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Thursday, July 23, 2009


If you've been involved in some sort of practice improvement initiative in recent years, it is likely you have learned how frustrating it can be to submit an improvement project you propose to undertake to an "Institutional Review Board" (aka the 'IRB' Committee). And you would find it difficult to believe that the profession of medicine had identified 'practice-based learning and improvement' as a critical competency area which all physicians now need to master.

This is because many of the requirements and criteria IRB's rightly apply to research projects don't fit improvement projects. What it all comes down to is that research projects are almost always proposing to change the standard of care. Whereas improvement projects are usually trying to implement the prevailing standard of care (as laid out in national guidelines or similar protocols) in a better, more effective way. Many times, what is going on in an improvement project is an alteration in procedures, organization of care and/or systems - some sort of process.

The effectiveness of an improvement effort can and should be evaluated. But this kind of "research" is usually substantially different from the kind of research appropriate for the clinical trials of new medications, new medical procedures or other new and/or improved standards of care.

For example, requiring consent forms could be viewed as overkill for many improvement initiatives. On the other hand, compliance with HIPPA guidelines is probably just as important, particularly if there is the possibility that those conducting the improvement effort will want to publish what they learn from their work.

Moreover, most IRB committees haven't been staffed at a level that would allow them to deal with a large number of submissions on an ongoing basis. As a result, even if there is some kind of partial exemption granted, the review process may significantly delay the start of an improvement effort.

Routine initiation of thoughtful improvement efforts is something we are coming increasingly to associate with sound practice. This is something we want all clinicians to do all the time. But the growing IRB logjam will almost certainly impede and discourage the very sort of activities that leaders in the health professions are putting so much effort and resources into fostering via education and certification programs.

We need to begin to draw sharper and better distinctions between clinical research and practice improvement. There should be two, entirely separate committees reviewing these two different kinds of activities. They should have their own criteria, their own procedures and their own timelines. This is essential if we don't want to see required review committees discouraging improvement initiatives or the sharing of improvement successes and failures by reflective practitioners.

The two committee approach has been implemented here and there. But widespread implementation of this approach has been retarded for fear of loss of funding and/or accreditation of one kind or another, or even fines. There are committees studying the problem. But prompt and unambiguous action at the national level is required, if leadership in healthcare wants to send the right signal to clinicians... namely: "We really are serious about wanting you to incorporate clinical systems improvement into your practice, and we intend to make it feasible for you to do so on an efficient, effective and timely basis."

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