Long Wait Times for New Minimal Risk Studies

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Human Research Protection Program

September 9, 2019

To: Investigators and Staff Conducting Minimal Risk Research

Long Wait Times for New Minimal Risk Studies

New minimal-risk studies receiving expedited or exempt review are experiencing significantly longer wait times before being assigned to an IRB Analyst for review, with a median wait time of several months before an IRB Analyst can start the initial screening.

Why is it Taking Longer?

There are several contributing factors to the increased wait time, including:

  • Loss of ~35% (2 FTE) of staff from the IRB Expedited/Exempt Review Team in 2019
  • Higher than usual volume of incoming studies (~350 new minimal risk studies submitted each month)
  • An increased volume of prioritized review requests

Our Plan to Improve the Situation

  1. Building our Team: HRPP leadership is working to fill the vacant positions and increase capacity by adding additional personnel.
    1. New contractors have been hired to fill the 2 currently empty positions, and existing contractors and IRB analysts are focusing their efforts towards the minimal risk submission queue.
    2. The IRB recently received a budget augmentation that includes 2 additional, permanent FTE. We are actively recruiting for these positions.

Please note that while these staff additions will ultimately help shorten our review time, it may be several months before the impact is noticeable, due to new staff training requirements.

  1. Focusing our Efforts: The IRB normally receives daily calls and emails for “status checks” and “rush” requests for submitted studies. Understandably, the volume of calls and emails has increased as a result of the review delays, impacting our ability to devote time to processing your studies. Please allow 48 hours for us to respond to specific requests regarding minimal risk studies.

Can the Study Team Help Speed Things Up?

One of the most frequent reasons the IRB sends stipulations is that the submission materials are incomplete or inconsistent. Here are our tips for a smoother review experience:

  • Before submitting your study, have a colleague proofread ALL of your submission materials and give feedback on anything that seems missing, confusing, or inconsistent. If you are a student, resident, or post-doc, your faculty mentor/advisor should do this review for study design and completeness. Having your study carefully proofread and corrected could improve approval time by weeks.
  • Respond to stipulations promptly. On average, the time that study teams take to respond to stipulations accounts for nearly one-half of the total time to approval.
  • Consider the option to seek IRB approval from a commercial IRB, if your funding would support this. Read about the criteria and guidance here.

What is a Prioritized or “Rush” request?

Generally, new minimal risk submissions are reviewed in the order that they were submitted. However, sometimes there are conditions which necessitate that a study skips the line, and we refer to these as “rush” requests. The most common examples of circumstances in which the IRB would honor a rush request are:

  • NIH “Just in Time” (JIT) studies, where the PI is informed of a short turnaround time to provide IRB approval in order to receive an award
  • Disease outbreak or a disease “season”
  • Students/Residents/Fellows on a timeline for educational reasons

How to Request a “Rush”

In iRIS, once you have completed the application you will be brought to a form called the Initial Review Submission Packet. This form has a section titled “Special Processing Instructions or Information about the Submission” where you should explain your timeline and state when approval is needed.

If you are informed of a timeline issue after the study has been submitted, please send an email to the main IRB inbox and the message will be forwarded to the Expedited/Exempt Manager for prioritization.

New minimal risk studies are triaged daily by the IRB administrative staff, and each rush request is sent to the Expedited/Exempt Manager for consideration and prioritizes distribution to analysts based on the PI’s proposed deadlines.

Process for Assigning Minimal Risk Studies to an IRB Analyst

When a PI signs off on a minimal risk study, the iRIS system holds all of the studies in a queue designated for minimal risk research. When an analyst is ready to take a new study, they will select the oldest pending study and begin screening. This gives all PIs an equal chance of their study being reviewed in order of receipt, excepting “rush” requests.

If you’re thinking “This isn’t how it used to be, my studies used to be assigned to an Analyst right away,” you are correct. In the past, iRIS distributed new studies to an IRB Analyst upon receipt. With this old method, a PI could immediately see which analyst would be handling their study. This had an unanticipated negative consequence: If an analyst was working on a particularly time-consuming study, all the other studies in their queue would back up, while studies in another Analyst’s queue were moving forward in line. This ultimately resulted in studies not being reviewed in the order of receipt. To correct this, we initiated our current assignment method several years ago.

We look forward to reviewing your submissions.

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