Types of review
When a submission comes to the IRB it is evaluated to determine the appropriate category of review. The IRB uses four categories to classify submissions:
- Excluded
- Exempt
- Expedited
- Full Board
It is important for Investigators to understand that the Federal office that oversees research with human subjects (OHRP) has consistently stated that the regulations are a floor and not a ceiling in terms of human subjects' protections. The RIT IRB may require additional protections or modifications where applicable.
Excluded
The first step in identifying the appropriate category of review is determining if the proposed activity meets the Federal definition of research with human subjects. All submissions are evaluated and those that don’t meet the definition are considered to be Excluded. This means the proposed activity doesn’t fall under the scope of the IRB and researchers aren’t required to adhere to the Code of Federal Regulations relating to the protection of human subjects.
This most often happens when a proposed activity is a quality improvement activity, or “practice” instead of research. These non-research activities are usually intended to identify and control specific problems or improve programs or services. Practice includes interventions that are expected to enhance the well-being of a person through diagnosis or treatment and are not intended to provide generalizable results.
Exempt
Exempt research activities are those in which the only involvement of human subjects fall into specific categories defined in the Federal Regulations (45CFR46). These activities are considered research and are reviewed by the HSRO to determine which exemption category they fall under. These activities must present no more than minimal risk* and there are some restrictions.
Restrictions The following research activities cannot be reviewed under an Exempt category:
- Research involving prisoners as subjects except for research aimed at involving a broader subject population that only incidentally includes prisoners
- Benign behavioral interventions with adult subjects where deception is involved and the subject is not informed regarding the nature or purposes of the research
- Survey or interview procedures when the subjects are children
- Observation of public behavior of children when the researchers interact in the activities being observed
Expedited
Research activities that (1) present no more than minimal risk* to human subjects and (2) involve only procedures listed in one or more of the categories below may be reviewed by the IRB through the expedited review procedure.
NOTE: Expedited refers to the type of review – it is performed by the HSRO and may be reviewed by another experienced reviewer instead of the entire Board at a meeting. In spite of the name, it does NOT mean you can request this to make the IRB process go more quickly. There are very specific conditions under which a submission can be reviewed in this manner, it is not a type of review that an Investigator can request.
Full Board
The IRB at RIT consists of two branches, or committees. Each committee meets separately to review research activities. The members of each committee have a variety of backgrounds and areas of specializations. While they may be an expert in their own field, they review research activities from multiple areas of study within RIT. This helps them to ask questions which might seem obvious to a researcher, but which are very important to a subject. The Board members try to look at the proposed activity as a subject would.
* Minimal risk means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests