By Melinda Young
One method to improve regulatory compliance while maintaining IRB efficiency lies in teaching investigators how to conduct self-audits of their protocols and studies.
“We have thousands of studies, and we can’t talk to every single research team. We have to be innovative in the way we do things,” says Sana Khoury-Shakour, PhD, CCRP, director of the office of research compliance review at the University of Michigan. “We mainly do compliance reviews. Those outcomes inform our quality improvement [QI] initiatives.”
The office developed a self-audit process that can be used for any study and is available online. “We established this process to keep educating those study teams,” Khoury-Shakour says.
“It morphed into self-audit tools,” she adds. “We found that it was very helpful to study teams. We thought about how we could expand it and create additional self-assessment, self-audit tools that can be used for any study.”
The tools are available to the public. Multiple research institutions have asked if they could adapt the tools for their own use. “We’re all about sharing the practices and have shared them,” Khoury-Shakour says. You don’t need a login to access them online.” (The tools are available at: https://research-compliance.umich.edu/research-integrity/office-research-compliance-review-orcr/self-assessment-tools-investigators.)
The research compliance review office started with its existing tools, building on those and designing them to be self-administered. Making the tools available publicly online was part of the plan.
“Every year, we add one or two,” Khoury-Shakour says. “These do not replace any of our compliance reviews; they just complement it.”
This is how self-auditing tools were designed:
• Develop plan, goals, timeline. Creating the tools took a little time and required a plan, goal, and target dates.
“When we first started this, we investigated it for a few weeks before we had a target,” Khoury-Shakour explains. “Each year, we develop an annual plan of what we want to achieve. This project was one of the goals for that year.”
The office dedicated staff time and effort to the project with the goal of publishing six checklists. “Initially, we did invest some time into developing the tools,” Khoury-Shakour says. “Once you have the templates, it’s just thinking about it and not reinventing the wheel.”
Since the IRB office already used checklists, monitoring tools, and templates, they knew it would not be too challenging to make those existing tools available for study teams to use, she adds.
• Start each uniformly. “You will see one uniform approach for how we do those,” Khoury-Shakour says. “We make sure the look and feel of the tools are the same. They each start with an introduction and explanation on how to use the tool.”
It includes a table in which the investigator can insert study-specific information, Khoury-Shakour says. “We try to make them in a way that each study can tailor them to suit their study. We just try to create them in a way that people can download them and need minimal tweaking when they start to use them.”
• Create tools as needed. The University of Michigan’s office of research compliance website offers a dozen tools for download, including:
- ClinicalTrials.gov registration and results quality assurance/quality improvement checklist;
- A data security form for assessing the adequacy of data protection mechanisms for a study;
- Eligibility criteria;
- Informed consent documentation that study teams can modify to reflect the specifics of their study;
- Protocol adherence for researchers to assist in the required documentation of monitoring.
• Incorporate feedback. “People think the tools help them improve oversight, and they believe the checklist is educational in itself, putting best practices to the forefront,” Khoury-Shakour explains.
Researchers have noted the resource helps them improve the quality of their work. They find the self-auditing tools easy to tweak and tailor to their own studies. “I’ve heard mainly from people who like to oversee multiple studies within certain units,” she says. “They’ve used them in that way for various units within our schools and colleges that want to provide oversight or improve internal quality improvement for their own studies.”
Study teams use the tools to document their progress, and they report these tools are helpful. “The exercise of going to and using the checklist results in discussions among study teams and department leads. I think people are finding a way to improve their recordkeeping,” Khoury-Shakour says. “That information is readily available to them when they’re ready to submit a continuing review to the IRB.”
• Use tools for training. Sponsor-investigator studies, where faculty hold the investigational new drug (IND) application, require additional training. The self-auditing checklists are provided to them as part of that training, she says.
“That is one way those checklists have been used,” Khoury-Shakour says. “Units also are using them to improve oversight and improve the quality of the conduct of studies within their units.”
The checklists also are used for nonsignificant-risk device studies and in research for which monitoring is required by the Food and Drug Administration (FDA).
The FDA requires documentation proving investigators are providing oversight and self-monitoring. “This also is something we recommend if certain teams want to provide for any outside inspection,” Khoury-Shakour says. “It’s a good tool to document how they are monitoring and documenting their work. We also have a monitoring unit, but it is not to replace those services.”
• Provide minimal education. The research compliance review office needed to provide little education and outreach about the self-auditing tools.
“When we first posted them, we published the information in various internal newsletter articles to let the community know there was a new resource available to them,” Khoury-Shakour says. “When we conduct a study start-up and routine audits, we remind study teams that this tool is available to them, and we hand them the tool, saying it could be really useful to their study.”
Since not every checklist is applicable to every study, compliance review staff point out the specific tools that could be useful to the study team.
“We work closely with IRBs, and all are aware of the checklists,” she adds. “They also can point people to use them and download something and provide assistance.”
One method to improve regulatory compliance while maintaining IRB efficiency lies in teaching investigators how to conduct self-audits of their protocols and studies.
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