May 21, 2004
DF/HCC first to receive accreditation for protecting patients in clinical trials
Following a review by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), the Dana-Farber/Harvard Cancer Center has become the first comprehensive cancer center in the United States to receive an accreditation for its safety standards covering participants in clinical trials.
The approval is deemed "qualified" while DF/HCC officials make a few administrative changes recommended by the association. With that process already under way, officials expect the rating to be upgraded to full status within a few months.
"We're very pleased and proud to have received this accreditation," comments DF/HCC Quality Assurance Officer for Clinical Trials Jane Russell, on behalf of herself and Deborah Barnard, director of the Office for Protection of Research Subjects. "It's a tangible sign of the importance we place on the protection of research subjects, and it will be a major 'plus' when the cancer center's support grant from the National Cancer Institute comes up for renewal early next year."
The news follows a visit by AAHRPP representatives to Dana-Farber and its DF/HCC affiliates last year. They reviewed policies and procedures relating to patient protection and met with clinical researchers and their staffs, members of the Institutional Review Board (which evaluates research protocols from a patient-safety standpoint), and leaders of the cancer center. Like all assessments given by the AAHRPP, which was formed in 2001, the review was voluntary and came in response to a request from DF/HCC last year.
Four areas were cited by the AAHRPP for special distinction: the scientific review process for clinical studies; the level of cooperation between the many units involved in clinical research; the availability of safety policies and procedures to investigators (both print and online); and ongoing quality-improvement programs in patient protection. The areas cited for improvement dealt primarily with administrative matters, Russell remarks.
"This has been an enlightening process for everyone," she says. "The give and take between researchers and AAHRPP representatives has made our program even stronger."
The AAHRPP serves as a nonprofit, independent accrediting organization for institutions conducting clinical research with patients. It seeks to ensure compliance with safety standards and, in the process, raise the bar on human research protection across the country.
"AAHRPP accreditation signifies more than regulatory compliance, says Barbara Bierer, association president and former vice president for patient safety at Dana-Farber. "It is a testament to the fact that DF/HCC, the first National Cancer Institute-designated cancer center to achieve this distinction, has a quality-driven research program that values human participant safety and welfare.
