Not-for-cause audits can keep program on track
Not-for-cause audits can keep program on track
Discover trends early to fix system problems
Quality assessments can be a good strategy for finding compliance problems that otherwise would fly under the radar. These not-for-cause audits require some staffing resources, but if handled efficiently they uncover problematic trends and bad habits before an issue becomes serious.
For instance, a quality assessment found a student researcher who was running a small study's funding through a personal bank account. The student was unaware of the correct budgeting procedures, says Susan Rose, PhD, executive director of the office for protection of research subjects at the University of Southern California in Los Angeles, CA.
"This researcher was keeping careful records, but it's not okay to run a study like that," Rose says.
The assessment's findings gave the research office an opportunity to educate this budding researcher, as well as to improve communication and education for all new researchers about how to handle grant and other sponsor funds.
The research office now has changed its application form to ask if a researcher has funding, and if the answer is "no," then the form asks if there is funding that is pending. The communication needed to be made clearer because inexperienced investigators often would say they didn't have funding because the money was not yet in their hands, Rose adds.
Now the office has a clearer picture of who is doing funded research, and a "yes" answer can trigger additional communication and information about how to handle budgets and sponsor or grant money.
In another example, a quality assessment found that student investigators were using the wrong informed consent forms. They were supposed to use the form that had been corrected, approved, and stamped, and they were not using that one.
"The second time we saw the wrong informed consent form we knew we had a problem," Rose says. "That immediately identified a pattern."
They discovered that students were using the wrong forms because they couldn't find the correct ones when navigating the online system. So the research office fixed the online system and continues to refine its navigation and communication features.
"Now we have a direct link in the electronic approval letter, and it's much easier to find," Rose adds. "We made sure the source of approved documents is labeled and much more visible."
The quality assessments often result in some findings large or small that require a fix and process change.
For instance, the research office staff discovered that investigators misunderstood an application question pertaining to whether they had initiated a drug or device trial, Rose recalls.
"We had dozens of folks saying, 'Yes,' even to applications for studies funded by the National Institutes of Health (NIH)," she explains. "So we changed the language in the application so they now understand that even though they have the study, they're not the sponsor if they receive grant funding."
Each year the research office summarizes the findings and changes and communicates these to the research community. The office also publicizes the results of its annual survey that is sent to every investigator who has an active project.
"We let researchers know what fixes have happened from their comments on the survey and on the audits," Rose says.
The quality assessments are performed 10 times a year by a continuous quality improvement (CQI) team that consists of one person who works in the IRB office and one person who works in the office for the protection of research subjects. There are limited funds for the role, so staff resources are pulled from other work, and the CQI team takes time each month to do one review, she explains.
"We spent a whole year learning how to do them and interviewing every auditor on campus, including the finance people, compliance staff, and others," Rose says. "We had two students who interned with us, and they both were from other countries where they had done audits previously, and we learned from them while they received credit for it."
Selection criteria
The research office established an outline, checklist and matrix for conducting the audits. Since the staff time is limited, they decided to have selection criteria for quality assessments, rather than to make these random. The selection criteria is as follows:
- Schools and/or departments that submit high volumes of studies to the IRBs;
- Investigators who have a high volume of active protocols;
- Investigator-initiated protocols;
- Studies including vulnerable subjects;
- Studies conducted outside of the United States.
"We ask people for suggestions of studies," Rose says. "We have one phone call a month with the whole team, including IRB directors, chairs, and our office, and we ask folks if there's anyone we should take a closer look at."
When a study is selected for an assessment, the CQI team writes to the principal investigator and requests that documents are made available.
"The team reads everything they can ahead of time," Rose says. "I want them to focus on the style of the PI's study conduct."
The CQI team also reviews the informed consent forms and privacy/HIPAA documents.
The quality assessment activities, according to the research department's policies and procedures, include the following:
- Interviews with the PI/research team to assess their knowledge of the study procedures;
- Obtaining feedback from researchers on the IRB process;
- Inspection of subjects meeting inclusion criteria;
- Records inspection and storage facilities;
- Inspecting documents and coding mechanisms used to protect confidentiality;
- Review of adverse events and unanticipated problems documents;
- Inspection of PI and researcher curriculum vitaes (CVs) and education certificates (human subjects, HIPAA, as applicable);
- Inspection of payment logs.
"The CQI team spends two to three hours on the review," Rose says. Then they write a report, which Rose edits. It includes items that need to be corrected, and it's sent to the PI.
"We might say we will have to come back or that we're available for education sessions and could help them stay on track," Rose says.
Education includes a list service and news bulletins in which regulatory and policy changes are posted.
The department also has held large educational sessions that were so well attended that $2,000 was spent on pizza, which was the incentive for attending, she notes.
One change resulting from the quality assessments involved more formalized education for faculty mentors of students who are engaging in human subjects research.
The faculty members who were not doing research themselves had objected to having to attend the educational sessions, but the research office informed them that they'd have to learn more about human subjects research since they were mentoring students engaged in those types of studies, Rose says.
"We also made a booklet for faculty advisors," she adds.
Quality assessments can be a good strategy for finding compliance problems that otherwise would fly under the radar. These not-for-cause audits require some staffing resources, but if handled efficiently they uncover problematic trends and bad habits before an issue becomes serious.Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.