Impacts of COVID-19 on Human Subjects Research

As we resume in-person research activities, please review the following information for updates and guidance. Principal investigators (PIs) and their study teams should carefully consider their research protocols in light of the rapidly evolving environment, while being mindful of university and sponsor guidelines.

The GW IRB always encourages investigators to take such steps as necessary to eliminate apparent additional risks or immediate hazards to participants or GW personnel. Changes that are necessary to eliminate apparent immediate hazards to study subjects may be made immediately.

Resuming Human Subjects Research

Phase 3 of ramping-up research activities on campus began Friday, June 11, 2021.

View the current version of the research reopening guidance (PDF) - Release v3

Main changes for OHR submissions

  • PRIFs to resume in-person research activities are no longer required. You are still encouraged to obtain department chair approval before resuming in-person activities. 
  • Use of the COVID-19 information sheet for in-person research is now optional and not required.
  • Modifications:
    • If your current IRB application allows for both in-person and virtual study activities, you do not need to submit a modification to resume in-person interactions.
    • If you previously deleted an in-person component of your study due to the pandemic and currently your IRB application only describes virtual study activities, you should submit a modification to allow for resumption of in-person activities, to ensure our records are consistent with study activities.

Communicate with OHR as Necessary

If you must modify study procedures immediately in order to protect researchers and/or study participants, you may implement changes without prior IRB approval, but may need to report such action to the IRB via iRIS as soon as possible.

If you must temporarily suspend research due to concerns about participant safety, you should submit this suspension as Promptly Reportable Information in iRIS as soon as possible.

If you decide to voluntarily suspend study activities, but that decision is not immediately related to participant safety and there is no increased risk to human subjects from that suspension, then the IRB does not need to be notified.

You may implement procedures to ask research participants about questions related to recent travel, contacts, and current symptoms prior to study. You do NOT need IRB approval to incorporate those questions into your study visit scheduling.

Requesting Rush Review

The Office of Human Research (OHR) experienced a larger-than-normal volume of submissions and modifications as a result of the COVID-19 pandemic. Our review times are back to 7-10 business days for most submissions. You are still encouraged to use the Rush Request Form in situations when a review deadline is urgent. Please follow the process for requesting rush review.

Contacting OHR/Requesting Consultations

We realize that this is a challenging time for you and for our communities. Please feel free to contact OHR at any time if you have any questions or concerns.

OHR staff are available for consultation via meetings or office hours. Please see the Contact Us section of the GW OHR website for more information.

Additional Information

Please refer to these useful sites for more guidance: