Dear IHI —
I am planning a QI project to improve adherence to isolation precautions for antibiotic resistant bacteria in the ICUs of my health care system. I’m getting conflicting advice about whether I need to have the protocol reviewed by our institutional review board (IRB). There’s a lot of paper work, and the process takes time. I want to get started! —WAITING
Dear WAITING —
Before giving you my take on this issue, I want to make it absolutely clear that caution should be the rule when performing human research.
Many of you are too young to remember clearly the origins of the Common Rule, the basis for IRB review. But I’m sure you all know that German physicians performed abominable experiments on prisoners during WWII, and these atrocities led to the Nuremberg Code, which articulated 10 principles for ethical research on humans. Even then, many investigators assumed the Code applied only to egregious offenses, and many post-war medical advances were based on research that appears ethically questionable in retrospect. The Tuskegee Study, which withheld treatment from black men with syphilis who lived in an impoverished rural region in Alabama, definitively changed the dialogue. The Belmont Report, released in 1978, codified principles of ethical human experimentation that now constitute the heart of the Common Rule.
What is the role of IRBs in quality improvement work? My point of view is that rigorous QI is a form of translational research — it takes evidence-based practices proven through health services research or clinical trials and tries to implement them to improve outcomes. I don’t believe that this type of research generally raises the same ethical concerns as basic science research.
To determine whether your project needs IRB review, consider the following criteria, which we use where I work at Boston Children’s Hospital. When in doubt, take your project to the IRB. You may get a waiver, or your IRB even may agree that projects that meet these criteria don’t need to be reviewed at all.
- The project must pose minimal risk to patients.
- The improvement project’s goal should be to bring care closer to the accepted standard. In the case of your project, that sounds like it’s the case. The only caveat is that you must consider possible unintended consequences — even harmful effects — that could result from your improvement effort. This is really important, and too often overlooked. To the extent possible, harmful effects should be anticipated, mitigated, and monitored. For example, in your enthusiasm to prevent the spread of antibiotic resistant bacteria through isolation, consider whether caregivers may not enter the room as frequently to monitor the patient, that the patient could feel stigmatized, or that the time required to comply with isolation protocol of gowning, masking, and gloving might make it hard for staff to fulfill all of their clinical responsibilities.
- Patient privacy must be protected. This means, in part, that data must be anonymized and presented in aggregate form so that individual patients cannot be identified. In the US, this is specified in HIPPA — the Health Insurance Portability and Accountability Act of 1996.
What about improvement studies in which randomization to intervention and control groups is planned? Personally, I think that the criteria I just outlined still apply, but the jury is out on this issue, and I definitely would recommend consulting with your IRB before proceeding.
Even if your study meets all of these criteria, there still is a potential ethical issue. The study needs to be designed well so that you’ll be able to learn from it. If it’s poorly designed, then it’s certainly futile, a waste of time, and in my view, probably unethical.
Don Goldmann, MD
Chief Scientific Officer Emeritus and Senior Fellow, IHI