Does your research study require IRB review?   The MedStar Research Institute?s Research Committee (MRI-RC) and Institutional Review Board (IRB) have established criteria for determining which studies conducted in our institution should be considered as "research" and thus subject to review by the IRB. Currently, these studies may be called ?research,? ?quality improvement? projects, ?performance improvement? projects, or ?bench marking studies.? The guidelines listed below will assist you in determining the need for IRB submission. Further, will facilitate a consistent approach to identifying projects that fall under the purview of the IRB.       Definition of Research: A systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge All methods that attempt to apply experimental method to a problem, or which could influence the patient care environment If you are not sure whether or not your proposed project is, in fact, research, you may want to consider the following questions. If the answer to any of these questions is ?yes,? then you must submit it to the IRB for review. Many projects will be eligible for expedited or ?fast track? review. Chart reviews are considered research, but can be submitted for the expedited review process. You may contact the MRI Office of Research Programs for additional information.       Generalizable Knowledge: YES NO Are the results of the study intended to have applicability at facilities or institutions other than our own? YES NO Are the results of the study intended to contribute to the existing body of knowledge on the topic through dissemination in professional peer-reviewed publications or similar scientific meetings? YES NO Are the results of the study intended to contribute to a change in the ?standard of care? for a particular diagnostic or treatment modality?       Experimental Design (Randomization): YES NO Is the selection of patients predicated on statistical/quantitative method rather than the individual patient's clinical needs?       Data Collection: YES NO Does the study require data collection, surveys, interviews, or observations regarding patients where the primary purpose of such information gathering is for the study and not for patient care?       Patient Contact: YES NO Does the study require direct contact with patients for whom the investigator is not the primary clinical provider?       Patient Identification: YES NO Will any of the study data contain information that could be linked to a particular patient?s identity (e.g., patient name, medical record number, social security number, etc.)?       Sampling: YES NO Does the study require administration of tests and/or treatments that are not performed on all patients with comparable presenting conditions and where the decision is not based solely on the primary clinician's judgment and choice?       Measurement Testing: YES NO Does the study propose measurement or testing that is not "typically" applied to patients with similar diagnoses and/or conditions, and is the measurement and testing performed primarily to determine effect?   Download File Word Format   WP8 Format     Membership - Washington Membership-Baltimore Meetings-Washington Meetings-Baltimore