OBJECTIVES: Institutional Review Boards (IRBs) are charged with ensuring the protection of humans enrolled in research. IRB activities are governed by the United States Office for Human Research Protections, which does not clearly differentiate quality improvement from research. More clear standards are needed so that the protection of human subjects (including their right to privacy) can be ensured and health care providers can efficiently meet their objective of improving patient care through quality improvement efforts. While past commentaries on this subject have provided some guidance, no standard definitions exist that distinguish "quality improvement" from "research." METHODS: We conducted a national survey of IRBs serving academic medical centers to determine whether local guidelines exist that make this distinction, and if so, what criteria are used to guide decision making. RESULTS: On the basis of the findings of our survey, we propose a decision algorithm to guide IRBs and quality improvement oversight committees as they define local policies that distinguish research projects from quality improvement efforts. CONCLUSIONS: The decision algorithm should result in greater ability to conduct quality improvement work in an efficient manner without compromising the protection of human subjects. The criteria identified are consistent with, but clearer than, the exemption standards provided in the common rule.
OBJECTIVES: Institutional Review Boards (IRBs) are charged with ensuring the protection of humans enrolled in research. IRB activities are governed by the United States Office for Human Research Protections, which does not clearly differentiate quality improvement from research. More clear standards are needed so that the protection of human subjects (including their right to privacy) can be ensured and health care providers can efficiently meet their objective of improving patient care through quality improvement efforts. While past commentaries on this subject have provided some guidance, no standard definitions exist that distinguish "quality improvement" from "research." METHODS: We conducted a national survey of IRBs serving academic medical centers to determine whether local guidelines exist that make this distinction, and if so, what criteria are used to guide decision making. RESULTS: On the basis of the findings of our survey, we propose a decision algorithm to guide IRBs and quality improvement oversight committees as they define local policies that distinguish research projects from quality improvement efforts. CONCLUSIONS: The decision algorithm should result in greater ability to conduct quality improvement work in an efficient manner without compromising the protection of human subjects. The criteria identified are consistent with, but clearer than, the exemption standards provided in the common rule.
Authors: Yann Joly; Derek So; Gladys Osien; Laura Crimi; Martin Bobrow; Don Chalmers; Susan E Wallace; Nikolajs Zeps; Bartha Knoppers Journal: Eur J Hum Genet Date: 2016-01-20 Impact factor: 4.246