What type of IRB review requires a determination?

Exempt Research Although the category is called “exempt,” this type of research does require IRB review and the determination of exemption must be made by the IRB.

What are the three levels of an IRB?

IRB must review all projects that meet the definition of research and that involve human participants prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major levels of human subjects’ research review: Exempt, Expedited, and Full.

Which type of review is done by a single member of the IRB?

Full review: Submissions that meet the criteria for full review are typically reviewed by a quorum (aka majority) of IRB members which must include at least one member whose primary concern is in a nonscientific area.

What is a full IRB review?

Federal regulations and institutional policy require an IRB Full Board Review for applications where the research involves more than minimal risk to human subjects or has been referred to the committee by an expedited reviewer or the Chair.

What is a convened Review IRB?

A convened meeting is one at which a majority of members must be present, including a member whose primary concern is in a non-scientific area, before official actions may be taken. In order for the research application to be approved, it must receive approval of a majority of those members present at the meeting.

What kind of review is done on projects that deal with children or members of other vulnerable populations?

IRBs ensure that a parent or guardian provides approval for any research involving children (under age 18). Children are also required to assent to participate, that is, they must understand the study and any risks involved and agree to participate in the research.

What is an exempt IRB review?

Research can qualify for an exemption if it is no more than minimal risk and all of the research procedures fit within one or more of the exemption categories in the federal IRB regulations. Studies that qualify for exemption must be submitted to the IRB for review before starting the research.

Is full board review the same as convened review?

Studies that involve more than minimal risk require review at full board IRB meeting (also referred to as Convened Review). The research requires approval from a majority of those members.