Data collection at point of care: Does project require IRB approval?
Requirements seen by some as overly burdensome
There is a need to observe how care is delivered and to make improvements on the basis of what is learned, underscores Mildred Z. Solomon, EdD, president of The Hastings Center in Garrison, NY. "In the United States, we've finally awakened to the fact that in order to improve health care, we have to study it," she says.
U.S. health care is twice as expensive as health care in other developed nations, says Solomon, "yet our quality is poorer, our medical error rates unconscionable, and disparities in access and utilization unacceptable."
Solomon believes that clinicians need guidance from bioethicists with expertise in research ethics on how to apply the current regulatory framework to quality improvement (QI) research, comparative effectiveness research (CER), and implementation science.
Solomon would like to see a set of research protocols analyzed and discussed and organized into a casebook with guidance from bioethicists as to the nature and extent of oversight each type of protocol requires.
"Working from particular protocols from the ground up would also test whether fundamental changes in the regulations need to be made, or whether people simply need to be helped to apply existing regulations with greater flexibility and nuance," she says.
QI researchers want to make things better, but it's unclear what kind of oversight is needed, says Solomon. For example, researchers may want to identify the best way to motivate patients with hypertension to adhere to their prescribed medications. "It's well known that a large percentage of patients do not take their drugs as prescribed," says Solomon. "So now the QI folks decide to design an enhanced intervention."
To find out whether the intervention — a follow-up call from a nurse, perhaps — is worth the extra cost, half the patients diagnosed with hypertension are assigned to get the call, and half get only the prescription and a brochure.
Does this type of QI activity constitute research and does it require institutional review board (IRB) approval, and must patients give consent? There is widespread uncertainty within health care systems across the country as to how to answer these questions.1
"Observing how care is delivered means collecting patient data at the point of care," says Solomon. "Inevitably, the line between research and treatment is going to be blurred."
New paradigm is suggested
In traditional research, the goal is to determine the effectiveness of an as-yet unapproved drug or device. "The gold standard way of doing that is to enroll people in randomized, controlled trials, with half the research participants receiving the drug or device and the other half not," says Solomon.
Now that more research is being done as a way of enhancing quality and lowering cost of care, there is growing interest in QI research and CER. In CER, two proven drugs, devices, or interventions are compared to find out which ones work better with subgroups, which are easier to implement, or which are less expensive.
Since both interventions are a form of acceptable care and are known to be efficacious, the question is whether assigning patients to receive one rather than the other really needs IRB approval and informed consent.
"Some people believe that there should be disclosure about the fact that they are being asked to enter into a trial and their informed consent sought," Solomon says. "Others ask, 'Why create so many layers of approval, and create burdensome procedures, when all we want to do is learn by observing usual care?'"
Some researchers point out that the main purpose of human research participant protection is to protect people from undue risk, and argue that some treatments bring more risk than some forms of QI research or CER.1"They want to see a new paradigm — one that is based on level of risk — rather than on whether something is categorized as research or treatment," says Solomon.
The question to ask, says Solomon, is "Is participation in the study adding more risk than would otherwise be the case from receiving the treatment alone, if it weren't being studied?"
"In my view, if enrollment in the study truly does not add more risk, consent may be waived," says Solomon. "But the level of likely risk and its potential magnitude must be authentically, wholeheartedly examined."
Another ethical question is whether, simply on the grounds of truth telling and respect for persons, there is an obligation to reveal that a person has been assigned to one arm of a study rather than another. Even if there is no increased risk, patients may have preferences about what arm they go into.
"When patient preferences are likely, that is, when reasonable people may have very different views about receiving a given intervention, consent should be requested," says Solomon. "In those cases, researchers should not assume a willingness to participate, or a willingness to be assigned to either arm."
QA enmeshed with clinical care
Regardless of whether a project is research or QI, the need for adherence to good ethical standards is an imperative, according to Blair Henry, an ethicist at Sunnybrook Health Sciences Centre in Toronto, Ontario, Canada. Henry's interest in quality assurance (QA) ethics started during his tenure as vice chair of the organization's institutional research ethics board.
"For many years, we saw considerable 'ethics creep' from QI leaders bringing their projects to the IRB for approval to facilitate future publication efforts," says Henry. He says that both QI and research projects necessitate good ethical practice, and that the difference between research and QI is more related to the oversight mechanism used to meet that end.
"Given that research is voluntary, and it entails a burden or risk not typically borne by patients, the field of research ethics has evolved to ensure good oversight of research projects occurs before enrollment of subjects begins," he says. "The world of QA has lagged behind on this."
In many organizations, no similar oversight body exists to review QI projects. "This can be concerning when we consider that it is now expected that all patients will engage and support quality endeavors, thereby throwing the concept of voluntariness into question," says Henry.
In addition, the enterprise of improving quality is now seen as the responsibility of all staff, but many are not trained in the privacy/confidentiality requirements of QI and evaluating additional risks.
As an ethicist involved in the organization's QA structure, Blair developed learning modules to help front-line staff understand basic ethical principles and how they should be applied to QI work.
"Additionally, experienced QI and patient safety specialists have increased the rigor of QI measurements," says Henry. "This has pushed the line between QI and research even closer."
Clinical staff consult with ethics more frequently for assistance addressing the complex ethical issues involved in larger QI projects. "This enmeshing of QA with daily clinical care has resulted in a renewed engagement between clinicians and ethicists at a very foundational level," reports Henry.
- Solomon MZ, Bonham AC. Ethical oversight of learning health care systems. Hastings Center Report Special Report 2013;43:S2-S3.
- Kass N, Faden R, et al. The research-treatment distinction: A problematic approach for determining which activities should have ethical oversight. Ethical Oversight of Learning Health Care Systems, Hastings Center Report Special Report 2013;43:S4-S15.