Full Board Review

“Full board” or “Full board meeting” refers to a convened meeting of an institutional review board (IRB) where research applications are reviewed. Enough IRB members attend to achieve quorum and per regulatory requirements, at least one member who is a nonscientist is always present to discuss and vote on agenda items at a meeting. Scientific members with the necessary expertise and qualifications to review research will be present. If research with prisoners as participants will be reviewed, a prisoner advocate is also in attendance.

The IRB members discuss the study and make determinations about the risk level of studies and whether to approve, require changes to secure approval, defer to another meeting or deny research proposals. If any other determinations are required, for example, significant risk device determinations for device studies or whether an IND application is needed for a drug study, the board will also vote on these items at the meeting. After the meeting, IRB staff communicates the results of the discussion to study teams, usually within 24 hours.

IRB members reviewing studies that qualify for expedited review can decide that full board review is appropriate for any reason, however, some applications and studies are more likely to require full board review.

Situations that make full board review more likely:

• Studies involving drugs. 
• Studies involving medical devices.
• Substantial modifications to research that has already received a greater than minimal risk determination by the board.
• Continuing review of research that has been determined to be greater than minimal risk by the board.
• Studies that necessitate collection of data on sensitive topics that if disclosed outside of the research context, could create negative consequences for a participant legally, financially or for their reputation.

No. The process for submitting any study to the Georgetown IRB involves staff and IRB members selecting the appropriate level of review for all studies.

IRB members must have adequate time to review applications. Please see individual committee webpages to access the schedule of meetings and deadlines for each board. Submitting on time allows the IRB staff time to work with you to ensure completeness and accuracy of the application prior to the board making determinations about approval, modifications required to secure approval, deferment etc… The submission deadlines selected for each board are intended to ensure that IRB members will have at least one week to conduct their review prior to a meeting where a study will be discussed.

For studies involving GHUCCTS or CRU resources please note that full board studies will likely need SEPCOM approval prior to being reviewed at a full board GHUCCTS committee meeting.  [LINK TO SEPCOM REVIEW FIGURE HERE]

Ensuring that your application clearly demonstrates to individuals not involved in the project how the study will be conducted when recruiting, consenting, collecting data and storing data will assist the IRB during their review. IRB members should be able to have a clear understanding of the timeline of events for a participant in any specific condition of a study from their initial recruitment through completion of the study. Whether a new study or a modification, maintaining consistency between protocols and consent forms will also reduce the need for edits. Although the board has many different members with various scientific and nonscientific backgrounds, spelling out scientific acronyms can help prevent confusion to those outside of your area of expertise that will discuss your study at a board meeting.