COVID-19 UPDATE: Human Subject Research – Important Additional Guidelines and Update

IMPORTANT:  Please read this announcement (issued 3/23/20) from Dr. Srirama Rao, Vice President for Research and Innovation, and Dr. Peter Buckley, Interim CEO, VCU Health System, Interim Senior Vice President, VCU Health Sciences, Dean, VCU School of Medicine, regarding important additional guidelines and updates related to human subjects research during the COVID-19 pandemic.

  • Tier 1/ Tier 2 – Studies within Tier 1 or Tier 2 (those seeking to continue in-person visits/interactions) must follow the steps outlined in the announcement including submission of a justification through the VCU COVID-19 Human Research Continuation Request Portal. All justifications should have been submitted by Wednesday, March 25th. If you have not yet submitted a justification through the portal, you must do so immediately. Following submission to this portal, the PI’s Department Chair and Dean/Associate Dean for Research will review the justification for consideration of approval (by Friday, March 27, 2020). Please ensure completion of the processes outlined in the below notice for studies that you determine to fall in Tier 1 or Tier 2.
    • New studies proposed during the COVID-19 pandemic that likely fit the description of Tier 1 or Tier 2 may be approved by the IRB, however, they may not begin to enroll participants until/unless cleared to do so via the  VCU COVID-19 Human Research Continuation Request Portal.

Please review the notice in its entirety for additional requirements and information related to all four tiers. If you have questions about how this guidance affects your research, please contact the IRB Coordinator assigned to your study.

For the most up-to-date information regarding human subjects research, see the OVPRI COVID-19 Website and the Human Subject Research Protection (HRPP) Blog. Our COVID-19 and Human Research: FAQs page will also be kept up-to-date with new information as it is available.

COVID-19 and Human Research: FAQs

The VCU HRPP has developed a Frequently Asked Questions (FAQ) document addressing common questions from investigators about the impact of COVID-19 on human research. Below is a table of contents listing all the questions addressed in the document. Simply click on a question, and you will be taken directly to the corresponding answer within the FAQ document. This document will continue to be updated as the situation develops.

Table of Contents

IRB Status, Ongoing Research, & HRPP Contact Info

Study Modifications for COVID-19

Reliance Studies (Relying on VCU or VCU Relying on Other IRB)

VCU Health FAQ (UPDATED 03/20/2020)

FAQs Regarding Research Tiers and the Continuation Request Portal (ADDED 03/30/2020)

COVID-19 UPDATE: Pause to In-Person Interactions For Studies With Little/No Health Benefits

Please see the announcement below from the Vice President for Research and Innovation, Dr. Sriram Rao. Please continue to monitor the OVPRI COVID-19 Website and this blog for updates on COVID-19 impacts on human research. If you have questions about how this guidance affects your research, please contact the IRB Coordinator assigned to your study.

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Dear colleagues,

Following consultation with VCU’s research leadership and to ensure the continued safety of our human research participants, patients, and our community, VCU is further restricting access to its campuses.

All human research activity involving little or no potential health benefit to participants must pause all in-person interaction with participants immediately. This requirement applies regardless of the IRB of record approving the VCU human research activity.

Safety is our priority. This action is being taken to decrease potential exposure to COVID-19 by our staff, faculty and others. The following guidance has been prepared to assist research teams in acting on this decision:

You should determine if your study should be paused in accordance with this notice or can be modified to eliminate in-person study participant visits (e.g. telehealth or virtual visits):

  • For studies that will be paused: Log-in to RAMS IRB and submit a public comment to document that you have paused in-person visits. The study team should notify all active study participants that study activity is paused. This notification may be done via telehealth, phone, or other personal means and may provide an opportunity to reassure participants that their safety is our priority.
  • For studies that will continue by eliminating in-person visits: This action should be submitted as an amendment to the IRB of record prior to implementing the change. If prior amendment is not possible, the change must be reported to the IRB record in accordance with their policies. The VCU IRB process for submitting amendments in response to the COVID-19 pandemic can be found here.

