Monday, January 21, 2013

IRB: Quality Improvement or Quagmire of Innovation

The medical community has come a long way in improving protection of patient privacy and basic human rights in it's efforts to discover new diagnostics and therapies through clinical research. One of the mainstays of modern clinical research is the Institutional Review Board (IRB). The IRB vets research proposals to ensure that it is ethical and adequately protects research subjects from undue harm. The IRB can also serve to drastically slow down the process of quick testing of interventions. In fact, IRB approval can take anywhere from weeks to months and the cost of IRB approval from a time and cash perspective may preclude innovators from even testing their idea.

IRB review is a necessary evil and it is a net good for patient care. But it doesn't have to altogether stifle lean testing. The following approach can expedite IRB review of a quick test for value generation of an intervention and lead to faster realization of problem-solution fit within the hospital or healthcare setting.

It is better to err on the side of caution and notify the IRB of your intent to perform an intervention. If in fact that intervention is  the same or less risk to patient care than the current standard of care, then you can seek IRB exempt status.  I recommend using some permutation of the following language in your opening paragraphs:

“We are applying for IRB exempt status for the evaluation of the intervention at hand. The intervention is part of routine operations. The data is not currently intended for use for research purposes but rather for quality improvement. If and when the data will be used for publication purposes, the IRB will be consulted  and all personal health information will be deidentified. Although we do not currently intend to publish this data for research purposes, we would like to give you a brief snapshot of the intervention so you are aware of it: [describe intervention in very loose terms]."

This language can help you breeze through the IRB in a few weeks and get to the clinical minimal viable product with minimal friction. If the data from the intervention show promise and a larger scale trial is needed for further validation, then further IRB review may be warranted. But until small-scale, qualitative value is demonstrated, applying for full IRB approval may be a waste of time.

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