Chapter 12: Research versus Quality Improvement Distinctions Between Research versus Quality Improvement or Quality Assurance Quality Improvement or Research Quality Assurance Test a formal hypothesis or Purpose research question and advance Assess a process, program, or system science/discipline A prospectively designed, Starting Point formal, written research An established set of standards hypothesis Knowledge sought may not Knowledge sought directly benefits Benefits benefit participants involved in process/program/system/and may study benefit patients No risk, with exception of possibly Risks/Benefits May put participants at risk privacy/confidentiality concerns Data Collection Systematic data collection Systematic data collection End Point Answer research question Improve program/ process/ system Involves an review of Compare the program/process/system relevant literature. to established set of standards. Determine validity of hypothesis. findings with only those individuals Share findings with individuals associated with the process/ Intended associated with investigation program/system. If findings are shared with individuals unassociated with the Result and individuals not associated with investigation. process/program/system, then activities are considered research. IRB Review & Required Not Required Approval *Modified from guidance used by George Washington University Committee on Human Research IRB & Cambridge Health Alliance. Permission granted for use on 3/2/2011 by George Washington University.
Chapter 12: Research versus Quality Improvement Distinctions Between Research versus Quality Improvement or Quality Assurance Research Quality Improvement or Quality Assurance Purpose Test a formal hypothesis or research question and advance science/discipline Assess a process, program, or system Starting Point A prospectively designed, formal, written research hypothesis An established set of standards Benefits Knowledge sought may not benefit participants involved in study Knowledge sought directly benefits process/program/system/and may benefit patients Risks/Benefits May put participants at risk No risk, with exception of possibly privacy/confidentiality concerns Data Collection Systematic data collection Systematic data collection End Point Answer research question Improve program/ process/ system Involves an review of relevant literature. Determine validity of hypothesis. Compare the program/process/system to established set of standards. Intended Result Share findings with individuals associated with investigation and individuals not associated with investigation. findings with only those individuals associated with the process/ program/system. If findings are shared with individuals unassociated with the process/program/system, then activities are considered research. IRB Review & Approval Required Not Required *Modified from guidance used by George Washington University Committee on Human Research IRB & Cambridge Health Alliance. Permission granted for use on 3/2/2011 by George Washington University.