Institution's QI form serves as educational tool for PIs

It helps in identifying strengths, weaknesses

Education is the foundation of quality improvement, which is why one IRB's main educational tool for investigators is an on-line form for quality improvement through self-assessment.

"We want to help investigators identify strengths and weaknesses in their own systems, and we want to help them understand how to fix it," says Judi Kuhl, BS, CIP, quality improvement program coordinator in the office of research integrity at the University of Kentucky in Lexington, KY.

"We looked at a lot of different models, and we came up with an educational approach," Kuhl says. "We thought that was the best thing to keep a good rapport and to keep the focus on quality improvement instead of a punitive approach."

The IRB has the authority to require that an investigator complete this form if necessary, but that's not the form's primary focus, she adds.

With help from consultants, Kuhl refined a less comprehensive QI form after she joined the office of research integrity in 2003.

Before launching the tool system-wide, the institution piloted it among several investigators and experts outside of the university, Kuhl says.

"The feedback I got was it was very, very thorough, and it seemed comprehensive in terms of what investigators need to be doing," she says.

Investigators can use the tool to see what mechanisms are in place to protect human subjects and how they can fix problems within their own systems, Kuhl says.

The self-assessment tool is completed entirely on-line, and there's a sample completed form that investigators can use as a reference.

Under its menu, there are 10 sections to complete. They are as follows:

  • Regulatory documents: "If it's an FDA-regulated study, they have questions to answer pertaining to that," Kuhl explains.
  • IRB documentation: These questions are about how well the investigator is maintaining records for IRB correspondence. These include both institutional policy and regulatory issues, she explains.
  • Subject recruitment procedures: The idea here is to make certain the investigator is following any recruitment methods approved by the IRB.
  • Unanticipated problems/adverse event reporting: "This section gets into whether they've submitted everything they're supposed to submit to the IRB," Kuhl says.
  • Drug/device accountability: "We have an investigational drug service [IDS] at our university, and that operates through our pharmacy where they handle all research drugs," Kuhl explains. "The questions cater to those individuals who do not use the investigational drug service because the IDS does a lot of accountability type control things."
  • Record keeping: Questions pertain to how long the investigator maintains files.
  • Other compliance categories: There are a number of committees to which a principal investigator will have to submit forms, so this section covers the other submissions, including those to the institutional biosafety committee, the general clinical research center, the radioactive drug research committee, the radiation safety committee, and the cancer center's committee, Kuhl says.
  • Informed consent categories: Investigators will answer questions about how they are conducting the informed consent process and whether they have a signed consent form on file for subjects. The form also requests the investigator list dates when a sample of consent forms were signed and the date when the IRB approved the consent form document.
  • Individual subject review: Questions here include these: Did any research procedures commence prior to IRB approval, and is there an inclusion/exclusion criteria checklist?
  • Case report form/source documents: "These questions include: Are there source documents? Do you have case report forms? Are the data in source documents matching what you have in the case report forms?" Kuhl says.

Kuhl frequently shares the form, which was developed with funds from the National Institutes of Health with other institutions and IRB professionals.

"I get e-mails regularly, and I send them the completed version," Kuhl says. "They need only to get into the web page and enter a password that I've given them."

University of Kentucky investigators also use the sample completed form this way, and this is one way that it serves as an educational tool, she notes.

When investigators instead use the form as a QI tool, they answer questions electronically and save the data into a database that Kuhl can access.

"They can save each section's information as they work on it," she says. "I don't analyze the data until they've submitted the form as completed."

Investigators also can retrieve their existing form's answers and change these if they need to.

When an investigator's answer indicates a compliance problem, the system will automatically send the investigator a corrective action suggestion.

"Corrective actions are automatic," Kuhl says. "The answer they give is what triggers whether or not a corrective action will show up."

Once an investigator makes the correction, he or she can change the answer.

"When they feel like they are done with the form, they hit the button that says it's completed, and all of the data goes into a database where I can look at it and analyze it," Kuhl says.

"In analyzing the data, I wouldn't necessarily bring a problem to the IRB as a QI issue unless I saw something that was significantly deficient," Kuhl says. "For example, if the investigator had not obtained consent from any of his subjects, then that would be an example of a major deficiency."

Most of the answers are requested in a "yes," "no," or "N/A" (not applicable) format.

Here are some sample questions regarding the IRB process and the corrective actions when the answer demonstrates noncompliance:

Is all correspondence (e.g., e-mails, submissions) to and from the IRB on file?

Corrective Action: Obtain/retrieve all research-related correspondence to and from the IRB that may be missing from your records. You may contact the Office of Research Integrity for comparison with their IRB records.

Is the initial IRB approval letter on file?

Corrective Action: Obtain/retrieve the initial approval letter issued by the IRB, or request a duplicate from the Office of Research Integrity, and place a note in your records explaining the letter copy.

If subjects withdrew from the study, was an explanation for each withdrawal submitted to the IRB?

Corrective Action: Report to the IRB in writing how many subjects have withdrawn from the study (i.e., could not follow the process, PI terminated their participation) and explain why they withdrew. If the subject withdrawal was due to an adverse event or unanticipated problem, it may be necessary to also submit an UK/VA Adverse Event/Unanticipated Problem Form to the IRB if one has not already been submitted.

Is the most recently approved list of key personnel still accurate?

Corrective Action: Submit in writing to the IRB a current list of all key personnel holding responsibilities with the study, using the format provided to the key personnel section of the General Information Sheet (in IRB application). Include a cover memo describing who is being added or removed.

At the end of each section there is a field in which the principal investigator can enter explanations or comments about any information they've provided, Kuhl says.

"We thought that was necessary because we understand that in reality not everything is a 'yes' or 'no,'" Kuhl says. "So we wanted to give them a chance to explain something if they needed to."

The next step for Kuhl's office is to update the tool, a process that's underway now.

"Because our institution has gone through the accreditation process, we have a lot of things that have changed policy-wise and document-wise, and there are a lot of references in the tool where the documents no longer exist or have moved," Kuhl explains. "So I'm in the middle of updating it regarding that."

As she updates, Kuhl is making certain the answers still are relevant to current regulations.

"That's why the form was very time consuming to develop," Kuhl says. "It wasn't just asking a question and getting a 'yes' or 'no' answer; we went a step further and got all kinds of information about why we're asking that question, and that includes federal information and references."