If you determine that your study should continue with in-person study participant visits:

  • Reduce risk by limiting in-person visits where possible (relying upon telehealth or virtual visits, including Zoom). This action should be submitted as an amendment to the IRB of record prior to implementing the change. If prior amendment is not possible, the change must be reported to the IRB of record in accordance with their policies. The VCU IRB process for submitting amendments in response to COVID-19 can be found here.
  • Reminder:  In person study participant visits must be in the best interest of the participant and should be evaluated daily, as the public health conditions evolve.

New human research studies with health benefits to research participants will be evaluated on a case by case basis. Priority will be given to studies with clear statements regarding therapeutic benefit and/or specific COVID-19 outcomes.

VCU’s research enterprise is a critical component of the University’s mission. We understand that this guidance will significantly impact your research. OVPRI will issue additional guidance as to how to manage research delays and sponsor requirements on the OVPRI COVID-19 website. Please visit the website daily for updates.

If you have questions regarding continuing your study, contact your VCU IRB Coordinator (assigned in RAMS-IRB). For other questions related to clinical research, you may find additional resources within your center, college or school and may also contact Lisa Ballance, Executive Director for Clinical Research and Compliance, lballanc@vcu.edu or 804-241-6223.

Please take care and stay safe.

P. Srirama Rao, Ph.D.
Vice President for Research and Innovation

COVID-19 IRB Amendments: Streamlined Contingency Protocol Form Available for Researchers

The VCU HRPP is aware that the current COVID-19 situation will have a significant impact on human subjects research, with many study protocols requiring amendments to adjust study procedures in light of the risks introduced by the COVID-19 outbreak, and the need for social distancing. 

To assist investigators in developing COVID-19 contingency plans, the VCU HRPP has developed a COVID-19 Contingency Protocol form, intended to guide investigators through the process of creating these contingency plans. For existing studies, this form can be completed by investigators and uploaded as a separate document in an amendment submission in RAMS-IRB. This will allow investigators to develop contingency plans for COVID-19 without the need to make granular changes within the RAMS-IRB SmartForm itself, which will streamline the review of these amendments, and allow investigators to easily revert back to approved study procedures upon the conclusion of the situation. If you need to amend your research protocol to address COVID-19 concerns, we strongly encourage the use of this form.

To use the form, follow these instructions:

  1. Access and download the COVID-19 Contingency Protocol form from either the OVPRI COVID-19 site (under the Human Subjects Research section), or our Forms page (under the Supplemental Submission Forms section).
  2. Follow the instructions in the form to develop your COVID-19 contingency plan
  3. Create an amendment to your currently-approved IRB submission in RAMS-IRB, and indicate within the amendment cover sheet that this amendment is in response to COVID-19.
  4. Upload the completed COVID-19 Contingency Protocol form to the amendment. 
  5. Submit the amendment in RAMS-IRB.

The form is intended to address the areas of a research protocol most likely to be impacted by the COVID-19 situation. If the form is utilized, most amendments will not require modifications within the SmartForm itself. However, we encourage investigators and research teams to contact the IRB Coordinator assigned to their study with questions or concerns, prior to submitting an amendment.

As a reminder, all changes to a research protocol require IRB review and approval, prior to implementation, with the exception of changes made to avoid apparent immediate hazard to a study participant.  Changes implemented to avoid apparent immediate hazard to a participant may be implemented without prior IRB approval but must be reported to the IRB using the RAMS-IRB reporting function within 30 days as required by WPP VIII-5 section 2.7.

During this time, the VCU HRPP will be prioritizing amendments related to addressing COVID-19. For investigators submitting new studies or amendments not related to COVID-19, we appreciate your patience as we shift our priorities for the duration of this situation.

We thank the research community for its collaboration in ensuring the health and safety of research participants and personnel during this time. We encourage the research community to continue to monitor the OVPRI COVID-19 page for updates and guidance as the situation develops. We encourage investigators and research staff to subscribe to our listserv to receive updates and guidance. You can subscribe to the VCU HRPP Listserv on our News & Events page