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You’ve sent in your OHRP registration, gotten your federalwide assurance out of the way, and just passed the certification exam — now you’ve got what it takes to run a top-notch IRB. Think again — there’s one more hurdle to jump, but experts say it could put you miles ahead of the pack if you prepare now. The question is, just which organization will get to serve as an accrediting body?
The Boston-based Association for the Accreditation of Human Research Protection Programs (AAHRPP), an organization formed out of the Public Responsibility in Medicine & Research (PRIM&R) was created last March in an effort to promote "best practices" among IRBs. But it’s one of several groups vying to serve as an accreditor for IRBs. Other players include the National Committee for Quality Assurance (NCQA), the Association of American Medical Colleges, and the Institute of Medicine, all located in Washington, DC.
NCQA, the accrediting organization for managed care organizations, currently is developing accreditation standards for the IRBs within the Veterans Affairs health system’s 151 research facilities. Pilot testing of the accreditation process is scheduled to begin in March and last through June 2001.
Perhaps the best solution is for the IRB community to develop best practices and have a federal regulatory oversight to eliminate any apparent conflicts of interest, says Robert M. "Skip" Nelson, MD, PhD, associate professor of anesthesia and pediatrics at The Children’s Hospital of Philadelphia. As for accreditation, Nelson supports it, and suggests incorporating the accreditation requirement into good clinical practice guidelines.
Specifically, AAHRPP will "provide a process of voluntary peer review and education among organizations concerned with research involving human subjects, in order to promote preservation of the rights and welfare of subjects in research and compliance with relevant regulatory and ethical standards."
When completed, human research protection programs will first use the performance standards to self-assess their programs, then AAHRPP reviewers will use them during site-visit assessments, says Sanford Chodosh, MD, president of PRIM&R and professor of medicine at Boston University School of Medicine.
Here’s the four-step development process for the AAHRPP performance standards:
1. Development (including pilot testing and revising) of performance standards to be used in the self-assessment and in the peer review site visit.
2. Recruitment and training of site visitors.
3. Gathering of demographic and program information on the human research protection programs to be assessed.
4. Identification and cataloging of educational materials. The performance standards and "best practices," combined with on-site reviews focusing on education, will encourage institutions to achieve a high level of performance beyond the minimal adherence to federal requirements, and will thereby foster a program of continuing quality improvement.
The standards will provide goals for targeted educational intervention in deficient areas through self-assessment, outside reviewers, or both. In addition, standards will be categorized according to general or narrow applicability and whether they are federal requirement level or above and beyond federal requirement level.
The general consensus among IRB administrators is that accreditation is a needed step in the evolution of the field. Accreditation "assures that all of the IRB administrators in the group are professionals and specialists in their field," says Leilani S. Price, PhD, IRB administrator at Santa Barbara, CA-based Cottage Health System.
Accreditation, Price adds, creates a minimum criteria for knowledge level and ensures IRB administrators are familiar with the knowledge. And the standards should be developed from the professional organization, not the government, she says. "This job is currently so complicated, it is no place for someone who has no training in the field."
Some IRB administrators would like to see accreditation taken further. "Should accreditation be mandatory, it should be mandatory for all studies, not just those that are federally sponsored," says Laurie Landrum, RN, MSA, CCRC, clinical trials compliance coordinator at the Medical College of Georgia in Augusta. Further, accreditation standards should meet the requirements for all involved regulatory bodies, such as the Office for Human Research Protections and the Office of Research Integrity, she says.
Landrum adds that any proposed accreditation process should not hamper the research process itself or be too restrictive. "I am leery of implementing an accreditation process similar to the Joint Commission [on Accreditation of Healthcare Organizations]. Having been through several Joint Commission reviews, I feel that the review process does not achieve the goal and is an inefficient use of valuable resources," she explains.
One area still unresolved is measuring performance against the standards, says Nelson. "The key question is how one measures IRB performance in association with those standards. On this, the draft guidelines are silent."