FAQ: Study Review

  1. Who reviews my study/application?

    When an application is received by the IRB, it is triaged (based on information in the application) to be reviewed either by the convened board or, the IRB chair or a designee of the chair (vice chairs, the IRB director, assistant director or a senior Analyst). Before being forwarded to the reviewer, the application is pre-reviewed by an Analyst to ensure that it is ready to be reviewed (e.g. scientific review has been conducted, the protocol and consent form are attached, as applicable).

  2. I have submitted an application in eIRB. How do I know where it is in the review process?

    The current study state (i.e. where the submission is in the review process) is always indicated in the red bar in the top left hand corner in your eIRB application. Examples of common states your submission may be in are:

    • “In Department/Division Review” (the study awaits review by your Department Chair or Division Chief and has therefore not yet been submitted to the IRB);
    • “In Pre-Review” or “In Review” (it is being reviewed by the IRB);
    • “Changes Requested” (it is with you to respond to stipulations); or
    • “Ancillary Approval Pending” (all IRB issues have been addressed but approval from one or more ancillary committees, such as Conflict of Interest, Technology Transfer etc., may be outstanding).

    If the approval of ancillary committees is pending, you can find which ones are outstanding by going to the “Pre Review Status” tab in your study workspace (it can be found next to your “History”, “IRB Correspondence” and “Documents” tab”).

  3. Who should I contact with questions about the stipulations sent to me?

    The first contact for questions about stipulations sent to you is the Analyst assigned to the study (either by email, phone, office hours or one-on-one meeting as necessary). S/he will then either be able to provide you with the information needed or, if necessary, will contact the reviewer to set up a teleconference or meeting between the PI and the reviewer. In general, questions about the eIRB application and consent form should be directed at the Analyst for the study first. Questions regarding the protocol, reasons for deferral, risk/benefit or waiver determinations should be directed to the reviewer.

  4. Are the same Analyst and reviewer looking at all amendments to my study?

    While it is the IRB’s goal to maintain consistency and keep the same Analyst/reviewer pair on a study throughout its duration, this has to be balanced by the necessity of a timely flow of submissions through the office. Depending on the nature of the amendment (staff change, change to recruitment materials versus substantial changes to the study design) and overall workload (full board meetings, high submission volume, vacation schedules), amendments will also be assigned to Analysts/reviewers who have not reviewed the study before.

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