Best Practices Spotlight: Create lean, efficient, compliant SOPs

Expert keeps SOPs up-to-date

The IRB office at the University of Utah in Salt Lake City takes its standard operating procedures (SOPs) very seriously. The IRB even dedicates one highly experienced, part-time professional to make frequent revisions and improvements to the SOPs and guidance.

“She literally works with senior staff members to constantly review the SOPs and guidance and continually update them,” says John Stillman, CIP, IRB director.

In Stillman’s 11 years with the IRB, it has been a struggle — especially early on — to develop the SOPs and make ongoing reviews of them. But when one of the most experienced members of the IRB office’s 15-employee staff had to move across the country, the IRB made this an opportunity to secure the ideal person for the job of monitoring and updating SOPs and guidance. The employee was offered a job that could be done electronically and remotely since the entire human subjects protection program is automated and Web-based, Stillman explains.

“She has access on our website to this online system, and the way we’ve designed the system, it’s relatively easy for her to do that in Indiana,” he adds. “The fact that we’re automated has helped us to maintain that relationship; she can Skype with us to attend senior staff meetings.”

All suggested modifications to the SOPs and guidelines are reviewed by the associate director before they are approved and posted online, Stillman says.

The IRB’s guidance and SOPs are extensive. The IRB’s website has links to nearly 50 SOPs and even more guidance and policies. The SOPs are brief — mostly a couple of pages — and they are written in a numbered format. For instance, the SOP on training and education has two short paragraphs on policy and three numbered points on procedures, including IRB staff training, IRB member training, and investigator and study personnel training.

The goal of the SOPs and guidance is to have them communicate what should be seriously considered for any given policy and procedure, Stillman says.

The SOPs and guidance inform investigators, IRB staff, and others without dictating precise actions. This is to prevent deviations that violate policy. For instance, the SOP on IRB staff training says, simply, that “IRB staff will be encouraged to attend workshops and other educational opportunities focused on IRB functions and human subject research.” If the policy were to specify sending staff to a specific workshop, then when that workshop suddenly becomes unavailable the IRB office could be in violation of its SOPs.

The IRB kept the SOPs written without explicit details for that reason, Stillman says.

“What we hope is that investigators will use the guidance more than the SOPs, so they can see these are the definitions and time frames,” he says. “We generally drive them toward the guidance and, depending on the event, I might provide a link to the guidance in an email.”

The guidance is more detailed and typically longer than the SOPs. The guidance contains a shaded box of “points to consider,” which lists questions that will be asked in the study application, pertaining to this subject. The IRB’s specific culture and expectations also are listed in the guidance.

For example, the four-page investigator guidance on recruitment methods states under the subhead “telephone calls” that the IRB generally does not allow cold calling in order to recruit participants. “If a researcher wishes to contact potential participants by telephone, a recruitment letter should be sent prior to the telephone call. The IRB strongly recommends that this letter include contact information for a potential participant to call in the event they chose to ‘opt out’ of forthcoming telephone contact,” according to the guidance.

The IRB office uses the SOPs to make sure policies and procedures are correct and to make sure all rules are being followed, Stillman adds.

“We also use SOPs as a tool to help our investigators,” he adds.

For instance, the three-page SOP on the definition of human subject research gives researchers the specific definitions under FDA and HHS regulations, as well as the University of Utah’s policies regarding human subject research.

The IRB worked with a media consulting firm to improve its Web design based on data about which pages received the most hits, Stillman says.

“For years we had tons of information you could access, but it was so much information that it might have been overwhelming or difficult to find exactly what you wanted,” he adds.

The Web design changes were geared toward making the site more interesting to users and to lead them to the answers they need, Stillman says.