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The UR IRB Process in Brief

1. The IRB's process begins with the receipt of a research proposal or a query to the IRB Chair about the proposed research.  Researchers who have submitted proposals in the past will often simply email a proposal to the IRB Chair asking that the proposal receive expedited review or full board review.  Researchers who have never submitted a proposal before are encouraged to study this IRB website.  Both the full review form and the expedited forms are designed to guide the researcher through the proposal development process.  Researchers are welcome to contact the IRB Chair either by email (irb@richmond.edu).  New research proposals should be emailed to irb@richmond.edu .

2. Upon receipt of a proposal, the IRB Chair will determine if the proposal is eligible for expedited review or must go to the full board for review at one of its scheduled meetings.  To qualify for expedited review, a proposal must pose no more than minimal risk* to subjects and meet one of the nine categories that OHRP has determined can be reviewed using an expedited process.

3. If the proposal is expeditable, the Chair will take action, usually within several days.  The Chair can approve the proposal; approve the proposal with conditions that must be met prior to final approval; or, return an incomplete or unclear proposal for more information.  The expedited process can not be used to disapprove a proposal.  The Chair informs the researcher of the determination by email.  All expedited actions are reported in writing to the IRB convened board at its next meeting.  At that time, the board could act to change the expedited action of the Chair but this very rarely happens.

4. If a proposal is not expeditable, it is reviewed by the convened board at a regularly scheduled meeting.  See Schedules and Deadlines for 2016-2017 IRB meetings.  The board is authorized to take actions including approval, disapproval, approval with conditions and other actions as specified by OHRP.  OHRP specifies criteria for an IRB's approval of research.  A board approval must be reviewed and renewed within one year of the date of approval, unless the board specifies more frequent reviews.  By law, an IRB approval can not be for a period in excess of one year.

5. After the board has taken action on a proposal, the IRB Chair communicates the board's action to the researcher(s), typically by an email "IRB notice of action".  The board typically meets on Tuesdays and the IRB Chair will communicate the board's decision to a researcher in a timely manner, usually no later than the following Friday (three days).

6. If a proposal has been approved, the research can begin upon receipt of the notice of action sent by the IRB Chair.  If a proposal has been "approved with conditions" the researcher must resubmit the proposal, addressing the conditions of approval stipulated in the notice of action.  Typically the board will authorize the Chair to take expedited action on revisions.  Consequently, the convened board usually does not have to re-review a proposal.  That said, it is not uncommon for the convened board to require a full board review of revisions.  When the researcher receives a final approval from the IRB Chair, research on the project may begin.

7.  If research extends more than one year beyond the approval date, the researcher must resubmit the proposal in a timely manner to ensure that there is not a gap in IRB approval.

8.  All IRB approvals will be communicated in writing, typically via email.  There are no verbal approvals of proposals under any circumstances.

Timeframe for IRB Action on Proposals: The IRB strives to issue notices of action during the week after the Tuesday convened meeting of the Board.  In most cases this self-imposed deadline is adhered to.  The timeliness of University of Richmond IRB actions can be compared to the National Research Network 2012 Benchmark Report.  This report shows an average "decision to letter" average of 6 days.  The University of Richmond normally provides action to complete proposals on a more timely basis than this benchmark.  The University of Richmond typically provides expedited review decisions on a much more timely basis than the 15 day turnaround period cited in this same 2012 report.  More recent data may be found in the 2014 report 2013 Metrics on Human Research Protection Program Performance; see Figure 16: IRB Review Times by Type of Review.  Persons reviewing these data should be aware that the respondents are primarily from research institutions, such as R-1 universities.

* As defined in 46.102(i), "Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."