UAH policy mandates that all research/scholarly activity involving human subjects receive Institutional Review Board (IRB) approval before initiating any recruitment or data collection. This process protects participant welfare, adheres to federal regulations (45 CFR 46), and applies to faculty, staff, and student research. General Guidelines Human Subjects Research: If your research project involves active data collection or interaction with human participants, regardless of whether or not identifying information is being collected, IRB approval must be obtained prior to beginning the study. Non-human Subjects Research Determination: If your research involves the use of existing data collected from human participants (e.g., secondary datasets, existing biological samples), but there are no identifiers linking human participants to the data/samples themselves, then the activity may be considered "non-human subjects research." The IRB is the only institutional authority authorized to issue an official determination that a project does not meet the regulatory definitions of human subject’s research. Investigators may not self-determine this status; instead, the IRB must assess whether the activity meets the definitions of research and human subjects under the Common Rule. Quality Improvement/Program Evaluation Determination: If the activity is designed to evaluate and improve performance in a clinical area, educational setting, or department, then the activity may be considered “Quality Improvement/Program Evaluation.” The IRB is the only institutional authority authorized to issue an official Quality Improvement/Program Evaluation determination. Investigators may not self-determine this status; instead, the IRB must assess whether the activity meets the definitions of research and human subjects under the Common Rule.
