NCQA releases draft standards for research

Program seeks to promote self-evaluation

The National Committee for Quality Assurance (NCQA) recently released draft standards for its Human Research Protection Accreditation Program (HRPAP) for public comment. The new program is designed to ensure that rigorous processes are in place to protect and inform volunteers in clinical trials and other research.

Margaret E. O’Kane, NCQA president, says an explosion in the volume of medical research, drug trials, and other studies involving human subjects over the past 10 years has increasingly overwhelmed existing programs’ capacity to ensure that studies’ risks and benefits are thoroughly weighed, that volunteers are adequately informed, and that adverse events are disclosed.

"We all benefit from advances in research," she says. "But we need to ensure that the good intentions of researchers are translated into robust processes for protecting the volunteers who make progress possible. Accreditation will help ensure that protecting volunteers is paramount."

NCQA developed the nation’s first HRPAP in 2001 for the Department of Veterans Affairs (VA). The draft standards are based on the VA standards and NCQA’s experience in accrediting research efforts conducted at VA Medical Centers.

The new program is designed to address other governmental and nongovernmental entities where research takes place, such as hospitals, medical schools, and pharmaceutical firms, and for independent institutional review boards (IRBs) that review, but do not conduct, research. The standards are organized into four domains: organizational responsibilities; IRB structure and operations; consideration of risks and benefits; and informed consent. NCQA’s program is designed to promote self-evaluation and continuous quality improvement (QI) and is equally applicable to research organizations and IRBs.

Calls for more formal research oversight processes also have come from within the research community itself. "Progress in medical and other research is contingent on people’s confidence in the systems we have established to protect them," says Mary Faith Marshall, PhD, professor of medicine and bioethics at the University of Kansas Medical Center in Kansas City. "NCQA’s HRP Accreditation Program will help restore people’s confidence and ensure that our protections are strong."

The bulk of an accreditation review will be conducted via the Standards, Guidelines and Assessment Tool (SGAT), a web-based application. The SGAT for human research protection will provide organizations with the means to assess their readiness for an accreditation review, and to identify areas where improvement is needed. Once an organization has committed to a review, the SGAT is used to transfer and store documents on-line, minimizing an organization’s preparation efforts and resulting in rapid turnaround time for accreditation decisions. Also, upon completion of the on-site portion of the review, the SGAT will allow organizations to receive detailed performance reports, which they can use to advance future QI activities. The draft HRPAP standards and instructions for submitting comments are available at NCQA’s web site,

[For more information, contact:

  • Margaret O’Kane, President, National Com-mittee for Quality Assurance, 2000 L St., N.W., Suite 500, Washington, DC 20036. Telephone: (202) 955-3500.
  • Mary Faith Marshall, PhD, Professor of Medi-cine and Bioethics, University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160. Telephone: (913) 588-5000.]