On May 5, 2016, PRIM&R hosted a webinar titled Tools, Templates, and Checklists for Streamlining IRB Protocol Review, presented by Sharon Freitag, BS, director of the research ethics office at St. Michael’s Hospital in Toronto, and Megan Kasimatis Singleton, JD, MBE, CIP, associate director for human research protections at the University of Pennsylvania.
During this webinar, speakers demonstrated how to identify, develop, and successfully implement tools, templates, and checklists to aid in streamlining aspects of protocol review that often present challenges for human research protections programs (HRPPs) and their staff.
Tools for streamlining protocol review are abundant, and are often generously shared between and among institutions. Speakers offered a five-step strategy to follow when introducing a new tool:
- Identify your objective. What are you trying to achieve with your tool? Singleton highlighted some common challenges in protocol review, including issues of completeness (your IRB staff aren’t completing all required steps of processing a submission), consistency (there is variability among your staff in the way they’re processing submissions), and compliance (your program has trouble properly documenting compliance).
- Determine which type of tool will address your need. You may determine that a pre-existing tool needs to be expanded, or perhaps an entirely new tool is needed. Not all problems can be fixed with a template or checklist; sometimes, educating and re-training staff directly is more effective.
- Develop your tool. Singleton shared some general tips for creating tools. Importantly, tools should facilitate thoughtfulness on the part of the completer. They should not encourage mere rote completion and they should not create additional work.
- Implement your tool. Consider a “soft rollout” of a new tool by piloting it with individuals who are amenable to trying something new. When it’s time to fully implement the new tool, be sure to define how it will be used in your standard operating procedures (SOPs).
- Evaluate your tool. Before you implement the new tool, gather data on the prevalence of the problem you are trying to fix. Six months later, after the tool has been implemented, see if there has been an improvement. If not, refine and modify the tool. Assess end-user satisfaction by conducting an informal survey of those using your tool.
The speakers provided a number of examples to illustrate the process of identifying, developing, and evaluating a new tool. Tool-based solutions were offered for screening protocols, facilitating IRB member review, recording and documenting IRB meeting minutes, and engaging in IRB correspondence.
The webinar concluded with links and references to pre-existing tools, templates, and checklists for attendees to adopt and utilize at their own institutions. Speakers emphasized that, as long as authorship credit to the original institution is provided, there is no need to reinvent the wheel when it comes to tools, templates, and checklists to facilitate protocol review.
Are you looking for specific additional resources to use at your own institution? PRIM&R members can access a vast collection of forms, templates, and SOPs provided by other PRIM&R members across the country in the Knowledge Center. Log in to access this and many other valuable resources in the Knowledge Center.
PRIM&R would like to thank our presenters for their time and expertise!
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