Prepping for accreditation survey has quality improvement benefits

OHRP offers alternative to survey

As IRBs prepare for their first accreditation surveys or consider the pros and cons of applying for accreditation, some who have gone through it say that preparation can be its own reward.

"I feel it’s important for an IRB to be up to standards and to show and prove that you know you’re out there to protect human subjects," says Lisa Korcuska, CCRC, CCRP, IRB accreditation and human subject education officer at the University of South Dakota in Vermillion.

Working successfully toward an accreditation is a good way to demonstrate an IRB’s quality, she says.

"You’re showing all the people you work with, including sponsors, that you are up to the standards and are doing what you need to be doing with human subjects," Korcuska explains. "You’re showing that people overseeing human subject protection have been reviewed very thoroughly."

The University of South Dakota IRB has been preparing for accreditation through the Association for the Accreditation of Human Research Protection Programs (AAHRPP) of Washington, DC.

The New England Institutional Review Board of Wellesley, MA, also has chosen to become accredited through AAHRPP, says Carol Saunders, RN, executive director of the IRB and the president and chief executive officer of the Center for Clinical Research Practice in Wellesley.

Initially, the New England IRB was impressed with the accreditation program developed for veteran administration systems by the National Committee for Quality Assurance (NCQA), she says.

Then the accreditation standards developed by AAHRPP were significantly revised and expanded and, by the summer of 2002, the New England IRB felt that AAHRPP’s program had ripened into a well-developed tool for self-assessment and external evaluation, Saunders explains.

"The NCQA program was still undergoing evaluation, refinement, and adaptation for broader application," she adds. "This program promises to be an excellent accreditation model alongside AAHRPP."

NCQA recently released its draft Human Research Protection Accreditation Program standards on its web site at www.ncqa.org.

The IRB at the McGuire Veteran’s Hospital in Richmond, VA, was the third site to be surveyed by NCQA and was accredited with conditions for the period of Oct. 9, 2001, to Oct. 8, 2002, reports Alison Faulk, IRB coordinator. The focus of the survey was on the Human Research Protection Program, and on institutional responsibility and commitment, she says. This is a different approach than in the past when subject protections were looked at as just an IRB responsibility, Faulk says.

"An NCQA survey encompasses more than an audit by the Food and Drug Administration [FDA] because it reviews policies and procedures that go beyond federal requirements," she explains. "The FDA reviewed four charts front to back to determine compliance with federal regulations. The NCQA reviewed 32 charts for performance standards that went far beyond federal requirements and included reviews of institutional quality assurance procedures for the investigational pharmacy, the informed consent process, the investigator, and IRB performance."

The Richmond NCQA surveyor team met with Faulk, the IRB chair, two members of the IRB, the chair of the research and development committee, the chief of research, the director, and chief of staff.

"Words and schmooze count little," Faulk says. "The key is documentation. If it’s not written down, you get a zero."

Richmond’s result was accreditation with conditions. A corrective action plan incorporated a series of procedural changes to assure that all aspects of the review process were systematically documented.

"We started writing everything down — everything," Faulk says. "We had no choice. However, there is a negative. We now have so much process stuff in our IRB minutes and files that it’s often difficult to find basic information."

For example, NCQA wanted specific documentation that the IRB considered the risk-benefit ratio, Faulk says. "Our explanation to the surveyors was that if the IRB approved a protocol then the committee obviously felt it had an acceptable risk-benefit ratio," Faulk explains. "But that was not good enough, and we got zero on that standard because our minutes did not specifically state that the risk-benefit ratio was appropriate to human subjects protection." So now the IRB writes this information down. Likewise, the IRB now works off checklists to make certain that nothing is missed, Faulk adds.

The NCQA process has been on pause since April 19, 2002, and then on Dec. 2, 2002, the VA Office of Research and Development sent a letter to the field, extending the pause indefinitely while the standards are being reviewed and refined.

