I think my project is exempt and should not have to be submitted. Are all research projects involving human subjects required to undergo full IRB Committee review?
A. No. Federal regulations permit the exemption of some types of research from full IRB review and allow other research to be reviewed in an expedited process. The determination of the type of review or exemption status rests with the IRB or with an administration official named by your institution. The determination does not rest with the investigator. Therefore, all projects must be submitted to the IRB for initial review. Some IRBs have special forms for requests for exemptions while others use the same application materials for all projects.
No. Federal regulations permit the exemption of some types of research from full IRB review and allow other research to be reviewed in an expedited process. The determination of the type of review or exemption status rests with the IRB or with an administration official named by your institution. The determination does not rest with the investigator. Therefore, all projects must be submitted to the IRB for initial review. Some IRBs have special forms for requests for exemptions while others use the same application materials for all projects. Exempted projects must meet one or more of the following criteria listed in 45 CFR 46.101(b): Category 1 – Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: (a) research on regular and special education instructional strategies; or (b) research on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods. Category 2
Related Questions
- I think my project is exempt and should not have to be submitted. Are all research projects involving human subjects required to undergo full IRB Committee review?
- I generally require my entire class to conduct research projects involving human subjects. Does each student need to file an application with the IRB?
- Several of my students want to conduct a research project involving human subjects. Do they need to file with the IRB?