Communication of the Boards Decision
The IRB may take up to 2 weeks to review any proposal (full or expedited), so plan ahead!
All research proposals are evaluated by the IRB with regard to the degree of “risk”, if any, to human subjects. It is expected that most research projects will fall into the Expedited Review category. This determination must be made by the UC IRB and not by the individual researcher.
Full committee review is required when the procedures of the research present more than minimal risk to the subject (see Proposals Requiring Full Review) and/or fall into one or more of the categories specified under Full Committee Review.
If a proposal can be reviewed through the Expedited or Exempt Review Procedure, the Board will review the proposal following its Standard Operating Procedures and regulations in 45 CFR 46, and will consult with at least one other member of the Board regarding the proposal. If a proposal is not in a category eligible for Exempt or Expedited Review, it will be considered under the Full Review procedure.
Any research project that cannot be reviewed using the Expedited Review procedure will be subject to Full Review by the Board. All members of the Board will discuss the proposal. A majority vote of the Board is required for approval of a proposal. The Chair votes only in case of a tie by the other members. Minutes of Full Review discussions will be kept, and a summary of those minutes will be available, on request, to the principal investigator, the human subjects of the research project, and relevant federal, state, or local authorities and funding agencies.
After review of the proposal, a letter will be sent to the investigator by the IRB chair, indicating one of three possible outcomes:
Approved - A protocol which has been approved by the IRB requires no further action from the investigator prior to initiating the study. If the study should extend beyond 12 months, the investigator may be required to submit a Continuing Review Form for further IRB review.
Revise and Resubmit - More extensive changes are required before the study may begin. A protocol that has been deferred by the IRB usually requires that additional information be submitted to the IRB prior to approval. A revised application should be submitted to the IRB clarifying the issues involved or providing the requested documentation. Depending on the nature of the concern, the revised proposal will be reviewed by the Chair, the IRB member specifically assigned to the proposal, or the full IRB at its next meeting. Principal Investigators may request the IRB to review its decision, and may write to, or appear before, the committee to discuss the decision.
Denied - The proposed research, because of the level of risk involved, cannot be initiated. Principal Investigators may request the IRB to review its decision, and may write to, or appear before, the committee to discuss the decision.
Board approval of a project is valid for 12 months. If the project closes before the year mark, a Study Closure Form should be submitted at that time. Upon the year mark, a Principal Investigator may be required to submit a Continuing Review Report Form. Research approved by the IRB that is continuing, may need to be re-reviewed every twelve months by the IRB. The IRB Chair will determine whether a full or expedited review is required. If, during the one year period, the scope of the study changes (for example, if a new experiment is designed and implemented, or if additional human subjects are enrolled in the study) a Revision Form, accompanied by a revised protocol, the most recent version of the approved consent form and the revised (if applicable) consent form, must be submitted for Board review. If there are changes made to student investigators, an Add/Remove/Change Form, including the student names and years, and the Certificate of Training, must be submitted for Board review. Once the approved research is underway, the investigators will promptly report to the IRB, via an Adverse Events/Protocol Deviation/Unanticipated Problems Report Form, any unanticipated problems that pose risks to subjects or others.
Many proposals initially receive a “Revise and Resubmit” decision. Often the required revisions are very small; sometimes they are quite extensive. The IRB works to respond to revisions as quickly as possible. To resubmit your proposal, please follow these instructions:
- Fill out a new application, checking the “Revised proposal” line in the “Review Status” section
- Write a letter or narrative in which you respond, point by point, to the issues raised in the IRB’s decision letter, explaining how you have addressed each issue.
- Submit new or revised documents (consent forms, protocols, etc.) that incorporate the required changes For instance, if the IRB requests clarification about how research participants will be recruited, do not just explain in your letter, but modify the original proposal to incorporate the clarification.
As with the original proposal, you should submit the revised proposal to firstname.lastname@example.org
Noncompliance will result in the termination of the study and could result in future submissions being denied. The IRB is required to report violations of the Common Rule regulations and internal policies and procedures to the Office of Human Research Protections.
Further, complaints or questions regarding compliance with this Policy should be directed to the Chair of the Board. Such reports will lead to an investigation and may be cause for suspension or termination of IRB approval for the project.
Research proposals in need of expedited review may be sent to the Administrator of the IRB at any time. The IRB is available as an advisory board if there are any questions regarding the review process and categories of review.