OVPRI Human Subject Research Protection Blog

Posted on December 18, 2020 by preslaned

Dear Members of the VCU Research Community,

As we approach the VCU Winter Closure, the HRPP and IRB would like to thank the research community for their collaboration with us this year. We faced some new challenges, and we are proud that we worked together to facilitate research that benefits our patients, students, and community.

The VCU Human Research Protection Program (IRB) Office will be closed for the holidays December 19, 2020 through January 3, 2021. However, we are continuing to monitor the impact COVID-19 is having on researchers, and we are prepared to support our investigators if new restrictions are put in place.

Investigator Responsibilities during the VCU Winter Closure:

1. Continue to work with your Department Chairs, Deans, Building Managers, Return-to-Campus Coordinators, Human Resource Representatives, and the facility where your research takes place regarding the study’s approvals and permissions for building access and the return of research staff to campus. 

Studies reviewed by external IRBs continue to be subject (as applicable) to VCU and VCU Health’s institutional requirements related to staffing and building safety. External IRB studies must also follow their reviewing IRB’s policies and procedures for prospectively submitting amendments for any changes in procedures and communicating with the reviewing IRB about COVID plans and pausing study activities

2. Monitor your email for communications from the Office of the Vice President of Research and Innovation, the HRPP, and from the facility where your research is carried out. We know that things can change quickly as the COVID-19 situation evolves, so stay informed.

• Clinical research studies can visit the VCUHS clinical research intranet page at intranet.vcuhealth.org for the most up-to-date information about VCU Health’s status.
• A blog post is available at Guidance for Clinical Research Teams as COVID-19 Cases Rise – One VCU Clinical Research
• All investigators can visit the OVPRI or VCU webpages for more information: https://research.vcu.edu/about/phased-return-to-research-r2r/ and https://together.vcu.edu/ 

3.  Log a public comment to the IRB if your study chooses (or is required) to pause research activities. This keeps the IRB informed and provides written documentation for your study team about the conduct of the study.

4.   Identify whether your study already has an IRB-approved COVID-19 Contingency Protocol that outlines temporary adjustments to research procedures in response to COVID, and familiarize yourself with what those procedures are.

Here are instructions of what to do in several of the most common scenarios:

• If your study already has and is following an IRB-approved COVID-19 Contingency Protocol:
  • Great – you’re prepared and will hopefully be able to continue your remote procedures with minimal impact if the COVID-19 situation changes.
    
• If your study is currently following the study’s approved smartform/protocol and needs to switch back to following the study’s IRB-approved COVID-19 Contingency Protocol:
  • Log a public comment to notify the IRB that you are doing this.
    
• If a COVID-19 Contingency Protocol is already IRB-approved but requires changes:
  • Plan ahead for the potential need to submit an amendment for IRB review. Add the changes to the existing COVID-19 Contingency Protocol Form (don’t fill out a new document or delete information). Submit the updated version of the document in an amendment using the instructions outlined in this blog post.

5. If your study does NOT currently have an IRB-approved COVID-19 Contingency Protocol, the IRB will expect the study to continue following the approved smartform/protocol procedures or to pause research activities that can no longer be carried out due to COVID.

Here are instructions of what to do in several of the most common scenarios:

• If following your IRB-approved smartform/protocol becomes impossible due to COVID-19 restrictions:
  • Log a public comment to the IRB if you choose (or are required) to pause research activities. This keeps the IRB informed and provides documentation for the study team about the conduct of the study.
• If you need to make any changes to your IRB-approved smartform/protocol to be able to continue research:
  • Plan ahead for the potential need to submit an amendment for IRB review.
    As a reminder for VCU expedited and full board research, federal regulations require that modifications to research activities not be initiated without prior IRB review and approval, except when necessary to eliminate apparent immediate hazards to subjects (in which case the investigator must promptly submit a report to the IRB) (WPP VII-6). 

6.   Report to the IRB any unanticipated problems involving risk to subjects or others that occur during this time. External IRB studies should check their reviewing IRB’s policies.

• Investigators are responsible for taking any actions necessary to ensure the ongoing safety of research participants.
• To report an unanticipated problem involving risk to subjects or others to the IRB:
  • 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 during the Winter Closing holiday: 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.

Please Note: Investigators may experience a delay in the review turnaround time for submissions received around the holidays since the HRPP office will be closed. With the exception of urgent reports for unanticipated problems or other emergencies, the HRPP office will not be processing or reviewing routine submissions during the closing, and the IRB’s full board will not convene between December 21, 2020 and January 8, 2021. We appreciate your patience and understanding.

We wish you all a happy, and safe, holiday season.  

VCU HRPP Staff