Comparative effectiveness research (CER) compares treatments and strategies to improve health. This information is essential for clinicians and patients when it comes to deciding on the best treatment options. It has been said that it also seeks to enable our nation to improve the health of communities and the performance of the health system.
The need for IRB review in this type of research is often misunderstood or even at times, underestimated until the researcher seeks to publish their findings. The Agency for Healthcare Research and Quality (AHRQ) identifies two ways that evidence is found.
- Systematic review of existing evidence from clinical trials, clinical studies, and other research; and
- Conduct of studies to generate new evidence of effectiveness or comparative effectiveness of a test, treatment, procedure, or health-care service.
IS IRB REVIEW NEEDED FOR CER STUDIES?
It is not always clear whether or not CER studies involve human subjects. Two resource which can assist in making this determination include:
1. The decision tree that helps you work through whether the research does or does not involve humans as subjects and, if so, if IRB review is required.
2. The journal(s) in which you hope to publish. Many journals have adopted requirements for publication or have adapted them as needed. After using the decision tree, consult the journal requirements.
WHAT ARE THE MAJOR ISSUES IN IRB REVIEW OF CER STUDIES?
After deciding that IRB review is needed, there are some issues that commonly arise.
In order to use expedited process, it must be clear that the study involves less than minimal risk to subjects. To decide this, it is necessary to know what is being done for study purposes. Many CER protocols fail to distinguish baseline healthcare that would be delivered regardless of the existence of the study from those interventions (e.g., changes in regimen) or interactions (surveys, interviews, phone calls) or use of private information (chart abstraction) that are done solely for purposes of the evaluation.
Many CER protocols do not adequately describe the process by which subjects are recruited, informed and asked for consent.
E&I's Comparative Effectiveness / Qualitative Review administrative team can help you determine if IRB involvement is necessary in your project.
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