The Review Process

The protocol application and review process can take from 4 to 12 weeks, and up to 16 weeks (for non-exempt protocols) during the fall and spring Graduate Studies deadline periods. Research with human subjects—including recruitment of subjects—cannot proceed until the researcher receives final approval from the protocol office.

Notice of final approval will be received via e-mail from protocol@sfsu.edu. Researchers may not use any data collected before the final approval is received, and proceeding with research before approval can result in suspension from the university.

All communication from the IRB office is conducted entirely by email. The office informs investigators when a protocol or revisions have been received, and when the protocol is scheduled to go to a committee meeting (if the protocol is non-exempt.)

The Revision Cycle

Once a protocol enters the CPHS 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 CPHS office staff conduct 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 next level of in-office review considers substantive ethical issues regarding human research subjects protection, and determines if you have made all prior requested changes. Frequently, additional questions are generated by the new material, so a second round of revisions is the norm
• For the non-exempt protocol: after all pre-review revisions have been made, or a researcher has explained why a revision cannot be made, a non-exempt protocol will be assigned to a committee meeting for review by the full Institutional Review Board. Final revisions may be requested at this stage by the committee to bring your protocol into compliance.
• For the exempt or expedited protocol: after all pre-review revisions have been received, the exempt or expedited protocol will be assigned to a committee chair for final review. Final revisions may be requested at this stage.
• Once all revisions have been received, the committee 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.

If a graduate student decides at some point to change the culminating experience to a project that does not involve human subjects, please let the IRB office know by e-mail. Be aware that a revised proposal describing your new project must then be submitted to Grad Studies.

How to avoid a lengthy review process:

• Consider conducting an exempt research project, which will be reviewed by office staff 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.
• See Review Categories: Research that does not need review to determine whether the research even requires IRB review. While the committee’s charge is broad, there are several categories of projects that are not considered “research” in the NIH sense, or are research but do not involve human subjects.
• Submit all documents before the semester deadline if you plan to graduate in the following semester. Please be aware that each department and college has its own, usually earlier, deadlines that the student must follow. Generally, documents are submitted to the department office for the final signatures by graduate coordinator or department chair, then forwarded to the CPHS office by the department. The office sends acknowledgement of receipt once a week on Friday.
• Submit a complete protocol package from the start. Make sure to have two different faculty signatures, after your own, on the PAF.
• 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 subjects when, 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.