COVID-19 AND HUMAN RESEARCH STUDIES

In accordance with federal law, the U.S. White House issued a letter of intent to have published in the Federal Register a notice of an extension beyond March 1, 2021 of the national emergency Proclamation 9994 concerning the COVID-19 pandemic. As published February 26, 2021, the COVID national emergency proclamation will remain in effect until rescinded or terminated. Go here for the letter and here for the Federal Register notice. 

In-person Human Research Activities on Hold Until Further Notice

To minimize COVID-19 and Coronavirus Disease risks to human research participants and to our community, the FSU Office of Research and the Office for Human Subjects Protection (OHSP) announced the immediate cessation effective March 24, 2020 and until further notice of research activities that involve in-person activities with human research participants. Then and now some exceptions apply, including those initially approved by the Board of Governors of the State University System of Florida (see page 20).

April 26, 2021 UPDATE: Exceptions to FSU COVID-19-related restrictions are further revised provided that certain conditions, including FSU IRB review and approval (to minimize COVID-19 risks to human subjects or others) are satisfied. See Exceptions below.

Exceptions:

1. COVID-19 Vaccination: In-person study activities involving human subjects are permitted IF all individuals (human subjects and study staff) that take part in these activities have completed a full COVID-19 vaccination series (see COVID-19 Vaccination Requirements under Requirements for Excepted Studies below); otherwise and alternatively,
2. COVID-19 Precautions Required: In-person study activities involving human subjects on the condition that COVID-19 precautions are implemented for any unvaccinated individual. However, no unvaccinated persons deemed at higher risk for severe illness from COVID-19, including persons who are 65 years of age or older, may be included as participants in any in-person or face-to-face activity (see COVID-19 Precautions Required under Requirements for Excepted Studies below).

Special note: the above exceptions are FSU IRB conditions to minimize risks to human subjects and others, and are imposed pursuant to the IRB's authority in accordance with federal law at Title 45 of the U.S. Code of Federal Regulations, Part 46 (45 CFR 46), sections 46.109 and 46.111. Institutional officials are prohibited from approving of any study that is not approved by the IRB, including failure to satisfy the conditions and requirements noted above and below (45 CFR 46, section 46.112).

For all exceptions, refer to the Requirements for Excepted Studies section below.

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Requirements for Excepted Studies

The FSU Office of the Vice President for Research (OVPR) and the IRB have the following requirements in order for studies to satisfy the exception criteria above.

