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NCQA accredits human protection program The National Committee for Quality Assurance (NCQA) granted full accreditation to the human research protection program of the Ralph H. Johnson VA Medical Center (VAMC) and its affiliated Institutional Review Board (IRB) at MUSC.  The NCQA, which has been designated by the National Academy of Sciences’ Institute of Medicine as the preferred model for accrediting human research protection programs, gave the VA/MUSC program a score of 96.4 percent, resulting in a full three-year accreditation. This is the highest score of any VA facility in the nation that has gone through the accreditation process. A score less than 85, but greater than 55 would have resulted in one-year accreditation, and a score of 55 or less would not have earned accreditation.  A major component of a research institution’s human research protection program is its Institutional Review Board (IRB), the body charged with the protection of human research subjects. The VAMC shares the IRB of the Medical University of South Carolina. The MUSC IRB is made up of three separate IRBs, covering different research areas and funding sources, and it is composed of a variety of health care professionals including physicians, nurses, basic scientists and pharmacists, and members of the community. All members volunteer their time. By federal regulations, the IRBs review all research involving human subjects to determine if the potential benefits of the research are reasonable and risks are minimized within the context of the importance of the knowledge to be gained from the research. They also review a variety of other protection issues such as whether the consent forms are written in a way understandable to participants and whether the consent forms are skewed to highlight benefits. After approving the protocol, the IRBs monitor the research for the length of the study. They can at any time halt the study if new information surfaces that would put the participants at an unacceptable risk. “The accreditation process was long and arduous,” said Rita Young, Ph.D., associate chief of staff for research for the VAMC. “About a dozen staff members spent months supplying the NCQA with detailed documentation for a 12-month period showing compliance with the rigid standards of the accrediting body.  Then NCQA did a site visit, probing in great detail selected protocols and interviewing staff members.” “We are extremely pleased with the results of the accreditation survey,” said Florence N. Hutchison, M.D., chief of staff at VAMC. “Individuals who volunteer for medical research help our investigators gain new knowledge that will benefit our patients and others for generations to come. Their welfare is paramount to us, and this accreditation validates our human protection program.” The VA accreditation program is relatively new and only seven VA programs nationally have been accredited. It is now mandatory, and during the next three years, all VA programs doing human research will be required to become accredited. Human research protection program accreditation is new for universities as well, and few have completed it. “I am pleased that the MUSC IRB through its affiliation with the VAMC has been put through an extremely rigorous accreditation process,” said John Raymond, M.D., MUSC provost and former associate chief of staff for research at VAMC. “The results of the accreditation speak highly not only of the VAMC’s total human protection program and its affiliated IRB at MUSC, but of the long and mutually beneficial history of cooperation between the two institutions. I am proud of my association with both institutions and the superlative results of the accreditation that recognize the shared commitment to the protection of human subjects.” Catalyst Online is published weekly, updated as needed and improved from time to time by the MUSC Office of Public Relations for the faculty, employees and students of the Medical University of South Carolina. Catalyst Online editor, Kim Draughn, can be reached at 792-4107 or by email, catalyst@musc.edu. Editorial copy can be submitted to Catalyst Online and to The Catalyst in print by fax, 792-6723, or by email to petersnd@musc.edu or catalyst@musc.edu. To place an ad in The Catalyst hardcopy, call Community Press at 849-1778.