OHRP’s QI program: You can go another way
It’s free and has three stages
IRBs that are not quite ready to apply for an accreditation might take advantage of a free quality improvement (QI) program established by the Office for Human Research Protection (OHRP) in Rockville, MD.
Comprising three stages, the program was designed to assist IRBs and human research protection programs with reaching their quality goals, says George Gasparis, director of the Division of Assurances and Quality Improvement for OHRP.
"We developed the QI program to complement our education efforts out of the Division of Education and the Division of Compliance Oversight to strengthen human protection programs and IRBs," he says. "The goals we have are the goals most institutions share. They want to provide a quality review of research for their facility and investigators, and they usually have an interest in improving performance and efficiency."
Here’s how the QI program works:
• Stage 1 - Quality Assurance: First, OHRP will guide institutions in efforts at self-assessment, providing IRBs with a self-assessment tool for this purpose. IRBs are asked to submit their operating procedures and minutes from three meetings for a preliminary review, Gasparis says.
Officials will then review the IRB’s operating procedures and evaluate the assessment, providing feedback to the institution through the use of written correspondence and a teleconference, a video conference, or an on-site consultation.
"After assessing an institution, we provide consultation on areas they may need to focus a little more attention on," Gasparis says. "Eventually, we want to do 30 consultations a month and then 60 consultations a month."
• Stage 2 - Quality Improvement: Once an IRB has been through the quality assurance stage, it’s time to work on improving the existing processes, he says.
QI consultants will offer advice on how an institution can improve its processes, and IRBs can access best practice, examples of procedures, and tools that may assist in quality improvement.
"We highlight for institutional officials their strengths and weaknesses," Gasparis says. "If we find a weakness we give a consultation on how they can make improvement in that area by offering examples of what we’ve seen implemented successfully in other institutions."
These examples of best practices will be posted anonymously on the OHRP web site if the institution grants permission.
Also, the QI program will foster networking relationships where best practices can be shared between institutions and IRBs.
• Stage 3 - Continuous Quality Improvement: The QI program will assist IRBs in developing their own continuous quality improvement programs.
As with all of the stages, any information shared between the IRB and the OHRP QI program is kept confidential and may qualify for exemption from the Freedom of Information Act.
Also, the QI program will not share its observations during the QI consultation with the OHRP Division of Compliance Oversight unless there is a threat to research subjects’ safety, Gasparis says.
"Any information we collect for evaluation of the program we would return to the institution and not keep copies in our office," he says. "As soon as we complete the consultation, we return any sensitive information to them, including IRB minutes."
IRBs that are not quite ready to apply for an accreditation might take advantage of a free quality improvement (QI) program established by the Office for Human Research Protection (OHRP) in Rockville, MD.
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