Is the Whole Greater than the Sum of Its Parts? Lessons on Reviewing a Protocol

“We lost our quorum,” presenter Susan S. Fish, PharmD, MPH quipped as a few stragglers were still finding their seats after a short coffee break. I recognized her wonderful sense of humor and ability to engage the audience from last year’s IRB 101 course, and was delighted that she and her co-presenter Karen N. Hale, RPh, MPH, CIP continued to exceed expectations at this year’s AER Pre-Conference Program, IRB 201: An In-Depth Analysis of the Criteria for Review.

This course, designed to build on the concepts learned in IRB 101, focused on the eight criteria for IRB approval of research from the Code of Federal Regulations that governs the operations of IRBs (45 CFR 46.111). Before this course, I knew that each of the eight criteria must be met in order for an IRB to approve a protocol. I did not know that by conducting high-level pre-reviews without treating each criterion distinctly, I might have only been scratching at the surface. For example, if a protocol did not include participant inclusion and exclusion criteria, I knew to request the missing information to complete the submission package, but I did not consider why this information was so critical—and I certainly could not cite 45 CFR 46.111(a)(3), the sub-section that ensures that the selection of subjects is equitable, as the unmet criterion.

Ms. Fish and Ms. Hale constructed this interactive course in a way that cleverly compelled its attendees to participate in this kind of deductive reasoning. After a brief review of The Belmont Report principles (i.e., respect for persons, beneficence, and justice) and a reminder that the federal regulations reflect these principles, we broke into small groups to review a Harry Potter-inspired clinical protocol. For the rest of the day, our small group “IRBs” would re-convene after each of the eight criteria were presented and discuss concerns specific to that criterion about our wizardly protocol. This method allowed groups to tease apart the complex issues that were relevant to each criterion. Reviewing the criteria for approval instead of reviewing the protocol for common red flags allowed me to organize my method of review and ensure that I exhausted all avenues that might concern the protection of human subjects. 

Reviewing a protocol can be an overwhelming endeavor when we consider the importance of our jobs as human subject advocates. We are the agents responsible for the ethical conduct of research, the last stop for participant advocacy before a study goes into the field. We cannot afford to leave any stone unturned. This session provided a map for reviewers to follow to cover all the ground necessary to approve a protocol, in part by asking, “What criterion does that concern fall under?” Treating each as a distinct element enabled reviewers to expound on relevant issues necessary to ensure the protection of human subjects. I left this session with a tangible, concrete approach for reviewing a protocol, and I am confident that its application will ensure that no stone goes unturned going forward. 

Sydney Boone, IRB research operations assistant at Westat, is a member of the PRIM&R Blog Squad for the 2016 AER Conference. The PRIM&R Blog Squad is composed of PRIM&R members who are blogging here, on Ampersand, to give our readers an inside peek of what happened at the conference in Anaheim, CA.