"A major problem with the NCQA accreditation process at Richmond was that the 100-page NCQA standards were published in August 2001, but Richmond’s survey was based on IRB performance during the previous 12 months," Faulk says. "We were lucky to have done as well as we did. Regardless of the problems with the accreditation process, its time has come, and there is no question that we are doing a better job protecting subjects now than we did last year."

IRBs that participate in accreditation programs benefit from the peer-based assessment of their human research protection program, and it can help them achieve regulatory compliance, says Jeffrey Cooper, MD, MMM, deputy director of AAHRPP. Cooper previously was the interim chair of radiology and a professor of radiology and pediatrics at Albany (NY) Medical Center, and served on the Albany Medical Center IRB for about 15 years.

"AAHRPP accreditation demonstrates that an entire organization — not just the IRB — takes the safety of human research participants very seriously," he says. "Accreditation can inspire sponsors’ confidence in an organization as a research site and, ultimately, can restore public trust in research."

AAHRPP reevaluates organizations every three years. When noncompliance is found, the information is brought to the organization’s officials, but is not reported to regulatory or government agencies, Cooper says. Application fees for accreditation are determined by the IRB’s number of protocols and range from $7,000 to more than $23,000, he says. "For successive years, organizations pay an annual fee that is somewhat less than the application fee," Cooper adds.

OHRP offers an alternative

For IRBs that would like to have their processes reviewed for quality improvement purposes, especially if they are not yet ready to apply for accreditation, the Office for Human Research Protection (OHRP) of Rockville, MD, offers a quality improvement alternative. OHRP has a quality improvement (QI) program that will help an IRB meet its goals in assuring human subjects protection and ensuring compliance with federal regulations, says George Gasparis, director of the Division of Assurances and Quality Improvement of OHRP.

The program has three stages: quality assurance, quality improvement, and continuous quality improvement, he says. The advantage to participation in OHRP’s program are threefold, Gasparis says:

  • It allows for direct confirmation with OHRP that existing processes are in compliance with regulations.
  • It could be a good step toward preparing for accreditation.
  • It doesn’t cost anything.

A potential disadvantage is that some IRBs and institutions might be wary of voluntarily sharing their program’s attributes and weaknesses with OHRP, which also is a regulatory agency, Gasparis notes.

"One area we’ve had to address is the regulatory requirement that institutions report to OHRP any serious ongoing noncompliance," he says. "We have determined that if an institution reports to the QI program or if we observe the problem during a visit, then they don’t have to report it to the Division of Compliance Oversight."

An exception would be if subjects are being harmed, Gasparis notes. In such cases of serious noncompliance, the QI division of OHRP would ask the institution to prepare a corrective action plan and OHRP’s director would then determine whether the Division of Compliance Oversight needed to review the compliance plan, he says.

"Some people may be skeptical because the QI division and compliance division are in the same office and on the same floor," Gasparis adds. "But we explain that if we weren’t serious about protecting confidentiality and we had the Division of Compliance Oversight follow up on our consultation, and that division imposed sanctions or a compliance action against an institution, then it wouldn’t take long for this to get out into the research community; that the QI team really is a Trojan horse."

Since the division’s goal is to help IRBs and institutions improve their human subject protection, this breach in confidentiality would violate trust and put an end to the QI program, he says.

There are a number of reasons an IRB would be willing to pay for and prepare for a full accreditation program, Saunders says.

"Accreditation as a process has been successfully implemented in other health care venues, such as hospitals, managed care, and animal research," she says. "It is a proven process to establish standards and benchmark performance." Some of the benefits are as follows, Saunders explains:

  • Accreditation elevates operations from a single review unit to a program.
  • It validates the strengths and highlights the weaknesses.
  • It distributes responsibility across organizations and institutions.
  • It focuses accountability within the human research protection program.
  • It establishes standards that go beyond the regulations.
  • It promotes ethics as integral to clinical investigators.

And it’s possible that in the future as a greater number of IRBs become accredited that regulatory agencies will shift their focus and their limited oversight resources to reviewing those organizations that have not been accredited, Saunders adds.