Thursday, July 26, 2012

Transforming the Research Review Process and Faculty Perceptions

Case Study: University of California, Los Angeles
AAHRPP Accredited Since 2009

The Situation
The University of California, Los Angeles (UCLA) has long been regarded as one of the nation’s top public research universities. Within the university, however, several years ago researchers developed a marked dissatisfaction with the institutional review board (IRB), which often was viewed as obstructionist. In addition, UCLA’s decision to seek AAHRPP accreditation was not popular with senior faculty. They were especially concerned that the effort required to meet AAHRPP standards would increase demands on IRB staff and result in additional delays for IRB approvals.

The Challenge
In truth, many of the complaints about the IRB were justified. Research review times were excessive, the review process was not transparent, and IRB staff responsiveness was not consistent because of high staff turnover. To build support for the IRB and AAHRPP accreditation, UCLA had to make fundamental changes in IRB policies, practices, and procedures. UCLA also had to educate researchers about the benefits of AAHRPP accreditation, including streamlined processes and improved turnaround times.

“The researchers had a lot of misconceptions about AAHRPP,” says Sharon Friend, MS, CIP, Director of UCLA’s Office of the Human Research Protection Program (OHRPP). “Contrary to what many of them had heard, AAHRPP standards allow a level of flexibility in interpretation of the regulations that UCLA had not previously applied.”

The Solution
UCLA recruited Ms. Friend to spearhead IRB improvements and AAHRPP-accreditation efforts. 
She had helped shepherd another institution through the AAHRPP-accreditation process and had experience as an AAHRPP site visitor. At UCLA, Ms. Friend made three key decisions:
  1. To begin by focusing on customer service. It was critical for staff to understand that by facilitating the IRB review process they were not only helping the researchers but also serving the research participants.
  2.  To reach out to faculty and others who were dissatisfied with the IRB and invite them to provide input and play a role in turning the situation around. The OHRPP established a faculty review committee to make sure faculty were involved in designing a new application, revising policies and procedures, and developing a new Web-based IRB submission, review, and approval process. In response to faculty requests, the OHRPP focused the changes on federal and state requirements and used national best practices as guidelines.
  3. To use AAHRPP standards to overhaul the IRB and, in the process, prepare the OHRPP for AAHRPP accreditation. UCLA drew on AAHRPP’s standards and on best practices from AAHRPP-accredited institutions to set requirements and develop guidelines.
“We changed everything,” Ms. Friend recalls, “from the application forms and criteria to turnaround times and, most importantly, attitudes.”

Communication, education, customer service, and quality improvement all played key roles. Ms. Friend took every opportunity to meet with IRB clients to solicit their input and educate them about upcoming changes. She emphasized the shared responsibility for human research protections. She also appealed to faculty and others at UCLA by citing the university’s proud reputation as a leader in the research community.

“I posted a list of highly respected organizations, both public and private, that had attained AAHRPP accreditation,” Ms. Friend says. “There’s no question that we belong in that group.”

The Results
The changes adopted by the OHRPP had significant, positive effects on the human research protection program at UCLA, as well as on the relationship between researchers and the IRB.

  • Researchers now look to IRB members and staff as colleagues and facilitators who can and do contribute to the high quality of research being conducted at UCLA.
  • Research quality improved because the IRB and researchers began to focus their attention and efforts more on risk assessment and risk reduction and less on minor administrative matters. The review process became more rigorous and more transparent. For example, it specifically requires provisions to reduce risk to research participants and detailed information on data safety monitoring.
  • Despite the added rigor, the new process is more user-friendly, more efficient, and more flexible. Turnaround times have improved, in part because the IRB now uses expedited reviews for research that poses minimal risk. Of the more than 4,000 studies submitted for review each year, roughly three-quarters are reviewed using the expedited procedure. About 1,000 are reviewed by the convened IRB, and the rest are exempt.
  • UCLA attained AAHRPP accreditation in June 2009 and was reaccredited in June 2012.

“Before accreditation, the IRB review process was considered capricious and cumbersome,” Ms. Friend says. “Now, we have standardized systems that protect participants while enabling researchers to be competitive and innovative. AAHRPP accreditation provided us with a road map to make these improvements.”

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