OVPRI Human Subject Research Protection Blog

The VCU Human Research Protection Program is dedicated to facilitating ethically and scientifically sound research through robust review of research projects and through effective education and outreach to the VCU research community.

Beginning with submissions scheduled for review at the November 20th IRB meeting, submissions will first undergo a staff only pre-review process. The pre-review by staff is meant to do three things:

  1. Ensure completeness and accuracy of the information provided in the submission before it is sent to reviewers.
  2. Provide PIs with an opportunity to make minor revisions in advance of IRB review in order to address common issues or findings.
  3. Provide assigned reviewers with guidance on the regulatory implications of the study as they begin their review.

In order to be successful, it is critical that IRB staff, Principal Investigators, and study teams adhere to timelines communicated during the review process. Typically, a submission will move to Full Board IRB review as follows:

An image of a table describing the full board timeline. Wednesday: PI submits study. Thursday through Tuesday, Staff prescreen. Wednesday through Monday, PI makes changes. Tuesday: assigned to Meeting. Wednesday through Tuesday: panel review. Wednesday: panel meeting. Thursday: minutes. Friday: letter sent. Monday and Tuesday: PI makes changes.

 

  • PI submits study
  • IRB Staff provide initial comments to the PI within 4 business days
  • PI and Team will have 4 business days to respond to initial comments
  • Study is assigned to an IRB meeting agenda
  • IRB members have 5 business days to review before IRB Meeting

This change brings our process in line with best practices identified by other HRPPs and is consistent with feedback we received as part of the 2019 Community Survey. We recognize that the process adds time between submission and IRB review, however, we believe that placing IRB staff review before review by the convened IRB may improve the overall timeline to IRB approval by reducing the likelihood of a study being deferred or tabled. It is possible that this change in process might also increase the number of studies that are approved on first review by the IRB.

If you have questions about this change in process, please contact the HRPP at 804-828-0131 or via email at ORSP@vcu.edu

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