A Path to an Even More Effective Social-Behavioral and Educational Research Program

Case Study: Utah State University
AAHRPP Accredited Since 2009

The Situation
Utah State University (USU) focuses its human research portfolio primarily on social-behavioral and educational research (SBER) and has one institutional review board (IRB). The university became interested in AAHRPP accreditation early on “because we thought it was the right thing to do,” says Russ Price, Federal Compliance Manager, Compliance Assistance, USU Office of Research and Graduate Studies. “We felt it was a direction that made sense for the nation and for our program.”

USU also was seeking to differentiate itself from others engaged in social and behavioral research and thought accreditation might help achieve that objective. As one of the first SBER programs to achieve AAHRPP accreditation, “we continue to receive inquiries from SBER institutions that are considering applying for accreditation or that have decided to apply and have questions about the process,” says True Rubal, Director, USU IRB.

The Challenge
USU faced two challenges. Resources were tight. The IRB staff consisted of a single administrator, and it would fall to her to codify existing practices. In addition, USU was in the early stages of building consensus around the concept of a human research protection program (HRPP). The university was still delivering the message that responsibility for protections extends beyond the IRB and is shared across the institution.

The Solution
USU tackled the challenges on three different fronts:

1. HRPP officials recruited “champions” throughout USU. Their role was not only to advocate for AAHRPP accreditation but also to make the case for increased resources and for a culture of shared responsibility for protecting research participants. 
2. Partnering with the University of Utah to take advantage of a capacity-building grant, USU hired a part-time assistant to help formalize and communicate HRPP policies and procedures.
3. USU relied on AAHRPP standards as the framework for policies on research, human subject protections, and institutional conflict of interest. “We started by formalizing policies,” Mr. Price recalls, “and ended up building momentum around the idea of organizational infrastructure.” 

The Results
For USU, the accreditation process made a good program even better. In preparation for AAHRPP accreditation, USU developed a comprehensive HRPP, complete with standardized policies and procedures. The HRPP was integrated with USU’s academic structure, especially with departments and schools—such as the Department of Psychology and the School for Teacher Education and Leadership—that are responsible for a sizable percentage of USU’s human research portfolio. To ensure continued quality improvement, USU now conducts an annual review of its HRPP and uses metrics to make decisions on issues such as training needs and IRB membership.

AAHRPP accreditation also cleared the way for USU to partner with the University of Utah, which now reviews all USU Food and Drug Administration (FDA)-related research. Since both organizations are AAHRPP accredited, they share common standards and are comfortable collaborating. The partnership gives USU an efficient, reliable review process and an assurance of quality for FDA-funded protocols.

“We were already a very effective organization,” Mr. Price says, “so for us, AAHRPP accreditation provided a path to evaluate and improve our processes. It changed the way we approach research and resulted in stronger scientific and ethical reviews of protocols. It absolutely strengthened our program.”

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.”

Using AAHRPP Accreditation to Guide Expansion

Case Study: Schulman Associates Institutional Review Board
AAHRPP Accredited Since 2008

The Situation
Schulman Associates Institutional Review Board (IRB) had built a reputation as one of the nation’s leading independent IRBs. For decades, the Ohio-based company was known primarily as a reviewer of multicenter phase 2 and phase 3 clinical trials. In 2009, Schulman decided to branch out and capture a larger share of the single-site phase 1 market.

The Challenge
Schulman was proud of its commitment to quality and, in keeping with that commitment, attained AAHRPP accreditation in 2008. The company was looking to grow but wanted assurances that any new partner or venture would reflect Schulman’s high standards.

“We have always been absolutely unwilling to compromise on research protections and the quality of the review,” says Michael Woods, President and CEO, Schulman Associates. “At the same time, we provide the highest level of customer service. In our business, we have to.”

The Solution
The company took a two-pronged approach to growth, adding capacity from within and via acquisition. And AAHRPP accreditation played a key role on both fronts.

