Assess your QI program and adjust according

Education reflects audit findings

Through evaluation programs, a research institution can learn what works and what doesn't in its quality improvement efforts.

Many research organizations have quality improvement (QI) and auditing programs that conduct for-cause and/or not-for-cause audits of research projects. This checks and balance strategy works well for ensuring compliance in human subjects research. But it might not go far enough in improving overall institutional quality. For instance, who evaluates the QI or auditing program to make certain it is working as well as it should be working?

Winthrop University Hospital in Mineola, NY, started an audit program in 2004, focusing on the educational aspects of the program, says Tina P. Berry, CIP, IRB director.

"About a year ago, I thought we needed to evaluate the program and see how it's doing," she says.

Berry met with the QI coordinator and others in the research program to identify how the educational effort was working and to assess its results. They looked at trends found in the QI audits and how these were being addressed.

Among the issues discovered, Berry found that communication about QI issues could be improved between investigators and their staffs.

Another issue involved the QI coordinator's role and clinical trial staff's perception of that role. Too often people saw the QI audits as punitive rather than educational, she adds.

To counter this perception, research staff and investigators were invited to a 2.5-hour educational session with the QI coordinator. Later, the attendees of the session were assessed for their compliance with human subjects research guidelines. The research institution also holds monthly educational sessions.

Both QI audits and the educational sessions have focused on informed consent issues, which tend to be one of the biggest identified trends, Berry notes.

Sites sometimes fail to use the right informed consent form, and documentation is sloppy, she adds.

The monthly educational sessions are marketed through fliers and newsletters. They are not mandatory, but are well-attended, Berry says.

The 2010 series included sessions on a variety of topics, including the following:

  • What is good clinical practice?
  • How do you navigate the process of investigator-initiated projects?
  • How does clinical research look like through the eyes of children?
  • How do you write a research protocol for IRB approval?
  • An overview of the use of biological specimens in human research.

The 2011 monthly workshop series agenda includes these topics:

  • Overview of consenting — especially in non-English-speaking subjects
  • Sample size and ethics
  • Investigator-initiated studies: phase I, II, and III
  • Internet research and electronic data security
  • Women in research
  • Grants and contracts
  • How to write an IRB-approvable research protocol
  • An overview of the use of biological specimens in human research — a discussion on the use of identifiable and unidentifiable samples
  • Ethical considerations in human subjects research.

The courses are taught by experts. These include IRB members, research coordinators, department chairs, and others. Their disciplines are varied, ranging from biostatistician, research pharmacist, grants specialist, and physicians.

"Sometimes these topics have to be repeated," Berry says. "We collect information from all of our audits and compile this information along with quality information, and come up with the issues we need to focus on."