The main goal of creating an IRB resource guide is for it to be used and useful. If it’s too large and difficult to search, such as a 50-page paper document, or if it’s too cumbersome, such as a spreadsheet, staff might avoid it.
One way to make a resource guide useful is to keep it short and to the point, and include hyperlinks to additional how-to steps, examples, tools, and references, one expert says.
“I wanted to make a guide that was accessible to everyone, that was more inclusive,” says Christine S. Epps, BS, CIP, senior research compliance administrator (RCA) and IRB education coordinator at the University of South Florida (USF) in Tampa.
Epps had created a spreadsheet resource guide for her own use, but as it grew larger, she became disenchanted with its format. The advantages of having an electronic guide that could be edited and revised continuously were apparent, but she also wanted something more nimble and dynamic.
“To answer a question, I wanted more than one line, which was what my spreadsheet had,” Epps says. “The spreadsheet was not easy to review; you had to look hard to find your answer.”
That’s when she came up with the idea of a searchable, hyperlinked word processing document that would allow users to quickly find answers.1
Flexibility for pre-review
The guide was created solely for internal use by RCAs, who pre-review studies, work with researchers to prepare complete applications, and then send those to the board for review.
“It’s about how to do your job as an RCA, where to look for things,” Epps says. “My future plan is to do it for other audiences: to write a guide for IRB members as they do their full review and to write one for researchers — especially student researchers at USF.”
The guide contains a table of contents, but was not designed to be read from beginning to end. It’s supposed to be searched at the moment an RCA needs more information.
The guide, which is under 20 pages, contains main headings of review categories, process of review, and elements of application.
“It is sorted in order of the broadest information down to more specific,” Epps says. “For example, it starts with review types and categories, such as asking the question: ‘Do I need to submit to the IRB?’”
Examples from the resource guide
One page on continuing review has these brief instructions:
“Full board determines Expedited 9 for a continuing review (CR):
“Change to Expedited 9 in ‘set approval period,’ note in minutes and add the following to the approval letter:
“At the convened meeting, the IRB determined the review type of this minimal risk study be changed from full board to expedited category 9 (Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply, but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified).”
“Full board determines Expedited 9 for an initial study:
“Set approval period, but do not change to Expedited 9, note in minutes and add the following to the letter. After the letter is sent, go back to the main study application and set approval period again, changing to Expedited 9 (necessary due to system issue).
“At the convened meeting, the IRB determined the review type of this minimal risk study be changed from full board to expedited category 9 (Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply, but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified).”
The page also contains hyperlinks to:
While creating the guide was time consuming, Epps was able to use information she had already put in the spreadsheet.
Its chief advantage is flexibility: It can be used quickly by experienced RCAs as confirmation of something they knew, and it can be used by new and inexperienced staff who might need detailed and extra explanations and tools, she says.
For instance, the guide contains screen shots as examples, links to sample consent forms, examples of approval letters, and federal regulations.1
The guide provides the information and tools RCAs need for consistency in pre-reviewing study applications, Epps says.
“While you’re doing a pre-review, you might come across something you saw a long time ago and you can’t remember what it was,” she says. “The information you need is in the guide.”
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Epps CS. Development of a searchable, hyperlinked resource guide for IRB staff. Poster presented at PRIM&R’s 2014 Advancing Ethical Research Conference, held Dec. 5-7, 2014, in Baltimore, MD.
