Levels of IRB 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 into one of the exempt review categories as defined by the Federal regulations 45 CFR 46.
All Exempt studies MUST be submitted to the Radford University IRB for review. Exempt reviews are conducted by a member of the IRB committee and do not require a convened committee meeting. These are reviewed individually as they are received. For further information, please contact the IRB Office at 540-831-5290 or firstname.lastname@example.org.
Examples of Commonly Exempted Research
The following types of research are commonly processed under exempt review:
- Research on educational practices or educational curriculums
- Benign behavioral interventions with adult subjects
- Anonymous surveys or interviews on non-sensitive topics
- Passive observation of public behavior without the collection of identifiers
Research that is Not Eligible for Exemption
The following types of research are not eligible for exempt review:
- Prisoners as subjects - When prisoners are being studied as a population. (The exemption is allowable if the research is aimed at a broader population and only incidentally includes prisoners)
- Children as subjects - Only allowed under certain conditions
- Medical records - With the exception of Limited Data Sets
- FDA regulated studies - With the exception of Taste and Food Quality and Consumer Acceptance
- Deception studies
Federal regulations mandating IRB review recognize that not all research rises to the level of full board review. In some cases, a protocol needs IRB approval but the level of risk in the protocol is considered minimal and the review can be expedited. If the proposed research meets the definition for minimal risk, in addition to one of the federally designated review categories, the IRB can expedite a protocol's review. Expedited reviews are conducted by a member of the IRB committee and do not require a convened meeting. 45 CFR 46.102(j) defines minimal risk as "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine or psychological examinations or tests."
FULL BOARD REVIEW
Research that does not qualify for exempt or expedited review, presenting more than minimal risk to subjects, will receive a review at a fully convened IRB committee meeting. The research requires approval from a majority of those members.
Examples of Full Board Research
Research involving greater than minimal risk procedures and:
- Clinical procedures with drugs, devices, or biologics, or innovative research into new medical or surgical procedures
- Disclosure of information that could require mandatory legal reporting (e.g. child/elder abuse, etc.)
- Vulnerable populations (Children, prisoner, pregnant women, and neonates, per Federal regulation)
- The IRB staff, board member, or designee determines risks are greater than minimal
If your protocol is greater than minimal risk, you will be notified by the IRB Office with any required changes/corrections to the protocol prior to distributing the protocol documents to the committee.
Full Board submissions are reviewed at convened meetings of the IRB and must be submitted three (3) weeks in advance of the IRB meeting for all faculty submissions and two (2) weeks in advance for all graduate student protocols.
The PI and/or research team is usually encouraged and invited to present and defend their research and to be available for any questions that the Board may have.