SQUIRE Blog

Ethics and The IRB

Susan Mooney

Memorial Day

The Friday before Memorial Day Weekend, I sat in on a meeting hosted by the VA Quality Scholars program.  I was invited because the topic was ethics and the meeting organizers thought that I might be interested.  I was.  So I attended and now I wish that I had not.  Although, that statement, is a bit misleading.  I am glad I went, but in light of the conversation, I am not sure that I know what to do next.  The basic premise that kicked off the meeting is that we need to assure that there is ethical oversight of Quality Improvement initiatives.  At academic medical centers or VA medical centers that are affiliated with academic centers, this has meant that selected QI projects are vetted through IRBs and Research Committees.  As a general rule, if a project leader has any thoughts of publishing his work, then he needs IRB approval.  No thoughts of publication, No IRB.  This simplistic reduction of a complex issue leaves me cold.  Especially when I hear that QI projects have been delayed for months on end, awaiting IRB approval.

Can a Non-academic Publish?

One of the goals of the SQUIRE guidelines is to encourage non-academic QI people to reflect on and publish their work.  In reality, this is an ambitious goal and the barriers are enormous.  Non-academic people are not routinely rewarded for undertaking a writing project.  They are rarely given time or support - they are too busy doing the work.  Demanding IRB approval for QI studies feels like the proverbial "nail in the coffin".  APD, where I work, has a small ethics committee that rarely meets.  How would I access an IRB?  If I only need IRB review so that I can publish, I will skip publication and just keep doing the work.  But what if the work itself is unethical?  How do we make sure that all QI work, published or not, is performed in an ethical way? The simplistic "if it is going to be published, it needs IRB approval" is wholly unsatisfactory.  Everyone at the meeting understood this - no one had a good answer.

Are Delays Ethical?

On the one hand, an argument can be made that the QI work I am doing should have some sort of ethical review regardless of whether or not I intend to publish my work.  But, on the other hand, I wonder about the academic facilities as well.  Researchers at the meeting I went to told me that projects have been delayed for upwards of a year, awaiting IRB approval.  Once we identify a gap in care and create a plan to close that gap, don't we have an ethical obligation to begin that work as soon as possible?  How do we rationalize allowing sub-optimal care to persist for years at a time?  And, oh, by the way, has anyone disclosed to the patients that the gap exists and that no one is working to fix it because the project plan is undergoing ethical review?  How much harm is done in that year?  Maybe less than what would have been done had the project moved forward, maybe more.  It feels to me as though the ethical thing to do would be to make the calculation explicit.