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.

Dear Members of the VCU Research Community,

The Virginia Commonwealth University Human Research Protection Program (HRPP) is aware of the iodine-based IV contrast shortage at Virginia Commonwealth University Health System (VCUHS) due to supply chain issues related to COVID-19. The potential impact on human subjects research may require submission of a protocol amendment to adjust study procedures and/or locations. The HRPP and Institutional Review Board (IRB) are prepared to support the research community to respond to the current situation.  

In an effort to uphold our duty to protect human subjects, the HRPP and IRB have prepared the following guidance to aid investigators and their research teams in responding to this national issue:

1. Identify whether your study will be impacted by the iodine-based IV contrast shortage.

For VCU IRB Review

Check the IRB-approved protocol and verify the following:

  1. Current use of imaging technology as a research procedure;
  • If the answer is yes, proceed to verify item (2) below. 
  • If the answer is no, then the protocol is not impacted and no action is required.

2. Current use of iodine-based IV contrast as a research procedure;

  • If the answer is yes to item (2), the protocol is impacted by the shortage and a contingency plan is required.
  • If the answer is no to item (2), the protocol is not impacted by the shortage. 
    • However, RAMS-IRB must be updated to reflect the status of the supply shortage. Log a public comment in RAMS-IRB specifying why the protocol was not impacted by the supply shortage. (To see how to log a public comment in RAMS-IRB, see the “Communicating With IRB Staff/Reviewers” section of this Gif Guide.)

Please note: In collaboration with VCUHS, all contingency plans must incorporate VCUHS’s procedures and/or guidance addressing the supply shortage. If further guidance is needed, please contact VCU’s IRB at orsp@vcu.edu

For External Review

Check the IRB-approved protocol and verify the following:

  1. Current use of imaging technology as a research procedure;
  • If the answer is yes, proceed to verify item (2) below. 
  • If the answer is no, then the protocol is not impacted and no action is required.

2. Current use of iodine-based IV contrast as a research procedure;

  • If the answer is yes to item (2), the protocol is impacted by the shortage and a contingency plan is required.
    • Submit an amendment to the IRB of Record. 
    • Update RAMS-IRB upon receipt of the IRB of Record approval.
  • If the answer is no to item (2), the protocol is not impacted by the shortage. 
    • However, RAMS-IRB must be updated to reflect the status of the supply shortage. Log a public comment in RAMS-IRB specifying why the protocol was not impacted by the supply shortage. (To see how to log a public comment in RAMS-IRB, see the “Communicating With IRB Staff/Reviewers” section of this Gif Guide.)

Please note: In collaboration with VCUHS, all contingency plans must incorporate VCUHS’s procedures and/or guidance addressing the supply shortage. If further guidance is needed, please contact VCU’s IRB at orsp@vcu.edu

Reminder: Studies reviewed by external IRBs continue to be subject (as applicable) to VCU and VCUHS’s institutional requirements related to study conduct. Study teams with external reliance studies are responsible for communicating with the reviewing IRB regarding any contingency plans and/or the pausing of any study activities at the VCU site. Contact irbreliance@vcu.edu if you need assistance. 

2. Monitor your email

Monitor your email for further communications and instructions from VCUHS and the HRPP (e.g., blog posts, listserv messages, comments in RAMS-IRB).

VCU and VCUHS are here to support investigators in protecting the rights, welfare, and safety of human subjects. Therefore, if the protocol experiences a reportable event (i.e., unanticipated problems or adverse events) that impacts the mission of VCU and VCUHS to protect human subjects, please follow the procedures listed below: 

  • Follow the normal procedure for submitting the Report within RAMS-IRB. For guidance on what constitutes an unanticipated problem, refer to WPP VII-6
  • To seek guidance regarding an unanticipated problem or any emergency situation: Call 804-828-0868 and leave a message, including a phone number where you can be reached. Messages will be checked daily, and your call will be returned.

Thank you for your time and consideration,

VCU HRPP Staff

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