Researchers Encounter Challenges with Study Development Protocols
Study protocols might be noncompliant with IRB requirements, which means several rounds of reviews before the research can proceed. “We wanted to address the issue of inconsistent compliance with research protocol requirements in order to reduce delays,” says Alison Oliveto, PhD, vice chair for research in the department of psychiatry and behavioral sciences at the University of Arkansas for Medical Sciences.
The institution implemented an online protocol development tool with the hope of reducing delays in IRB approval.1 Oliveto and colleagues examined whether the tool provided helpful guidance for investigators and whether it led to shorter times to IRB approvals. They surveyed 23 study investigators; this small sample hindered the work to some extent. It was unclear whether this small sample was because few investigators were developing protocols at the time or whether there was just a general lack of interest. “Also, the tool itself had more quirks than anticipated that were not apparent. This made the tool less intuitive and led to lost work that frustrated users,” Oliveto laments.
Oliveto and colleagues intended to collect follow-up data on the tool’s effectiveness. It turned out this was not possible. Not one protocol was submitted using the template the tool generated. Participants gave various reasons for not using the tool. For some, the issue was they were familiar with the existing protocol development templates at the institution and did not want to switch. Others did try the tool, but they struggled to save their work, and gave up. “One of the issues was that the online tool was not integrated into the institution’s existing templates,” Oliveto says.
Thus, a completed protocol had to be saved, downloaded, and then uploaded into the IRB submission system. The online tool has been discontinued, at least for now. Oliveto and colleagues remain open to the possibility of integrating protocol development tools into existing institutional templates as a possible way to expand use in the future. “Locally developed templates, when used, seem to help enhance protocol compliance, although the guidance in the template is not always followed,” Oliveto says.
Online protocol development tools that require completion of necessary protocol sections may help enhance protocol compliance. “However, these tools likely need to be customized to the institution and integrated within ongoing IRB processes in order to be more feasible and acceptable to investigators,” Oliveto says.
Delays in IRB approval happen for many reasons. “Often, study teams misclassify their study submissions or misunderstand what types of studies qualify for expedited IRB review,” says Edward Kuczynski, director of the human research protection program at the University of California, San Francisco (UCSF). Some common examples of issues that cause delays:
- Any study involving exposure to ionizing radiation cannot be considered minimal risk, although investigators often assume a simple chest X-ray represents no more than minimal risk.
- Studies involving the use of an assay are device studies and must be evaluated by full committee to make a risk determination. However, many study teams overlook this requirement.
- There are minimal risk limits on volume and frequency of blood draws for research, especially for children. These limits often are exceeded in the original submissions and must be modified before study approval.
“Any proposed procedures that are considered greater-than-minimal-risk will require full IRB committee review and inclusion of additional supporting material,” Kuczynski notes.
There may be additional ancillary committee reviews required (e.g., radiation safety if research X-rays are proposed). “These types of errors lead to returns for added details and delay the time to approval,” Kuczynski says.
Investigators can use consent form templates that identify required language for compliance with federal, state, and university policy. “Too often, investigators omit such language, resulting in delay of approval,” Kuczynski says.
The IRB prevents delays in a few ways. For example, study investigators are encouraged to collaborate with more experienced colleagues in their department or division. “This can improve the quality of initial submissions and help with identifying required elements,” Kuczynski says.
Elsewhere, UCSF provides extensive guidance on its IRB website to help study teams identify required components of a protocol. Also, UCSF hosts periodic training “boot camps” and webinars. The IRB education and training coordinator conducts these trainings as part of a more comprehensive training program. “It’s geared toward clinical research coordinators, but it’s open to all, and many individual principal investigators attend,” Kuczynski reports.
Topics start with the basics — what constitutes human subjects research, what research may be exempt from IRB review, and what constitutes minimal risk research. The training progresses to more complex issues, such as how investigators should determine risk to participants, protect privacy and confidentiality, and share data and biospecimens.
The IRB has used commercial protocol-building tools, but in a limited way. “The tools may be useful if they can be customized to address the local context in which IRB review occurs, including consideration of local, state, and campus policies,” Kuczynski says.
The IRB has found training videos are more effective. These illustrate how to submit a protocol using the institution’s particular software. The IRB also makes exemplary applications available as models.
“In the past, we considered licensing a commercial tool but found it to be inadequate to our particular needs,” Kuczynski says. “We think our training materials are more beneficial as they are targeted to our particular needs.”
- Boateng BA, Oliveto AH, Bailey M, et al. Utility of protocol development software for IRB protocol development: Experiences from one Institution. SOCRA Source 2021;107:39-42.
Tutorial videos and webinars, in-person training, and sample forms are some of the ways researchers try to keep up with IRB protocols to prevent any study delays.
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