Do I Need to Submit an IRB Protocol?

How Do I Know if I Need if I Need IRB Approval?

• Is it research as defined by the federal regulations?
• Is it research with human subjects as defined by the federal regulations?
• Is Radford University engaged in research with human subjects as defined by the federal regulations?

Is it Research?

45 CFR 46.102(l) defines research as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Is it Human Subjects Research?

45 CFR 46.102(e)(1) states a human subject is defined as a living individual about whom an investigator conducting research:
• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens (this includes manipulation of the human’s environment)
• Obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.

Do I need IRB approval through Radford University?

If you are affiliated with Radford University and acting as a researcher for Radford University, you are considered an agent or an employee. As a result, your research project (even if you are a student) will need IRB approval through Radford University. This is done through submitting an IRB application to the Radford University IRB or if completing collaborative research, through requesting a Reliance Agreement/Institutional Authorization Agreement (IAA), where one IRB relies on the review and approval of another IRB.

An institution’s employees or agents refers to individuals who:

• act on behalf of the institution.
• exercise institutional authority or responsibility.
• perform institutionally designated activities.

Employees and agents can include staff, students, contractors, and volunteers, among others, regardless of whether the individual is receiving compensation.

What does not need IRB Review?

Not Human Subjects Research (NHSR)

Not Human Subjects Research (NHSR) applications are used to determine if a project meets the regulatory definition of human subjects and/or research. When the IRB determines a project does NOT meet the regulatory definitions, a determination letter will be generated which states IRB approval is not required. If the IRB determines the project DOES meet the regulatory definitions, it will be reviewed normally as an IRB study application. NHSR determinations are made by the IRB and do not require a convened committee meeting.

Please submit your IRB application by filling out the IRBManager xForm and selecting "Not Human Subjects Research (NHSR Determination" in the "Type of Study" section of the IRBManager application. 

Quality improvement activities (that are not considered human subjects research)