Include criteria for review in policy manual
IRB chair finds helpful guide
If an IRB's policy and procedures manual needs updating, it might be time to write or revamp the section on criteria for review.
It's important to have these criteria in writing and with references or links to the regulatory sources so investigators and others can see where they come from, says Lawrence Stark, PhD, an associate professor and IRB chair at the Southern California College of Optometry in Fullerton.
Stark reviewed the IRB's policy manual a couple of years ago and found that some items were clear and provided all of the necessary information. But as he worked on revising and improving it, he found that criteria for review information came up short.
"I think the reason why the criteria for review is so difficult to explain is because there are so many different aspects people take into account when reviewing a study," Stark says. "And so many things happen in daily life that you can't account for every combination."
This leaves the person writing the update with the question of whether to write specific details into the criteria or simply to keep the criteria general, stating something about how the criteria for review are obtained from relevant laws, ethical principles, and other sources, Stark says.
This dilemma is partly a writing issue, he notes.
Once Stark found guidance for writing effective policies and procedures, the goals for writing criteria for review began to form more clearly. Stark read a book, published in 1998 by AMACOM and written by Nancy J. Campbell, titled, Writing Effective Policies and Procedures: A Step-By-Step Resource for Clear Communication.
"The book was interesting because in the first chapter, Campbell mentions the very questions I was having," Stark says. "Also, it struck me that writing these criteria requires a special type of writing I've never done before: technical writing, and there's a skill to doing that."
The key to rewriting the policy and procedures manual is to include general goals for the project and decide how specific the manual will be with regard to procedures, Stark says.
"It could become problematic if you have to describe every detail," he adds.
Another thing to keep in mind is that each policy and procedure comes from some identifiable source. The writer should know where they come from, although explaining this in the manual might not always work toward creating an effective and useful guide, he says.
"If I put in cross-references to a common procedure then it starts to get convoluted," Stark explains. "All the cross-references can become a little overwhelming."
Stark has found a solution to this dilemma by creating a format for each section in which the policy is described first and then the rationale is described, with subheadings. The section might also refer to a form that needs to be filled out.
For example, there is a policy for reporting and handling adverse events. The adverse event form has a series of questions and sheets to be filled out. In an electronic policies and procedures manual, this form could be accessed through a link.
When Stark completes the policy and procedures manual revisions, he plans to post it on the IRB's internal website in a PDF format for investigators and others to download and review.
"I've been reviewing parts of the policy manual and will make it more plain," Stark says. "Then I'll get input from the IRB members about what should be included in the manual."
If an IRB's policy and procedures manual needs updating, it might be time to write or revamp the section on criteria for review.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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