1. Class Projects, Research Practica, and Undergraduate Thesis Projects
Class projects, Research Practica, and Undergraduate Thesis Projects involving research methodology and course-assigned data collection. These activities generally do not constitute research because their purpose is to provide training in research as part of the overall educational mission of a program and are not designed to contribute to new knowledge. However, for example, if a student is involved in an activity designed to teach research methodologies and the instructor or student wishes to conduct further investigation and analyses in order to contribute to scholarly knowledge, the design of the project has changed such that it meets the above definition of research and requires USI IRB review. Regardless of when this change occurs, USI IRB must at this time review the research.
Course instructors are responsible for assessing whether these activities meet the definition of research as delineated above and require IRB review. All research protocols submitted by students as required by their instructors will be reviewed. It is the responsibility of the faculty member to review a student's IRB research protocol for accuracy and completeness prior to it being submitted for review.
2. Quality Assurance/Quality Improvement
Improvement activities that attempt to measure the effectiveness of programs or services such as program evaluations, model curriculums, or needs assessments. Such activities are not typically designed to be generalizable to the larger community and would be not be considered research if results will not be compared with other assessments. Those responsible for such projects must be certain that their activities are not human research.
3. Repository Research, Tissue Banking, and Databases
Repository Research, Tissue Banking, and Databases utilizing stored data or materials (cells, tissues, fluids, and body parts). If the investigator cannot readily ascertain the identity of the subject from whom the data or materials originated (i.e. the data is stripped of identifying information or coded and the investigator does not have access to the key), these activities would not require USI IRB review. However, repository research, tissue banking, and databases utilizing stored data or materials (cells, tissues, fluids, and body parts) from individually identifiable living persons must be reviewed by USI IRB.
4. Case Reports
Case reports utilizing private identifiable information such as medical information collected from a clinical activity. Case reports are generally carried out by retrospective review of records and highlight a unique treatment, case, or outcome. As the collection and organization of information for such reports usually involves no data analysis or testing of a hypothesis, they do not involve systematic investigation. Therefore, single case reports are not research and would not require USI IRB review. However, retrospective record reviews that incorporate data collection and data analysis to answer a research question must undergo USI IRB review. Additionally, meta-analysis of multiple case reports to examine and compare interventions or cases is considered to be human subjects research.
5. Research on Institutions or Social Processes
When the intent or focus of the research is to gain knowledge of an institution or social process (e.g., a political party, labor negotiations) and this research is not intended to produce generalizable knowledge about any particular individual or groups of individuals. Often, investigators wish to collect information from individuals about institutions or social processes. Such an activity is not human subjects research when the focus of the research is not on characteristics of an individual or groups of individuals because the information collected from the informant is not about the informant. There is often a fine line between human subjects research and research that collects information from individuals in order to understand institutions or social processes. Research on institutions or social processes, the purpose of which is to create generalizable knowledge about the attitudes, beliefs, or behaviors of individuals or groups (e.g., voters, prisoners, employees, teachers) as being representative of these institutions or social processes, is human subjects research.
The 6 exempt research categories defined and explained.
Explanations of the 7 expedited research categories.
Differences between the 3 vulnerable populations and 2 protected populations.
USI's definitions of 'human subjects' and 'research' to help determine if a protocol requires IRB review.
USI's definitions of 'secondary data' and information to help researchers determine what research category their secondary data research project meets.