The total review process for non-exempt protocols which require full committee review can take up to 8 weeks. Protocols which qualify for expedited review may take up to 4 weeks. Exempt protocols may take up to 2 weeks. In all cases, research —including recruitment of subjects— must not proceed until approved by IRB. Please leave adequate time for the revision cycle.
Communications to the IRB may be conducted via email to the firstname.lastname@example.org address or via campus mail to the Office of Research and Sponsored Programs, LI 2310, CSUEB.
Phone: (510) 885-4212 Fax: (510) 885-4618
The Revision Cycle
Once a protocol enters the ORSP office and is clerically processed, it enters the revision cycle. Be aware that the revision cycle is a process, and different reviewers may look at the protocol during this process. Revisions are common at every stage, so plan to submit a non-exempt protocol in time to accommodate at least two to three rounds of review, as described below.
- The IRB chair conducts an initial screening of the protocol to ensure that all pieces of the application are present, and that the protocol template has been followed to provide the information needed for review.
- The IRB chair then determines if the research falls into one of the federal exemption categories, and if so, whether the protocol will be considered exempt from further review or given more extensive review.
- For non-exempt research, the IRB chair determines if the research falls into one of categories of research which may undergo expedited review. Most non-exempt research conducted at CSUEB falls into this category.
- For expedited research, once all pre-review revisions have been made, or a researcher has explained why a revision cannot be made, the protocol will be assigned to a subset of the members of the IRB. They will review the protocol and pass their comments back to the IRB Chair. The chair will request the investigator to make modifications based on these comments.
- Research which does not qualify for expedited review requires review by the full Institutional Review Board. Again, modifications may be requested in order to bring the protocol into compliance.
- Once all revisions have been received, the IRB chair will approve the protocol and the investigator will be sent an official letter of approval via e-mail.
- At this point, the research may begin.
How to avoid a lengthy review process:
- Consider conducting an exempt research project, which will be reviewed by the IRB chair and will not need full committee review. We can advise an investigator prior to submission whether or not a project will qualify for exemption. In general, surveys and interviews of adults, about non-sensitive topics, are considered exempt.
- Submit a complete protocol package from the start. Include the Protocol Approval Form, research protocol, surveys, consent forms, etc.
- State your research purpose or question clearly. Know what research has been done in the field recently, and how that affects your study. Are you trying to replicate earlier results, or are you trying to prove something different?
- Explain your procedures clearly and concisely. Include the details. Tell the IRB and the subjectswhen, where, and how long the research will be, and exactly what they will experience during the research procedures. Tell them what you would like to know before volunteering as a research subject. This is the meaning of “informed consent.”
How to avoid a lengthy revision cycle:
- The single most frequent cause of delays in protocol approval is the time lag between the office’s request for revisions, and the researcher’s reply to that request.
- Return revisions in a timely manner, because they are reviewed in the order they are received.
- Make all the changes requested, or explain why a requested change was not made. There may be a very good reason for not making a change, due to the research purpose or methods, an advisor’s recommendation, or the requirements of the discipline. State what these reasons are.
- With all revisions, submit a cover letter explaining all changes, including any that were not requested by our office. Highlight all changes for faster review.