Human Research Protection Program

Researcher Guidance – COVID-19 and IRB Review

The situation involving the COVID-19 virus is rapidly changing. These FAQs contain information about COVID-19 as it relates to the conduct of research and IRB review operations so faculty and staff can best manage their ongoing research and scholarship activities. Please refer back to this webpage frequently for evolving guidance. Updates/New FAQs added March 26, 2020!

The Human Subjects Office (HSO) and IRB Committees are operating in accordance with USG and unversity guidance. HSO staff are working from home and conducting IRB meetings via Zoom.

For as long as in-person instruction is suspended and UGA asks all non-essential personnel to work from home, HSO Open Houses and class-presentations will be canceled and rescheduled, if possible, for later in the semester.

Modification of procedures to accommodate COVID-19 concerns may include the use of questionnaires, interviews or surveys delivered online or by telephone, telephone, Zoom, or email screening and consenting, and changes to administration of compensation (for studies that currently involve in-person payment). Modifications may also include mailing certain study materials to participants. In all cases, PIs must ensure that any study materials being sent are permitted to be mailed per any federal and state requirements.

Exempt Research – If your approved project was determined to be Exempt, this category would appear in your approval letter and at the top of your project workspace under “Review Category” or “Review Level”. Modifications to Exempt research like changing from in-person interviews to phone interviews or in-person surveys to online questionnaires do not require formal submission to the IRB for review. You should add a comment to your project describing the change and provide any revised instruments.

Non-Exempt Research – Changes made to project procedures to eliminate apparent immediate hazards to the subject must be reported to the IRB in the portal as a Report of New Information (RNI). If the changes must be sustained for multiple visits/participants, a Modification must also be submitted for review and approval.

Remember that using online methods to collect and store data may require additional information to be provided to participants regarding confidentiality and privacy. Refer to the HRPP Policy for Internet Research

We strongly advise researchers to use common UGA-recommended resources (e.g., Qualtrics and Zoom conferencing) in lieu of new apps or software.

Recruitment processes may involve the same risk as in-person (face-to-face) data collection so they must be conducted using remote procedures like phone calls, emails, listserv, social media posts, website announcements, posting flyers, and other media ads (e.g., radio, newspaper). Materials to be distributed at specific sites (external locations) should be delivered to the location using remote methods unless the site is allowing in-person contact for other reasons (e.g., a grocery store), they have granted specific permission for research materials to be posted at their location, and in-person contact is limited to posting the materials or handing them to someone at the site so that they can post them.

Given the real or perceived risk of viral transmission, the risk/benefit ratio for in-person contact associated with research activities must be assessed for each study. Ethical principles of research and federal regulations for the protection of human research participants require an acceptable risk/benefit ratio. The potential benefit to society would have to be both immediate and significant. Otherwise, the safest approach is to pause activities until the risk has been mitigated.

Restrictions may apply depending on location, subject population and risks/benefits to the participant population, and federal, international, and local policies (see GA DPHCDCWHO, and local health agencies for updates).

Pausing a study under the UGA policy (as long as it does not have adverse effects on study participants) does not need to be reported to the UGA IRB.

Studies that conduct data collection only through remote contact (e.g., online/electronically or via telephone) may continue. Studies where activities are limited to data analysis may also continue. See FAQ on data analysis procedures and data security.

First and foremost, consider methods of storing and moving data that respect participants’ confidentiality and privacy.  Revised processes, software platforms, and techniques must provide equitable protections to what was described in the consent process and approved submission.

UGA EITS is the main resource for questions about data security processes and platforms. There is helpful information available here: https://eits.uga.edu/access_and_security/infosec/protect_your_data/

If they haven’t already, study team members who will be using a personal device should go through all the steps listed under “On Your Personal Devices.”

They should also review all of the information in this policy: https://eits.uga.edu/access_and_security/infosec/pols_regs/policies/minsec_sensitive/

An option to distribute data for processing off-campus can be to have someone (with department permission) access the lab, encrypt the individual files, and then put them on UGA’s OneDrive. Only use UGA-provided/supported software, avoid Gmail accounts for any work related to the project, and be sure to only use study IDs when referring to participants.

