COVID-19 - Human Subjects Research

IRB-approved human research projects are also subject to additional institutional requirements that place limitations on in-person interactions.  The requirements are based on a tier structure and apply regardless of which IRB reviews the study (i.e. VCU IRB or an IRB external to VCU). In all cases, researchers should consult their study sponsor for additional applicable guidance. The VCU-designated tiers and corresponding requirements are summarized below. 

Studies may require modifications as outlined below (see Tier-specific requirements). When considering whether modifications are required to continue a study during the pandemic, investigators must consider all research activities (including but not limited to: recruitment, obtaining consent, interactions/interventions, data analysis, and provisions for privacy and confidentiality).  

Tier 1 Research: High Probability of Direct Health Benefit
Tier 2 Research: Moderate Probability of Direct Health Benefit
Tier 3 Research: Limited or No Direct Health Benefit
Tier 4 Research: No In-Person Interaction

Additional resources:
Guidance from External IRBs
HRPP COVID-19 FAQs
Guidance on Obtaining Consent (Signatures and Documentation)
HRPP Operating Status

 

Tier 1 Research: High Probability of Direct Health Benefit

Tier 1 research is research with high potential for direct health benefit to research participants due to life-saving or life-sustaining interventions or treatment. COVID-19 related clinical trials are Tier 1 trials. The requirements below apply to all Tier 1 research regardless of whether the research is reviewed by the VCU IRB or another IRB.

Requirements:

  1. PI’s must obtain institutional approval to continue in-person interactions using the VCU COVID-19 Human Research Continuation Request Portal. Submissions for previously approved trials should be made by March 25, 2020.  

  2. In addition, the IRB of record must approve any changes made to support continuation of the research in the context of the pandemic (for VCU IRB see COVID-19 amendment process). 

  3. All in-person interactions must be converted to virtual visits where possible. New enrollment may be permitted by your IRB and must be approved by your school/college/center via the. VCU COVID-19 Human Research Continuation Request Portal.

  4. Risk and resources must be evaluated daily and additional adjustments may be needed to ensure safety.

Tier 2 Research: Moderate Probability of Direct Health Benefit

Tier 2 research is research with moderate potential health benefit to research participants due to the therapeutic nature of the intervention or treatment which is not directly life-saving or life-sustaining. The requirements below apply to all Tier 2 research regardless of whether the research is reviewed by the VCU IRB or another IRB.

Requirements:

  1. PI’s must obtain institutional approval to continue in-person interactions using the VCU COVID-19 Human Research Continuation Request Portal. Submissions for previously approved trials should be made by March 25, 2020.  

  2. In addition, the IRB of record must approve any changes made to support continuation of the research in the context of the pandemic (for VCU IRB see COVID-19 amendment process). 

  3. All in-person interactions must be converted to virtual visits where possible. New enrollment may be permitted by your IRB and must be approved by your school/college/center via the. VCU COVID-19 Human Research Continuation Request Portal.

  4. Risk and resources must be evaluated daily and additional adjustments may be needed to ensure safety.

Tier 3 Research: Limited or No Direct Health Benefit

Tier 3 research is research with limited or no direct health benefit to research participants. PIs may log a public comment in RAMS-IRB denoting the study’s designation as Tier 3 to ensure the IRB has up-to-date information on the study status. The requirements below apply to all Tier 3 research regardless of whether the research is reviewed by the VCU IRB or another IRB.

Requirements:

  1. All in-person interactions must pause. 

    • Where possible, research may continue by converting interactions from in-person to virtual. To make this change, PIs must submit an amendment to the reviewing IRB prior to implementing the change. The VCU IRB process for submitting amendments in response to the COVID-19 pandemic can be found here.
    • Where converting interactions from in-person to virtual is not possible, the in-person interactions must pause until further notice from OVPRI. PIs must log-in to RAMS-IRB and submit a public comment to document the pause in the IRB’s records (please clearly indicate if only pausing certain activities vs the entire study).  
    In both scenarios, PIs should consider how changes will be communicated to current/future study participants and address this in their communication with the IRB.  
  1. New enrollment may only continue for virtual interactions. 

Tier 4 Research: No In-Person Interaction

Tier 4 research is research that involves no in-person interaction with human research subjects. PIs may log a public comment in RAMS-IRB denoting the study’s designation as Tier 4 to ensure the IRB has up-to-date information on the study status. The requirements below apply to all Tier 4 research regardless of whether the research is reviewed by the VCU IRB or another IRB. 

Requirements:

  1. PIs must assess whether VCU’s shift to telework impacts the study. If the shift to telework causes the PI to conduct the research differently than approved then the PI must amend the study before implementing these changes. The VCU IRB process for submitting amendments in response to the COVID-19 pandemic can be found here

    For example, if the approved study indicates all data analysis will take place in the PI’s private office on campus, and now the PI will conduct data analysis in a home office, the study must be amended to address this change.  

Additional resources:

Guidance from External IRBs

 

Guidance on Obtaining Consent (Signatures and Documentation)

E-Consent Comparison: REDCap vs. DocuSign
This infographic compares two methods of obtaining e-consent: REDCap and DocuSign.
(Click on the image to expand)
REDCAP VERSUS DOCUSIGN
e-CONSENT COMPARISON

REDCap: Platform for ensuring understanding of consent information
DocuSign: Platform for obtaining electronic consent signatures

REDCap: Uses interactive elements such as images, videos, narration, or quizzes to help educate and gauge comprehension
DocuSign: Uses a standard consent document that may or may not contain charts, images, or tables.

REDCap: Signatures might not be legally valid
DocuSign: Signatures are legally valid due to identity verification procedures (logins)

REDCap: Requires a 'waiver of documentation of consent' from the IRB
DocuSign: No waivers needed

REDCap: Supplements the discussion during in-person consent. Enhances participant experience
DocuSign: Can be used in-person or remotely. Enables remote consent signing for studies that don't qualify for waivers

Comparison of Different Methods of Obtaining Consent Signatures Remotely
This document compares different methods of obtaining and documenting consent remotely, and provides examples of options for common scenarios.

HRPP Operating Status

The VCU Human Research Protection Program and IRB continue to operate as normal with all personnel working remotely and IRB meetings continuing as scheduled. Highest priority for IRB review is given to COVID-19-related research and the IRB has created a sub-panel available to meet on short notice to accommodate the need for rapid turn-around. 

The IRB and HRPP continue to review and process research submissions.

  • All IRB submissions should utilize the normal RAMS-IRB review/submission process. 
  • IRB submissions related to investigational treatment of or changes to mitigate risks from COVID-19 will be prioritized. New studies related to COVID-19 should ensure the term “COVID-19” appears somewhere in the study title field in RAMS-IRB.
  • If amending a study in response to COVID-19, please follow the instructions in this COVID-19 Contingency Protocol form. (updated 3/17/20). Instructions for the use of this form can also be found here.