In October 2009, Schulman began providing research review services in Canada. The company added a Canadian IRB and earned AAHRPP accreditation for it. Two years later, Schulman acquired Independent Investigational Review Board (IIRB) of Florida. Like Schulman, IIRB was AAHRPP accredited.

“We would not have considered an organization that wasn’t AAHRPP accredited,” Mr. Woods says. “Increasingly, the expectation from sponsors and CROs [contract research organizations] is that their IRB will be AAHRPP accredited. Very often, our customers pose that question to us.”

The Results
Today, Schulman has clients from throughout North America, and every year it reviews hundreds of studies involving thousands of research sites. The company’s two-pronged strategy is proving successful. The total number of trials reviewed has increased significantly, as has the number of single-site phase 1 studies.

Thanks in part to AAHRPP accreditation, the assimilation of IIRB has gone smoothly. “Because we are both AAHRPP accredited, we followed the same standards and had the same high expectations,” Mr. Woods says, citing compliance with AAHRPP requirements for policies, procedures, and documentation.

“AAHRPP really worked with us to ensure that we could integrate the two organizations and maintain AAHRPP accreditation, and that’s important to us,” he adds. “In our industry, the way you distinguish yourself is through that magic combination of quality and customer service. AAHRPP accreditation helps us maintain that.”

From De Minimis to Gold Standard

Case Study: Lehigh Valley Health Network Accredited Since 2009

The Situation
Lehigh Valley Health Network routinely oversees approximately 400 research protocols. Most involve Phase 3 clinical trials designed to provide patients with treatment alternatives for chronic or life-threatening conditions. Back when Lehigh Valley Health Network began looking at accreditation, the organization had a single institutional review board (IRB) and was in compliance with federal regulations, but “was operating at a relatively de minimis level,” says Scott Lipkin, DPM, Chief, Network Office of Research and Innovation.

The Challenge
To meet AAHRPP’s accreditation standards, Lehigh Valley Health Network had to create a comprehensive, integrated human research protection program (HRPP). As part of that effort, the organization was required to develop policies and procedures, establish training programs, and professionalize and strengthen the IRB.

The Solution
Lehigh Valley Health Network reorganized and revamped its research protection efforts, including:

• Changing the reporting structure for the IRB to establish it as an independent committee.
• Adding a second IRB to ensure that research protocols receive the necessary, thorough review.
• Creating scientific review committees to ensure departmental review before research is submitted to the IRB.
• Developing an education program.
• Establishing a quality improvement/quality assurance program.
• Creating a community outreach program.
• Integrating the work of the IRB with other departments, including pharmacy, materials management, and legal services.
• Strengthening conflict-of-interest reporting requirements and integrating them with corporate compliance efforts. 
• Hiring additional staff.

In essence, Lehigh Valley Health Network built an HRPP that emphasized that the responsibility for research protections is borne not just by the IRB but by the entire organization. Change of that magnitude would not have been possible, Lipkin says, without “an unyielding financial and political commitment from the institutional official and the rest of the senior leadership team.”

The Results
Lehigh Valley Health Network’s efforts were officially recognized March 27, 2009, when the organization was awarded AAHRPP accreditation. That distinction boosted Lehigh Valley Health Network’s standing with researchers, with regulators, and among its peers. Accreditation also acknowledged that “we were doing a better job,” Lipkin says. “We didn’t just strengthen protections; we created a comprehensive, sustainable HRPP to ensure enhanced protections for the long term.”

A greater emphasis on education helped IRB chairs, members, and staff gain a better understanding of the federal regulations. That, in turn, bolstered confidence and increased the IRB’s willingness to take advantage of the flexibility in the regulations―to lessen the regulatory burden while providing equivalent protections.

The bottom line, according to Lipkin, is that Lehigh Valley Health Network transformed its research operation for the good of patients, researchers, and the organization as a whole. “We were a big success story,” he says. “In 2 ½ years, we went from functioning at a low level to achieving the gold standard of accreditation.”