JCAHO, NCQA form human research quality group
Partnership to offer new accreditation program
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the National Committee for Quality Assurance (NCQA) have announced the formation of the Partnership for Human Research Protection (PHRP) to offer a new accreditation program that will seek to protect the safety and rights of participants in clinical trials and research programs in public and private hospitals, academic medical centers, and other research facilities in the United States and abroad.
The PHRP Accreditation Program will invite organizations to demonstrate their commitment to safeguarding the interests of human research participants through engagement in the new accreditation process. Standards are to be released in April 2003, and accreditation reviews will begin shortly thereafter, says Margaret E. O’Kane, NCQA president. "We need to ensure that the invaluable efforts of researchers are matched with robust processes for protecting the volunteers that make progress possible," she says.
"By applying one set of standards across many different biomedical research settings, NCQA and JCAHO will bring their decades of expertise to bear in ensuring that protection of volunteers is paramount," O’Kane adds.
The rapid expansion of medical research, drug trials, and other studies involving human subjects is placing increased demand on existing HRP programs to ensure that studies’ risks and benefits are thoroughly weighed, volunteers are properly informed, adverse events are carefully monitored, and research risks are minimized, says Paul Gelsinger, vice president of Citizens for Responsible Care and Research (CIRCARE) in Baltimore and a noted advocate for improving clinical trial oversight processes.
"Study participants need to be able to trust the research system," he says. "This joint accreditation program will go a long way toward assuring research participants that they will be well protected and thoroughly informed of any risks."
NCQA developed the nation’s first HRP accreditation program in 2001 for the Department of Veterans Affairs (VA). Both the federal Office of Human Research Protections and the Food and Drug Administration have supported private accreditation, such as the new PHRP Accreditation Program, as a critical component of an overall national strategy to better protect human research participants and promote greater accountability.
The NCQA and JCAHO collaboration will provide a national set of standards and a voluntary oversight process that complements current regulatory efforts. The new accreditation program will seek to optimize performance and promote continuous improvement, rather than simply accept compliance with minimum standards.
The new PHRP Accreditation Program specifically addresses the principal issues identified in the 2001 Institute of Medicine report, Preserving Public Trust: Accreditation and Human Research Protection Programs. The draft standards address organization responsibilities, institutional review board structure and operations, consideration of risks and benefits, and informed consent. The accreditation process will feature use of a web-based self-assessment tool, which organizations will use both to evaluate themselves against the standards and to determine their readiness for a full review. The self-assessment results will be reported to the PHRP Accreditation Program.
The actual accreditation review will be conducted in two parts: 1) an off-site review of the self-assessment results and supporting documentation; 2) an on-site review, during which a team of PHRP surveyors — research clinicians and others experienced in biomedical research — will validate performance against the standards.
The on-site component of the review is expected to be two to three days long and will include interviews with organization leaders. The program will offer an accreditation award for a maximum of three years and will include annual reporting requirements to assess continued standards compliance. Accreditation decisions will be publicly reported.
[For more information, contact:
- National Committee for Quality Assurance, 2000 L St. N.W., Suite 500, Washington, DC 20036. Telephone: (202) 955-3500.
- CIRCARE, 24 Indian Lane, Baltimore, MD 21210. Telephone: (410) 435-4895.]
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