Random audits of research protocols originally were intended primarily to help monitor compliance with federal regulations to protect research participants. But research administrators say the audits are even more valuable as educational and quality improvement tools, especially when researchers and institutional review board (IRB) staff view the process as a two-way street.
At the Cleveland Clinic, for example, “We prefer to use the term ‘inspection’ instead of ‘audit’ and have developed a program that combines inspection and education to help us evaluate and continually improve human subjects protection,” says Daniel Beyer, MS, MHA, CIP, Executive Director, IRB and Human Research Protections.
“Over the years, we’ve learned that what’s most important is that it’s a two-way street. We are helping the researchers and their team, and they are helping us,” he adds. “Together, we have developed a culture of compliance that extends beyond a traditional auditing program.”
AAHRPP requires continuing review of research studies but allows accredited organizations to set their own policies and procedures for post-approval monitoring.
Department of Veterans Affairs (VA) facilities, for example, must audit each protocol at least once every three years. Other organizations have more flexibility. Some choose to audit studies that present the greatest risk to participants. Others target a particular area—such as conflict of interest—to gauge researchers’ understanding of changing federal regulations.
At the Mayo Clinic, the IRB and the quality management team develop an annual plan to guide their self-monitoring. The plan, which they update quarterly, takes into account a variety of factors, including perceived risk, data on non-conforming events and participant complaints, inquiries from researchers, and the information supplied to AAHRPP in status reports. Random audits then focus on the areas selected for self-monitoring.
According to Gary Cseko, M.S.P.H., M.B.A., Administrator, Research Operations, the emphasis is not on catching mistakes but on preventing them. “Everyone recognizes that this office is constantly looking for opportunities for improvement,” he says. “If we discover a problem, we find the root cause, change the procedure, and educate to the new procedure to prevent the problem in the future.”
At the University of Pennsylvania (UPenn), about 70 percent of research is biomedical. Random audits tend to target the more risky protocols and to mimic what researchers would expect from an external audit. “It’s an opportunity for improvement: a way to make sure everything is in order in the event of an external audit,” says Tracy Ziolek, M.S., C.I.P., Director, Human Research Protections.
UPenn is about to introduce random audits for nonclinical research and will start by making at least three site visits per month. “Our approach will be more supportive than audit driven,” Ms. Ziolek says. “We call it ‘verification,’ and we view it as directed education—identifying where we may have knowledge gaps and filling them in.”
At the Charlie Norwood VA Medical Center, the research compliance officer (RCO) audits at least one-third of all protocols every year, plus 100 percent of all informed consent documents. These are scanned and uploaded to the patient’s medical record and reviewed immediately.
“Everybody wants the same thing,” she continues: “to make sure it doesn’t happen again. We’re constantly checking ourselves to ensure that we’re in compliance and that our research is of the highest quality. We owe that to our veterans.”
“We can see them as soon as they’re completed, so if there’s an issue, we can pick up on it right away,” says Marie Andrews, Administrative Officer for Research and Integrated Ethics Program Officer. “I don’t think anyone other than the VA does that.”
The Charlie Norwood Center relies on metrics to track and address the most common findings. “Issues identified during audits direct the focus of the training we provide,” Research Compliance Officer Tiffye Rocke, R.N., says. “We’re constantly checking ourselves to ensure that we’re in compliance and that our research is of the highest quality. We owe that to our veterans.”