JCAHO, NCQA dissolve accrediting body
Effort never caught on among key stakeholders
With only nine organizations receiving accreditation through its Partnership for Human Research Protection (PHRP), the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and its partner in the effort, the National Commission on Quality Assurance (NCQA) have jointly decided to dissolve the agency.
"The need for critical improvements in protection for participants in research remains strong," says Mary Faith Marshall, chair of the PHRP’s board. "Unfortunately, there is not, as yet, enough demand for a rigorous oversight program like the one offered by PHRP from either the public or private sector."
The PHRP program was established in 2003 to provide a national set of standards on human subjects protections and a voluntary oversight process for institutions conducting research involving volunteers who participate in clinical trials and other research activities.
Institutions receiving federal funding are required to adhere to specific standards and processes for conducting research involving human subjects and submit to the oversight and review of the federal OHRP, but privately funded research efforts are not covered under the federal regulations.
The PHRP was an effort to standardize the quality of oversight and the protections offered to people volunteering as subjects in clinical trials and other research activities.
The NCQA and JCAHO collaborated on a national set of standards and a voluntary oversight process for institutions seeking national accreditation. The PHRP accreditation program was specifically designed to address issues identified in the 2001 Institute of Medicine report, Preserving Public Trust: Accreditation and Human Research Protection Programs. The standards addressed organization responsibilities, IRB structure and operations; consideration of risks and benefits; and informed consent.
But demand for such a high level of national accountability never materialized among the key players in clinical research, PHRP representatives said.
"Although the Joint Commission and NCQA continue to believe that an in-depth examination of the protections provided for human research subjects participating in clinical trials — such as a comprehensive accreditation review — is one of the best ways to ensure safety, government regulators, pharmaceutical companies and other stakeholders do not yet demand this level of public accountability," the PHRP stated in an announcement of the decision on its web site in August.
However, the PHRP is not the only organization offering national accreditation in this area, says Marjorie Speers, executive director of the Association for the Accreditation of Human Research Protection Programs (AAHRPP) in Washington, DC.
AAHRPP was founded in 2001 by seven nonprofit organizations: the Association of American Medical Colleges, Association of American Universities, Consortium of Social Science Associations, Federation of American Societies for Experimental Biology, National Association of State University and Land-Grant College, National Health Council, and Public Responsibility in Medicine and Research (PRIM&R).
Originally incorporated in Massachusetts by PRIM&R and later incorporated as a nonprofit organization in Maryland in 2001, AAHRPP now offers accreditation to institutions nationwide that conduct or review research with human participants. The AAHRPP accreditation program also uses a voluntary, peer-driven, educational model.
Since its founding, 24 entities representing 84 institutions have received accreditation and more than 200 research organizations currently are in the process, Speers reports. Among the accredited organizations are community hospitals, cancer centers, and teaching hospitals; independent IRBs; research institutes, and universities.
Accreditation for human subject protection programs is new and, as with other accreditation efforts in the past, it will take some time before such standards achieve universal support and buy-in. But progress is being made, she says.
"Industry is showing support for accreditation is a very tangible way. Our accredited organizations report that pharmaceutical companies have pre-approved them for clinical trials and canceled inspections because they were accredited," Speers notes. "As more organizations become accredited, industry’s placement of research at accredited sites is sure to grow."
The PHRP will be effectively dissolved as of Nov. 15, with JCAHO and NCQA assuming responsibility for supporting the nine currently accredited organizations through the duration of their three-year accreditation.
With only nine organizations receiving accreditation through its Partnership for Human Research Protection (PHRP), the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and its partner in the effort, the National Commission on Quality Assurance (NCQA) have jointly decided to dissolve the agency.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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