Non-Human Subject Research
Studies are considered “NHSR” when they do not meet the 45 CFR 46 definitions of human subjects research. Investigators who believe their project qualifies as NHSR can review the NHSR guide as a worksheet to determiine if their project falls in the IRB's non-human subject researh category. If an investigator determines their project is considered NHSR and they don't need a determination letter, they can start their project. In this case, there is no need for the researchers to submit the worksheet to the IRB either. If an investigator determines their research NHSR and needs a determination letter, they can make an NHSR request through the IRB online application system. The IRB must make this determination if the PI or student researcher requires a determination letter from the IRB stating the study does not require IRB review. Please keep in mind that any investigator that inappropriately determines their study NHSR would be subject to the CSUSBs non-compliance reporting requirements to the Office of Human Research Protections (OHRP).
Non-Human Subjects Research requires an initial turnaround time is 7 to 10 business days. The IRB highly recommends the application be submitted at least 1 month before the proposed start date of the study
Examples of NHSR:
- Data collection for internal departmental, school, or other university administrative purposes (e.g., teaching evaluations and customer service surveys).
- Service surveys issued or completed by University personnel for the intent and purpose of improving services and programs of the University or for developing new services or programs for students, employees, or alumni, as long as the privacy of the subjects is protected, the confidentiality of individual responses is maintained, and survey participation is voluntary. This would include surveys by professional societies or University consortia.
- Information-gathering interviews in which questions focus on things, products, or policies rather than people or their thoughts regarding themselves (e.g., canvassing librarians about inter-library loan policies or rising journal costs).
- Course-related activities designed specifically for educational or teaching purposes, in which data is collected from and about human subjects as part of a class exercise or assignment, but are not intended for use outside of the classroom (e.g., instruction on research methods and techniques).
- Biography or oral history research involving a living individual in which the information is not generalizable beyond that individual.
- Independent contracts for procedures carried out for an external agency (e.g., personnel studies, cost-benefit analyses, customer satisfaction studies, biological sample processing for a fee and not authorship or other credit, public park usage, IT usage, and software development.
- Research involving cadavers, autopsy material, or biospecimens from now deceased individuals. Some research in this category, however, such as genetic studies providing private or medical information about live relatives, may need IRB review.
- Innovative therapies, except when they involve "research" as defined by OHRP. (An innovative clinical practice is an intervention designed solely to enhance the well-being of an individual patient or client. The purpose of an innovative clinical practice is to provide diagnosis, preventive treatment, or therapy to particular individuals.)
- Quality improvement projects are generally not considered research unless there is a clear intent to contribute to generalizable knowledge and use the data derived from the project to improve or alter the quality of care or the efficiency of an institutional practice. If the data is re-examined or re-analyzed and new information surfaces that would contribute to generalizable knowledge, an application must be submitted to the IRB.
- Case histories that are published and/or presented at national or regional meetings are not considered research if the case is limited to a description of the clinical features and/or outcome of a single patient and do not contribute to generalizable knowledge.
- Publicly available data do not require IRB review (e.g., census data and labor statistics).
- Coded private information or biological specimens that were not collected for a currently proposed project do not need IRB review as long as the investigator cannot link the data/specimens back to individual subjects. If the data/specimen provider has access to the identity of the subjects (e.g., subjects’ names, addresses), the investigator must enter into an agreement with the data/specimen provider that states that under no circumstances will the identity of the subjects be released to the investigator.