Full Board review is appropriate for major changes in approved research, and when the amendment includes research involving more than minimal risk or does not fit an expedited review category published in the Federal Register. 

Some examples of major changes include: changes that adversely affect the risk/benefit ratio of the study or specifically increase the risk to participants; changes in inclusion/exclusion criteria that impact the risk/benefit ratio of the study; significant changes in study design, such as the addition of a new target population or the elimination of a study arm, etc.  

Full Board review is conducted by the convened Institutional Review Board (IRB). The HSPH IRB meets once a month.  The meeting agenda is determined three weeks prior to the meeting.  Submission deadlines are posted on the OHRA website under IRB Meetings/Deadlines.  A study cannot be placed on a full Board meeting agenda unless all necessary materials are complete and have been submitted by the meeting submission deadline.

Each submission under review is assigned to a Primary and Secondary Reviewer.  The Primary and Secondary Reviewers introduce the protocol to the remaining membership and highlight any issues for discussion.  The IRB may request that an investigator attend a meeting (or be available via phone) in order to respond to questions about a protocol.  The investigator, however, may not be present for the discussion and vote. 

Decisions are made by a majority vote of a quorum of the IRB membership. The IRB may vote to "approve", "require modifications", "defer", or "disapprove".

If you have questions about full Board review, feel free to contact Administrative Chair Julie Kaberry.

IRB Review Actions

Approve:
The IRB may approve research when all of the relevant regulatory requirements are satisfied. This means that the IRB approves the research protocol and research consent form and other documents as submitted, with no change.

Require Modifications:
The IRB may require modifications in the research to secure approval if the IRB determines that all of the relevant regulatory requirements would be satisfied if the investigator modifies the research protocol and research consent form as required by the IRB.  This means that the IRB provides the investigator with explicit modifications, and does not ask for additional information or for clarification of issues that may affect the risk benefit assessment or other regulatory requirements for IRB approval. In order to obtain IRB approval, the investigator must simply concur with the IRB's required modifications and make the specific changes to the affected documents.

Defer:
When the IRB needs additional information from the investigator in order to determine whether all of the relevant regulatory requirements are satisfied, the IRB must defer action until the information is provided.  If the research was initially reviewed by the full board, the PI's response and revised materials must be reviewed at a subsequent convened meeting.

Disapprove:
When the IRB has all of the information it needs to determine whether all of the relevant regulatory requirements are satisfied, and determines that the requirements cannot be satisfied by making modifications in the research, the IRB must disapprove the research. This action cannot be used if the research is being reviewed on an expedited basis.

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