Exempt Research
Some projects fall into a category called exempt. The term itself can be misleading; this does not mean that you don’t have to submit your work to the IRB for review. Rather, it means that you are doing regulatory research (see How to Determine If You Are Conducting Research), and that research is of such minimal risk that the IRB chair determines that it meets the specific OHRP requirements for exemption (the categories listed under 45 CFR 46 Section 101(b)(1)-(6)). Therefore, the research does not need to be reviewed by anyone other than the Chair, and once it has been reviewed, it will be exempted from continued review. The IRB Chair is the only person who can determine exempt status.
Research that is defined as exempt will be reviewed on a rolling basis and is therefore not subject to the dates for the scheduled IRB meetings. If the Chair determines that a research project is exempt from further review, this decision will be communicated to the principal investigator in writing. There is no expiration date for research that has been exempted. As long as no changes are made to the research protocol and there is no evidence that the risks associated with participation have changed, an exempt project will not need to be reviewed again by the IRB.
Expedited Research
A second category of review is called expedited. Research defined as expedited will be reviewed by two IRB committee members, typically the IRB Chair and one other voting member of the committee. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research.
Research that is defined as expedited will be reviewed on a rolling basis and is therefore not subject to the dates for the scheduled IRB meetings. Once the IRB Chair has received reviews from two committee members, the committee’s decision will be communicated to you in writing. IRB approval of expedited work will typically be valid for one calendar year. At that point, if the project is still active, all relevant materials will need to be submitted to the IRB Chair for re-review. In some cases, it might be determined that re-review is necessary more frequently than on a yearly basis. If that is the case for your research, that information will be communicated to you in your approval letter.
Full Review Research
The third category of review is called full. There are a number of reasons why research might require full review. For example, research that involves minors or other specially protected populations (e.g., prisoners) will always require full review. Other reasons why research might require full review include that the topic of the research is potentially disturbing to participants, there is a potential for loss of confidentiality, there is deception involved, etc.
Research that is defined as full review will be reviewed by the entire IRB committee at a regularly scheduled meeting. If you think your work might fall into a category necessitating full review, you should consult the calendar of scheduled meetings (available at the beginning of each semester on the IRB website) and plan accordingly.
After the IRB meeting, the committee’s decision will be communicated to you in writing. IRB approval of full review work will typically be valid for one calendar year. At that point, if the project is still active, all relevant materials will need to be submitted to the IRB Chair for re-review. In some cases, it might be determined that re-review is necessary more frequently than on a yearly basis. If that is the case for your research, that information will be communicated to you in your approval letter.