Conflicts of Interest in the IRB World

My first job after finishing graduate school has been as the manager of an institutional review board (IRB) at a mid–sized community hospital. In my graduate work, I learned about the important role IRBs are supposed to play in protecting the rights and welfare of research participants. I learned that IRBs should be independent bodies, free from biased influences that may sway deliberations about how—or if—research takes place. As a protection against this bias, the federal rules governing IRB structure and function make it clear that researchers should not review their own research proposals.

My own IRB experience has been far from independent. Yet, the pressures placed on me as the IRB manager rarely come from the investigators themselves. In my case, my direct supervisor is the institution’s Director of Research. In other words, the person who completes my annual evaluations is the same person responsible for promoting a culture of research in our hospital. He serves as the institution’s liaison to research sponsors, seeking to attract funded studies to offset the cost of supporting a research study and the large chunk of non–paying studies that take place at our hospital. This reporting structure has resulted in a number of uncomfortable favors or requests. In isolation, no single request has been so egregious that I believed what I was being asked to do was putting the lives of others at significant risk. Yet, I’ve often felt that my supervisor has taken advantage of his position in order to make the research process “smoother” or “more efficient” for investigators.

For example, our IRB (like most IRBs) has strict deadlines for investigators and their support staff to submit research proposals for review at each convened IRB meeting. We post these deadlines online and provide them to investigators approximately one year in advance in order to ensure that the researchers are well informed about when they can expect their proposals to be reviewed. More importantly, the deadlines ensure that we have a two–week period between proposal submission and IRB review so that our IRB members have sufficient time to devote to their reviews. On several occasions, my supervisor has asked me to place a submission on the IRB’s agenda well after the posted deadline and with little time for thorough review by IRB members. At times, I politely refuse. At other times, I have acquiesced. Each time I refuse, I worry about my job security. Each time I give in, I worry my allegiance is slowly shifting away from the research participants I am tasked to protect and toward the institution supporting the study.

In another instance, my supervisor called me one Saturday morning to ask if I would be willing to come to the office sometime during that weekend. At the time, my spouse and I were out of town for a relaxing trip away from home. According to my supervisor, an influential researcher and frequent collaborator with our institution had scheduled an appointment with a new research participant for 8:00 A.M. the following Monday morning. However, he needed a proposed amendment to his study to be approved by the IRB before that appointment (even though the amendment had only been submitted the day prior). Without IRB approval, the investigator would be left with a choice: cancel the appointment or knowingly engage in noncompliance by implementing the amendment without approval. Of course, my supervisor made it clear that I wasn’t required to come to the office to perform the expedited review. He was merely asking if I would be able to do a small favor. Although it went unsaid, it was clear that I had my own choice: I could return to the office over the weekend to review the amendment or I could deal with a report of noncompliance when I returned on Monday. Further, it would be noncompliance that I could have prevented, if only I had taken my supervisor’s suggestion. I found myself back in the office at 8:00 P.M. Sunday evening, reviewing the amendment and sending the investigator an IRB approval...