Call to revamp ethical framework on human research

Move is toward integrated health care learning systems

The longstanding ethical framework for protecting human volunteers in medical research needs to be replaced because it is outdated and can impede efforts to improve health care quality, according to a Hastings Center Report special report, “Ethical Oversight of Learning Health Care Systems.1

Ruth R. Faden, PhD, MPH, Philip Franklin Wagley Professor of Biomedical Ethics and director of the Johns Hopkins Berman Institute of Bioethics in Baltimore, says a lot of effort is spent determining whether quality improvement (QI) initiatives should be considered as research or practice.

“It is work that is sometimes called research and sometimes called practice. But if you scratch the labels off them, they look exactly the same,” says Faden. “Conscientious stakeholders across all fronts want to get the work done and don’t want to be unnecessarily held back.”

Moving toward truly integrated health care learning systems is “morally important,” adds Faden. “And the traditional way of thinking about clinical research and clinical practice as sharply distinguished from one another is antithetical to what a learning health system calls for.”

In a 2012 report, The Institute of Medicine called on health care organizations to become learning health care systems.2 Faden describes this as the complete integration, on a daily, continuous level, of the generation of new knowledge with the delivery of high-quality care.

“If you are continuously adding new knowledge in the process of delivering care, and then using new knowledge to improve the delivery of that care, that is a complete integration of research with practice,” says Faden. “But to get there in the context of the old way of thinking, which puts a sharp line between the two, is very difficult.”

Overly protective

At one end of the spectrum are activities that have immediate benefits for patients and pose minimal risk. “Such activities should have local institutional oversight, minimizing regulatory burden so that they can move ahead expeditiously,” says Steven Joffe, MD, MPH, associate professor of pediatrics and global health and social medicine at Harvard Medical School and hospital ethicist at Dana-Farber Cancer Institute in Boston, MA.

At the other end of the spectrum are activities that impose substantial risks on individuals, with benefits that are speculative and only occur down the line. These activities should have prospective scrutiny by a group that’s accountable to the public through a regulatory body, he argues.

In addition, activities closer to the latter type should essentially always require individual informed consent, whereas those at the former end may require only disclosure within the context of other routine health system disclosures, says Joffe.

“The current system is overly protective and burdensome. I think we have to get away from asking whether or not these activities are research or not,” says Joffe. “We need to focus on the nature of various types of activities and the risks that they pose, and adapt our oversight to that nature.”

Massive amounts of information are being gathered through electronic health systems and billing records, which permit relatively low-cost analyses looking for patterns of relationships and events across huge numbers of people. “There are problems of data standardization, quality, and cleanliness that need to be solved, as well as regulatory barriers, but the promise is there,” says Joffe. “If we go this route, every time a person touches the health care system, he or she will leave tracks that can be used to improve that system.”

Joffe argues that “absolutist” positions that value potential health and quality benefits over privacy, or vice versa, threaten the ability to achieve these improvements. “Among other things, we need patient and family engagement in oversight and governance mechanisms,” he says. “At their best, bioethicists can help stakeholders weigh and balance the relevant values, and can promote healthy dialogue and debate among all the stakeholder groups.”

The authors of the framework used the term “learning activity” instead of the terms “research” and “practice.” “Instead of putting a lot of energy trying to figure out what goes in each bucket, which has caused so much confusion, we used the best term we could come up with at the moment,’” Faden explains. “What we are trying to do is say, ‘Stop worrying about whether something is QI practice or QI research.’ If you are trying to improve quality in a way that is systematic, then you are going to be generating new knowledge.”

What to do now

Faden recommends that institutions begin working with various stakeholders to identify the kinds of activities that really should be able to go forward without too much in the way of elaborate prospective ethics review.

“Now is the time to start working with patients and families and advocacy groups and health care professionals, to think through the kinds of designs that people feel comfortable with, and don’t feel comfortable with, and what sorts of things require a higher degree of commitment to careful solicitation of consent,” she says.

The team conducted focus groups with researchers in patient safety and comparative effectiveness to learn their concerns. “We heard from a number of folks that they take pains to describe what they are doing as not research, and they don’t publish what they learn, to avoid the resources that are necessary for going through an IRB [Institutional Review Board] system,” says Faden. “This is really unfortunate for several reasons.”

Researchers might be using suboptimal designs to identify whether their QI project is effective, in order to avoid the appearance of employing the trappings of research. Also, if something valuable is learned, it’s not shared, so efforts have to be duplicated.

“Another problem is that IRB systems are often overworked and inadequately staffed,” says Faden. “They are caught up having to spend their limited resources in reviewing projects that are really unproblematic. That causes them not to have sufficient resources to review carefully those activities that are very high stakes and really should be carefully scrutinized.”

References

1. Solomon MZ, Bonham AC. Ethical oversight of learning health care systems. Hastings Center Report Special Report 43, no. 1 (2013):S1-S44.

2. Institute of Medicine. Best Care at Lower Cost: The Path to Continuously Learning Health Care in America. Washington, DC: The National Academies Press, 2012.

Sources

• Ruth R. Faden, PhD, MPH, Philip Franklin Wagley Professor of Biomedical Ethics/Director, Johns Hopkins Berman Institute of Bioethics, Baltimore. Phone: (410) 614-5553. E-mail: rfaden@jhu.edu.

Steven Joffe, MD, MPH, Associate Professor of Pediatrics, Global Health and Social Medicine, Harvard Medical School/Dana-Farber Cancer Institute, Boston, MA. Phone: (617) 632-5295. E-mail: steven_joffe@dfci.harvard.edu.