¼ªÏé·»

If you disagree with a request or determination about your study, please follow these steps to engage the IRB in considering your perspective.

1.ÌýRespond to the reviewer in Cayuse.ÌýIf an investigator feels that a requested change to their study protocol or materials is unduly burdensome without a clear benefit to participant health and safety, the first step is always to engage the reviewer in conversation. We often find that these disagreements can be attributed to miscommunication between the reviewer and the investigator, and that fundamentally irreconcilable views on the ethical acceptability of the research are quite rare.Ìý Therefore, we ask that the investigator first use the "Add Comment" feature within Cayuse to provide a clear justification of both the burden presented by the requested change and why participant rights are not potentially affected. There may be some dialogue on these points,Ìýand it is important to have this communication exchange preserved in the context of the original IRB application.

Please note: further appeals and/or escalationÌýwill not be consideredÌýuntil there is evidence of a conversation between the reviewer and the investigator in Cayuse.Ìý Investigators will be redirected to Step 1 until complete.

2. If the conversation is truly at an impasse,Ìýemail a request for subcommittee review toÌýirb@csun.eduÌýwith the following information:

• Study protocol number (e.g., IRB-FY##-###)
• Request for "subcommittee review" of a reviewer's determination, stipulation, or required change
• The specific item number(s) of the disputed change (e.g., "F3a")
• The IRB Analyst will respond within two business days confirming receipt of your subcommittee review request.

3. A subcommittee of three or more IRB committee members,ÌýexcludingÌýthe initial reviewer, will be convened to review the disputed item(s), including all prior conversation and justifications between the initial reviewer and the investigator. Please note that subcommittee members will access the entire application for context that may inform the disputed content. Subcommittee members may include alternate members of the IRB, but will not include anyone with a conflict of interest on the specific protocol (such as a co-investigator or faculty advisor).Ìý The subcommittee will document their opinions about the disputed item(s) in the appropriate section(s) of Cayuse; note, however, these discussions may not necessarily be visible to the investigator.

4. In the event that the subcommittee ultimately agrees with the investigator, the disputedÌýrevisionÌýwill be removed. Investigators are still responsible for revising the application to comply with all non-disputed revisions and re-certifying the application upon resubmission.Ìý If the subcommittee ultimately agrees with the initial reviewer, the requirement to revise the protocol accordingly will stand.Ìý In either case, the determination and next steps will be sent by email fromÌýirb@csun.eduÌýto the investigator.

5. If the subcommittee found in favor of the initial reviewer and the investigator still wishes to pursue appeal, the investigator shouldÌýreply directly to the determination email (fromÌýirb@csun.edu) requesting chair-level review. The IRB chair and vice-chairs will examine the accrued evidence and written opinions to date.Ìý If the chairs determine that there is merit to the investigator's dispute - i.e., if it is an ethical gray area; if the dispute reflects ambiguity or inconsistency in the IRB process; or if the discussion highlights a need to establish new policy - the chairs will bring the question before the full committee at the next convened IRB meeting, and the full committee will vote.

6. The vote of the full IRB committee is considered final and cannot be overruled by administrative action.Ìý The determination of the committee will be communicated to the investigator via email within five business days of the IRB meeting at which the issue was discussed.

As a reminder, the IRB is an independent oversight committee charged with ensuring the ethical treatment and protection of human research subjects.Ìý Although the IRB reports to the Institutional Official and the IO appoints committee members, the IO only has the authority to shut down IRB-approved research that is deemed to be non-compliant, harmful or unethical, or poses insufficiently managed risk or liability to ¼ªÏé·».ÌýÌýThe IO may not override an IRB requirement or approve research the IRB has previously disapproved.