Life as an IRB Administrator: Advocate or Advisor, Protector or Promoter?

by Cynthia Hahn, PRIM&R member and guest blogger

A robust human subject protections program is one in which the system is set up from the start to facilitate the ethical conduct of research.

News of the Physicians for Human Rights (PHR) request that the Office for Human Research Protections (OHRP) investigate the Central Intelligence Agency (CIA) alleged torture “studies” has generated a lot of discussion in the Institutional Review Board (IRB) community. In a recent meeting at my institution, members of our IRB staff wondered whether OHRP has jurisdiction to conduct such an investigation, and if so, what they could do about the “studies.”

Then we asked: what if an IRB had reviewed it? Could an IRB ever have approved any aspect of the research? For example, could an IRB have determined that the monitoring of individuals undergoing torture was, in fact, for medical purposes, and that the collection and analysis of the data was the sole research intention? Could an IRB see this case as a secondary review of data collected for performance improvement?

Allegations like PHR’s raise questions not only about how IRBs might handle this case, but also about the roles IRB members play. What would you do as an IRB administrator if an investigator at your institution came forward with a retrospective review of existing data for a procedure that was (in your IRB’s opinion) morally objectionable, but approvable under the existing federal regulations?

What if that investigator argues he/she performed the intervention for the treatment, monitoring, or diagnosis of individual patients, and not for research? What if you find nothing counter to this point? What if your IRB thinks that it would be important for this information to become public?

The discussion could go on for hours, and in angst the committee may turn to their IRB administrator and ask, “What are our options?” IRB administrators would hold a lot of power in that moment.

Resources exist to guide IRBs in ethically challenging situations. For example, projects like the Clinical and Translational Science Awards (CTSA) consortium, the Federal Demonstration Partnership (FDP), and the OHRP’s and Secretary’s Advisory Committee on Human Research Protections (SACHRP)‘s work on IRB Authorization Agreements all strive to provide innovative strategies to improve IRB efforts. Additionally, the programs seek something often referenced as “reducing administrative burden.” But how can we balance this reduction of burden with the history of high-profile IRB shutdowns in the late 1990’s, the tragic deaths of Ellen Roche and Jesse Gelsinger, and the Illinois White Paper on IRB Mission Creep?

Websites such as IRBwatch, as well as many IRB administrators in the field, raise concerns about this balance in the investigator community. IRB administrators walk a tightrope between protecting human subjects, protecting their institution, and reducing administrative burden for investigators. As a result, most academic medical centers today offer IRB services, through IRB administrators, to help investigators achieve compliance. These services range from writing consent forms to providing IRB pre-submission assistance, and assisting with protocol development. While these services are almost always helpful, the questions remain: Do they help investigators develop an ethically responsible protocol with the least amount of paperwork, or do they help him/her craft a good argument around the regulations?

So, what is the role of an IRB administrator: ethicist, or administrator? Advocate for subjects, or the investigator? Can they be all of the above?