Levels of IRB Review
Not Human Subjects Research (NHSR)
If you think your research project does not meet the regulatory definition of human subjects research, please contact the IRB at firstname.lastname@example.org to discuss project details. Consistent with Rice Policy 326, the decision of whether research activity involves human subjects can be made only by the IRB or a designated IRB Administrator. In cases where the Investigator has incorrectly identified their research as NHSR, the IRB can’t retroactively grant IRB approval and conducting human subject research without an approved protocol will result in a compliance incident.
If the IRB determines a project does NOT meet the regulatory definition of human subjects research, a determination letter will be provided to the Investigator which states IRB approval is not required. If the IRB determines the project DOES meet the regulatory definition, the investigator will need to submit a protocol application in Cayuse IRB.
According to 45 CFR 46, a human subject is "a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
- Interaction includes communication or interpersonal contact between investigator and subject.
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Levels of Review
Human subjects research is reviewed by the IRB according to the following categories:
Research can be approved as “exempt” if it is no more than “minimal risk” and fits one of the exempt review categories as defined by federal regulation 45 CFR 46. Protocols that may qualify for “Exempt” must be submitted to the IRB for review. The IRB Administrator will conduct an initial review of exempt research and provide feedback as needed. The IRB Chair will provide final review and approval of the protocol.
NOTE: Exempt protocols do not require a convened IRB meeting for review and approval.
Research can be reviewed through expedited review procedures if the research activities present no more than minimal risk to human subjects, and involve only procedures listed in one or more of the expedited categories.
NOTES: ‘Expedited’ does not refer to speed at which the protocol is reviewed, but a regulatory review pathway. Also, Expedited protocols do not require a convened IRB meeting for review and approval.
Full Board Review
Research must be reviewed by the Full Board if the research presents greater than minimal risk to subjects or does not fall into one or more of the Expedited review categories.