Susie Project Manager’s PI directed her to create a human subjects submission for a killer research project. Susie was well-versed on the topic, having been instrumental in providing feedback on the initial phases of the grant submission. Writing the Initial Review Questionnaire (IRQ) and study materials was a breeze and, with the submission under her belt, she knew she and her PI would get the study through review and approval in a snap.
Imagine her dismay when the study was kicked back, with the IRB coordinator requesting changes to descriptions and completion of what were noted as non-required sections in the IRQ! Susie was frustrated. She felt like the IRB coordinator was asking her to provide unnecessary information that the office had already indicated was not required and at the study team’s discretion to complete.
When IRB coordinators undergo training, they are told to look for certain language and descriptions that provide a holistic picture of a proposed research project, in light of the federal regulations related to human subjects. Sometimes the information provided in an IRQ doesn’t give the whole picture, which is why we ask for non-required questions to be answered or descriptions to be edited. Remember, we are coming to your project with a fresh set of eyes, so we can’t fill in gaps in the submission like a study team member who is an expert in the project.
IRB coordinators are charged with making sure the IRB has all of the information it needs to proceed with review and approval, and if we feel an IRQ needs more information, we will ask for it, not to further burden you, but in anticipation of what the Board will want to see. Our goal is to avoid deferral.
The required questions in an online IRB system also function as “work flows” for moving a study to submission; in other words, there are basic questions everyone has to answer. We include some non-required questions because, while they are not applicable to all studies, there are instances where we need to collect that information as part of the review process. Non-required questions then do not affect the eIRB system workflow but we do include them in case the IRB coordinator, IRB member, IRB chair, etc. need additional information.
Back to our friend Susie. She stopped in to talk with her IRB coordinator about the additional information that had been required. The coordinator explained that answering the non-required questions filled in gaps in the information needed to provide a holistic picture of the research project. Susie realized she had more working knowledge of the protocol so had filled in the gaps in her mind without writing down the information. Answering the questions helped the IRB team see the big picture regarding study activities and move the project forward to approval.
At RSPO we are committed to open, collaborative communication. If you are confused by a question posed to you as part of the IRB review process, we are always willing to talk it through and explain the rationale for the information being requested. Even when a question is not required in the IRQ, if your IRB coordinator asks for it to be completed, that request is not arbitrary but couched in the criteria for approval and KP IRB review requirements and processes.
Ultimately, we are here to help you provide the information required to meet federal regulations and guidelines to receive approval for your research projects. Think of us as an extension of your study team: a resource that is trained to know the IRB requirements so you don’t have to!