By Mary-Tara Roth, RN, MSN, MPH,
Director, Clinical Research Resources Office (CRRO)
Consistency Matters: Avoiding a Common IRB Submission Pitfall
Even relatively simple IRB submissions can feel like a complex puzzle. While there are many regulatory and procedural requirements to navigate, sometimes it is the “simple” issues that most delay IRB approval.
One very common issue that we see in CRRO reviews that can drastically slow down the IRB review timeline is INCONSISTENCY - when submission components are not aligned either within a single document or between documents.
This creates a confusing submission in which key research processes or study elements are described differently across the research plan. These discrepancies make it very difficult for the IRB analyst and board reviewers to make determinations on whether the study meets the Federal regulatory criteria for IRB approval (the “111 criteria”). When this occurs, the IRB analyst will have to write formal stipulations for the study team to respond to. This can, of course, slow down the IRB approval process.
It is very important that information within a single study document is internally consistent. It is equally important that the various documents submitted to the IRB present a cohesive and consistent research plan. Here are a few “real life” examples of inconsistencies within documents and between documents that we have seen in CRRO consults.
Within document inconsistency:
- The Protocol Summary table at the beginning of the detailed protocol document lists primary and secondary objectives that are different from what is provided in the Objectives section in the body of the detailed protocol document.
- The INSPIR Recruitment section does not mention phone screening, but the Procedures section describes a phone screening process.
- The Consent document Overview section lists risks and benefits that are not consistent with the Risks and Benefits sections further on in the consent form.
Between documents inconsistency:
- The INSPIR application notes in Section 8.1 that there is no detailed protocol attached, but there is a detailed protocol that has been written and attached.
- The risks section of the consent form is substantively different from what is listed in the risks section of the detailed protocol. Important risks described in the protocol should align with risks presented in the consent form (though the language in the consent form may be in simpler, lay language).
- Protocol exclusion criteria in the detailed protocol are not consistent with the exclusion criteria in the INSPIR application.
The good news is that the research team can put some steps in place to ensure consistency! Here are a few strategies you can put in place:
- Some teams find it helpful to create a single “source of truth” document for key study elements (objectives, procedures, risks, eligibility criteria, recruitment methods, safety monitoring, etc.) and refer to that document when drafting all submission materials. This can be especially helpful if different members of the team are working on different components of the IRB submission.
- Another strategy is to conduct a deliberate cross-document review of the entire submission before IRB submission to find and correct any inconsistencies.
Consistency across IRB submission materials is more than an administrative detail — it is essential for clear IRB review and accurate representation of the research plan. Taking time to ensure alignment within and across documents can have big impacts: reducing stipulations, improving review efficiency, and supporting a smoother path to IRB approval!
The CRRO is supported by the Boston University Clinical Translational Science Institute (CTSI) and the Office of Human Research Affairs.