A Taste of IRB + A Pharmacy Student’s Battle Cry to Action

Yummmm. You see that delicious plate right there? That’s what you could be eating, if you went to the Institutional Review Board (IRB) meeting.

As a participant of the MCRiT program, a few weeks ago I was allowed to go to an IRB meeting. I got a first hand account on what happens during those important meetings.

For those of you unfamiliar with what the IRB does, essentially it is an ethics committee that must approve of all research studies before they can commence. In the past, researchers did not take into account patient safety, and many patients were seriously harmed or other ethical violations occurred. This led to the Federal Government creating these IRB to ensure patient safety in research studies. One way that the IRB works to ensure patient safety is by including non-researchers on the board: there was community representation, prisoner representation (prisoner participants in research has a cruel history), and other non-scientists present.

This is what the IRB meeting looks like:

Sitting in this meeting, it reminded me of the City Council meetings you see on C-SPAN. Everything was official and professional. I found the whole experience rather intellectually stimulating. To get a sense of what happens, imagine Dean Welage’s Evidence Based Medicine Class when we critically appraised articles and studies. Now imagine a room full of professional researchers who do this. You will hear words and phrases tossed around like: minor increase over minimal risk, APO (approved pending office), APR (approved pending reviewer). It again showed me how critical proper study design is – from recruitment and compensation to patient withdrawal policies. After they review the case, the board votes – favor, oppose, or abstain on the research proposal or amendment.

Here’s a picture of my mentor for the meeting. Thank you again Dr. Stephan Taylor!

The University of Michigan actually has multiple IRBs. We aren’t called the Leaders and Best without reason. I learned that there are 5 IRBs alone in the Medical School (for human subject research) and 1 IRB located on Central Campus for Health Behavior Research (psych, physics experiments, etc).

Sitting through the IRB, I learned how vital it is that Pharmacists be pro-active and take initiative to expand our profession. Unfortunately, there wasn’t any Pharmacy representation at the IRB I was in. I only hope that we are represented on the other IRBs because I know we have the clinical knowledge to be effective on these boards. There was a study pending approval regarding a prospective randomized control of simvistatin on the prevention of COPD being lead by a physician and not a pharmacist. I always assumed that we were the drug experts. Perhaps I need a better understanding of the US Health Care System and its politics. But regardless, my point is that we are at a tipping point in our great profession. The time to expand our scope of practice can only be achieved if we get out of our comfort zones of dispensing and demonstrate how we can improve patient care with our knowledge and training. UofM is teaching and preparing me the clinical knowledge, but I know it will be up to me to either actively participate or simply sit on the sidelines when I graduate.

I hope that by the time I practice, I will continue to have this fire to push our profession and inspire those around me to do the same.

Go Blue!