Nation's Leading Health Care Evaluators JCAHO and NCQA Announce New Program for Accrediting Human Research Programs

1/16/2003

From: Charlene D. Hill of JCAHO, 630-792-5175 Brian Schilling of NCQA, 202-955-5104

OAKBROOK TERRACE, Ill., Jan. 16 -- The nation's leading advocates for quality in health care, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the National Committee for Quality Assurance (NCQA), today announced the formation of the Partnership for Human Research Protection, Inc., (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. Draft standards for the accreditation program are now available for public comment at www.ncqa.org. Release of the final standards is planned for April 2003, and accreditation reviews will begin shortly thereafter.

"We need to ensure that the invaluable efforts of researchers are matched with robust processes for protecting the volunteers that make progress possible," said NCQA President Margaret E. O'Kane. "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."

"JCAHO and NCQA have long been dedicated to improving the safety and quality of care provided to the public," said Dennis S. O'Leary, M.D., President, JCAHO. "This important initiative represents a major extension of our combined commitment to the public interest."

Biomedical research is a critical enterprise that yields benefits for millions of people each year, but it is not without risks. Adverse events can and do occur, and some have been widely publicized. The PHRP program has been designed to create a credible, objective framework for ensuring that processes are in place to inform and protect the thousands of volunteer human subjects who participate in clinical trials and other research activities every year. 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, that volunteers are properly informed, that adverse events are carefully monitored, and that research risks are minimized.

"Study participants need to be able to trust the research system," said Paul Gelsinger, Vice President of Citizens for Responsible Care and Research (CIRCARE) and a noted advocate for improving clinical trial oversight processes. "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."

The new program is also drawing support from representatives of the research community. "Standardized accreditation guidelines will offer all HRP programs the opportunity to operate from a single, level starting point," said Mary Faith Marshall, Ph.D., Professor of Medicine and Bioethics, Kansas University Medical Center. "This will allow HRP programs to focus on achieving excellence in protecting participants."

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. Further, 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 -- 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 and (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 Jessica Briefer French, Assistant Vice President, Human Research Protection, at 202-955-5177. --- Founded in 1951, the Joint Commission on Accreditation of Healthcare Organizations seeks to continuously improve the safety and quality of care provided to the public through the provision of health care accreditation and related services that support performance improvement in health care organizations. The Joint Commission evaluates and accredits nearly 17,000 health care organizations and programs in the United States, including approximately 9,000 hospitals and home care organizations, and 8,000 other health care organizations that provide long term care, assisted living, behavioral health care, laboratory and ambulatory care services. The Joint Commission also accredits health plans, integrated delivery networks, and other managed care entities. An independent, not-for-profit organization, the Joint Commission is the nation's oldest and largest standards-setting and accrediting body in health care.

NCQA is a private, non-profit organization dedicated to improving health care quality. NCQA accredits and certifies a wide range of health care organizations and manages the evolution of HEDIS(r), the performance measurement tool used by more than 90 percent of the nation's health plans. NCQA is committed to providing health care quality information through the Web and the media in order to help consumers, employers and others make more informed health care choices.