Does My Project Need IRB Review?听
There are a few categories of research-related projects that do not meet the definition of Human Subject Research, which means they may not require IRB review. Please refer to the list below for the most common on these situations.
If you are still unsure whether your project requires IRB review, we recommend that you submit a Human Subjects Research Determination Form. This form can be found in the IRBNet library and should be submitted through IRBNet. Upon receipt of your HSR Determination Form, it will be forwarded to an IRB member for review (reviewers have up to 7 business days to review Determination Forms; Please keep this in mind when deciding to submit your form). If it is determined that your project does not meet the definition of HSR, you will receive a letter confirming this determination.听
1. Class Projects, Research Practica, and Undergraduate Thesis Projects
Class projects, Research Practica, and Undergraduate Thesis Projects听involving research methodology and course-assigned data collection. These activities generally do not constitute research听because their purpose is to provide training in research as part of the听overall educational mission of a program and are not designed to听contribute to new knowledge. However, for example, if a student is听involved in an activity designed to teach research methodologies and the instructor or student wishes to conduct further investigation and analyses听in order to contribute to scholarly knowledge, the design of the project听has changed such that it meets the above definition of research and听requires 91社区 IRB review. Regardless of when this change occurs, 91社区 IRB听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.听
2. Quality Assurance/Quality Improvement
Improvement activities that听attempt to measure the effectiveness of programs or services such as听program evaluations, model curriculums, or needs assessments. Such听activities are not typically designed to be generalizable to the larger听community and would be not be considered research听if听results will听not be compared with other assessments. Those responsible for such听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听investigator cannot readily ascertain the identity of the subject from听whom the data or materials originated (i.e. the data is stripped of听identifying information or coded and the investigator does not have听access to the key), these activities would not require 91社区 IRB review. However,听repository research, tissue banking, and databases utilizing stored data听or materials (cells, tissues, fluids, and body parts) from individually听identifiable living persons must be reviewed by 91社区 IRB.
4. Case Reports
Case reports utilizing private identifiable information such as听medical information collected from a clinical activity. Case reports are听generally carried out by retrospective review of records and highlight a听unique听treatment, case, or outcome. As the collection and听organization of information听for such reports usually involves no data analysis or testing of a听hypothesis, they do not involve systematic investigation. Therefore,听single case reports are not research and would not require 91社区 IRB review.听However, retrospective record reviews that incorporate data collection and data analysis to answer a research question must undergo 91社区 IRB review.听Additionally, meta-analysis of multiple case reports to examine and听compare interventions or cases is considered to be human subjects听research.
5.听 Research on Institutions or Social Processes
When the intent or focus of the research is to gain听knowledge of an institution or social process (e.g., a political party,听labor negotiations) and this research is not intended to produce听 generalizable knowledge about any particular individual or groups of听individuals. Often, investigators wish to collect information from听individuals about institutions or social processes. Such an activity is听not听human subjects research when the focus of the research is not on characteristics听of an individual or groups of individuals because the information collected from the informant is not about the informant. There is often a听fine line between human subjects research and research that collects听information from individuals in order to understand institutions or social听processes.听Research on institutions or social processes, the听purpose of which is to create generalizable knowledge about the attitudes, beliefs, or behaviors of individuals or groups (e.g., voters, prisoners,听employees, teachers) as being representative of these institutions or听social processes, is human subjects research.