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Changes to the Common Rule
Once the Common Rule is approved (slated to be July 19, 2018), there will be an added review process available. Called limited IRB review, it will apply only to certain exempt categories of research and will be done to ensure that there are adequate provisions to protect the privacy of subjects and to maintain confidentiality of data in the proposed research. You can learn more about limited IRB review here.
Proposal Review Timeline
When a primary investigator (PI) submits a research proposal to the IRB, the IRB compliance officer will pre-screen the proposal and contact the PI with any immediate changes that must be made before it is eligible for further review. If a study does not qualify as human subjects research under the federal definition, IRB staff will determine this and notify the PI that no further oversight is required. The IRB office will provide a letter stating that the study does not meet the parameters for human subject research.
Exempt proposals are reviewed by the IRB office to ensure exempt status and to verify that all federal human subject protection guidelines are followed.
Exempt proposals that undergo limited review and expedited proposals are reviewed by the IRB office as well as at least one other Board member.
Full Board Review proposals must be reviewed by a quorum of Board members. They need to be received by the office at least one week before an IRB meeting in order to be considered for review at that meeting.
Once any initial changes are made, the approximate timeline to hear back from the IRB office with further revisions is as follows:
|Exempt Review||1 week|
|Expedited Review||2 weeks|
|Full Board Review||Within 1 week of the IRB meeting during which your proposal was reviewed|
Exempt and Expedited proposals may be submitted for review any time during the fall and spring semesters. For Full Board Review proposals, see below.
For your scheduling purposes, allow a minimum of two weeks for review of proposals and up to four weeks for final approval.
The IRB is not in service during the summer months.
IRB Meeting Schedule, Fall 2018
Proposals must be received a week before the board meeting in order to be considered. If a submitted proposal requires significant revisions, the review may have to wait until the following meeting.
Please note that full-board review proposals submitted after May 4, 2018 may not be reviewed until the beginning of the Fall 2018 semester. Expedited and exempt proposals will be reviewed on a limited basis during the summer months.
IRB Review Outcomes
The IRB will notify the researcher with one of the following once the application has been reviewed:
- Approval — the application is complete, the risks to subjects are minimal/minimized, and the procedures are appropriate. The IRB gives approval for the research to be conducted.
- Revisions/Clarifications Needed — the application is complete but there are issues/changes that must be addressed before the project can begin. Once a satisfactory response to these contingencies is received and approved by the IRB, the review is complete.
- Incomplete review — applications that are found to have deficiencies (risk to subjects, unclear procedures, serious omissions, ethical issues, or major contingencies) will be deferred. The researcher is sent an e-mail listing the concerns that must be addressed for approval to proceed. The researcher's response is reviewed by the IRB and will be approved or deferred until all issues are addressed satisfactorily.
- Non-Approval — Applications that are found to have risks that outweigh the potential benefits to subjects and/or society will receive a non-approval and the research will not be allowed to be conducted as designed. Institutional administrative officials may not override this decision.