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. New FAQ added August 28, 2020!

The HRPP has the responsibility to protect participants and the community.

In order to protect participants, Investigators must thoroughly consider all relevant external factors surrounding SARS-CoV-2 exposure and COVID-19 illness when proposing to start/resume in-person human research projects.

External factors include rate of community transmission (# active cases in community), the capacity of local healthcare system, availability of local testing and contact tracing, availability of PPE, and local/State Orders pertaining to stay-at-home directives.

In order to protect the community, the HRPP will evaluate proposed in-person human research in the context of the applicable External factors with the goals of supporting the proposed study to the extent possible; supporting the capacity of local hospitals to care for the sick; preventing infection with particular attention to those at high risk for severe disease; and building the community’s capacity to protect the health and well-being of the public.

The Human Subjects Office (HSO) and IRB Committees are operating in accordance with USG and university guidance. HSO staff are in the office and working from home on rotating schedules during the Fall semester 2020. IRB meetings will be conducted via Zoom.

Outreach and training requests can be scheduled for Fall classes. All outreach will be conducted via Zoom.

The Human Research Protection Program has prepared a toolkit pertaining to in-person research activities aligned with institutional plans to resume previously halted research activities as soon as possible while maintaining adherence to public health guidance and maintaining appropriate hazard mitigation strategies.

PIs of all human research projects must take some action in order to begin or resume in-person activities involving in-person contact with participants.  For some projects, the PI may only need to complete a checklist and upload it to the IRB Portal.  For other projects, the PI may need to submit a protocol modification, which the IRB must review and approve before in-person human research may begin or resume.

The study PI must submit a plan to ensure that the research can be conducted safely. The plan should include:

    1. A screening process and materials to determine COVID-19 risk for the in-person activity
    2. A completed checklist corresponding to the risk Level for the project (see HRPP Toolkit Decision Tools) and, for Level 4, an SOP for: maintaining social distancing requirements, PPE, proper cleaning of materials, equipment, and commonly touched areas where the activities will take place.
    3. Any activities that can be conducted remotely, even if there is in-person contact necessary for other activities, should be conducted remotely. For example, if a study visit includes completion of questionnaires and a treadmill protocol, consider moving the administration of questionnaires to an online mechanism and schedule the activity to be completed in the participant’s home before or after the treadmill protocol.
    4. The current/revised risk-benefit assessment, (key considerations of risk and risk mitigation are not limited to necessary and reasonable precautions but should also include community expectations), and/or revisions/exclusions to the study population to ensure protection of those persons at higher risk of serious illness related to COVID-19 infection.

When possible, the consent materials should be provided by text or email prior to the consent process. The consent process should be conducted prior to the in-person visit using remote methods such as phone or Zoom. Information about the risk of COVID-19 exposure must be provided such as in the following example: Although the study team will attempt to reduce the risk of COVID- 19 infection during your participation, there is still a risk that you may become ill with this infection. This could lead to severe respiratory or other organ failure, and death. These complications would be more likely if you have one of the higher risk health conditions. Please review your health history with the study team member to see if you have one of these conditions.

PIs must ensure comprehension of the consent information using methods such as teach-back. The PI must consider if additional information such as more detail pertaining to conditions that lead to higher risk of serious COVID-related illness or information pertaining to UGA’s commitment to participate in DPH contact tracing programs should be relayed.

The above measures may serve to shorten the amount of in-person interaction to obtain signed consent.

In addition to determining that risks have been minimized by procedures that are consistent with sound research design and that do not unnecessarily expose participants to risk, the IRB must determine that risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result. [45 CFR §46.111 – Criteria for IRB approval of research].

So that the IRB has the information needed to make the regulatory determinations required for approval, PI’s must propose changes to the study and appropriate precautions. PI’s must consider the study population, procedures, protections, and external factors including, but not limited to, rate of community transmission, the capacity of the local healthcare system, availability/robustness of local testing and contact tracing, availability of PPE, and local/State ordinance pertaining to stay-at-home directives.

The HRPP notes that local, federal and State policies are not always aligned. The UGA HRPP will follow Office of Human Research Protections (OHRP) guidance that encourages the research community to prioritize public health and safety and, therefore, will consider not only regulatory guidance but also community expectations when reviewing requests for in-person human research activities.

Contact the PMAB Help Desk for assistance with: Administrative and engineering controls related to reducing and minimizing the spread of Covid-19, Personal Protective Equipment (PPE) use for control of exposure to Covid-19, social distancing practices and control measures, and cleaning and disinfection methods, materials and frequencies related to Covid-19

All research activities conducted at UGA research sites (even if conducted off-campus by UGA researchers) require an approved Research Resumption Plan (RRP). Information pertaining to local restrictions or requirements, including any changes to procedures or subject selection, should be provided to the reviewing IRB along with pertinent information from the RRP such as use of PPE, changes to study personnel (e.g., how many researchers are present during study visits), and any applicable engineering controls.

Carefully consider the proposed research activities and use the decision tool. The decision tool is designed to work for new studies and already-approved studies.

Considerations for choosing between Level 2 or Level 3 at the following step in the Level 2 Decision tool: “Is the project federally funded and reviewed via Expedited or Full Board?”

  • Select Level 2 if the project is not federally funded
  • Select Level 2 if you have selected “Project is Exempt” on the Study Scope page of the submission and determined that one of the Exempt categories on the following submission page applies (even if it is federally funded)

Yes, the process and materials in the HRPP Toolkit apply to research conducted off-campus. The toolkit materials must be provided according to the process corresponding to the risk level as described in the Toolkit Guide.
An approved Research Resumption Plan (RRP) is also required to begin activities.

Recruitment processes may involve the same risk as in-person (face-to-face) data collection so they should 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) when possible. Materials to be distributed at specific sites (external locations) should be delivered to the location using remote methods. If materials are distributed to sites in-person, pubic health guidelines and site policies for social distancing and the wearing of face masks must be followed. Researchers must ensure that the site has 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.

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.

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.

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 as RNIs. However, they must be tracked and reported during continuing review or when submitting a progress report to the IRB.

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. In the Modification Summary, be sure to describe changes to ensure safe resumption of human research activities. Make specific changes to other pages as applicable.

For some studies, regulations do not allow approval to be granted for a period greater than one year. Federal guidance has not, as yet, provided pandemic-related flexibility to institutions on this matter. For all studies, an expiration date is assigned to provide the IRB with the opportunity to check on the status of the project. The Principal Investigator (PI) is responsible for submitting a completed progress report for continuing review or closure of the study no later than 30 days before the expiration date. The failure to request continuing review, continuation of research activities involving human subjects after expiration, or lapse in approval is considered non-compliance.

Travel to UGA campus to obtain the information necessary to apply for continuing review is considered to be an essential activity; therefore the PI may access necessary research records from his/her campus office as long as pandemic-related precautions pertaining to social distancing and other personal protections (e.g., hand-washing) are adhered to.

In the event that the information cannot be obtained, the PI should submit a request for continuing review and explain what information is missing and why. The IRB has passed a temporary policy and procedure to provide business continuity for research projects under a limited continuing review approval.

For more information, review the Continuing Review –  Addendum for Business Continuity 2020

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

Advarra’s blog on Internet research is also quite helpful.

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