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.
EDIT 4/28/2021: As of April 27, 2021, the Tiering system referenced in this FAQ has been retired. Investigators are no longer required to make a Tiering determination for their study.
Table of Contents
IRB Status, Ongoing Research, & HRPP Contact Info
- Is the IRB still reviewing Research?
- How will the IRB know my submission is related to COVID-19?
- How do I reach HRPP staff?
- Can I continue my research?
Does the HRPP have a policy for limiting exposure for at-risk participants?
My study involves meeting with participants at other sites, what if those sites close?
My study involves home visits, can I continue? (UPDATED 03/24/2020) - Is the AAHRPP site visit still taking place on March 17th and 18th?
- Can my research team work from home?
If I’m a PI can I work on my research from home? - Can I continue data collection for my study?
- If VCU shuts down, will doctoral students be able to continue their research?
- Do I need to tell the IRB if a participant canceled their visit because they don’t want to risk exposure?
- What should I do if I/my study team is not available to meet with participants?
- What do I do if a study participant doesn’t want to come to VCU/VCU Health to get investigational products?
- I just received approval for a new study submitted before the COVID-19 crisis began. What do I need to do now?
- If we don’t have an interpreter in-person and we use MARTTI and CyraCom, how does this impact research conducted with Limited English Proficiency (LEP) subjects? (ADDED 04/06/2020)
Study Modifications for COVID-19
- I need to change my study to address COVID-19, what do I do?
- How do I know if I need to change my study? (UPDATED 04/02/2020)
- How do I know if my research must pause or if it can continue? (ADDED 03/24/2020)
- My research is Tier 1 or Tier 2 — what must I do to continue this research? (ADDED 03/24/2020)
- I’m not sure what changes I should make to my study, who can I ask?
- My research project is exempt. Do I need to submit an amendment for any changes to exempt studies? (ADDED 04/02/2020)
- Can I make changes to my study without IRB approval?
- How quickly will the IRB review my amendment or COVID-19-related study?
- Can I add screening questions about COVID-19?
- What are my options for consenting participants remotely? (ADDED 06/03/2020)
- Can I change the way I compensate participants if I’m not meeting them in person?
Can I use Venmo? - Do I need to contact my sponsor about changes?
- What do I need to tell the DSMB about changes made during the epidemic?
Reliance Studies (Relying on VCU or VCU Relying on Other IRB)
- My study is reviewed by an IRB at another institution, what should I do? (UPDATED 03/18/2020)
- Does VCU’s decision to pause in-person interactions for research with little to no direct health benefit apply to my research if it’s reviewed by another IRB? (UPDATED 03/18/2020)
- NCI Sponsored Studies may have different sponsors, do we need to contact each of them if we make changes or change our accrual status?
- My study has other sites relying on the VCU IRB, do I need to do anything else?
VCU Health FAQ (UPDATED 03/20/2020)
- Where can I get information on how VCU Health is addressing COVID-19?
- Will the clinical research unit remain open?
- Will other services be available at VCU Health?
- Will the investigator(s) and subject(s) be at risk for COVID-19 when coming to the clinical research unit?
- What can the Research Teams do to further protect our patients, families, visitors & team members?
- What if I have a patient who tells me they have COVID-19 symptoms?
- Does VCU Health have any restrictions on visitors at this time?
- Will valet parking remain available at VCU Health during the COVID-19 emergency?
- How does HIPAA impact the provision of telehealth? (ADDED 03/20/2020)
FAQs Regarding Research Tiers and the Continuation Request Portal (ADDED 03/30/2020)
- Is IRB approval required to continue to enroll new participants on existing IRB-approved Tier 1 and Tier 2 studies?
- Is all COVID-19 related research considered Tier 1, or only COVID-19-related clinical trials?
- Are Humanitarian Use Devices (HUDs) specifically used for treatment (not research), Emergency Use, and Expanded Access Treatment Use (Compassionate use) protocols required to submit for continuation in the VCU COVID-19 Human Research Continuation Request Portal?
- Do I need to make any changes to my Tier 3 or Tier 4 studies? The announcement suggests no action is needed.
- If I submit a study for review that isn’t COVID-19 related, when can I start my research?
- I have a submission in queue for IRB review by Full Board; does the requirement to submit via the VCU COVID-19 Human Research Continuation Request Portal affect the IRB’s review?