1. Remote activities to the extent feasible. Study activities (e.g., recruitment, consenting, pre- or eligibility screening, enrollment, baseline, initial and/ or follow-up) involving human subjects that feasibly can be done remotely should be done that way.
2. COVID-19 screening of human research participants and staff, and other preparations, before in-person interactions. All studies must include the following COVID-19 screening procedures:
   • Persons with a history of COVID-19 disease or exposure. No in-person activity may involve any individual (human subject or study staff) with or who has had COVID-19, or who has been in close contact with someone who has COVID-19, unless the individual has completed, at least 14 days before any in-person human research activity, a full FDA authorized or approved COVID-19 vaccination series, or alternatively has completed the CDC-recommended isolation and/or quarantine period (see CDC web pages on COVID-19 isolation and quarantine). An exception may be made for clinical trials for which COVID-19 or Coronavirus Disease is the focus of the study, and where all in-person activities occur only within the context of a necessary clinical care visit and which activities take place only at a licensed health care facility or medical practice office. Clinical trial-related activities (such as for example screening, follow-up or safety monitoring) that can be done remotely must be done that way. 
   • Non-contact screening of human research participants and study staff for COVID-19, Coronavirus Disease or higher risk of severe illness from COVID-19. For screening tools, consider the following COVID-19 screening links: https://www.apple.com/covid19/ (Apple/CDC link) or the CDC Coronavirus self-checker.
3. COVID-19 Vaccination. If the COVID-19 vaccination exception is requested, then a full FDA authorized or approved COVID-19 vaccination series must be completed at least 14 days before any in-person human research activity. Apart from items 1 and 2 above, other COVID-19 precautions (see item 4 below) are not required; however, as evolving scientific evidence suggests that even fully vaccinated individuals may be at some COVID-19-related risk, out of an abundance of caution COVID-19 precautions are recommended.
   • A list of FDA authorized or approved COVID-19 vaccinations is available at this FDA COVID-19 Vaccines web page or here: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines.
   • Authoritative COVID-19 vaccination completion must be documented in the study record for each such person (see this CDC web page, under the Vaccination Schedule and Use FAQs: https://www.cdc.gov/vaccines/covid-19/hcp/faq.html#schedule).
   • COVID-19 vaccination must be listed as an inclusion criterion in the study protocol.
   • Below is template language to convey to prospective study subjects and staff about the COVID-19 vaccination option:
     • For the consent process, include in the consent form a statement to the effect: For in-person study activities, we are required to follow certain COVID-19-related precautions like social distancing and use of masks. However, we don’t have to do this for persons who have completed a full COVID-19 vaccination. You may if you’d like share with us information about your COVID-19 vaccination, but this is your decision and is not required. You can still come to the study location and we will follow our usual COVID-19 precautions. If you do share your COVID-19 vaccination information with us, then we will make a note of it in our study records.
   • If the COVID-19 vaccination exception is not requested or implemented, then the COVID-19 precautions exception below must be implemented.
4. COVID-19 Precautions Required. If the conditions and requirements for implementing the COVID-19 vaccination exception above cannot be satisfied, then social distancing, use of masks and other COVID-19-related precautions are required and apply to all human research participants and study staff in any in-person study activity involving human subjects. As indicated above, federal law prohibits institutional officials from approving of research if a condition of IRB approval (e.g., COVID-19 vaccination in lieu of COVID-19 precautions; use of masks as a COVID-19 precaution) has not been satisfied. 
   • Refer to and adopt as applicable the COVID-19-related precautions at these CDC web pages: https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/returning-to-work.html#protect; https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html.
   • If social distancing is manifestly not practicable for a specific study intervention (e.g., affixing, applying or fitting human subjects with certain study devices or equipment such as electrodes or wearable devices; direct collection of human subjects’ biospecimens such as a blood draw or check swab; or any other close proximity—within 6 feet—required to administer or execute a study intervention), then OVPR review and approval for an exception to social distancing for a specific study intervention is required. OVPR consideration of an exception will only take place after IRB approval, not before. In any study submission, a detailed description of and rationale for specific study interventions for which social distancing is not practicable must be provided for both IRB and OVPR review.
   • No unvaccinated persons deemed at higher risk for severe illness from COVID-19, including persons who are 65 years of age or older, may be included as participants in any in-person or face-to-face activity. See this CDC web page for a list higher risk health conditions: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/groups-at-higher-risk.html.
5. Refer to the Related Instructions below for additional information, guidance and templates.

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Related Instructions

1. Log into RAMP IRB to obtain our HRP-092 SOP for COVID-19-related risk mitigation planning; you will find the SOP under the IRB, Library and Standard Operating Procedures tabs (scroll down to HRP-092). For guidance, you may use our HRP-350 Worksheet (Research-specific COVID-19 risk mitigation plan); find HRP-350 under the IRB, Library and Worksheets tabs (scroll down to HRP-350).
2. For protocol and consent-related templates and instructions, use our HRP-502COVID-Protocol- and Consent-related COVID Template and Instructions document (under the RAMP IRB Library and Templates tabs, also here; for some studies you may use our HRP-502iC COVID-19-related Information Sheet template in lieu of revising consent forms to include COVID-19-related precautions, available here). 
3. Modifications. IRB approval is required before implementing any COVID-19-related changes to studies except for:

• • Changes necessary to eliminate an immediate hazard to subjects or staff. These must be reported within 10 days to the IRB, using the Report of New Information (RNI) process.
  • Communications to subjects explaining the cessation in activities or generally discussing the COVID-19 situation. Communications about modifications and changes in procedures must however be prospectively reviewed and approved by the IRB.

Log into RAMP IRB to use our HRP-219 Form (COVID-19 Modification) for COVID-19-related study modifications; you will find HRP-219 under the IRB, Library and General tabs (scroll down to HRP-219).

See also HRP-103A-12 COVID-19 Considerations for Investigators Conducting Human Research (an Appendix 12 to the FSU Investigator Manual) for additional COVID-19-related guidance and instructions. To find the appendix, log into RAMP IRB; under the IRB, Library and General tabs, scroll down to HRP-103A-12 COVID-19 Considerations for Investigators Conducting Human Research.

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Other Requirements

Human research participants and study staff who have/had COVID-19 or close contact with someone who has COVID-19

If a human research participant (human subject) or study staff has COVID-19 or has been in close contact with someone who has COVID-19, take the following actions:

1. Immediately suspend any study activity that involves in-person or face-to-face contact between and among human subjects and/or study staff;
2. Take all steps necessary to eliminate immediate hazards to subjects or staff (see related CDC quarantine guidance, and refer to FSU COVID-19 Workplace guidance and the FSU COVID-19 Case Response Protocol);
3. Promptly (as soon as practicably possible, but no later than 10 days of learning about the incident) report this incident to the IRB as a Report of New Information (RNI), using HRP-214 - FORM - Reportable New Information. The form is accessible in RAMP IRB under the IRB, Library and General tabs, and also here. Include in the RNI form specific information about the COVID-19 case, contact or exposure, study suspension and risk mitigation. The IRB may, based upon its review of the submitted RNI, permit in-person or face-to-face study activities that involve human subjects and study staff who do not have COVID-19 or who have not been in close contact with someone who has COVID-19. In such a case, you may resume these activities ONLY AFTER the IRB has notified you accordingly. For additional detailed information and instructions about the above matter, refer to our COVID-19 FAQs here.

For CDC guidance about what counts as “close contact” go here.

Study location

This temporary cessation and the exceptions noted above apply to research in all settings, including research taking place at other non-FSU institutions.

Exempt research

All ongoing or new exempt research are also subject to the temporary cessation unless these research meet the criteria for excepted studies.

Review by an external IRB

The temporary cessation and the exceptions noted above apply to all FSU-conducted research, even if reviewed by an external (non-FSU) IRB. Contact your external IRB for required reporting or communications. For multi-site studies, you may need to work with the core or coordinating center, central study site and/or single IRB.

Other sites reviewed by the FSU IRB acting as the Single IRB

This temporary cessation and the exceptions noted above apply to all sites reviewed by the FSU IRB. The FSU study team should report the cessation and exceptions to the non-FSU sites and to the IRBs (or other compliance office, if no IRB) at the non-FSU sites.

Effect on new and pending IRB submissions

New applications and modifications to current studies may still be submitted for review, will be triaged for review, and are still subject to the temporary cessation unless they meet one or more of the criteria for excepted studies. New applications and modifications are prioritized as follows:

1. All new applications and modifications that involve COVID-19 or Coronavirus Disease or their impact on ongoing research.
2. All new applications and modifications for activities that are permitted as exceptions under the temporary cessation.
3. All other new applications and modifications. These reviews may be delayed, so plan accordingly.

New studies or study procedures that involve in-person activities with human research participants will only be referred to the FSU IRB for review if the studies meet the above exceptions and conditions, OR if researchers document in their protocols that such studies or procedures will not be implemented until the FSU cessation is lifted.

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Other COVID-19 Resources

1. To see the review pathway and decision points for studies that may involve in-person research activities, refer our COVID-19 Human Research Review Algorithm; plan accordingly.
2. For related National Institutes of Health (NIH) research guidance click here or the July 2, 2020 FAQs. For related U.S. Food and Drug Administration (FDA) clinical trials guidance (updated September 21, 2020 with FAQs) click here.
3. For comprehensive COVID-19 and Coronavirus Disease-related information, visit the U.S. Centers For Disease Control and Prevention (CDC) link: https://www.coronavirus.gov/; visit this CDC link for re-opening gating criteria or https://www.cdc.gov/media/releases/2020/s0520-cdc-resources-open.html 
4. FSU is offering a complimentary online course, COVID-19: Back to Campus, to train researchers and others on COVID-19 safety; click here for access instructions. The course is scheduled to close October 1, 2021.
5. Check out our slide deck for the March 31, 2020 COVID Town Hall, and or get the Zoom audio recording. Due to the date, this slide deck does not incorporate the additional exceptions announced June 5, 2020. 

IRB-related COVID-19 Frequently Asked Questions

See our IRB-related Coronavirus (COVID-19) Frequently Asked Questions (FAQs) by clicking here.

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