Accreditation is a sure thing, but is the cart now in front of the horse?
Organizations vying for certification rights
Everyone, it seems, wants to jump on the bandwagon when it comes to establishing a national accreditation certification system for institutional review boards (IRBs). In April, the Institute of Medicine (IOM) jumped into the fray when it released a report recommending that the recently developed accreditation standards for the U.S. Department of Veterans Affairs (VA) medical centers be adapted for all IRBs. The report was prepared by IOM’s Committee on Assessing the System for Protecting Human Research Subjects in response to a request from then-Secretary of Health and Human Services Donna Shalala — but not everyone is agreeing with IOM on its conclusion.
The IOM committee’s decision to endorse the standards developed for the VA is puzzling to some researchers because the standards were developed for a closed system. Perhaps more puzzling is the committee’s assessment that the accreditation standards in development from the Boston-based Public Responsibility in Medicine and Research (PRIM&R) are not desirable for the nation’s IRBs. (Click here to see the table, "Comparison of Draft NCQA and PRIM&R Accreditation Standards.")
In the executive summary, the committee concludes "the standards proposed by [National Commission for Quality Assurance in Washington, DC] for VA facilities appear promising for use in the accreditation of VA facilities."
But IOM’s conclusion has left some experts in the research community wondering. IOM’s original six-month deadline to develop performance standards was impossible to meet, so it subcontracted with PRIM&R to deliver its performance standards that had been in development for 18 months, notes Sanford Chodosh, MD, president of PRIM&R and an associate professor at Boston University School of Medicine.
PRIM&R also proposed that, in addition to the performance standards, criteria should be developed to demonstrate compliance with the standards at the same time. Instead, IOM opted to fund only the performance standards. "Their subcommittee’s major complaints about the work provided by PRIM&R was directly related to the failure of IOM to fund the whole package," adds Chodosh.
On the heels of the IOM report, the Rockville, MD-based Association for the Accreditation of Human Research Protection Programs (AAHRPP) announced its decision to offer voluntary accreditation using its accreditation standards. Like NCQA, AAHRPP presented its accreditation proposal to the VA, but couldn’t meet the VA’s requested deadline to get the standards completed.
AAHRPP announced the accreditation standards in anticipation of a scheduled Senate hearing on human research protection programs by the subcommittee on public health. The Senate postponed the meeting, however, and is scheduled to revisit the issue later this summer. AAHRPP’s standards will be pilot tested this summer and be in place by January 2002, says Chodosh.
A better suitor?
"The IOM committee regards the standards prepared by NCQA to be more suitable than those prepared by PRIM&R for not only pilot testing in VA facilities, but also with modification, for the accreditation of other research institutions."
Specifically, the IOM committee says the standards developed by NCQA address quality improvement, provide flexibility in achieving performance goals, which allows for increased research participant protection, and are explicitly grounded in current regulations.
"The IOM favored the NCQA standards because they were more specific and linked to the regulations and had specific comments about deficiencies that would need to be addressed. I’m not surprised by the outcome because NCQA was formed to accredit managed care organizations, so they can be thought of as doers,’ and PRIM&R is a professional group, so they can be thought of as thinkers.’ The final product will need to be a combination of the two," explains Robert M. Nelson, MD, PhD, associate professor of anesthesia and pediatrics at The Children’s Hospital of Philadelphia.
The IOM committee does, however, acknowledge the need for modifications to the NCQA standards, and included 11 recommendations (see "Summary of IOM recommendations according to the three implementation phases of an accreditation process," in this issue) in three implementation phases:
- development of an accreditation program;
- development of standards;
- development of an evaluation process.
The NCQA accreditation standards developed for the VA could not be adopted verbatim within the broader IRB community, says Sandra Sanford, RN, MSN, CCRC, CIP, director of VA human research protection program accreditation at NCQA. "The VA is a unique, closed system and incorporating those standards for others would not work. For example, there are specific forms the VA centers use that are referenced in the standards themselves, and do not lend to outside use," says Sanford.
"NCQA developed its standards for a closed system, and therefore they are not relevant for an open system. For example, there’s no focus on vulnerable patients within the standards," says Roger Meyer, MD, senior consultant for clinical research in the division of biomedical and health sciences research at the Association of American Medical Colleges in Washington, DC.
"They ignore establishing standards for the other essential components of a complete human research protection program, the institutional management, and the investigators," adds Chodosh.
The pilot testing concept is needed because the standards need to evolve and be tested, say Nelson and Sanford. But which standards to pilot test is an entirely different matter. "I, along with many others, believe [IOM’s] proposal to use the very incomplete NCQA standards to do pilot testing and to then build a set of performance standards on that experience was a very confusing approach," notes Chodosh.
The scope of NCQA’s standards are limited to already existing requirements in the federal government, and PRIM&R disagrees with IOM that the NCQA standards are an adequate basis for pilot testing, says Chodosh.
Despite the differences about which accreditation standards ultimately win out in the regulatory realm, there is one area of agreement. The IOM recommended that the Congressional watchdog agency the General Accounting Office (GAO) conduct an evaluation of accreditation, but the GAO may be too late. "The GAO should evaluate the process starting now. We need to learn what we can learn, even if it’s the mistakes," says Nelson.
The current regulations would exempt private research programs from the accreditation requirement. "I don’t think the GAO has such authority. Even if they do, this would compromise having the accrediting bodies separate from governmental influence," adds Chodosh.
Another certainty is that both AAHRPP and NCQA are moving ahead with pilot testing, which means accreditation — in some fashion — will be here within the next year. "We don’t agree that it will take three years to start a credible accreditation process," notes Chodosh.
AAHRPP founding organizations
• Association of American Colleges and Universities, 1818 R St. N.W., Washington, DC 20009. Telephone: (202) 387-3760. Fax: (202) 265-9532. E-mail: [email protected]. Web: www.aacu-edu.org.
• Association of American Medical Colleges, 2450 N St. N.W., Washington, DC 20037-1126. Telephone: (202) 828-0400. Fax: (202) 828-1125. Web: www.aamc.org.
• Consortium of Social Science Associations, 1522 K St. N.W., Suite 836, Washington, DC 20005. Telephone: (202) 842-3525 Fax: (202) 842-2788. E-mail: [email protected]. Web: www.cossa.org.
• Federation of American Societies for Experimental Biology, 9650 Rockville Pike, Bethesda, MD 20814-3998. Web: www.faseb.org.
• National Association of State Universities and Land-Grant Colleges, 1307 New York Ave. N.W., Suite 400, Washington, DC 20005-4722. Telephone: (202) 478-6040. Fax: (202) 478-6046.
• National Health Council, 1730 M St. N.W., Suite 500, Washington, DC 20036. Telephone: (202) 785-3910. Fax: (202) 785-5293. E-mail: [email protected]. Web: www.nationalhealthcouncil.org.
• Public Responsibility in Medicine and Research, 132 Boylston St., Fourth Floor, Boston, MA 02116. Telephone: (617) 423-4112. Fax: (617) 423-1185. Email: [email protected]. Web: www.primr.org.
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