records."
Lead author Joann Lynn is a former senior natural scientist with the RAND Corp., and a physician with a medical specialty in geriatrics. Lynn said allowances can be made for objectors, but she doesn't expect there will be many.
"If the doctor and that office decide they are going to tackle waiting times, they don't have to come back and ask you if they could use your waiting time to tackle the problem," Lynn said. Consent for routine QI should be, "whatever the level of consent is for treatment, but it should be widely understood that whatever the current uses of existing data, it should not require special consent. If it's one patient in 10,000 (who objects) you can make accommodations for it. But people should expect that your care delivery system should get better. I think people in very large numbers would agree they would want their care experiences used to improve care.
"What we're saying with QI is there needs to be supervision of QI," she said. "It's not carte blanche. But in the sense that QI is intrinsic to good practice, it should be regulated in the same way that clinical practice is. It should be in the ordinary supervisory change and should not be seen as separate from getting good healthcare."What do you think? Write us with your comments at [email protected]. Please include your name, title and hometown.