9
Apr2015

by Michael (Mike) Kraten, PhD, CPA, IRB Chair at Providence College

It's the news that no academic institution ever wants to hear. A life-threatening infection has struck a student on campus, and then a second student reports the same condition.

Recently, at Providence College in Rhode Island, two students contracted meningococcal infections and were rushed immediately to inpatient facilities. Working closely with the Rhode Island Department of Health (DOH), the College then managed to vaccinate over 3,000 at-risk undergraduate students in a single, brief, and intense outreach campaign with extensive information and medical applications.

That caught the attention of the Centers for Disease Control and Prevention (CDC), where epidemiologists and public health professionals seized an opportunity to conduct an evaluation on baseline nasal carriage of serotype B meningococcal bacteria, and to assess the impact of the vaccine after the targeted population was vaccinated. But because of the physical effects of the vaccination itself, all three parties (i.e., the College, the DOH, and CDC) needed to "fast track"their standard operating procedures.

That included the IRB review processes for both the DOH and Providence College. Current DOH director Dr. Michael Fine and incoming DOH director Dr. Nicole Alexander-Scott took the lead in expediting the project's IRB application. According to Dr. Alexander-Scott: "For this crucial evaluation to be conducted appropriately, we depended on a comprehensive IRB process in an expedited fashion. The Providence College IRB responded above and beyond this call."

And what of the Providence College IRB? As its chair, I had experienced requests for "fast tracking" applications in the past. But at a liberal arts institution with no schools of medicine, nursing, pharmacy, or other professional programs of health sciences, I had never managed a review of such an application. And I had certainly never "fast tracked" one.

Fortunately, having attending PRIM&R's 2014 Advancing Ethical Research (AER) Conference in Baltimore, I had recently enjoyed an opportunity to interact with colleagues in both the social, behavioral and educational, and biomedical research fields. The Ebola outbreak was "in the news" at that time, and the steps (and missteps) that medical researchers, politicians, and others were making in regards to that infectious illness served as some of the primary topics of conversation.

Because PRIM&R encourages researchers in very different fields to enjoy full access to sessions that focus on other disciplines, I took advantage of the opportunity to learn more about managing research activities during events like the Ebola outbreak. Not because I had any foreknowledge that I'd soon be managing an IRB "fast track" review about an on-campus meningococcal outbreak, of course; rather, out of simple curiosity, and a desire to expand my knowledge across disciplines.

Then, two months later, I found myself employing so many of the practices that I had learned and discussed in Baltimore: finding a qualified physician to contribute supplemental expertise to IRB deliberations; using advanced communication technologies to communicate with a geographically dispersed IRB membership; and establishing an immediate working relationship with a pair of organizations (i.e., the DOH and CDC) while maintaining an appropriate degree of independence.

It certainly wasn't an easy task, and it would have been immensely more difficult if not for my attendance at the 2014 AER Conference. Although I obviously never wished for a meningococcal outbreak, when I was confronted with one, I was relieved to know that my conference participation had prepared me for it.

Michael Kraten was a member of the PRIM&R Blog Squad for the 2014 AER Conference. The PRIM&R Blog Squad included of PRIM&R members who blogged here, on Ampersand, about the conference to give our readers an inside peek of what happened December 4-7 in Baltimore, MD, and how they have used what they've learned there since they returned home.

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