EITS considers human subjects research data to be sensitive data, and it has policies related to the use of sensitive data. Essentially, access to the data needs to be restricted, and the files should be encrypted. The full list of requirements for working with sensitive data is available here: https://eits.uga.edu/access_and_security/infosec/pols_regs/policies/dcps/

Finally, be sure to follow any data processing and security measures required by data use/transfer agreements, as applicable.

Participant research visits (for UGA research conducted at both domestically and international locations) should be performed remotely (e.g., by phone, Zoom, or other means) whenever possible. In general, treat research activities the same way UGA is treating classes, conferences, and other events that involve in-person interactions, and hence normally should be paused or canceled if they cannot be conducted remotely.

Contact Kim Fowler (kfowler@uga.edu) if you want to petition to continue in-person research activities. The Human Research Protection Program (HRPP) will need the following information to consider the request:

  1. The academic unit’s Department Head/Associate Dean of Research assessment that the research has been deemed essential and VPR David Lee’s concurrence.
  2. The investigator’s assessment of the risk of coronavirus exposure at the study site location and a description of proposed risk mitigation strategies.

The HRPP will prioritize the following studies when considering the continuation of in-person research activities:

  1. Studies which offer treatment for life-threatening health conditions
  2. Studies which offer direct therapeutic benefit to participants: the direct benefit must be stated in the approved consent and be more than minimally likely beneficial
  3. Studies where stopping the intervention could be harmful to participants

If the HRPP determines that in-person activities may continue, specific instructions for submitting a modification for IRB determination/approval will be provided.

Restrictions may apply depending on location, subject population and risks/benefits to the participant population, and federal, international, and local policies (see GA DPHCDCWHO, and local health agencies for updates).

Be sure to communicate with any external sites and follow their local policies. 

For health and safety reasons, changes from in-person activities to remote conduct can be instituted immediately; notify the IRB by entering a Report of New Information (RNI) to report an Unreviewed Change to eliminate hazards to participants. For non-Exempt research, please also submit a modification in the IRB portal for review if these activities were initially approved for in-person (face-to-face contact.)

PIs must not begin enrollment of research participants for research that will be conducted in-person (face-to-face) unless there is a compelling reason. Contact Kim Fowler (kfowler@uga.edu) if you want to petition to begin (face-to-face) research activities.

This research activity would need to stop as there is no direct therapeutic benefit to the research participant and it includes in-person contact and the use of PPE.

The UGA policy pertains to all UGA researchers so if the activities involve in-person interaction, the activities must stop and the reviewing IRB should be notified.

See information for continuation of in-person (face-to-face) research activities.

Most federal sponsors allow for a one-time no cost extension for 12 months at the end of the project. Sponsors are considering the impact of COVID-19 on project timelines.

If the study needs to be paused, follow sponsor guidance and if required, notify the sponsor as soon as feasible. Utilize the standard process for informing sponsors of changes to the research.

Protocol deviations such as changes to visit and data collection timelines due to local in-person activity restrictions do not have to be formally reported to the IRB at this time. However, they must be tracked and reported during continuing review or when submitting a progress report to the IRB.

  • If you are proposing research that can be conducted under current in-person activity restrictions, the IRB will review and make determinations or approvals as applicable.
  • While the IRB will review and make determinations or approvals of proposed research which cannot be conducted under current in-person activity restrictions, review resources will be prioritized to focus first on modifications to ongoing studies to change procedures from in-person to remote, new COVID-19 related work, and then submissions in the order received. Any determinations or approvals granted for future in-person activities will be contingent upon the understanding that work may not begin until in-person restrictions (institutional, federal, or local) have been lifted.

The regulations require IRB suspension of research to be reported to the Office of Human Research Protections. The UGA announcement that all routine research not conducted remotely from UGA campuses should wind down and come to a stop as soon as possible does not come from the IRB so it does not need to be reported to federal regulatory agencies.

Create a Modification or Version for the approved study. Select Modification as the Purpose of the submission and Other Parts of the Study as the Modification Scope in order to open the portal record but do not make changes to any of the portal pages other than to the Modification Information page. In the Modification Summary, be sure to specify what activities will be stopped (e.g., “all activities” “enrollment”, “data collection”). The IRB will provide a formal letter of acknowledgement that enrollment/activities are suspended. A corresponding Modification/Version to restart activities will be required when applicable.