Research Ethics and Quality Improvement

By chance, as I was writing about Atul Gawande’s New Yorker article about checklists for yesterday’s posting, the Sunday New York Times arrived with his Op Ed piece about how the Federal Office for Human Research Protections has put the project on hold for lack of informed consent from patients and clinicians.

Today I reviewed the letters sent to the research team at Johns Hopkins by OHRP on July 19 and November 6. It looks to me as if the OHRP has followed the letter of its regulations, while entirely ignoring the spirit of its mission. The letters cite numerous details that indicate that research was being done. Luckily, it was. The Johns Hopkins team was studying, in a rigorous manner, the impact of an effort to systemize good clinical care. The question was not whether an experimental drug helped or hurt research subjects, but whether a disciplined managerial approach to doing what we know is the right thing to do produced measurable improvements.

If Kristina C. Borror, Ph.D., Director of the Division of Compliance Oversight at OHRP, who wrote the letters to Johns Hopkins, reported to me, this is what I would have said:

“The purpose of our office is to protect people in the health care system. The checklists aren’t research. They are part of a managerially sophisticated effort to make ICUs accountable for doing what all ICUs agree should be done, in order to protect people in the health care system. It is great that Johns Hopkins is studying that care management process. Please show them how their application could be corrected so that we don’t erroneously subject the project to a misguided requirement for individual informed consent.”

In 2006 the Hastings Center published an excellent report on “The Ethics of Using QI Methods to Improve Health Care Quality and Safety.” The conclusions are sensible, well thought out, and practical. None of the conclusions would require individual informed consent from patients or ICU staff:

* QI is any systematic, data-guided activity that is designed to bring about the immediate improvement of care in a local setting.
* QI is both appropriate and vital to health care.
* QI is marked most distinctly by the prompt feedback of the effects of deliberate changes to the same care delivery setting that is making the changes.
* QI is intrinsic to health care delivery and obligatory for both professionals and patients.
* Though QI is often driven by a priori evidence that suggests substantial benefits are likely for the patients and/or staff involved, QI can pose some risks to some
patients.
* Not undertaking QI in the face of recognized quality deficiencies also puts patients at risk.
* QI should itself be implemented ethically.
* Low-risk QI should generally have the same review and standards as routine health care delivery.
* Higher-risk QI should undergo routine and orderly review within the usual arrangements for clinical supervision or by an advisory group.
* Some projects are correctly counted both as QI and as research involving human subjects and should meet the requirements for review of protection of human subjects
in research.
* Meeting those requirements might be more readily accomplished with a QI-IRB that met regulations, but whose policies and procedures were also tailored to the needs and expectations of QI.
* Certain issues might trigger the requirement for formal review of a proposed QI project: randomized designs, novel treatments, involvement of researchers, delayed
feedback of monitoring, or external funding.
* Federal agencies and voluntary organizations should cooperate in further developing and implementing these ideas.

We have had so many examples of the Bush administration subjugating scientific integrity to ideology that it is hard to avoid suspicion about the motives of the OHRP for scuttling the project. But whatever the motivation behind OHRP’s actions, it is important for the agency to reverse course promptly.