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:
- 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 IRB may require additional protections or modifications where applicable.
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 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 to determine which exemption category they fall under. These activities must present no more than minimal risk* and there are some restrictions.
The following subject populations are not eligible for an Exemption:
- Incarcerated individuals
- Pregnant woman if they are the targeted subject population
- Projects that include deception of subjects
Children as Subjects
The following types of research activities are not eligible for an Exemption if the subject population includes children:
- Research involving survey or interview procedures
- Observation of public behavior when the researchers interact with the children
- Note: Educational testing with children does qualify for an exemption.
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 Chair of the Board or an appointed Member 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.
The IRB committee meets to review research activities. The members of the 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 AUIS. 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.
Note: In absence of Iraqi or KRG law/regulation regrading research ethics, AUIS through its IRB adopted the United States of America code of federal regulations number 45CFR46 as a policy for the protection of human subjects to form the bases (floor) of research ethics regulations in AUIS.